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Testare l'aggiunta di un farmaco anticancro, Cabozantinib al farmaco immunoterapia Cemiplimab (Regn2810), negli adolescenti e negli adulti con carcinoma surrenocorticale avanzato

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

Uno studio di fase II di Cabozantinib in combinazione con Cemiplimab (Cabo-Cemiplimab) rispetto a Cabozantinib da solo negli adolescenti e negli adulti con carcinoma surrenocorticale avanzato

This phase II trial compares the effect of giving cabozantinib with or without cemiplimab in patients with adrenocortical cancer that has spread to nearby tissue or lymph nodes (locally advanced), and that cannot be removed by surgery (unresectable) or that has come back after a period of improvement (recurrent) or that has spread from where it first started (primary site) to other places in the body (metastatic). Cabozantinib is in a class of medications called tyrosine kinase inhibitors. It works by blocking the action of an abnormal protein that signals cancer cells to multiply, which may help keep cancer cells from growing. Immunotherapy with monoclonal antibodies, such as cemiplimab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Giving cabozantinib with cemiplimab may kill more tumor cells in patients with locally advanced unresectable or recurrent/metastatic adrenocortical cancer.

Panoramica dello studio

Stato

Reclutamento

Condizioni

Intervento / Trattamento

Descrizione dettagliata

PRIMARY OBJECTIVE:

I. To determine whether the combination of cabozantinib plus cemiplimab (REGN2810) (Cabo-Cemiplimab [REGN2810]) improves progression-free survival (PFS) per Response Evaluation Criteria in Solid Tumors (RECIST) version (v.) 1.1 relative to cabozantinib alone in patients with locally advanced unresectable or recurrent/metastatic advanced adrenocortical cancer.

SECONDARY OBJECTIVES:

I. To assess tolerability and adverse events of Cabo-Cemiplimab (REGN2810) in advanced adrenocortical cancer (ACC) patients.

II. To assess objective response rate as per RECIST v 1.1. III. To assess duration of objective response, time to progression (TTP), and overall survival (OS) in ACC patients receiving Cabo-Cemiplimab (REGN2810).

EXPLORATORY OBJECTIVE:

I. To assess PFS from re-registration (per RECIST 1.1) and OS for patients who crossover to receive Cabo-Cemiplimab after progressing on cabozantinib alone.

OUTLINE: Patients are randomized to 1 of 2 arms.

ARM A: Patients receive cabozantinib orally (PO) once daily (QD) on days 1-21 of each cycle. Cycles repeat every 21 days for 2 years in the absence of disease progression or unacceptable toxicity. Patients undergo computed tomography (CT) scan or magnetic resonance imaging (MRI) and blood sample collection throughout the study. Upon disease progression, patients may elect to crossover to receive combination therapy on Arm B.

ARM B: Patients receive cemiplimab intravenously (IV) over 30 minutes on day 1 and cabozantinib PO QD on days 1-21 of each cycle. Cycles repeat every 21 days for 2 years in the absence of disease progression or unacceptable toxicity. Patients undergo CT scan or MRI and blood sample collection throughout the study.

After completion of study treatment, patients are followed up every 12 weeks until disease progression and then every 6 months for 4 years post-registration.

Tipo di studio

Interventistico

Iscrizione (Stimato)

