- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07198074
- Original Trial
Testing the Addition of an Antiangiogenic Drug (Bevacizumab) to Chemotherapy (Carboplatin and Paclitaxel) Combined With Immunotherapy (Pembrolizumab) for pMMR, TP53 Mutated Endometrial Cancer
A Randomized Phase III Trial of Carboplatin, Paclitaxel, Pembrolizumab Versus Carboplatin, Paclitaxel, Bevacizumab Versus Carboplatin, Paclitaxel, Pembrolizumab, Bevacizumab in the Treatment of pMMR, TP53 Mutated Advanced or Recurrent Endometrial Cancer
Study Overview
Status
Detailed Description
PRIMARY OBJECTIVE:
I. To demonstrate that bevacizumab, an anti-VEGF antibody therapy, (or an anti-VEGF antibody biosimilar) in combination with carboplatin, paclitaxel, and pembrolizumab is superior to carboplatin, paclitaxel, and pembrolizumab (the control arm) or carboplatin, paclitaxel, and bevacizumab in prolonging progression-free survival (PFS) in patients with pMMR, TP53 mutated advanced stage (III or IV) or recurrent endometrial cancer.
SECONDARY OBJECTIVES:
I. To demonstrate that bevacizumab in combination with carboplatin, paclitaxel, and pembrolizumab is superior to carboplatin, paclitaxel, and pembrolizumab or carboplatin, paclitaxel, and bevacizumab in prolonging overall survival (OS) in patients with pMMR, TP53 mutated advanced stage (III or IV) or recurrent endometrial cancer.
II. To examine the impact of the addition of bevacizumab in combination with carboplatin and paclitaxel or with carboplatin, paclitaxel, and pembrolizumab on PFS and OS based on type of p53 immunohistochemistry (IHC) aberrancy (over expression/cytoplasmic expression versus null [complete absence of staining]) and mutation type.
III. To evaluate toxicity on treatment with bevacizumab when combined with carboplatin, paclitaxel, and/or pembrolizumab as assessed by Common Terminology Criteria for Adverse Events (CTCAE) version (v.)5.0.
IV. To explore the anti-tumor activity in each treatment arm as assessed by objective response rate in the subset of patients with measurable disease by Response Evaluation Criteria in Solid Tumors (RECIST) 1.1.
OUTLINE: Patients are randomized to 1 of 3 arms.
ARM 1 (REFERENCE ARM): Patients receive paclitaxel intravenously (IV) over 3 hours, carboplatin IV and pembrolizumab IV over 30 minutes on day 1 of each cycle. Cycles repeat every 3 weeks for up to 6-10 cycles in the absence of disease progression or unacceptable toxicity. Starting 3 weeks after last combination phase cycle, patients may continue to receive maintenance pembrolizumab IV over 30 minutes on day 1 of each cycle. Cycles repeat every 6 weeks for up to an additional14 cycles. Additionally, patients undergo urine and blood sample collection and computed tomography (CT) or magnetic resonance imaging (MRI) throughout the study.
ARM 2 (EXPERIMENTAL TRIPLET ARM): Patients receive paclitaxel IV over 3 hours, carboplatin IV, and bevacizumab IV or anti-VEGF antibody biosimilar on day 1 of each cycle. Cycles repeat every 3 weeks for up to 6-10 cycles in the absence of disease progression or unacceptable toxicity. Starting 3 weeks after last combination phase cycle, patients may continue to receive maintenance bevacizumab IV on day 1 of each cycle. Treatment repeats every 3 weeks for up to an additional 28 doses. Additionally, patients undergo urine and blood sample collection and CT or MRI throughout the study.
ARM 3 (EXPERIMENTAL QUADRUPLET ARM): Patients receive paclitaxel IV over 3 hours, carboplatin IV, pembrolizumab IV over 30 minutes, and bevacizumab IV or anti-VEGF antibody biosimilar on day 1 of each cycle. Cycles repeat every 3 weeks for up to 6-10 cycles in the absence of disease progression or unacceptable toxicity. Starting 3 weeks after last combination phase cycle, patients may continue to receive maintenance pembrolizumab IV over 30 minutes every 6 weeks for up to an additional 14 cycles and bevacizumab IV every 3 weeks for up to an additional 28 doses. Additionally, patients undergo urine and blood sample collection and CT or MRI throughout the study.
