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Valutazione dell'aggiunta del farmaco immunoterapico Atezolizumab al trattamento chemioterapico standard per i carcinomi neuroendocrini avanzati o metastatici che hanno origine al di fuori del polmone

5 novembre 2026 aggiornato da: National Cancer Institute (NCI)

Randomized Phase II/III Trial of First Line Platinum/Etoposide With or Without Atezolizumab (NSC#783608) in Patients With Advanced or Metastatic Poorly Differentiated Extrapulmonary Neuroendocrine Carcinomas (NEC)

This phase II/III trial compares the effect of immunotherapy with atezolizumab in combination with standard chemotherapy with a platinum drug (cisplatin or carboplatin) and etoposide versus standard therapy alone for the treatment of poorly differentiated extrapulmonary (originated outside the lung) neuroendocrine cancer that may have spread from where it first started to nearby tissue, lymph nodes, or distant parts of the body (advanced) or that has spread from where it first started (primary site) to other places in the body (metastatic). The other aim of this trial is to compare using atezolizumab just at the beginning of treatment versus continuing it beyond the initial treatment. Immunotherapy with monoclonal antibodies, such as atezolizumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Cisplatin and carboplatin are in a class of medications known as platinum-containing compounds that work by killing, stopping or slowing the growth of cancer cells. Etoposide is in a class of medications known as podophyllotoxin derivatives. It blocks a certain enzyme needed for cell division and DNA repair, and it may kill cancer cells. Giving atezolizumab in combination with a platinum drug (cisplatin or carboplatin) and etoposide may work better in treating patients with poorly differentiated extrapulmonary neuroendocrine cancer compared to standard therapy with a platinum drug (cisplatin or carboplatin) and etoposide alone.

Panoramica dello studio

Stato

Reclutamento

Condizioni

Intervento / Trattamento

Descrizione dettagliata

PRIMARY OBJECTIVES:

I. Compare the combination of induction platinum/etoposide and atezolizumab followed by maintenance atezolizumab (Arm 1) versus induction platinum/etoposide alone (Arm 3).

II. Compare the combination of induction platinum/etoposide and atezolizumab followed by observation (Arm 2) versus induction platinum/etoposide alone (Arm 3).

III. Compare the combination of induction platinum/etoposide and atezolizumab followed by maintenance atezolizumab (Arm 1) versus the combination of induction platinum/etoposide and atezolizumab followed by observation (Arm 2).

SECONDARY OBJECTIVES:

I. To compare overall survival (OS), measured from start of observation/maintenance, across arms.

II. To compare progression free survival (PFS) (measured from randomization and measured from start of observation/maintenance) across arms.

III. To compare objective response rate (ORR = confirmed and unconfirmed partial response [PR] + confirmed and unconfirmed complete response [CR]) across arms among patients with measurable disease at randomization.

IV. To compare clinical benefit rate (CBR = confirmed and unconfirmed PR + confirmed and unconfirmed CR + stable disease [SD]) across arms among patients with measurable disease at randomization.

V. To compare duration of response (DOR) across arms. VI. To evaluate the safety and tolerability of each arm.

ADDITIONAL OBJECTIVE:

I. To bank tumor and blood samples for future biomarker correlative studies.

OUTLINE: Patients are randomized to 1 of 3 arms.

ARM I: During induction phase, patients receive atezolizumab intravenously (IV) over 30-60 minutes on day 1 of each cycle, carboplatin IV over 30 minutes or cisplatin IV over 60 minutes on day 1 of each cycle, and etoposide IV on days 1-3 of each cycle. Treatment repeats every 21 days for 4 cycles in the absence of disease progression or unacceptable toxicity. During maintenance phase, patients receive atezolizumab IV over 30-60 minutes on day 1 of each cycle. Treatment repeats every 21 days for up to 17 cycles in the absence of disease progression or unacceptable toxicity.

ARM II (CLOSED TO ACCRUAL 7/9/26): During induction phase, patients receive atezolizumab IV over 30-60 minutes on day 1 of each cycle, carboplatin IV over 30 minutes or cisplatin IV over 60 minutes on day 1 of each cycle, and etoposide IV on days 1-3 of each cycle. Treatment repeats every 21 days for 4 cycles in the absence of disease progression or unacceptable toxicity. Patients then undergo observation for 1 year.

ARM III: During induction phase, patients receive carboplatin IV over 30 minutes or cisplatin IV over 60 minutes on day 1 of each cycle and etoposide IV on days 1-3 of each cycle. Treatment repeats every 21 days for 4 cycles in the absence of disease progression or unacceptable toxicity. Patients then undergo observation for 1 year.

Patients in all arms also undergo computed tomography (CT) scan and/or magnetic resonance imaging (MRI) throughout the trial and blood sample collection on study.

After completion of study treatment, patients are followed up for 5 years.

Tipo di studio

Interventistico

Iscrizione (Stimato)