48

Fase

  • Fase 2

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
    • Arizona
      • Phoenix, Arizona, Stati Uniti, 85054
        • Reclutamento
        • Mayo Clinic Hospital in Arizona
        • Contatto:
          • Site Public Contact
          • Numero di telefono: 855-776-0015
        • Investigatore principale:
          • Julie E. Hallanger Johnson
    • California
      • La Jolla, California, Stati Uniti, 92093
        • Reclutamento
        • UC San Diego Moores Cancer Center
        • Contatto:
        • Investigatore principale:
          • Yu-Wei Chen
      • Madera, California, Stati Uniti, 93636
        • Reclutamento
        • Valley Children's Hospital
        • Contatto:
        • Investigatore principale:
          • Ruetima Titapiwatanakun
    • Colorado
      • Aurora, Colorado, Stati Uniti, 80045
        • Reclutamento
        • UCHealth University of Colorado Hospital
        • Investigatore principale:
          • Laura Graham
        • Contatto:
          • Site Public Contact
          • Numero di telefono: 720-848-0650
    • Florida
      • Jacksonville, Florida, Stati Uniti, 32224-9980
        • Reclutamento
        • Mayo Clinic in Florida
        • Contatto:
          • Site Public Contact
          • Numero di telefono: 855-776-0015
        • Investigatore principale:
          • Julie E. Hallanger Johnson
    • Illinois
      • Chicago, Illinois, Stati Uniti, 60611
        • Reclutamento
        • Lurie Children's Hospital-Chicago
        • Contatto:
          • Site Public Contact
          • Numero di telefono: 773-880-4562
        • Investigatore principale:
          • Elizabeth A. Sokol
      • 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:
          • Priyank P. Patel
        • Contatto:
      • DeKalb, Illinois, Stati Uniti, 60115
        • Reclutamento
        • Northwestern Medicine Cancer Center Kishwaukee
        • Investigatore principale:
          • Mary F. Mulcahy
        • Contatto:
      • Effingham, Illinois, Stati Uniti, 62401
        • Reclutamento
        • Carle Physician Group-Effingham
        • Contatto:
        • Investigatore principale:
          • Priyank P. Patel
      • 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
      • 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:
          • Priyank P. Patel
      • Normal, Illinois, Stati Uniti, 61761
        • Reclutamento
        • Carle BroMenn Medical Center
        • Investigatore principale:
          • Priyank P. Patel
        • Contatto:
      • Normal, Illinois, Stati Uniti, 61761
        • Reclutamento
        • Carle Cancer Institute Normal
        • Investigatore principale:
          • Priyank P. Patel
        • Contatto:
      • Oak Brook, Illinois, Stati Uniti, 60523
      • Orland Park, Illinois, Stati Uniti, 60462
      • Shiloh, Illinois, Stati Uniti, 62269
        • Reclutamento
        • Memorial Hospital East
        • Contatto:
        • Investigatore principale:
          • Nikolaos Trikalinos
      • Urbana, Illinois, Stati Uniti, 61801
        • Reclutamento
        • Carle Cancer Center
        • Contatto:
        • Investigatore principale:
          • Priyank P. Patel
      • Warrenville, Illinois, Stati Uniti, 60555
        • Reclutamento
        • Northwestern Medicine Cancer Center Warrenville
        • Investigatore principale:
          • Mary F. Mulcahy
        • Contatto:
    • Iowa
      • 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
      • Carroll, Iowa, Stati Uniti, 51401
        • Reclutamento
        • Saint Anthony Regional Hospital
        • Contatto:
        • Investigatore principale:
          • Seema Harichand-Herdt
      • 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
      • 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
        • UI Healthcare Mission Cancer and Blood - Fort Dodge
        • Investigatore principale:
          • Seema Harichand-Herdt
        • Contatto:
      • 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
    • Massachusetts
      • Boston, Massachusetts, Stati Uniti, 02215
        • Reclutamento
        • Dana-Farber Cancer Institute
        • Investigatore principale:
          • Stephanie A. Berg
        • Contatto:
          • Site Public Contact
          • Numero di telefono: 877-442-3324
    • Michigan
      • Ann Arbor, Michigan, Stati Uniti, 48109
        • Reclutamento
        • University of Michigan Rogel Cancer Center
        • Investigatore principale:
          • Francis P. Worden
        • Contatto:
    • Minnesota
      • Rochester, Minnesota, Stati Uniti, 55905
        • Reclutamento
        • Mayo Clinic in Rochester
        • Contatto:
          • Site Public Contact
          • Numero di telefono: 855-776-0015
        • Investigatore principale:
          • Julie E. Hallanger Johnson
    • Missouri
      • City of Saint Peters, Missouri, Stati Uniti, 63376
        • Reclutamento