After completion of study treatment, patients are followed every 3 months for 2 years then every 6 months for up to 3 years.
Study Type
Enrollment (Estimated)
Phase
- Phase 3
Contacts and Locations
Study Locations
-
-
Alabama
-
Birmingham, Alabama, United States, 35233
- Recruiting
- University of Alabama at Birmingham Cancer Center
-
Principal Investigator:
- Michael D. Toboni
-
Contact:
- Site Public Contact
- Email: gingerreeves@uabmc.edu
-
-
Alaska
-
Anchorage, Alaska, United States, 99508
- Recruiting
- Alaska Women's Cancer Care
-
Principal Investigator:
- Dan S. Zuckerman
-
Contact:
- Site Public Contact
- Phone Number: 907-212-6871
- Email: AKPAMC.OncologyResearchSupport@providence.org
-
-
Arizona
-
Phoenix, Arizona, United States, 85004
- Recruiting
- Cancer Center at Saint Joseph's
-
Principal Investigator:
- Shahzad Siddique
-
Contact:
- Site Public Contact
- Phone Number: 720-874-1881
- Email: ResearchInstituteInquiries@CommonSpirit.org
-
-
Arkansas
-
Fayetteville, Arkansas, United States, 72703
- Recruiting
- Highlands Oncology Group - Fayetteville
-
Principal Investigator:
- Joseph T. Beck
-
Contact:
- Site Public Contact
- Phone Number: 479-872-8100
- Email: research@hogonc.com
-
Little Rock, Arkansas, United States, 72205
- Recruiting
- University of Arkansas for Medical Sciences
-
Contact:
- Site Public Contact
- Phone Number: 501-686-8274
-
Principal Investigator:
- Heather R. Williams
-
Rogers, Arkansas, United States, 72758
- Recruiting
- Highlands Oncology Group - Rogers
-
Principal Investigator:
- Joseph T. Beck
-
Contact:
- Site Public Contact
- Phone Number: 479-872-8130
- Email: research@hogonc.com
-
Springdale, Arkansas, United States, 72762
- Recruiting
- Highlands Oncology Group
-
Principal Investigator:
- Joseph T. Beck
-
Contact:
- Site Public Contact
- Phone Number: 479-872-8130
- Email: research@hogonc.com
-
-
California
-
Carmichael, California, United States, 95608
- Recruiting
- Mercy San Juan Medical Center
-
Principal Investigator:
- Shahzad Siddique
-
Contact:
- Site Public Contact
- Phone Number: 720-874-1881
- Email: ResearchInstituteInquiries@CommonSpirit.org
-
Carmichael, California, United States, 95608
- Recruiting
- Mercy Cancer Center - Carmichael
-
Principal Investigator:
- Shahzad Siddique
-
Contact:
- Site Public Contact
- Phone Number: 720-874-1881
- Email: ResearchInstituteInquiries@CommonSpirit.org
-
Elk Grove, California, United States, 95758
- Recruiting
- Mercy Cancer Center - Elk Grove
-
Principal Investigator:
- Shahzad Siddique
-
Contact:
- Site Public Contact
- Phone Number: 720-874-1881
- Email: ResearchInstituteInquiries@CommonSpirit.org
-
Los Angeles, California, United States, 90033
- Recruiting
- USC / Norris Comprehensive Cancer Center
-
Contact:
- Site Public Contact
- Phone Number: 323-865-0451
-
Principal Investigator:
- Koji Matsuo
-
Los Angeles, California, United States, 90033
- Recruiting
- Los Angeles General Medical Center
-
Principal Investigator:
- Koji Matsuo
-
Contact:
- Site Public Contact
- Phone Number: 323-865-0451
- Email: uscnorrisinfo@med.usc.edu
-
Palo Alto, California, United States, 94304
- Recruiting
- Stanford Cancer Institute Palo Alto
-
Contact:
- Site Public Contact
- Phone Number: 650-498-7061
- Email: ccto-office@stanford.edu
-
Principal Investigator:
- Kristin L. Bixel
-