189

Fase

  • Fase 2
  • Fase 3

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Luoghi di studio

  • Stati Uniti
    • Alaska
      • Anchorage, Alaska, Stati Uniti, 99508
        • Sospeso
        • Alaska Women's Cancer Care
    • Arizona
      • Phoenix, Arizona, Stati Uniti, 85004
      • Phoenix, Arizona, Stati Uniti, 85054
        • Reclutamento
        • Mayo Clinic Hospital in Arizona
        • Investigatore principale:
          • Jacob Orme
        • Contatto:
          • Site Public Contact
          • Numero di telefono: 855-776-0015
    • California
      • Anaheim, California, Stati Uniti, 92806
        • Reclutamento
        • Kaiser Permanente-Anaheim
        • Contatto:
        • Investigatore principale:
          • Helen H. Moon
      • Auburn, California, Stati Uniti, 95602
      • Auburn, California, Stati Uniti, 95603
        • Reclutamento
        • Sutter Cancer Centers Radiation Oncology Services-Auburn
        • Investigatore principale:
          • Kristie A. Bobolis
        • Contatto:
      • Baldwin Park, California, Stati Uniti, 91706
        • Reclutamento
        • Kaiser Permanente-Baldwin Park
        • Contatto:
        • Investigatore principale:
          • Helen H. Moon
      • Bellflower, California, Stati Uniti, 90706
        • Reclutamento
        • Kaiser Permanente-Bellflower
        • Contatto:
        • Investigatore principale:
          • Helen H. Moon
      • Berkeley, California, Stati Uniti, 94704
        • Reclutamento
        • Alta Bates Summit Medical Center-Herrick Campus
        • Investigatore principale:
          • Kristie A. Bobolis
        • Contatto:
      • Cameron Park, California, Stati Uniti, 95682
        • Reclutamento
        • Sutter Cancer Centers Radiation Oncology Services-Cameron Park
        • Investigatore principale:
          • Kristie A. Bobolis
        • Contatto:
      • Carmichael, California, Stati Uniti, 95608
      • Carmichael, California, Stati Uniti, 95608
      • Elk Grove, California, Stati Uniti, 95758
      • Fontana, California, Stati Uniti, 92335
        • Reclutamento
        • Kaiser Permanente-Fontana
        • Contatto:
        • Investigatore principale:
          • Helen H. Moon
      • Fremont, California, Stati Uniti, 94538
        • Reclutamento
        • Palo Alto Medical Foundation-Fremont
        • Investigatore principale:
          • Kristie A. Bobolis
        • Contatto:
      • Harbor City, California, Stati Uniti, 90710
        • Reclutamento
        • Kaiser Permanente South Bay
        • Contatto:
        • Investigatore principale:
          • Helen H. Moon
      • Irvine, California, Stati Uniti, 92618
        • Reclutamento
        • Kaiser Permanente-Irvine
        • Contatto:
        • Investigatore principale:
          • Helen H. Moon
      • Los Angeles, California, Stati Uniti, 90027
        • Reclutamento
        • Kaiser Permanente Los Angeles Medical Center
        • Contatto:
        • Investigatore principale:
          • Helen H. Moon
      • Los Angeles, California, Stati Uniti, 90034
        • Reclutamento
        • Kaiser Permanente West Los Angeles
        • Contatto:
        • Investigatore principale:
          • Helen H. Moon
      • Modesto, California, Stati Uniti, 95355
      • Mountain View, California, Stati Uniti, 94040
        • Reclutamento
        • Palo Alto Medical Foundation-Camino Division
        • Investigatore principale:
          • Kristie A. Bobolis
        • Contatto:
      • Ontario, California, Stati Uniti, 91761
        • Reclutamento
        • Kaiser Permanente-Ontario
        • Contatto:
        • Investigatore principale:
          • Helen H. Moon
      • Palo Alto, California, Stati Uniti, 94301
        • Reclutamento
        • Palo Alto Medical Foundation Health Care
        • Investigatore principale:
          • Kristie A. Bobolis
        • Contatto:
      • Panorama City, California, Stati Uniti, 91402
        • Reclutamento
        • Kaiser Permanente - Panorama City
        • Contatto:
        • Investigatore principale:
          • Helen H. Moon
      • Riverside, California, Stati Uniti, 92505
        • Reclutamento
        • Kaiser Permanente-Riverside
        • Contatto:
        • Investigatore principale:
          • Helen H. Moon
      • Rocklin, California, Stati Uniti, 95765
      • Roseville, California, Stati Uniti, 95661
        • Reclutamento
        • Sutter Cancer Centers Radiation Oncology Services-Roseville
        • Investigatore principale:
          • Kristie A. Bobolis
        • Contatto:
      • Roseville, California, Stati Uniti, 95661
      • Sacramento, California, Stati Uniti, 95816
      • Sacramento, California, Stati Uniti, 95816
      • San Diego, California, Stati Uniti, 92120
        • Reclutamento
        • Kaiser Permanente-San Diego Zion
        • Contatto:
        • Investigatore principale:
          • Helen H. Moon
      • San Francisco, California, Stati Uniti, 94115
        • Reclutamento
        • California Pacific Medical Center-Pacific Campus
        • Investigatore principale:
          • Kristie A. Bobolis
        • Contatto:
      • San Marcos, California, Stati Uniti, 92078
        • Reclutamento
        • Kaiser Permanente-San Marcos
        • Contatto:
        • Investigatore principale:
          • Helen H. Moon
      • Santa Cruz, California, Stati Uniti, 95065
        • Reclutamento
        • Palo Alto Medical Foundation-Santa Cruz
        • Investigatore principale:
          • Kristie A. Bobolis
        • Contatto:
      • Santa Rosa, California, Stati Uniti, 95403
        • Reclutamento
        • Sutter Pacific Medical Foundation
        • Investigatore principale:
          • Kristie A. Bobolis
        • Contatto:
      • Sunnyvale, California, Stati Uniti, 94086
        • Reclutamento
        • Palo Alto Medical Foundation-Sunnyvale
        • Investigatore principale:
          • Kristie A. Bobolis
        • Contatto:
      • Vallejo, California, Stati Uniti, 94589
        • Reclutamento
        • Sutter Solano Medical Center/Cancer Center
        • Investigatore principale:
          • Kristie A. Bobolis
        • Contatto:
      • Woodland, California, Stati Uniti, 95695
      • Woodland Hills, California, Stati Uniti, 91367
        • Reclutamento
        • Kaiser Permanente-Woodland Hills
        • Contatto:
        • Investigatore principale:
          • Helen H. Moon
    • Colorado
      • Denver, Colorado, Stati Uniti, 80210
      • Littleton, Colorado, Stati Uniti, 80122
      • Parker, Colorado, Stati Uniti, 80138
    • Connecticut
      • Derby, Connecticut, Stati Uniti, 06418
        • Reclutamento
        • Smilow Cancer Hospital-Derby Care Center
        • Contatto:
        • Investigatore principale:
          • Matthew Austin
      • Fairfield, Connecticut, Stati Uniti, 06824
        • Reclutamento
        • Smilow Cancer Hospital Care Center-Fairfield
        • Contatto:
        • Investigatore principale:
          • Matthew Austin
      • Glastonbury, Connecticut, Stati Uniti, 06033
        • Sospeso
        • Smilow Cancer Hospital Care Center at Glastonbury
      • Greenwich, Connecticut, Stati Uniti, 06830
        • Reclutamento
        • Smilow Cancer Hospital Care Center at Greenwich
        • Contatto:
        • Investigatore principale:
          • Matthew Austin
      • Guilford, Connecticut, Stati Uniti, 06437
        • Reclutamento
        • Smilow Cancer Hospital Care Center - Guilford
        • Contatto:
        • Investigatore principale:
          • Matthew Austin
      • Hartford, Connecticut, Stati Uniti, 06105
        • Sospeso
        • Smilow Cancer Hospital Care Center at Saint Francis
      • New Haven, Connecticut, Stati Uniti, 06520
        • Reclutamento
        • Yale University
        • Contatto:
        • Investigatore principale:
          • Matthew Austin
      • North Haven, Connecticut, Stati Uniti, 06473
        • Reclutamento
        • Yale-New Haven Hospital North Haven Medical Center
        • Contatto:
        • Investigatore principale:
          • Matthew Austin
      • Stamford, Connecticut, Stati Uniti, 06902
        • Reclutamento
        • Smilow Cancer Hospital Care Center at Long Ridge
        • Contatto:
        • Investigatore principale:
          • Matthew Austin
      • Torrington, Connecticut, Stati Uniti, 06790
        • Reclutamento
        • Smilow Cancer Hospital-Torrington Care Center
        • Contatto:
        • Investigatore principale:
          • Matthew Austin
      • Trumbull, Connecticut, Stati Uniti, 06611
        • Reclutamento
        • Smilow Cancer Hospital Care Center-Trumbull
        • Contatto:
        • Investigatore principale:
          • Matthew Austin
      • Waterbury, Connecticut, Stati Uniti, 06708
        • Reclutamento
        • Smilow Cancer Hospital-Waterbury Care Center
        • Contatto:
        • Investigatore principale:
          • Matthew Austin
      • Waterford, Connecticut, Stati Uniti, 06385
        • Reclutamento
        • Smilow Cancer Hospital Care Center - Waterford
        • Contatto:
        • Investigatore principale:
          • Matthew Austin
    • Florida
      • Fort Lauderdale, Florida, Stati Uniti, 33308
        • Reclutamento
        • Holy Cross Hospital
        • Investigatore principale:
          • Tareq Al baghdadi
        • Contatto:
      • Jacksonville, Florida, Stati Uniti, 32224-9980
        • Reclutamento
        • Mayo Clinic in Florida
        • Investigatore principale:
          • Jacob Orme
        • Contatto:
          • Site Public Contact
          • Numero di telefono: 855-776-0015
      • Tampa, Florida, Stati Uniti, 33612
        • Reclutamento
        • Moffitt Cancer Center
        • Contatto:
        • Investigatore principale:
          • Mintallah Haider
    • Hawaii
      • Honolulu, Hawaii, Stati Uniti, 96813
        • Reclutamento
        • Hawaii Cancer Care Inc - Waterfront Plaza
        • Contatto:
        • Investigatore principale:
          • Elizabeth S. Nakasone
      • Honolulu, Hawaii, Stati Uniti, 96813
        • Reclutamento
        • Queen's Cancer Cenrer - POB I
        • Contatto:
          • Site Public Contact
          • Numero di telefono: 808-532-0315
        • Investigatore principale:
          • Elizabeth S. Nakasone
      • Honolulu, Hawaii, Stati Uniti, 96813
        • Reclutamento
        • Queen's Medical Center
        • Contatto:
          • Site Public Contact
          • Numero di telefono: 808-545-8548
        • Investigatore principale:
          • Elizabeth S. Nakasone
      • Honolulu, Hawaii, Stati Uniti, 96813
        • Reclutamento
        • Straub Clinic and Hospital
        • Contatto:
          • Site Public Contact
          • Numero di telefono: 808-522-4333
        • Investigatore principale:
          • Elizabeth S. Nakasone
      • Honolulu, Hawaii, Stati Uniti, 96813
        • Reclutamento
        • University of Hawaii Cancer Center
        • Contatto:
          • Site Public Contact
          • Numero di telefono: 808-586-2979
        • Investigatore principale:
          • Elizabeth S. Nakasone
      • Honolulu, Hawaii, Stati Uniti, 96817
        • Reclutamento
        • Queen's Cancer Center - Kuakini
        • Contatto:
          • Site Public Contact
          • Numero di telefono: 808-531-8521
        • Investigatore principale:
          • Elizabeth S. Nakasone
      • ‘Aiea, Hawaii, Stati Uniti, 96701
        • Reclutamento
        • Hawaii Cancer Care - Westridge
        • Contatto:
        • Investigatore principale:
          • Elizabeth S. Nakasone
      • ‘Aiea, Hawaii, Stati Uniti, 96701
        • Sospeso
        • Pali Momi Medical Center
      • ‘Ewa Beach, Hawaii, Stati Uniti, 96706
        • Reclutamento
        • The Queen's Medical Center - West Oahu
        • Contatto:
        • Investigatore principale:
          • Elizabeth S. Nakasone
    • Idaho
      • Coeur d'Alene, Idaho, Stati Uniti, 83814
        • Reclutamento
        • Kootenai Health - Coeur d'Alene
        • Investigatore principale:
          • John M. Schallenkamp
        • Contatto:
      • Nampa, Idaho, Stati Uniti, 83687
        • Reclutamento
        • Saint Alphonsus Cancer Care Center-Nampa
        • Contatto:
        • Investigatore principale:
          • Tareq Al baghdadi
      • Post Falls, Idaho, Stati Uniti, 83854
        • Reclutamento
        • Kootenai Clinic Cancer Services - Post Falls
        • Investigatore principale:
          • John M. Schallenkamp
        • Contatto:
      • Sandpoint, Idaho, Stati Uniti, 83864
        • Reclutamento
        • Kootenai Clinic Cancer Services - Sandpoint
        • Investigatore principale:
          • John M. Schallenkamp
        • Contatto:
    • Illinois
      • Aurora, Illinois, Stati Uniti, 60504
        • Sospeso
        • Rush-Copley Medical Center
      • Centralia, Illinois, Stati Uniti, 62801
        • Reclutamento
        • Centralia Oncology Clinic
        • Investigatore principale:
          • Bryan A. Faller
        • Contatto:
      • Chicago, Illinois, Stati Uniti, 60637
        • Reclutamento
        • University of Chicago Comprehensive Cancer Center
        • Contatto:
        • Investigatore principale:
          • Ardaman Shergill
      • Chicago, Illinois, Stati Uniti, 60611
        • Reclutamento
        • Northwestern University
        • Investigatore principale:
          • Mary F. Mulcahy
        • Contatto:
      • Danville, Illinois, Stati Uniti, 61832
        • Reclutamento
        • Carle at The Riverfront
        • Investigatore principale:
          • Vamsi K. Vasireddy
        • Contatto:
      • DeKalb, Illinois, Stati Uniti, 60115
        • Reclutamento
        • Northwestern Medicine Cancer Center Kishwaukee
        • Investigatore principale:
          • Mary F. Mulcahy
        • Contatto:
      • Decatur, Illinois, Stati Uniti, 62526
        • Reclutamento
        • Cancer Care Specialists of Illinois - Decatur
        • Investigatore principale:
          • Bryan A. Faller
        • Contatto:
      • Decatur, Illinois, Stati Uniti, 62526
        • Reclutamento
        • Decatur Memorial Hospital
        • Investigatore principale:
          • Bryan A. Faller
        • Contatto:
      • Effingham, Illinois, Stati Uniti, 62401
        • Reclutamento
        • Carle Physician Group-Effingham
        • Contatto:
        • Investigatore principale:
          • Vamsi K. Vasireddy
      • Effingham, Illinois, Stati Uniti, 62401
        • Reclutamento
        • Crossroads Cancer Center
        • Investigatore principale:
          • Bryan A. Faller
        • Contatto:
      • Geneva, Illinois, Stati Uniti, 60134
        • Reclutamento
        • Northwestern Medicine Cancer Center Delnor
        • Investigatore principale:
          • Mary F. Mulcahy
        • Contatto:
      • Glenview, Illinois, Stati Uniti, 60026
        • Reclutamento
        • Northwestern Medicine Glenview Outpatient Center
        • Investigatore principale:
          • Mary F. Mulcahy
        • Contatto:
          • Site Public Contact
          • Numero di telefono: 312-695-1102
      • Grayslake, Illinois, Stati Uniti, 60030
        • Reclutamento
        • Northwestern Medicine Grayslake Outpatient Center
        • Investigatore principale:
          • Mary F. Mulcahy
        • Contatto:
          • Site Public Contact
          • Numero di telefono: 312-695-1102
      • Harvey, Illinois, Stati Uniti, 60426
        • Reclutamento
        • Ingalls Memorial Hospital
        • Investigatore principale:
          • James A. Wallace
        • Contatto:
      • Lake Forest, Illinois, Stati Uniti, 60045
        • Reclutamento
        • Northwestern Medicine Lake Forest Hospital
        • Investigatore principale:
          • Mary F. Mulcahy
        • Contatto:
      • Mattoon, Illinois, Stati Uniti, 61938
        • Reclutamento
        • Carle Physician Group-Mattoon/Charleston
        • Contatto:
        • Investigatore principale:
          • Vamsi K. Vasireddy
      • Mount Vernon, Illinois, Stati Uniti, 62864
        • Reclutamento
        • SSM Health Good Samaritan
        • Investigatore principale:
          • Jay W. Carlson
        • Contatto:
      • New Lenox, Illinois, Stati Uniti, 60451
        • Reclutamento
        • UC Comprehensive Cancer Center at Silver Cross
        • Contatto:
        • Investigatore principale:
          • Ardaman Shergill
      • Normal, Illinois, Stati Uniti, 61761
        • Reclutamento
        • Carle BroMenn Medical Center
        • Investigatore principale:
          • Vamsi K. Vasireddy
        • Contatto:
      • Normal, Illinois, Stati Uniti, 61761
        • Reclutamento
        • Carle Cancer Institute Normal
        • Investigatore principale:
          • Vamsi K. Vasireddy
        • Contatto:
      • O'Fallon, Illinois, Stati Uniti, 62269
        • Reclutamento
        • Cancer Care Center of O'Fallon
        • Investigatore principale:
          • Bryan A. Faller
        • Contatto:
      • Orland Park, Illinois, Stati Uniti, 60462
        • Reclutamento
        • University of Chicago Medicine-Orland Park
        • Contatto:
        • Investigatore principale:
          • Ardaman Shergill
      • Orland Park, Illinois, Stati Uniti, 60462
      • Rockford, Illinois, Stati Uniti, 61114
        • Reclutamento
        • UW Health Carbone Cancer Center Rockford
        • Contatto:
        • Investigatore principale:
          • Fahrettin Covut
      • Springfield, Illinois, Stati Uniti, 62702
        • Reclutamento
        • Southern Illinois University School of Medicine
        • Investigatore principale:
          • Bryan A. Faller
        • Contatto:
          • Site Public Contact
          • Numero di telefono: 217-545-7929
      • Springfield, Illinois, Stati Uniti, 62702
        • Reclutamento
        • Springfield Clinic
        • Investigatore principale:
          • Bryan A. Faller
        • Contatto:
          • Site Public Contact
          • Numero di telefono: 800-444-7541
      • Springfield, Illinois, Stati Uniti, 62781
        • Reclutamento
        • Springfield Memorial Hospital
        • Investigatore principale:
          • Bryan A. Faller
        • Contatto:
      • Urbana, Illinois, Stati Uniti, 61801
        • Reclutamento
        • Carle Cancer Center
        • Contatto:
        • Investigatore principale:
          • Vamsi K. Vasireddy
      • Warrenville, Illinois, Stati Uniti, 60555
        • Reclutamento
        • Northwestern Medicine Cancer Center Warrenville
        • Investigatore principale:
          • Mary F. Mulcahy
        • Contatto:
      • Yorkville, Illinois, Stati Uniti, 60560
        • Sospeso
        • Rush-Copley Healthcare Center
    • Indiana
      • Crown Point, Indiana, Stati Uniti, 46307
        • Reclutamento
        • UChicago Medicine Northwest Indiana
        • Investigatore principale:
          • Ardaman Shergill
        • Contatto:
    • Iowa
      • Ames, Iowa, Stati Uniti, 50010
        • Reclutamento
        • Mary Greeley Medical Center
        • Investigatore principale:
          • Joseph J. Merchant
        • Contatto:
          • Site Public Contact
          • Numero di telefono: 515-956-4132
      • Ames, Iowa, Stati Uniti, 50010
        • Reclutamento
        • McFarland Clinic - Ames
        • Investigatore principale:
          • Joseph J. Merchant
        • Contatto:
      • Ankeny, Iowa, Stati Uniti, 50023
        • Reclutamento
        • UI Health Care Mission Cancer and Blood - Ankeny Clinic
        • Contatto:
          • Site Public Contact
          • Numero di telefono: 515-241-3305
        • Investigatore principale:
          • Seema Harichand-Herdt
      • Boone, Iowa, Stati Uniti, 50036
        • Sospeso
        • McFarland Clinic - Boone
      • Carroll, Iowa, Stati Uniti, 51401
        • Reclutamento
        • Saint Anthony Regional Hospital
        • Contatto:
        • Investigatore principale:
          • Seema Harichand-Herdt
      • Clive, Iowa, Stati Uniti, 50325
        • Reclutamento
        • Mercy Cancer Center-West Lakes
        • Contatto:
          • Site Public Contact
          • Numero di telefono: 515-241-3305
        • Investigatore principale:
          • Richard L. Deming
      • Clive, Iowa, Stati Uniti, 50325
        • Reclutamento
        • UI Health Care Mission Cancer and Blood - West Des Moines Clinic
        • Contatto:
          • Site Public Contact
          • Numero di telefono: 515-241-3305
        • Investigatore principale:
          • Seema Harichand-Herdt
      • Creston, Iowa, Stati Uniti, 50801
        • Attivo, non reclutante
        • Greater Regional Medical Center
      • Des Moines, Iowa, Stati Uniti, 50314
        • Reclutamento
        • Broadlawns Medical Center
        • Contatto:
          • Site Public Contact
          • Numero di telefono: 515-282-2200
        • Investigatore principale:
          • Seema Harichand-Herdt
      • Des Moines, Iowa, Stati Uniti, 50314
        • Reclutamento
        • Mercy Medical Center - Des Moines
        • Contatto:
          • Site Public Contact
          • Numero di telefono: 515-241-3305
        • Investigatore principale:
          • Richard L. Deming
      • Des Moines, Iowa, Stati Uniti, 50309
        • Reclutamento
        • Iowa Methodist Medical Center
        • Contatto:
          • Site Public Contact
          • Numero di telefono: 515-241-6727
        • Investigatore principale:
          • Seema Harichand-Herdt
      • Des Moines, Iowa, Stati Uniti, 50309
        • Reclutamento
        • UI Health Care Mission Cancer and Blood - Des Moines Clinic
        • Contatto:
          • Site Public Contact
          • Numero di telefono: 515-241-3305
        • Investigatore principale:
          • Seema Harichand-Herdt
      • Des Moines, Iowa, Stati Uniti, 50314
        • Reclutamento
        • UI Health Care Mission Cancer and Blood - Laurel Clinic
        • Contatto:
          • Site Public Contact
          • Numero di telefono: 515-241-3305
        • Investigatore principale:
          • Seema Harichand-Herdt
      • Fort Dodge, Iowa, Stati Uniti, 50501
        • Reclutamento
        • McFarland Clinic - Trinity Cancer Center
        • Investigatore principale:
          • Joseph J. Merchant
        • Contatto:
          • Site Public Contact
          • Numero di telefono: 515-956-4132
      • Jefferson, Iowa, Stati Uniti, 50129
        • Sospeso
        • McFarland Clinic - Jefferson
      • Marshalltown, Iowa, Stati Uniti, 50158
        • Reclutamento
        • McFarland Clinic - Marshalltown
        • Investigatore principale:
          • Joseph J. Merchant
        • Contatto:
          • Site Public Contact
          • Numero di telefono: 515-956-4132
      • Waukee, Iowa, Stati Uniti, 50263
        • Reclutamento
        • UI Health Care Mission Cancer and Blood - Waukee Clinic
        • Contatto:
          • Site Public Contact
          • Numero di telefono: 515-241-3305
        • Investigatore principale:
          • Seema Harichand-Herdt
      • West Des Moines, Iowa, Stati Uniti, 50266
        • Reclutamento
        • Mercy Medical Center-West Lakes
        • Contatto:
          • Site Public Contact
          • Numero di telefono: 515-241-3305
        • Investigatore principale:
          • Richard L. Deming
    • Louisiana
      • Baton Rouge, Louisiana, Stati Uniti, 70805
        • Reclutamento
        • LSU Health Baton Rouge-North Clinic
        • Contatto:
        • Investigatore principale:
          • Marshall P. Stagg
      • Baton Rouge, Louisiana, Stati Uniti, 70808
        • Reclutamento
        • Our Lady of the Lake Physician Group
        • Contatto:
        • Investigatore principale:
          • Marshall P. Stagg
      • Metairie, Louisiana, Stati Uniti, 70006
        • Reclutamento
        • East Jefferson General Hospital
        • Contatto:
        • Investigatore principale:
          • Tara Castellano
      • Metairie, Louisiana, Stati Uniti, 70006
        • Reclutamento
        • LSU Healthcare Network / Metairie Multi-Specialty Clinic
        • Contatto:
        • Investigatore principale:
          • Tara Castellano
      • New Orleans, Louisiana, Stati Uniti, 70112
        • Reclutamento
        • University Medical Center New Orleans
        • Contatto:
        • Investigatore principale:
          • Tara Castellano
    • Massachusetts
      • Burlington, Massachusetts, Stati Uniti, 01805
      • Peabody, Massachusetts, Stati Uniti, 01960
        • Reclutamento
        • Lahey Clinic Peabody
        • Contatto:
        • Investigatore principale:
          • Andrew Piper-Vallillo
    • Michigan
      • Ann Arbor, Michigan, Stati Uniti, 48109
        • Reclutamento
        • University of Michigan Rogel Cancer Center
        • Investigatore principale:
          • Vaibhav Sahai
        • Contatto:
      • Ann Arbor, Michigan, Stati Uniti, 48106
        • Reclutamento
        • Trinity Health Saint Joseph Mercy Hospital Ann Arbor
        • Contatto:
        • Investigatore principale:
          • Tareq Al baghdadi
      • Battle Creek, Michigan, Stati Uniti, 49017
        • Reclutamento
        • Bronson Battle Creek
        • Contatto:
        • Investigatore principale:
          • Kathleen Y. Butler
      • Brighton, Michigan, Stati Uniti, 48114
        • Reclutamento
        • Trinity Health IHA Medical Group Hematology Oncology - Brighton
        • Contatto:
        • Investigatore principale:
          • Tareq Al baghdadi
      • Brighton, Michigan, Stati Uniti, 48114
        • Reclutamento
        • Trinity Health Medical Center - Brighton
        • Contatto:
        • Investigatore principale:
          • Tareq Al baghdadi
      • Brownstown, Michigan, Stati Uniti, 48183
        • Reclutamento
        • Henry Ford Cancer Institute-Downriver
        • Contatto:
        • Investigatore principale:
          • Haythem Y. Ali
      • Canton, Michigan, Stati Uniti, 48188
        • Reclutamento
        • Trinity Health IHA Medical Group Hematology Oncology - Canton
        • Contatto:
        • Investigatore principale:
          • Tareq Al baghdadi
      • Canton, Michigan, Stati Uniti, 48188
        • Reclutamento
        • Trinity Health Medical Center - Canton
        • Contatto:
        • Investigatore principale:
          • Tareq Al baghdadi
      • Chelsea, Michigan, Stati Uniti, 48118
        • Reclutamento
        • Trinity Health IHA Medical Group Hematology Oncology - Chelsea Hospital
        • Contatto:
        • Investigatore principale:
          • Tareq Al baghdadi
      • Chelsea, Michigan, Stati Uniti, 48118
      • Clinton Township, Michigan, Stati Uniti, 48038
        • Reclutamento
        • Henry Ford Macomb Hospital-Clinton Township
        • Contatto:
        • Investigatore principale:
          • Haythem Y. Ali
      • Dearborn, Michigan, Stati Uniti, 48126
        • Reclutamento
        • Henry Ford Medical Center-Fairlane
        • Contatto:
        • Investigatore principale:
          • Haythem Y. Ali
      • Dearborn, Michigan, Stati Uniti, 48124
        • Reclutamento
        • Corewell Health Dearborn Hospital
        • Contatto:
          • Site Public Contact
          • Numero di telefono: 248-551-7695
        • Investigatore principale:
          • Andrew A. Muskovitz
      • Detroit, Michigan, Stati Uniti, 48202
        • Reclutamento
        • Henry Ford Hospital
        • Contatto:
        • Investigatore principale:
          • Haythem Y. Ali
      • Detroit, Michigan, Stati Uniti, 48201
        • Attivo, non reclutante
        • Wayne State University/Karmanos Cancer Institute
      • Detroit, Michigan, Stati Uniti, 48236
        • Reclutamento
        • Henry Ford Health Saint John Hospital
        • Investigatore principale:
          • Tareq Al baghdadi
        • Contatto:
      • East China Township, Michigan, Stati Uniti, 48054
        • Reclutamento
        • Henry Ford River District Hospital
        • Investigatore principale:
          • Tareq Al baghdadi
        • Contatto:
      • Farmington Hills, Michigan, Stati Uniti, 48334
        • Attivo, non reclutante
        • Weisberg Cancer Treatment Center
      • Farmington Hills, Michigan, Stati Uniti, 48336
        • Reclutamento
        • Corewell Health Farmington Hills Hospital
        • Contatto:
          • Site Public Contact
          • Numero di telefono: 248-551-7695
        • Investigatore principale:
          • Andrew A. Muskovitz
      • Flint, Michigan, Stati Uniti, 48503
        • Reclutamento
        • Genesys Hurley Cancer Institute
        • Contatto:
        • Investigatore principale:
          • Tareq Al baghdadi
      • Flint, Michigan, Stati Uniti, 48503
        • Reclutamento
        • Hurley Medical Center
        • Contatto:
        • Investigatore principale:
          • Tareq Al baghdadi
      • Flint, Michigan, Stati Uniti, 48503
        • Sospeso
        • Genesee Hematology Oncology PC
      • Flint, Michigan, Stati Uniti, 48503
        • Reclutamento
        • Cancer Hematology Centers - Flint
        • Contatto:
        • Investigatore principale:
          • Tareq Al baghdadi
      • Grand Rapids, Michigan, Stati Uniti, 49503
        • Reclutamento
        • Trinity Health Grand Rapids Hospital
        • Contatto:
        • Investigatore principale:
          • Tareq Al baghdadi
      • Grand Rapids, Michigan, Stati Uniti, 49503
        • Reclutamento
        • Corewell Health Grand Rapids Hospitals - Butterworth Hospital
        • Contatto:
        • Investigatore principale:
          • Kathleen Y. Butler
      • Grosse Pointe Woods, Michigan, Stati Uniti, 48236
        • Reclutamento
        • Henry Ford Saint John Hospital - Breast
        • Contatto:
        • Investigatore principale:
          • Tareq Al baghdadi
      • Grosse Pointe Woods, Michigan, Stati Uniti, 48236
        • Reclutamento
        • Henry Ford Saint John Hospital - Academic
        • Investigatore principale:
          • Tareq Al baghdadi
        • Contatto:
      • Grosse Pointe Woods, Michigan, Stati Uniti, 48236
        • Reclutamento
        • Henry Ford Saint John Hospital - Van Elslander
        • Investigatore principale:
          • Tareq Al baghdadi
        • Contatto:
      • Jackson, Michigan, Stati Uniti, 49201
        • Reclutamento
        • Allegiance Health
        • Contatto:
        • Investigatore principale:
          • Haythem Y. Ali
      • Kalamazoo, Michigan, Stati Uniti, 49007
        • Reclutamento
        • Bronson Methodist Hospital
        • Contatto:
        • Investigatore principale:
          • Kathleen Y. Butler
      • Kalamazoo, Michigan, Stati Uniti, 49007
        • Reclutamento
        • West Michigan Cancer Center
        • Contatto:
        • Investigatore principale:
          • Kathleen Y. Butler
      • Lansing, Michigan, Stati Uniti, 48910
        • Attivo, non reclutante
        • Karmanos Cancer Institute at McLaren Greater Lansing
      • Livonia, Michigan, Stati Uniti, 48154
        • Reclutamento
        • Trinity Health Saint Mary Mercy Livonia Hospital
        • Contatto:
        • Investigatore principale:
          • Tareq Al baghdadi
      • Macomb, Michigan, Stati Uniti, 48044
        • Reclutamento
        • Henry Ford Warren Hospital - Breast Macomb
        • Investigatore principale:
          • Tareq Al baghdadi
        • Contatto:
      • Macomb, Michigan, Stati Uniti, 48044
        • Reclutamento
        • Henry Ford Saint John Hospital - Macomb Medical
        • Investigatore principale:
          • Tareq Al baghdadi
        • Contatto:
      • Muskegon, Michigan, Stati Uniti, 49444
        • Reclutamento
        • Trinity Health Muskegon Hospital
        • Contatto:
        • Investigatore principale:
          • Tareq Al baghdadi
      • Niles, Michigan, Stati Uniti, 49120
        • Reclutamento
        • Corewell Health Lakeland Hospitals - Niles Hospital
        • Contatto:
          • Site Public Contact
          • Numero di telefono: 616-391-1230
        • Investigatore principale:
          • Kathleen Y. Butler
      • Norton Shores, Michigan, Stati Uniti, 49444
        • Sospeso
        • Cancer and Hematology Centers of Western Michigan - Norton Shores
      • Novi, Michigan, Stati Uniti, 48377
        • Reclutamento
        • Henry Ford Medical Center-Columbus
        • Contatto:
        • Investigatore principale:
          • Haythem Y. Ali
      • Pontiac, Michigan, Stati Uniti, 48341
        • Reclutamento
        • Trinity Health Saint Joseph Mercy Oakland Hospital
        • Contatto:
        • Investigatore principale:
          • Tareq Al baghdadi
      • Reed City, Michigan, Stati Uniti, 49677
        • Reclutamento
        • Corewell Health Reed City Hospital
        • Contatto:
        • Investigatore principale:
          • Kathleen Y. Butler
      • Royal Oak, Michigan, Stati Uniti, 48073
        • Reclutamento
        • Corewell Health William Beaumont University Hospital
        • Contatto:
          • Site Public Contact
          • Numero di telefono: 248-551-7695
        • Investigatore principale:
          • Andrew A. Muskovitz
      • Saint Joseph, Michigan, Stati Uniti, 49085
        • Reclutamento
        • Corewell Health Lakeland Hospitals - Marie Yeager Cancer Center
        • Contatto:
        • Investigatore principale:
          • Kathleen Y. Butler
      • Saint Joseph, Michigan, Stati Uniti, 49085
        • Reclutamento
        • Corewell Health Lakeland Hospitals - Saint Joseph Hospital
        • Contatto:
        • Investigatore principale:
          • Kathleen Y. Butler
      • Traverse City, Michigan, Stati Uniti, 49684
        • Reclutamento
        • Munson Medical Center
        • Contatto:
        • Investigatore principale:
          • Kathleen Y. Butler
      • Troy, Michigan, Stati Uniti, 48085
        • Reclutamento
        • Corewell Health Beaumont Troy Hospital
        • Contatto:
          • Site Public Contact
          • Numero di telefono: 248-551-7695
        • Investigatore principale:
          • Andrew A. Muskovitz
      • Warren, Michigan, Stati Uniti, 48093
        • Reclutamento
        • Henry Ford Madison Heights Hospital - Breast
        • Investigatore principale:
          • Tareq Al baghdadi
        • Contatto:
      • Warren, Michigan, Stati Uniti, 48093
        • Reclutamento
        • Henry Ford Health Warren Hospital
        • Investigatore principale:
          • Tareq Al baghdadi
        • Contatto:
      • Warren, Michigan, Stati Uniti, 48093
        • Reclutamento
        • Henry Ford Warren Hospital - GLCMS
        • Investigatore principale:
          • Tareq Al baghdadi
        • Contatto:
      • West Bloomfield, Michigan, Stati Uniti, 48322
        • Reclutamento
        • Henry Ford West Bloomfield Hospital
        • Contatto:
        • Investigatore principale:
          • Haythem Y. Ali
      • Wyandotte, Michigan, Stati Uniti, 48192
        • Reclutamento
        • Henry Ford Wyandotte Hospital
        • Investigatore principale:
          • Haythem Y. Ali
        • Contatto:
      • Wyoming, Michigan, Stati Uniti, 49519
        • Reclutamento
        • University of Michigan Health - West
        • Contatto:
        • Investigatore principale:
          • Kathleen Y. Butler
      • Ypsilanti, Michigan, Stati Uniti, 48106
      • Ypsilanti, Michigan, Stati Uniti, 48197
        • Reclutamento
        • Trinity Health IHA Medical Group Hematology Oncology Ann Arbor Campus
        • Contatto:
        • Investigatore principale:
          • Tareq Al baghdadi
    • Minnesota
      • Burnsville, Minnesota, Stati Uniti, 55337
        • Reclutamento
        • Minnesota Oncology - Burnsville
        • Contatto:
        • Investigatore principale:
          • David M. King
      • Duluth, Minnesota, Stati Uniti, 55805
        • Attivo, non reclutante
        • Saint Luke's Hospital of Duluth
      • Edina, Minnesota, Stati Uniti, 55435
        • Reclutamento
        • Fairview Southdale Hospital
        • Contatto:
        • Investigatore principale:
          • David M. King
      • Edina, Minnesota, Stati Uniti, 55435
        • Reclutamento
        • Minnesota Oncology - Edina
        • Contatto:
        • Investigatore principale:
          • David M. King
      • Minneapolis, Minnesota, Stati Uniti, 55407
        • Reclutamento
        • Abbott-Northwestern Hospital
        • Contatto:
        • Investigatore principale:
          • David M. King
      • Minneapolis, Minnesota, Stati Uniti, 55415
        • Reclutamento
        • Hennepin County Medical Center
        • Contatto:
        • Investigatore principale:
          • David M. King
      • Rochester, Minnesota, Stati Uniti, 55905
        • Reclutamento
        • Mayo Clinic in Rochester
        • Investigatore principale:
          • Jacob Orme
        • Contatto:
          • Site Public Contact
          • Numero di telefono: 855-776-0015
      • Saint Louis Park, Minnesota, Stati Uniti, 55416
        • Reclutamento
        • Park Nicollet Clinic - Saint Louis Park
        • Contatto:
        • Investigatore principale:
          • David M. King
      • Saint Paul, Minnesota, Stati Uniti, 55101
        • Reclutamento
        • Regions Hospital
        • Contatto:
        • Investigatore principale:
          • David M. King
      • Saint Paul, Minnesota, Stati Uniti, 55102
        • Reclutamento
        • United Hospital
        • Contatto:
        • Investigatore principale:
          • David M. King
      • Shakopee, Minnesota, Stati Uniti, 55379
        • Reclutamento
        • Saint Francis Regional Medical Center
        • Contatto:
        • Investigatore principale:
          • David M. King
    • Missouri
      • Cape Girardeau, Missouri, Stati Uniti, 63703
        • Reclutamento
        • Saint Francis Medical Center
        • Investigatore principale:
          • Bryan A. Faller
        • Contatto:
          • Site Public Contact
          • Numero di telefono: 573-334-2230
          • Email: sfmc@sfmc.net
      • Joplin, Missouri, Stati Uniti, 64804
        • Reclutamento
        • Mercy Hospital Joplin
        • Investigatore principale:
          • Jay W. Carlson
        • Contatto:
      • Springfield, Missouri, Stati Uniti, 65804
        • Reclutamento
        • Mercy Hospital Springfield
        • Investigatore principale:
          • Jay W. Carlson
        • Contatto:
          • Site Public Contact
          • Numero di telefono: 417-269-4520
      • Springfield, Missouri, Stati Uniti, 65807
        • Reclutamento
        • CoxHealth South Hospital
        • Investigatore principale:
          • Jay W. Carlson
        • Contatto:
          • Site Public Contact
          • Numero di telefono: 417-269-4520
      • St Louis, Missouri, Stati Uniti, 63128
        • Reclutamento
        • Mercy Hospital South
        • Investigatore principale:
          • Jay W. Carlson
        • Contatto:
    • Montana
      • Anaconda, Montana, Stati Uniti, 59711
        • Reclutamento
        • Community Hospital of Anaconda
        • Investigatore principale:
          • John M. Schallenkamp
        • Contatto:
      • Billings, Montana, Stati Uniti, 59101
        • Reclutamento
        • Billings Clinic Cancer Center
        • Investigatore principale:
          • John M. Schallenkamp
        • Contatto:
      • Billings, Montana, Stati Uniti, 59102
        • Reclutamento
        • Saint Vincent Frontier Cancer Center
        • Contatto:
          • Site Public Contact
          • Numero di telefono: 800-648-6274
        • Investigatore principale:
          • Patrick W. Cobb
      • Great Falls, Montana, Stati Uniti, 59405
        • Reclutamento
        • Benefis Sletten Cancer Institute
        • Investigatore principale:
          • John M. Schallenkamp
        • Contatto:
      • Kalispell, Montana, Stati Uniti, 59901
        • Reclutamento
        • Logan Health Medical Center
        • Investigatore principale:
          • John M. Schallenkamp
        • Contatto:
      • Missoula, Montana, Stati Uniti, 59804
        • Reclutamento
        • Community Medical Center
        • Investigatore principale:
          • John M. Schallenkamp
        • Contatto:
    • New Hampshire
      • Lebanon, New Hampshire, Stati Uniti, 03756
        • Reclutamento
        • Dartmouth Hitchcock Medical Center/Dartmouth Cancer Center
        • Contatto:
        • Investigatore principale:
          • Kathryn C. Hourdequin
    • New York
      • Buffalo, New York, Stati Uniti, 14263
        • Attivo, non reclutante
        • Roswell Park Cancer Institute
      • New York, New York, Stati Uniti, 10029
        • Attivo, non reclutante
        • Mount Sinai Hospital
      • Stony Brook, New York, Stati Uniti, 11794
        • Attivo, non reclutante
        • Stony Brook University Medical Center
    • North Carolina
      • Cary, North Carolina, Stati Uniti, 27518
        • Sospeso
        • Duke Cancer Center Cary
      • Charlotte, North Carolina, Stati Uniti, 28203
        • Reclutamento
        • Carolinas Medical Center/Levine Cancer Institute
        • Investigatore principale:
          • Earle F. Burgess
        • Contatto:
          • Site Public Contact
          • Numero di telefono: 800-804-9376
      • Charlotte, North Carolina, Stati Uniti, 28210
        • Reclutamento
        • Atrium Health Pineville/LCI-Pineville
        • Investigatore principale:
          • Earle F. Burgess
        • Contatto:
          • Site Public Contact
          • Numero di telefono: 980-442-2000
      • Charlotte, North Carolina, Stati Uniti, 28211
        • Reclutamento
        • Levine Cancer Institute-SouthPark
        • Investigatore principale:
          • Earle F. Burgess
        • Contatto:
          • Site Public Contact
          • Numero di telefono: 980-442-2000
      • Charlotte, North Carolina, Stati Uniti, 28262
        • Reclutamento
        • Atrium Health University City/LCI-University
        • Investigatore principale:
          • Earle F. Burgess
        • Contatto:
          • Site Public Contact
          • Numero di telefono: 800-804-9376
      • Charlotte, North Carolina, Stati Uniti, 28277
        • Reclutamento
        • Levine Cancer Institute-Ballantyne
        • Investigatore principale:
          • Earle F. Burgess
        • Contatto:
          • Site Public Contact
          • Numero di telefono: 800-804-9376
      • Clinton, North Carolina, Stati Uniti, 28328
        • Reclutamento
        • Southeastern Medical Oncology Center-Clinton
        • Contatto:
        • Investigatore principale:
          • Samer S. Kasbari
      • Concord, North Carolina, Stati Uniti, 28025
        • Reclutamento
        • Atrium Health Cabarrus/LCI-Concord
        • Investigatore principale:
          • Earle F. Burgess
        • Contatto:
          • Site Public Contact
          • Numero di telefono: 800-804-9376
      • Durham, North Carolina, Stati Uniti, 27710
        • Reclutamento
        • Duke University Medical Center
        • Contatto:
          • Site Public Contact
          • Numero di telefono: 888-275-3853
        • Investigatore principale:
          • Tucker Coston
      • Gastonia, North Carolina, Stati Uniti, 28054
        • Reclutamento
        • Levine Cancer Institute-Gaston
        • Investigatore principale:
          • Earle F. Burgess
        • Contatto:
          • Site Public Contact
          • Numero di telefono: 800-804-9376
      • Goldsboro, North Carolina, Stati Uniti, 27534
        • Reclutamento
        • Southeastern Medical Oncology Center-Goldsboro
        • Contatto:
        • Investigatore principale:
          • Samer S. Kasbari
      • Jacksonville, North Carolina, Stati Uniti, 28546
        • Reclutamento
        • Southeastern Medical Oncology Center-Jacksonville
        • Investigatore principale:
          • Samer S. Kasbari
        • Contatto:
      • Pinehurst, North Carolina, Stati Uniti, 28374
        • Reclutamento
        • FirstHealth of the Carolinas-Moore Regional Hospital
        • Contatto:
        • Investigatore principale:
          • Charles S. Kuzma
      • Raleigh, North Carolina, Stati Uniti, 27609
        • Reclutamento
        • Duke Cancer Center Raleigh
        • Contatto:
        • Investigatore principale:
          • Tucker Coston
      • Shelby, North Carolina, Stati Uniti, 28150
        • Reclutamento
        • Atrium Health Cleveland/LCI-Cleveland
        • Investigatore principale:
          • Earle F. Burgess
        • Contatto:
          • Site Public Contact
          • Numero di telefono: 800-804-9376
    • Ohio
      • Columbus, Ohio, Stati Uniti, 43210
        • Reclutamento
        • Ohio State University Comprehensive Cancer Center
        • Contatto:
        • Investigatore principale:
          • Bhavana Konda
      • Toledo, Ohio, Stati Uniti, 43623
        • Sospeso
        • Toledo Clinic Cancer Centers-Toledo
    • Oklahoma
      • Lawton, Oklahoma, Stati Uniti, 73505
        • Reclutamento
        • Cancer Centers of Southwest Oklahoma Research
        • Contatto:
          • Site Public Contact
          • Numero di telefono: 877-231-4440
        • Investigatore principale:
          • Sagila George
      • Oklahoma City, Oklahoma, Stati Uniti, 73104
        • Reclutamento
        • University of Oklahoma Health Sciences Center
        • Contatto:
        • Investigatore principale:
          • Sagila George
      • Oklahoma City, Oklahoma, Stati Uniti, 73120
        • Reclutamento
        • Mercy Hospital Oklahoma City
        • Investigatore principale:
          • Jay W. Carlson
        • Contatto:
          • Site Public Contact
          • Numero di telefono: 405-752-3402
    • Oregon
      • Bend, Oregon, Stati Uniti, 97701
        • Reclutamento
        • Saint Charles Health System
        • Contatto:
        • Investigatore principale:
          • Charles W. Drescher
      • Clackamas, Oregon, Stati Uniti, 97015
        • Sospeso
        • Providence Cancer Institute Clackamas Clinic
      • Newberg, Oregon, Stati Uniti, 97132
        • Reclutamento
        • Providence Newberg Medical Center
        • Contatto:
        • Investigatore principale:
          • Charles W. Drescher
      • Oregon City, Oregon, Stati Uniti, 97045
        • Reclutamento
        • Providence Willamette Falls Medical Center
        • Contatto:
        • Investigatore principale:
          • Charles W. Drescher
      • Portland, Oregon, Stati Uniti, 97213
        • Reclutamento
        • Providence Portland Medical Center
        • Contatto:
        • Investigatore principale:
          • Charles W. Drescher
      • Portland, Oregon, Stati Uniti, 97225
        • Reclutamento
        • Providence Saint Vincent Medical Center
        • Contatto:
        • Investigatore principale:
          • Charles W. Drescher
    • Pennsylvania
      • Chambersburg, Pennsylvania, Stati Uniti, 17201
        • Reclutamento
        • WellSpan Medical Oncology and Hematology
        • Contatto:
          • Site Public Contact
          • Numero di telefono: 717-217-6020
        • Investigatore principale:
          • Marianne Spengler
      • Ephrata, Pennsylvania, Stati Uniti, 17522
        • Reclutamento
        • Ephrata Cancer Center
        • Contatto:
          • Site Public Contact
          • Numero di telefono: 717-721-4840
        • Investigatore principale:
          • Marianne Spengler
      • Gettysburg, Pennsylvania, Stati Uniti, 17325
        • Reclutamento
        • Adams Cancer Center
        • Contatto:
          • Site Public Contact
          • Numero di telefono: 877-441-7957
        • Investigatore principale:
          • Marianne Spengler
      • Hanover, Pennsylvania, Stati Uniti, 17331
        • Reclutamento
        • WellSpan Medical Oncology and Hematology
        • Contatto:
          • Site Public Contact
          • Numero di telefono: 717-632-1559
        • Investigatore principale:
          • Marianne Spengler
      • Lebanon, Pennsylvania, Stati Uniti, 17042
        • Reclutamento
        • Sechler Family Cancer Center
        • Contatto:
        • Investigatore principale:
          • Marianne Spengler
      • York, Pennsylvania, Stati Uniti, 17403
        • Reclutamento
        • WellSpan Health-York Cancer Center
        • Contatto:
          • Site Public Contact
          • Numero di telefono: 877-441-7957
        • Investigatore principale:
          • Marianne Spengler
      • York, Pennsylvania, Stati Uniti, 17403
        • Sospeso
        • Cancer Care Associates of York
    • Rhode Island
      • Westerly, Rhode Island, Stati Uniti, 02891
        • Reclutamento
        • Smilow Cancer Hospital Care Center - Westerly
        • Contatto:
        • Investigatore principale:
          • Matthew Austin
    • South Carolina
      • Charleston, South Carolina, Stati Uniti, 29425
        • Sospeso
        • Medical University of South Carolina
      • Rock Hill, South Carolina, Stati Uniti, 29732
        • Reclutamento
        • Levine Cancer Institute-Rock Hill
        • Investigatore principale:
          • Earle F. Burgess
        • Contatto:
          • Site Public Contact
          • Numero di telefono: 800-804-9376
    • South Dakota
      • Rapid City, South Dakota, Stati Uniti, 57701
        • Reclutamento
        • Rapid City Regional Hospital
        • Investigatore principale:
          • Abdel-Ghani Azzouqa
        • Contatto:
    • Tennessee
      • Nashville, Tennessee, Stati Uniti, 37232
        • Reclutamento
        • Vanderbilt University/Ingram Cancer Center
        • Contatto:
          • Site Public Contact
          • Numero di telefono: 800-811-8480
        • Investigatore principale:
          • Robert A. Ramirez
    • Texas
      • Dallas, Texas, Stati Uniti, 75390
        • Reclutamento
        • UT Southwestern/Simmons Cancer Center-Dallas
        • Contatto:
        • Investigatore principale:
          • Namrata I. Peswani
      • Dallas, Texas, Stati Uniti, 75235
        • Reclutamento
        • Parkland Memorial Hospital
        • Contatto:
        • Investigatore principale:
          • Namrata I. Peswani
      • Dallas, Texas, Stati Uniti, 75237
        • Reclutamento
        • UT Southwestern Simmons Cancer Center - RedBird
        • Investigatore principale:
          • Namrata I. Peswani
        • Contatto:
      • Fort Worth, Texas, Stati Uniti, 76104
        • Reclutamento
        • UT Southwestern/Simmons Cancer Center-Fort Worth
        • Contatto:
        • Investigatore principale:
          • Namrata I. Peswani
      • Houston, Texas, Stati Uniti, 77030
        • Reclutamento
        • Baylor College of Medicine/Dan L Duncan Comprehensive Cancer Center
        • Investigatore principale:
          • Tannaz Armaghany
        • Contatto:
          • Site Public Contact
          • Numero di telefono: 713-798-1354
          • Email: burton@bcm.edu
      • Houston, Texas, Stati Uniti, 77030
        • Reclutamento
        • Ben Taub General Hospital
        • Investigatore principale:
          • Tannaz Armaghany
        • Contatto:
          • Site Public Contact
          • Numero di telefono: 713-873-2000
      • Richardson, Texas, Stati Uniti, 75080
        • Reclutamento
        • UT Southwestern Clinical Center at Richardson/Plano
        • Contatto:
        • Investigatore principale:
          • Namrata I. Peswani
    • Utah
      • Salt Lake City, Utah, Stati Uniti, 84112
        • Reclutamento
        • Huntsman Cancer Institute/University of Utah
        • Contatto:
        • Investigatore principale:
          • Heloisa P. Soares
    • Vermont
      • Saint Johnsbury, Vermont, Stati Uniti, 05819
        • Reclutamento
        • Dartmouth Cancer Center - North
        • Contatto:
        • Investigatore principale:
          • Kathryn C. Hourdequin
    • Washington
      • Seattle, Washington, Stati Uniti, 98195
        • Reclutamento
        • University of Washington Medical Center - Montlake
        • Contatto:
          • Site Public Contact
          • Numero di telefono: 800-804-8824
        • Investigatore principale:
          • David B. Zhen
      • Seattle, Washington, Stati Uniti, 98109
        • Reclutamento
        • Fred Hutchinson Cancer Center
        • Contatto:
          • Site Public Contact
          • Numero di telefono: 800-804-8824
        • Investigatore principale:
          • David B. Zhen
    • West Virginia
      • Bridgeport, West Virginia, Stati Uniti, 26330
        • Reclutamento
        • United Hospital Center
        • Contatto:
        • Investigatore principale:
          • Nour Daboul
      • Morgantown, West Virginia, Stati Uniti, 26506
        • Reclutamento
        • West Virginia University Healthcare
        • Contatto:
        • Investigatore principale:
          • Nour Daboul
    • Wisconsin
      • Eau Claire, Wisconsin, Stati Uniti, 54701
      • La Crosse, Wisconsin, Stati Uniti, 54601
        • Reclutamento
        • Gundersen Lutheran Medical Center
        • Contatto:
        • Investigatore principale:
          • David E. Marinier
      • Marshfield, Wisconsin, Stati Uniti, 54449
      • Milwaukee, Wisconsin, Stati Uniti, 53226
        • Reclutamento
        • Medical College of Wisconsin
        • Contatto:
          • Site Public Contact
          • Numero di telefono: 414-805-3666
        • Investigatore principale:
          • Alexandria T. Phan
      • Minocqua, Wisconsin, Stati Uniti, 54548
      • Rice Lake, Wisconsin, Stati Uniti, 54868
      • Stevens Point, Wisconsin, Stati Uniti, 54482
      • Weston, Wisconsin, Stati Uniti, 54476