        • Siteman Cancer Center at Saint Peters Hospital
        • Contatto:
        • Investigatore principale:
          • Nikolaos Trikalinos
      • Creve Coeur, Missouri, Stati Uniti, 63141
        • Reclutamento
        • Siteman Cancer Center at West County Hospital
        • Contatto:
        • Investigatore principale:
          • Nikolaos Trikalinos
      • Kansas City, Missouri, Stati Uniti, 64108
        • Reclutamento
        • Children's Mercy Hospitals and Clinics
        • Investigatore principale:
          • Keith J. August
        • Contatto:
      • 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, 63110
        • Reclutamento
        • Washington University School of Medicine
        • Contatto:
        • Investigatore principale:
          • Nikolaos Trikalinos
      • St Louis, Missouri, Stati Uniti, 63129
        • Reclutamento
        • Siteman Cancer Center-South County
        • Contatto:
        • Investigatore principale:
          • Nikolaos Trikalinos
      • St Louis, Missouri, Stati Uniti, 63136
        • Reclutamento
        • Siteman Cancer Center at Christian Hospital
        • Contatto:
        • Investigatore principale:
          • Nikolaos Trikalinos
    • Nebraska
      • Bellevue, Nebraska, Stati Uniti, 68123
        • Reclutamento
        • Nebraska Medicine-Bellevue
        • Contatto:
        • Investigatore principale:
          • Apar Kishor Ganti
      • Omaha, Nebraska, Stati Uniti, 68198
        • Reclutamento
        • University of Nebraska Medical Center
        • Contatto:
        • Investigatore principale:
          • Apar Kishor Ganti
      • Omaha, Nebraska, Stati Uniti, 68118
        • Reclutamento
        • Nebraska Medicine-Village Pointe
        • Contatto:
          • Site Public Contact
          • Numero di telefono: 402-559-5600
        • Investigatore principale:
          • Apar Kishor Ganti
    • New Jersey
      • Basking Ridge, New Jersey, Stati Uniti, 07920
        • Reclutamento
        • Memorial Sloan Kettering Basking Ridge
        • Contatto:
          • Site Public Contact
          • Numero di telefono: 212-639-7592
        • Investigatore principale:
          • Nitya P. Raj
      • Middletown, New Jersey, Stati Uniti, 07748
        • Reclutamento
        • Memorial Sloan Kettering Monmouth
        • Contatto:
          • Site Public Contact
          • Numero di telefono: 212-639-7592
        • Investigatore principale:
          • Nitya P. Raj
      • Montvale, New Jersey, Stati Uniti, 07645
        • Reclutamento
        • Memorial Sloan Kettering Bergen
        • Contatto:
          • Site Public Contact
          • Numero di telefono: 212-639-7592
        • Investigatore principale:
          • Nitya P. Raj
    • New York
      • Commack, New York, Stati Uniti, 11725
        • Reclutamento
        • Memorial Sloan Kettering Commack
        • Contatto:
          • Site Public Contact
          • Numero di telefono: 212-639-7592
        • Investigatore principale:
          • Nitya P. Raj
      • Harrison, New York, Stati Uniti, 10604
        • Reclutamento
        • Memorial Sloan Kettering Westchester
        • Contatto:
          • Site Public Contact
          • Numero di telefono: 212-639-7592
        • Investigatore principale:
          • Nitya P. Raj
      • New York, New York, Stati Uniti, 10065
        • Reclutamento
        • Memorial Sloan Kettering Cancer Center
        • Contatto:
          • Site Public Contact
          • Numero di telefono: 212-639-7592
        • Investigatore principale:
          • Nitya P. Raj
      • Uniondale, New York, Stati Uniti, 11553
        • Reclutamento
        • Memorial Sloan Kettering Nassau
        • Contatto:
          • Site Public Contact
          • Numero di telefono: 212-639-7592
        • Investigatore principale:
          • Nitya P. Raj
    • North Carolina
      • Cary, North Carolina, Stati Uniti, 27518
        • Sospeso
        • Duke Cancer Center Cary
      • Durham, North Carolina, Stati Uniti, 27710
        • Reclutamento
        • Duke University Medical Center
        • Contatto:
          • Site Public Contact
          • Numero di telefono: 888-275-3853
        • Investigatore principale:
          • Diane L. Reidy-lagunes
      • Raleigh, North Carolina, Stati Uniti, 27609
        • Reclutamento
        • Duke Cancer Center Raleigh
        • Contatto:
        • Investigatore principale:
          • Diane L. Reidy-lagunes
    • Ohio
      • Columbus, Ohio, Stati Uniti, 43210
        • Reclutamento
        • Ohio State University Comprehensive Cancer Center
        • Contatto:
        • Investigatore principale:
          • Bhavana Konda
    • Oklahoma
      • Oklahoma City, Oklahoma, Stati Uniti, 73104
        • Reclutamento
        • University of Oklahoma Health Sciences Center
        • Contatto:
        • Investigatore principale:
          • Adanma Anji Ayanambakkam Attanathi
    • Pennsylvania
      • Pittsburgh, Pennsylvania, Stati Uniti, 15224
        • Reclutamento
        • Children's Hospital of Pittsburgh of UPMC
        • Contatto:
        • Investigatore principale:
          • Brittani K. Seynnaeve
    • South Carolina
      • Boiling Springs, South Carolina, Stati Uniti, 29316
        • Reclutamento
        • Prisma Health Cancer Institute - Spartanburg
        • Investigatore principale:
          • Aniket Saha
        • Contatto:
      • Columbia, South Carolina, Stati Uniti, 29203
        • Reclutamento
        • Prisma Health Richland Hospital
        • Investigatore principale:
          • Aniket Saha
        • Contatto:
      • Easley, South Carolina, Stati Uniti, 29640
        • Reclutamento
        • Prisma Health Cancer Institute - Easley
        • Investigatore principale:
          • Aniket Saha
        • Contatto:
      • Greenville, South Carolina, Stati Uniti, 29605
        • Reclutamento
        • BI-LO Charities Children's Cancer Center
        • Investigatore principale:
          • Aniket Saha
        • Contatto:
      • Greenville, South Carolina, Stati Uniti, 29605
        • Reclutamento
        • Prisma Health Cancer Institute - Faris
        • Investigatore principale:
          • Aniket Saha
        • Contatto:
      • Greenville, South Carolina, Stati Uniti, 29605
        • Reclutamento
        • Prisma Health Cancer Institute - Butternut
        • Investigatore principale:
          • Aniket Saha
        • Contatto:
      • Greenville, South Carolina, Stati Uniti, 29615
        • Reclutamento
        • Prisma Health Cancer Institute - Eastside
        • Investigatore principale:
          • Aniket Saha
        • Contatto:
      • Greer, South Carolina, Stati Uniti, 29650
        • Reclutamento
        • Prisma Health Cancer Institute - Greer
        • Investigatore principale:
          • Aniket Saha
        • Contatto:
      • Seneca, South Carolina, Stati Uniti, 29672
        • Reclutamento
        • Prisma Health Cancer Institute - Seneca
        • Investigatore principale:
          • Aniket Saha
        • Contatto:
    • Tennessee
      • Memphis, Tennessee, Stati Uniti, 38105
        • Reclutamento
        • Saint Jude Children's Research Hospital
        • Contatto:
        • Investigatore principale:
          • Catherine G. Lam
    • Texas
      • Austin, Texas, Stati Uniti, 78723
        • Reclutamento
        • Dell Children's Medical Center of Central Texas
        • Contatto:
        • Investigatore principale:
          • Shannon M. Cohn
      • Dallas, Texas, Stati Uniti, 75390
        • Reclutamento
        • UT Southwestern/Simmons Cancer Center-Dallas
        • Contatto:
        • Investigatore principale:
          • Suzanne M. Cole
      • Dallas, Texas, Stati Uniti, 75235
        • Reclutamento
        • Parkland Memorial Hospital
        • Contatto:
        • Investigatore principale:
          • Suzanne M. Cole
      • Dallas, Texas, Stati Uniti, 75237
        • Reclutamento
        • UT Southwestern Simmons Cancer Center - RedBird
        • Investigatore principale:
          • Suzanne M. Cole
        • Contatto:
      • Fort Worth, Texas, Stati Uniti, 76104
        • Reclutamento
        • Cook Children's Medical Center
        • Contatto:
        • Investigatore principale:
          • Kelly L. Vallance
      • Fort Worth, Texas, Stati Uniti, 76104
        • Reclutamento
        • UT Southwestern/Simmons Cancer Center-Fort Worth
        • Contatto:
        • Investigatore principale:
          • Suzanne M. Cole
      • Richardson, Texas, Stati Uniti, 75080
        • Reclutamento
        • UT Southwestern Clinical Center at Richardson/Plano
        • Contatto:
        • Investigatore principale:
          • Suzanne M. Cole
      • San Antonio, Texas, Stati Uniti, 78207
        • Reclutamento
        • Children's Hospital of San Antonio
        • Contatto:
        • Investigatore principale:
          • Julie Voeller
      • San Antonio, Texas, Stati Uniti, 78229
        • Reclutamento
        • University of Texas Health Science Center at San Antonio
        • Contatto:
        • Investigatore principale:
          • Aaron J. Sugalski
    • Virginia
      • Richmond, Virginia, Stati Uniti, 23235
        • Reclutamento
        • VCU Massey Cancer Center at Stony Point
        • Contatto:
        • Investigatore principale:
          • Asit K. Paul
      • Richmond, Virginia, Stati Uniti, 23298
        • Reclutamento
        • VCU Massey Comprehensive Cancer Center
        • Investigatore principale:
          • Asit K. Paul
        • Contatto:
    • 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:
          • Keith D. Eaton
      • Seattle, Washington, Stati Uniti, 98109
        • Reclutamento
        • Fred Hutchinson Cancer Center
        • Contatto:
          • Site Public Contact
          • Numero di telefono: 800-804-8824
        • Investigatore principale:
          • Keith D. Eaton