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

18 anni e precedenti (Adulto, Adulto più anziano)

Accetta volontari sani

No

Sessi ammissibili allo studio

Tutto

Descrizione

Inclusion Criteria:

  • Participants must have histologically-confirmed (local site pathological confirmation sufficient) extrapulmonary poorly differentiated, neuroendocrine carcinoma (NEC)

  • Participants must have disease that is unresectable or metastatic and not eligible for definitive therapy as deemed per the treating investigator

  • Participants must have radiologically evaluable disease, measurable or non-measurable, per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 criteria. All measurable and nonmeasurable lesions must be assessed by CT scan with IV contrast of the chest/abdomen/and pelvis (or CT chest without contrast and MRI abdomen/pelvis with gadolinium contrast, if contraindication to CT iodinated contrast) within 28 days prior to registration. While may be used for routine clinical evaluation, PET scans and bone scans alone are not acceptable for disease assessment while participating in this study. All known sites of disease must be assessed and documented on the Baseline Tumor Assessment Form

  • Participants must have brain MRI (or CT head with contrast if there is contraindication to MRI brain) if clinically indicated within 28 days prior to registration. Note: Brain imaging is not required in participants without known and/or clinical concern for brain metastases. Participants with asymptomatic central nervous system (CNS) metastases are eligible if one or more of the following apply:

    • Participants who have received treatment for brain metastases must have:

      • No evidence of radiological progression (by MRI brain or CT head with contrast if there is contraindication to MRI brain) within 28 days prior to registration
      • Discontinued all corticosteroids at least 14 days prior to registration

    • Participants with treatment-naive brain lesions must have:

      • No lesion measuring > 2.0 cm in size in any axis
      • MRI brain or CT head with contrast (if there is contraindication to MRI brain) demonstrating no evidence for mass effect, edema, or other impending neurological compromise within 28 days prior to registration
      • No evidence of radiological progression (by MRI brain or CT head with contrast if there is contraindication to MRI brain) within 28 days prior to registration
      • No need for > 2 mg of dexamethasone (or equivalent of > 10 mg prednisone) per day at time of registration

  • Participants must not have symptomatic central nervous system (CNS) metastases

  • Participants must not have known or suspected leptomeningeal disease

  • Participants with prior history of non-metastatic (localized/locally advanced disease) extrapulmonary poorly differentiated NEC may have had prior platinum-based therapy +/- radiation +/- surgery provided that all therapy was completed >= 6 months prior to registration

  • Participants must discontinue denosumab prior to study registration and plan to replace with a bisphosphonate while on the study

  • Participants must not have had prior treatment for advanced or metastatic NEC EXCEPT one cycle of platinum (carboplatin/cisplatin) + etoposide is allowed prior to registration. Other chemotherapy regimens are not allowed. For participants with prostate or urothelial NEC, prior chemotherapy for the non-NEC component (e.g. adenocarcinoma or urothelial) is allowed as long as such therapy was completed >= 24 weeks prior to registration and participants have recovered from all prior toxicities to =< grade 1.

  • Participants must not have had prior treatment with an anti-PD-1, anti-PD-L1, antiPD-L2, CD137 agonists, anti-CTLA-4 agent, or any other immune checkpoint inhibitors for any neuroendocrine neoplasm. Immune checkpoint inhibitors given for other cancer indications are allowed provided last therapy was given at least 12 months prior to study registration

  • Participants must not have received treatment with systemic immunostimulatory agents including, but not limited to, interferon and interleukin2 [IL-2] within 4 weeks or 5 half-lives of the drug (whichever is longer) prior to registration

  • Participants must not have had history of known severe allergy, anaphylactic, or other hypersensitivity reactions to chimeric or humanized antibodies, including to Chinese hamster ovary cell products or to any component of the atezolizumab formulation, cisplatin, carboplatin, or etoposide

  • Participants must not be on active systemic therapy for another cancer with the exception of hormonal therapy including androgen deprivation therapy (e.g., gonadotropin-releasing hormone [GnRH] agonists or antagonists), which can be continued while participants are receiving protocol therapy. Use of enzalutamide or apalutamide is permitted after completion of chemotherapy and must be held during chemotherapy for participants receiving prior to enrollment. Use of darolutamide is permitted during chemotherapy. Glucocorticoid-containing regimens, including abiraterone, are not permitted.