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

12 anni e precedenti (Bambino, Adulto, Adulto più anziano)

Accetta volontari sani

No

Sessi ammissibili allo studio

Tutto

Descrizione

Inclusion Criteria:

  • STEP 1: Patients must have documented histologically or cytologically confirmed adrenocortical carcinoma

  • STEP 1: Locally advanced unresectable or recurrent/metastatic disease

  • STEP 1: Evaluable disease as defined by RECIST v 1.1

  • STEP 1: Up to 3 prior lines of systemic therapy will be allowed in the unresectable/recurrent/metastatic setting. Treatment naïve patients will be allowed.

    • Note: Combination etoposide, doxorubicin, cisplatin, and mitotane (EDP-M) is considered 1 line of therapy. For patients who received mitotane ≤ 6 months prior to registration, mitotane should be discontinued 28 days prior to study registration AND a mitotane level must be documented to be < 2 mg/L prior to registration. Patients who have received mitotane within 6 months of enrollment and who have mitotane levels ≥ 2 mg/L will not be eligible to enroll

  • STEP 1: No prior treatment with cabozantinib or other cMET inhibitors, or anti-CTLA-4, or anti-PD-1/PD-L1 therapy

  • STEP 1: Prior external beam radiation therapy (any area radiated within a month prior to study registration cannot be used as an index lesion and only growth outside of the radiation field can be considered for disease progression), systemic cytotoxic chemotherapy, targeted therapies will be allowed, as long as not administered within 14 days before study registration, and provided any acute treatment-related associated toxicities have recovered to ≤ grade 1 except for alopecia, peripheral neuropathy or other residual toxicities that are not deemed clinically significant

  • STEP 1: Potential trial participants should have recovered from clinically significant adverse events, and wound healing is clinically adequate of their most recent therapy/intervention prior to enrollment

  • STEP 1: Age 12 years and above; and BSA ≥ 1.2m^2

  • STEP 1:

    • Eastern Cooperative Oncology Group (ECOG) performance 0 - 2 (age 18 and above); or
    • Patients 12 to <16 years of age will be assessed by the Lansky scale and should have a score ≥ 50; or
    • Patients ≥ 16 to <18 years of age will be assessed by the Karnofsky scale, and should have a score ≥ 50

  • STEP 1: Absolute neutrophil count (ANC) ≥ 1,000/mcL without colony stimulating factor support within 2 weeks prior

    • Transfusion support is allowed if ≥ 7 days from obtaining required initial laboratory

  • STEP 1: Platelet count ≥ 100,000/mcL

    • Transfusion support is allowed if ≥ 7 days from obtaining required initial laboratory

  • STEP 1: Hemoglobin ≥ 8 g/dL

    • Transfusion support is allowed if ≥ 7 days from obtaining required initial laboratory

  • STEP 1: Total bilirubin ≤ 1.5 x upper limit of normal (ULN)

    • For patients with known Gilbert's disease, bilirubin ≤ 3 mg/dL

  • STEP 1: Aspartate aminotransferase (AST)(serum glutamic oxaloacetic transaminase [SGOT])/ alanine aminotransferase (ALT) (serum glutamic pyruvic transaminase [SGPT]) ≤ 3 x upper limit of normal (ULN)

  • STEP 1: Random Urine Creatinine Ratio (UPCR) ≤ 1 mg/mg

  • STEP 1: Calculated (Calc.) creatinine clearance ≥ 30 mL/min

  • STEP 1: Mitotane level < 2 mg/L*

    • Only applicable for patients who have received mitotane ≤ 6 months prior to registration

  • STEP 1: Must have assessment of adrenal steroid production within 3 months prior to registration as patients will be stratified based on corticosteroid production

    • Patients will be classified as corticosteroid producing if random plasma adrenocorticotropic hormone (ACTH) is < 20 pg/mL plus random serum cortisol is > 20 mcg/dL in the absence of anti-cortisol therapy. Patients already on anti-cortisol therapy will be classified as having corticosteroid producing tumors regardless of their plasma ACTH and serum cortisol levels, as these levels can be affected by anti-cortisol therapy

  • STEP 1: Not pregnant and not nursing, because this study involves an agent that has known genotoxic, mutagenic and teratogenic effects based on animal reproduction studies. Therefore, for women of childbearing potential only, a negative urine or serum pregnancy test, per institution standard, done ≤ 14 days prior to registration is required

  • STEP 1: Patients with known history or current symptoms of cardiac disease, or history of treatment with cardiotoxic agents, should have a clinical risk assessment of cardiac function using the New York Heart Association Functional within 28 days of registration. To be eligible for this trial, patients should be class II or better

  • STEP 1: No known history of congenital long QT syndrome

  • STEP 1: No known history of myocarditis

  • STEP 1: No myocardial infarction (MI) or unstable angina within 6 months of registration

  • STEP 1: No clinically significant gastrointestinal abnormalities that may increase the risk for gastrointestinal bleeding within 6 months of registration including, but not limited to: active peptic ulcer, known endoluminal metastatic lesion(s) with history of bleeding, inflammatory bowel disease, or other gastrointestinal conditions with increased risk of perforation

  • STEP 1: No history of gastrointestinal (GI) perforation within 6 months of registration

  • STEP 1: No known tumor with invasion into the GI tract from the outside causing increased risk of perforation or bleeding within 28 days of registration

  • STEP 1: No current radiologic or clinical evidence of pancreatitis

  • STEP 1: No history of clinically significant non-healing wounds or ulcers within 28 days of registration

  • STEP 1: No uncontrolled hypertension within 14 days of registration (defined as sustained systolic blood pressure (SBP) ≥ 150 mmHg and/or diastolic blood pressure (DBP) ≥ 90 mmHg despite optimal medical management)

  • STEP 1: No known endobronchial lesions involving the main or lobar bronchi and/or lesions infiltrating major pulmonary vessels that increase the risk of pulmonary hemorrhage. (CT with contrast is recommended to evaluate such lesions.). No hemoptysis greater than ½ teaspoon (2.5 mL) or any other signs of pulmonary hemorrhage within the 3 months prior to registration

  • STEP 1: No history of pneumonitis

  • STEP 1: No known tumor invading or encasing any major blood vessels

  • STEP 1: No history of fracture within 28 days of registration

  • STEP 1: No known brain metastases or cranial epidural disease unless adequately treated with radiotherapy and/or surgery (including radiosurgery) and stable for at least 4 weeks after major surgery (e.g., removal or biopsy of brain metastasis) before registration. Eligible patients must be neurologically asymptomatic and without corticosteroid treatment at the time of the start of study treatment

  • STEP 1: Major surgery (e.g., laparoscopic nephrectomy, GI surgery, within 2 weeks before registration. Minor surgeries within 10 days before registration. Patients with clinically relevant ongoing complications from prior surgery are not eligible

  • STEP 1: Verbalizes the ability to swallow oral tablet formulation

  • STEP 1: No history of allergic reaction attributed to compounds of similar chemical or biological composition to cabozantinib

  • STEP 1: Patients with a prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or efficacy assessment of the investigational regimen will be eligible

  • STEP 1: HIV-infected patients on effective anti-retroviral therapy with undetectable viral load within 6 months prior to registration are eligible for this trial

  • STEP 1: For patients with evidence of chronic hepatitis B virus (HBV) infection, the HBV viral load must be undetectable on suppressive therapy, if indicated

  • STEP 1: Patients with a history of hepatitis C virus (HCV) infection must have been treated and cured. For patients with HCV infection who are currently on treatment, they are eligible if they have an undetectable HCV viral load