  • Participants must be >= 18 years of age

  • Participants must have a Zubrod performance status of =< 2 within 28 days prior to registration

  • Participants must have a complete medical history and physical exam within 28 days prior to registration

  • Absolute neutrophil count (ANC) >= 1.5 x 10^9 /L (obtained within 14 days prior to registration. For participants who received a cycle of chemotherapy prior to registration, at least 21 days must have elapsed between day 1 of platinum + etoposide and performance of these tests)

  • Hemoglobin >= 9.0 g/dl (obtained within 14 days prior to registration. For participants who received a cycle of chemotherapy prior to registration, at least 21 days must have elapsed between day 1 of platinum + etoposide and performance of these tests)

  • Platelet count >= 100 x 10^9/L (obtained within 14 days prior to registration. For participants who received a cycle of chemotherapy prior to registration, at least 21 days must have elapsed between day 1 of platinum + etoposide and performance of these tests)

  • Serum alanine aminotransferase (ALT) and aspartate aminotransferase (AST) =< 2.5 x institutional upper limit of normal (ULN) (obtained within 14 days prior to registration. For participants who received a cycle of chemotherapy prior to registration, at least 21 days must have elapsed between day 1 of platinum + etoposide and performance of these tests)

  • Serum total bilirubin =< 1.5 x ULN (obtained within 14 days prior to registration. For participants who received a cycle of chemotherapy prior to registration, at least 21 days must have elapsed between day 1 of platinum + etoposide and performance of these tests)

  • Adequate renal function as defined by any 1 of the following: 1) Measured creatinine clearance (CL) > 50 mL/min OR 2) Calculated creatinine CL > 50 mL/min by the Cockcroft-Gault formula OR by 24-hour urine collection for determination of creatinine clearance (obtained within 14 days prior to registration. For participants who received a cycle of chemotherapy prior to registration, at least 21 days must have elapsed between day 1 of platinum + etoposide and performance of these tests)

  • Participants must not have uncontrolled or symptomatic hypercalcemia (> 1.5 mmol/L ionized calcium or calcium > 12 mg/dL or corrected serum calcium > ULN) within 14 days prior to registration. Participants who have asymptomatic hypercalcemia are eligible provided that medical therapy to treat the hypercalcemia is planned

  • Participants must not have a diagnosis of immunodeficiency nor be receiving systemic steroid therapy (equivalent of > 20 mg of hydrocortisone per day) or any other form of immunosuppressive therapy within 14 days prior to registration

  • Participants must not have active or history of autoimmune disease or immune deficiency, including, but not limited to myasthenia gravis, myositis, autoimmune hepatitis, systemic lupus erythematosus, rheumatoid arthritis, inflammatory bowel disease, antiphospholipid antibody syndrome, Wegener granulomatosis, Sjogren syndrome, Guillain-Barre syndrome, or multiple sclerosis with the following exceptions:

    • Patients with a history of autoimmune-related hypothyroidism who are on thyroid-replacement hormone are eligible for the study

    • Patients with controlled type 1 diabetes mellitus who are on an insulin regimen are eligible for the study

    • Patients with eczema, psoriasis, lichen simplex chronicus, or vitiligo with dermatologic manifestations only (e.g., patients with psoriatic arthritis are excluded) are eligible for the study provided all of following conditions are met:

      • Rash must cover < 10% of body surface area
      • Disease is well controlled at baseline and requires only low-potency topical corticosteroids
      • No occurrence of acute exacerbations of the underlying condition requiring psoralen plus ultraviolet A radiation, methotrexate, retinoids, biologic agents, oral calcineurin inhibitors, or high-potency or oral corticosteroids within the previous 12 months

  • Participants must not have history of idiopathic pulmonary fibrosis, organizing pneumonia (e.g., bronchiolitis obliterans), drug-induced pneumonitis, idiopathic pneumonitis, or evidence of active pneumonitis on screening chest CT scan. NOTE: History of radiation pneumonitis in the radiation field (fibrosis) is permitted

  • Participants must not have significant cardiovascular disease, such as New York Heart Association class II or greater cardiac disease, myocardial infarction within 3 months prior to registration, unstable arrythmias, or unstable angina

  • Participants must not have had a major surgical procedure other than for diagnosis within 28 days prior to registration. Participant must not plan to receive a major surgical procedure during the course of protocol treatment. NOTE: Patient port placement is not considered a major surgery

  • Participants must not have severe infections (i.e., Common Terminology Criteria for Adverse Events [CTCAE] grade >= 2) at time of registration, including but not limited to hospitalization for complications for infection, bacteremia, or severe pneumonia

  • Participants must not have known active tuberculosis

  • Participants with evidence of chronic hepatitis B virus (HBV) infection must have undetectable HBV viral load, with testing performed as clinically indicated

  • Participants with a history of hepatitis C virus (HCV) infection must have been treated and cured. Participants with active HCV infection who are currently on treatment must have an undetectable HCV viral load, with testing performed as clinically indicated

  • Participants with known human immunodeficiency virus (HIV)-infection must be on effective anti-retroviral therapy at time of registration and have undetectable HIV viral load within 6 months of registration

  • Participants must not have prior allogeneic bone marrow transplantation or solid organ transplant

  • Participants must not have received administration of a live, attenuated vaccine (e.g., FluMist [registered trademark]) within 28 days prior to initiation of study treatment, during treatment with atezolizumab, and not plan to receive for 5 months after the last dose of atezolizumab

  • Participants must not be pregnant due to the possibility of harm to the fetus. Individuals who are of reproductive potential must have agreed to use an effective contraceptive method (with details provided as a part of the consent process) during the treatment period and for 5 months after the final dose of atezolizumab. A person who has had menses at any time in the preceding 12 consecutive months or who has semen likely to contain sperm is considered to be of "reproductive potential." In addition to routine contraceptive methods, "effective contraception" also includes refraining from sexual activity that might result in pregnancy and surgery intended to prevent pregnancy (or with a side effect of pregnancy prevention) including hysterectomy, bilateral oophorectomy, bilateral tubal ligation/occlusion, and vasectomy with testing showing no sperm in the semen

  • Participants must be offered the opportunity to participate in specimen banking. With participant consent, specimens must be collected and submitted via the Southwest Oncology Group (SWOG) Specimen Tracking System

  • Participants must be informed of the investigational nature of this study and must sign and give informed consent in accordance with institutional and federal guidelines

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Trattamento
  • Assegnazione: Randomizzato
  • Modello interventistico: Assegnazione parallela
  • Mascheramento: Nessuno (etichetta aperta)

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Sperimentale: Arm I (atezolizumab, platinum drug, etoposide)

During induction phase, patients receive atezolizumab IV over 30-60 minutes on day 1 of each cycle, carboplatin IV over 30 minutes or cisplatin IV over 60 minutes on day 1 of each cycle, and etoposide IV on days 1-3 of each cycle. Treatment repeats every 21 days for 4 cycles in the absence of disease progression or unacceptable toxicity. During maintenance phase, patients receive atezolizumab IV over 30-60 minutes on day 1 of each cycle. Treatment repeats every 21 days for up to 17 cycles in the absence of disease progression or unacceptable toxicity. Patients also undergo CT scan and/or MRI throughout the trial and blood sample collection on study.
Droga: Carboplatin

Given IV

Altri nomi:
  • Blastocarb
  • Carboplat
  • Carboplatino Hexal
  • Carboplatino
  • Carbosina
  • Carbosol
  • Carbotec
  • CBDCA
  • Displata
  • Ercar
  • JM-8
  • Nealorin
  • Novoplatino
  • Paraplatino
  • Paraplatino AQ
  • Platino
  • Ribocarbonio
  • JM8
Droga: Cisplatin

Given IV

Altri nomi:
  • CDDP
  • Cis-diamminedicloridoroplatino
  • Cismaplat
  • Cisplatino
  • Neoplatino
  • Platinolo
  • Abiplatino
  • Blastolem
  • Briplatino
  • Cis-diammina-dicloroplatino
  • Cis-diamminodicloro Platino (II)
  • Cis-diamminedicloroplatino
  • Cis-dicloroammina Platino (II)
  • Diammina dicloruro di cis-platino
  • Cis-platino
  • Cis-platino II
  • Diammina dicloruro di cis-platino II
  • Cisplatile
  • Citoplatino
  • Citosina
  • DDP
  • Lederplatino
  • Metaplatino
  • Cloruro di Peyrone
  • Sale di Peyrone
  • Placis
  • Plastistil
  • Platamina
  • Platiblastina
  • Platiblastin-S
  • Platinex
  • Platinol-AQ
  • Platinol-AQ VHA Plus
  • Platinoxan
  • Platino
  • Diamminodicloruro di platino
  • Platirano
  • Platistin
  • Platosina
Procedura: Biospecimen Collection

Undergo blood sample collection

Altri nomi:
  • Raccolta di campioni biologici
  • Biocampione raccolto
  • Raccolta di campioni
  • Raccolta campione
Procedura: Magnetic Resonance Imaging

Undergo MRI

Altri nomi:
  • Risonanza magnetica
  • Scansione di immagini a risonanza magnetica
  • Imaging medico, risonanza magnetica/risonanza magnetica nucleare
  • SIG
  • Imaging RM
  • Scansione MRI
  • Imaging NMR
  • RMN
  • Risonanza Magnetica Nucleare
  • Imaging a risonanza magnetica (MRI)
  • sMRI
  • Imaging a risonanza magnetica (procedura)
  • RM strutturale
Droga: Etoposide

Given IV

Altri nomi:
  • Demetil Epipodofillotossina Etilidina Glucoside
  • EPEG
  • Ultimo
  • Toposar
  • Vepesid
  • PV 16
  • PV 16-213
  • VP-16
  • VP-16-213
  • VP16
  • VP16213
  • VP-16213
Procedura: Computed Tomography

Undergo CT scan

Altri nomi:
  • CT
  • GATTO
  • TAC
  • Tomografia assiale computerizzata
  • Tomografia computerizzata
  • tomografia
  • Tomografia assiale computerizzata (procedura)
  • Scansione tomografia computerizzata (CT).
  • Scansione CAT diagnostica
  • Tipo di servizio di scansione CAT diagnostica
Biologico: Atezolizumab

Given IV

Altri nomi:
  • Tecentriq
  • MPDL3280A
  • RO5541267
  • RG7446
  • MPDL328OA
  • MPDL-3280A
  • RG-7446
  • RO-5541267
Sperimentale: Arm II (atezolizumab, platinum drug, etoposide, observation)