  • STEP 1: No active autoimmune disease: or history of autoimmune disease that might recur, and which may affect vital organ function or require immune suppressive treatment including systemic corticosteroids. These include but are not limited to patients with a history of:

    • immune related neurologic disease,
    • multiple sclerosis,
    • autoimmune (demyelinating) neuropathy,
    • Guillain-Barre syndrome (GBS), myasthenia gravis,
    • systemic autoimmune disease such as systemic lupus erythematosus (SLE),
    • connective tissue diseases,
    • scleroderma, inflammatory bowel disease (IBD),
    • Crohn's, ulcerative colitis,
    • patients with a history of toxic epidermal necrolysis (TEN),
    • Stevens-Johnson syndrome, or phospholipid syndrome should be excluded because of the risk of recurrence or exacerbation of disease,
    • Patients with vitiligo, endocrine deficiencies including thyroiditis managed with replacement hormones including physiologic corticosteroids are eligible,
    • Patients with rheumatoid arthritis and other arthropathies, Sjögren's syndrome, and psoriasis controlled with topical medication and patients with only positive serology, such as antinuclear antibodies (ANA) or anti-thyroid antibodies, should be evaluated for the presence of target organ involvement and potential need for systemic treatment but should otherwise be eligible

  • STEP 1: No steroid use > 10 mg prednisone equivalents daily. A brief course of corticosteroids for prophylaxis or for treatment of non-autoimmune conditions (e.g., delayed-type hypersensitivity reaction caused by contact allergen) is permitted, as is steroid pre-medication for contrast allergy

  • STEP 1: Chronic concomitant treatment with strong inhibitors of CYP3A4 is not allowed on this study. Patients on strong CYP3A4 inhibitors must discontinue the drug for 14 days prior to registration on the study

  • STEP 1: Chronic concomitant treatment with strong CYP3A4 inducers is not allowed. Patients must discontinue the drug 14 days prior to the start of study treatment

  • STEP 1: Herbal supplements and traditional Chinese medicines are not allowed

  • STEP 1: Active treatment with coumarin agents (e.g., warfarin), direct thrombin inhibitors (e.g., dabigatran), direct Xa inhibitor betrixaban or platelet inhibitors (e.g., clopidogrel) within 5 days of registration. Allowed use of anticoagulants include: prophylactic use of low-dose aspirin for cardio-protection (per local applicable guidelines) and low-dose low molecular weight heparins (LMWH), therapeutic doses of LMWH or anticoagulation with direct factor Xa inhibitors rivaroxaban, edoxaban, apixaban. Also use of anticoagulants is allowed in patients with known brain metastases who are on a stable dose of the anticoagulant for at least 1 week prior to registration without clinically significant hemorrhagic complications from the anticoagulation regimen or the tumor

  • STEP 2 (CROSSOVER): Patients must have demonstrated radiographic progression of disease on cabozantinib monotherapy (Arm A) per RECIST version 1.1 criteria

    • Patients must cross-over to Arm C within 4 weeks (+/- 1 week) after radiographic documented progression and do not need to have a repeat radiographic assessment prior to starting cabozantinib and cemiplimab (REGN2810). The progression CT may serve as eligibility for crossover and as the baseline tumor measurement

  • STEP 2 (CROSSOVER): Patients that were discontinued on cabozantinib, or currently meet criteria for discontinuation of cabozantinib due to toxicity are not eligible to cross-over.

    • Note: Patients who underwent dose reduction of cabozantinib during treatment on Arm A will not re-escalate dose at or after cross-over to Cabo-Cemiplimab (REGN2810) (Arm B)

  • STEP 2 (CROSSOVER): Not pregnant and not nursing, because this study involves an agent that has known genotoxic, mutagenic and teratogenic effects. Therefore, for women of childbearing potential only, a negative serum or urine pregnancy test done ≤ 14 days prior to re-registration is required

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 incrociata
  • Mascheramento: Nessuno (etichetta aperta)

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Sperimentale: Arm A (cabozantinib)

Patients receive cabozantinib PO QD on days 1-21 of each cycle. Cycles repeat every 21 days for 2 years in the absence of disease progression or unacceptable toxicity. Patients undergo CT scan or MRI and blood sample collection throughout the study. Upon disease progression, patients may elect to crossover to receive combination therapy on Arm B.
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
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
Droga: Cabozantinib

Given PO
Sperimentale: Arm B (cabozantinib and cemiplimab)

Patients receive cemiplimab IV over 30 minutes on day 1 and cabozantinib PO QD on days 1-21 of each cycle. Cycles repeat every 21 days for 2 years in the absence of disease progression or unacceptable toxicity. Patients undergo CT scan or MRI and blood sample collection throughout the study.
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
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
Droga: Cabozantinib

Given PO

Biologico: Cemiplimab

Given IV

Altri nomi:
  • REGN2810
  • Cemiplimab RWLC
  • Cemiplimab-rwlc
  • Libtaio
  • REGN-2810

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Progression free survival (PFS)
Lasso di tempo: From registration to either progression or death, assessed up to 4 years post-registration

Per Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v 1.1). Will be analyzed using an intention-to-treat approach. Kaplan-Meier methodology will be used to estimate the distributions for the treatment arms. The hazard ratio, median PFS, and estimated PFS rates at 5, 10 and 15 months will be estimated along with corresponding 95% confidence intervals. A one-sided log rank-test will be used to compare the PFS distributions between the two treatment arms.
From registration to either progression or death, assessed up to 4 years post-registration

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Incidence of adverse events
Lasso di tempo: Up to 4 years post-registration

Adverse events will be recorded using National Cancer Institute Common Terminology Criteria for Adverse Events version 5.0 for each patient. Frequency tables and summary statistics will be used and with the appropriate methods of evaluating categorical and continuous data.
Up to 4 years post-registration
Objective response rate
Lasso di tempo: Up to 4 years post-registration

Will be assessed based on RECIST 1.1 criteria and will be summarized by treatment arm. will be calculated as the number of patients who achieve a response (partial response, complete response) divided by the total number of patients randomized to the corresponding treatment arm. A contingency table comparing treatment arms and responders to non-responders will be generated and a Fisher's exact test with a p-value cutoff of 0.05 will be used for determining whether evidence of a significant association between treatment and response is found.
Up to 4 years post-registration
Duration of response
Lasso di tempo: From first date of the patient achieving either a complete or partial response and progression (via RECIST v 1.1), assessed up to 4 years post-registration

Kaplan-Meier methodology will be used to estimate the distributions of duration of response and a log-rank test between treatment arm will be calculated with corresponding p-value.
From first date of the patient achieving either a complete or partial response and progression (via RECIST v 1.1), assessed up to 4 years post-registration
Time to progression
Lasso di tempo: From registration date and progression date, assessed up to 4 years post-registration

Kaplan-Meier methodology will be used to estimate the distributions of time to progression.
From registration date and progression date, assessed up to 4 years post-registration
Overall survival
Lasso di tempo: From registration to death, assessed up to 4 years post-registration

Kaplan-Meier methodology will be used to estimate the distributions of overall survival.
From registration to death, assessed up to 4 years post-registration

Altre misure di risultato

Misura del risultato
Misura Descrizione
Lasso di tempo
Median PFS for patients who cross over
Lasso di tempo: From re-registration to progression or death, assessed up to 4 years post-registration

Calculated with corresponding 95% confidence interval.
From re-registration to progression or death, assessed up to 4 years post-registration

Collaboratori e investigatori

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

Sponsor

National Cancer Institute (NCI)

Investigatori

  • Investigatore principale: Bhavana Konda, Alliance for Clinical Trials in Oncology

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)

22 febbraio 2026

Completamento primario (Stimato)

2 giugno 2029

Completamento dello studio (Stimato)

2 giugno 2029

Date di iscrizione allo studio

Primo inviato

26 marzo 2025

Primo inviato che soddisfa i criteri di controllo qualità

26 marzo 2025

Primo Inserito (Effettivo)

28 marzo 2025

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 agosto 2026

Maggiori informazioni

Termini relativi a questo studio

Termini MeSH pertinenti aggiuntivi

Altri numeri di identificazione dello studio

  • NCI-2025-02021
  • U10CA180821 (Sovvenzione/contratto NIH degli Stati Uniti)
  • NCI-2025-02021 (Identificatore di registro: CTRP (Clinical Trial Reporting Program))
  • A092204 (Altro identificatore: CTEP)
  • A092204 (Altro identificatore: Alliance for Clinical Trials in Oncology)

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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