During induction phase, patients receive atezolizumab IV over 30-60 minutes on day 1 of each cycle, carboplatin IV over 30 minutes or cisplatin IV over 60 minutes on day 1 of each cycle, and etoposide IV on days 1-3 of each cycle. Treatment repeats every 21 days for 4 cycles in the absence of disease progression or unacceptable toxicity. Patients then undergo observation for 1 year. Patients also undergo CT scan and/or MRI throughout the trial and blood sample collection on study. (CLOSED TO ACCRUAL 7/9/26)
Droga: Carboplatin

Given IV

Altri nomi:
  • Blastocarb
  • Carboplat
  • Carboplatino Hexal
  • Carboplatino
  • Carbosina
  • Carbosol
  • Carbotec
  • CBDCA
  • Displata
  • Ercar
  • JM-8
  • Nealorin
  • Novoplatino
  • Paraplatino
  • Paraplatino AQ
  • Platino
  • Ribocarbonio
  • JM8
Droga: Cisplatin

Given IV

Altri nomi:
  • CDDP
  • Cis-diamminedicloridoroplatino
  • Cismaplat
  • Cisplatino
  • Neoplatino
  • Platinolo
  • Abiplatino
  • Blastolem
  • Briplatino
  • Cis-diammina-dicloroplatino
  • Cis-diamminodicloro Platino (II)
  • Cis-diamminedicloroplatino
  • Cis-dicloroammina Platino (II)
  • Diammina dicloruro di cis-platino
  • Cis-platino
  • Cis-platino II
  • Diammina dicloruro di cis-platino II
  • Cisplatile
  • Citoplatino
  • Citosina
  • DDP
  • Lederplatino
  • Metaplatino
  • Cloruro di Peyrone
  • Sale di Peyrone
  • Placis
  • Plastistil
  • Platamina
  • Platiblastina
  • Platiblastin-S
  • Platinex
  • Platinol-AQ
  • Platinol-AQ VHA Plus
  • Platinoxan
  • Platino
  • Diamminodicloruro di platino
  • Platirano
  • Platistin
  • Platosina
Procedura: Biospecimen Collection

Undergo blood sample collection

Altri nomi:
  • Raccolta di campioni biologici
  • Biocampione raccolto
  • Raccolta di campioni
  • Raccolta campione
Procedura: Magnetic Resonance Imaging

Undergo MRI

Altri nomi:
  • Risonanza magnetica
  • Scansione di immagini a risonanza magnetica
  • Imaging medico, risonanza magnetica/risonanza magnetica nucleare
  • SIG
  • Imaging RM
  • Scansione MRI
  • Imaging NMR
  • RMN
  • Risonanza Magnetica Nucleare
  • Imaging a risonanza magnetica (MRI)
  • sMRI
  • Imaging a risonanza magnetica (procedura)
  • RM strutturale
Droga: Etoposide

Given IV

Altri nomi:
  • Demetil Epipodofillotossina Etilidina Glucoside
  • EPEG
  • Ultimo
  • Toposar
  • Vepesid
  • PV 16
  • PV 16-213
  • VP-16
  • VP-16-213
  • VP16
  • VP16213
  • VP-16213
Procedura: Computed Tomography

Undergo CT scan

Altri nomi:
  • CT
  • GATTO
  • TAC
  • Tomografia assiale computerizzata
  • Tomografia computerizzata
  • tomografia
  • Tomografia assiale computerizzata (procedura)
  • Scansione tomografia computerizzata (CT).
  • Scansione CAT diagnostica
  • Tipo di servizio di scansione CAT diagnostica
Altro: Patient Observation

Undergo observation

Altri nomi:
  • Osservazione
  • Sorveglianza attiva
  • terapia differita
  • gestione attesa
  • Vigile attesa
Biologico: Atezolizumab

Given IV

Altri nomi:
  • Tecentriq
  • MPDL3280A
  • RO5541267
  • RG7446
  • MPDL328OA
  • MPDL-3280A
  • RG-7446
  • RO-5541267
Comparatore attivo: Arm III (platinum drug, etoposide, observation)

During induction phase, patients receive carboplatin IV over 30 minutes or cisplatin IV over 60 minutes on day 1 of each cycle and etoposide IV on days 1-3 of each cycle. Treatment repeats every 21 days for 4 cycles in the absence of disease progression or unacceptable toxicity. Patients then undergo observation for 1 year. Patients also undergo CT scan and/or MRI throughout the trial and blood sample collection on study.
Droga: Carboplatin

Given IV

Altri nomi:
  • Blastocarb
  • Carboplat
  • Carboplatino Hexal
  • Carboplatino
  • Carbosina
  • Carbosol
  • Carbotec
  • CBDCA
  • Displata
  • Ercar
  • JM-8
  • Nealorin
  • Novoplatino
  • Paraplatino
  • Paraplatino AQ
  • Platino
  • Ribocarbonio
  • JM8
Droga: Cisplatin

Given IV

Altri nomi:
  • CDDP
  • Cis-diamminedicloridoroplatino
  • Cismaplat
  • Cisplatino
  • Neoplatino
  • Platinolo
  • Abiplatino
  • Blastolem
  • Briplatino
  • Cis-diammina-dicloroplatino
  • Cis-diamminodicloro Platino (II)
  • Cis-diamminedicloroplatino
  • Cis-dicloroammina Platino (II)
  • Diammina dicloruro di cis-platino
  • Cis-platino
  • Cis-platino II
  • Diammina dicloruro di cis-platino II
  • Cisplatile
  • Citoplatino
  • Citosina
  • DDP
  • Lederplatino
  • Metaplatino
  • Cloruro di Peyrone
  • Sale di Peyrone
  • Placis
  • Plastistil
  • Platamina
  • Platiblastina
  • Platiblastin-S
  • Platinex
  • Platinol-AQ
  • Platinol-AQ VHA Plus
  • Platinoxan
  • Platino
  • Diamminodicloruro di platino
  • Platirano
  • Platistin
  • Platosina
Procedura: Biospecimen Collection

Undergo blood sample collection

Altri nomi:
  • Raccolta di campioni biologici
  • Biocampione raccolto
  • Raccolta di campioni
  • Raccolta campione
Procedura: Magnetic Resonance Imaging

Undergo MRI

Altri nomi:
  • Risonanza magnetica
  • Scansione di immagini a risonanza magnetica
  • Imaging medico, risonanza magnetica/risonanza magnetica nucleare
  • SIG
  • Imaging RM
  • Scansione MRI
  • Imaging NMR
  • RMN
  • Risonanza Magnetica Nucleare
  • Imaging a risonanza magnetica (MRI)
  • sMRI
  • Imaging a risonanza magnetica (procedura)
  • RM strutturale
Droga: Etoposide

Given IV

Altri nomi:
  • Demetil Epipodofillotossina Etilidina Glucoside
  • EPEG
  • Ultimo
  • Toposar
  • Vepesid
  • PV 16
  • PV 16-213
  • VP-16
  • VP-16-213
  • VP16
  • VP16213
  • VP-16213
Procedura: Computed Tomography

Undergo CT scan

Altri nomi:
  • CT
  • GATTO
  • TAC
  • Tomografia assiale computerizzata
  • Tomografia computerizzata
  • tomografia
  • Tomografia assiale computerizzata (procedura)
  • Scansione tomografia computerizzata (CT).
  • Scansione CAT diagnostica
  • Tipo di servizio di scansione CAT diagnostica
Altro: Patient Observation

Undergo observation

Altri nomi:
  • Osservazione
  • Sorveglianza attiva
  • terapia differita
  • gestione attesa
  • Vigile attesa

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Overall survival
Lasso di tempo: From date of registration or from date of start of observation/maintenance therapy to date of death due to any cause, assessed up to 5 years

Log-rank tests stratified by the randomization stratification factors will be used for null hypothesis (efficacy) tests. Cox regression models stratified by the randomization stratification factors will be used for alternative hypothesis (futility) tests.
From date of registration or from date of start of observation/maintenance therapy to date of death due to any cause, assessed up to 5 years

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Progression-free survival
Lasso di tempo: From date of registration or start of observation/maintenance therapy to date of first documentation of progression or symptomatic deterioration, or death due to any cause, assessed up to 5 years

Will be estimated using the Kaplan-Meier method and compared using log-rank tests.
From date of registration or start of observation/maintenance therapy to date of first documentation of progression or symptomatic deterioration, or death due to any cause, assessed up to 5 years
Duration of response
Lasso di tempo: Time from date of initial response to date of progression or death, assessed up to 5 years

Will be estimated non-parametrically using cumulative incidence curves.
Time from date of initial response to date of progression or death, assessed up to 5 years
Objective response rate (confirmed complete response [CR] or partial response [PR])
Lasso di tempo: Up to 5 years from study enrollment

Will be tabulated and compared between arms using Fisher's exact test.
Up to 5 years from study enrollment
Clinical benefit rate (confirmed CR or PR of any amount of time or stable disease for 6 months or longer)
Lasso di tempo: Up to 5 years from study enrollment

Will be tabulated and compared between arms using Fisher's exact test.
Up to 5 years from study enrollment

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

National Cancer Institute (NCI)

Investigatori

  • Investigatore principale: David B Zhen, SWOG Cancer Research Network

Pubblicazioni e link utili

La persona responsabile dell'inserimento delle informazioni sullo studio fornisce volontariamente queste pubblicazioni. Questi possono riguardare qualsiasi cosa relativa allo studio.

Pubblicazioni generali

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio (Effettivo)

28 giugno 2022

Completamento primario (Stimato)

1 ottobre 2028

Completamento dello studio (Stimato)

1 ottobre 2028

Date di iscrizione allo studio

Primo inviato

25 settembre 2021

Primo inviato che soddisfa i criteri di controllo qualità

25 settembre 2021

Primo Inserito (Effettivo)

28 settembre 2021

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

6 novembre 2026

Ultimo aggiornamento inviato che soddisfa i criteri QC

5 novembre 2026

Ultimo verificato

1 ottobre 2026

Maggiori informazioni

Termini relativi a questo studio

Termini MeSH pertinenti aggiuntivi

Altri numeri di identificazione dello studio

  • NCI-2021-09851
  • U10CA180888 (Sovvenzione/contratto NIH degli Stati Uniti)
  • NCI-2021-09851 (Identificatore di registro: CTRP (Clinical Trial Reporting Program))
  • S2012 (Altro identificatore: CTEP)
  • S2012 (Altro identificatore: SWOG)

Piano per i dati dei singoli partecipanti (IPD)

Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?

SÌ

Descrizione del piano IPD

NCI is committed to sharing data in accordance with NIH policy. For more details on how clinical trial data is shared, access the link to the NIH data sharing policy page.

Informazioni su farmaci e dispositivi, documenti di studio

Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti

Sì

Studia un dispositivo regolamentato dalla FDA degli Stati Uniti

No

prodotto fabbricato ed esportato dagli Stati Uniti

No

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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