Rancho Mirage, California, United States, 92270
- Recruiting
- Eisenhower Medical Center
-
Principal Investigator:
- Mark Genesen
-
Contact:
- Site Public Contact
- Phone Number: 760-834-3798
-
Rocklin, California, United States, 95765
- Recruiting
- Mercy Cancer Center - Rocklin
-
Principal Investigator:
- Shahzad Siddique
-
Contact:
- Site Public Contact
- Phone Number: 720-874-1881
- Email: ResearchInstituteInquiries@CommonSpirit.org
-
Sacramento, California, United States, 95817
- Recruiting
- University of California Davis Comprehensive Cancer Center
-
Contact:
- Site Public Contact
- Phone Number: 916-734-3089
-
Principal Investigator:
- Nancy T. Nguyen
-
Sacramento, California, United States, 95816
- Recruiting
- Mercy Cancer Center - Sacramento
-
Principal Investigator:
- Shahzad Siddique
-
Contact:
- Site Public Contact
- Phone Number: 720-874-1881
- Email: ResearchInstituteInquiries@CommonSpirit.org
-
Woodland, California, United States, 95695
- Recruiting
- Woodland Memorial Hospital
-
Principal Investigator:
- Shahzad Siddique
-
Contact:
- Site Public Contact
- Phone Number: 720-874-1881
- Email: ResearchInstituteInquiries@CommonSpirit.org
-
-
Delaware
-
Millville, Delaware, United States, 19967
- Recruiting
- Beebe South Coastal Health Campus
-
Contact:
- Site Public Contact
- Phone Number: 302-291-6730
- Email: research@beebehealthcare.org
-
Principal Investigator:
- Gregory A. Masters
-
Newark, Delaware, United States, 19713
- Recruiting
- Helen F Graham Cancer Center
-
Principal Investigator:
- Gregory A. Masters
-
Contact:
- Site Public Contact
- Phone Number: 302-623-4450
- Email: lbarone@christianacare.org
-
Newark, Delaware, United States, 19713
- Recruiting
- Medical Oncology Hematology Consultants PA
-
Principal Investigator:
- Gregory A. Masters
-
Contact:
- Site Public Contact
- Phone Number: 302-623-4450
- Email: lbarone@christianacare.org
-
Rehoboth Beach, Delaware, United States, 19971
- Recruiting
- Beebe Health Campus
-
Contact:
- Site Public Contact
- Phone Number: 302-291-6730
- Email: research@beebehealthcare.org
-
Principal Investigator:
- Gregory A. Masters
-
-
Georgia
-
Atlanta, Georgia, United States, 30322
- Recruiting
- Emory University Hospital/Winship Cancer Institute
-
Principal Investigator:
- Kristen Starbuck
-
Contact:
- Site Public Contact
- Phone Number: 404-778-1868
-
Atlanta, Georgia, United States, 30308
- Recruiting
- Emory University Hospital Midtown
-
Principal Investigator:
- Kristen Starbuck
-
Contact:
- Site Public Contact
- Phone Number: 888-946-7447
-
Augusta, Georgia, United States, 30912
- Suspended
- Augusta University Medical Center
-
Decatur, Georgia, United States, 30033
- Recruiting
- Emory Decatur Hospital
-
Principal Investigator:
- Kristen Starbuck
-
Contact:
- Site Public Contact
- Phone Number: 440-778-1868
- Email: clinicaltrialsoncology@dekalbmedical.org
-
-
Idaho
-
Coeur d'Alene, Idaho, United States, 83814
- Recruiting
- Kootenai Health - Coeur d'Alene
-
Principal Investigator:
- John M. Schallenkamp
-
Contact:
- Site Public Contact
- Phone Number: 406-969-6060
- Email: mccinfo@mtcancer.org
-
Post Falls, Idaho, United States, 83854
- Recruiting
- Kootenai Clinic Cancer Services - Post Falls
-
Principal Investigator:
- John M. Schallenkamp
-
Contact:
- Site Public Contact
- Phone Number: 406-969-6060
- Email: mccinfo@mtcancer.org
-
Sandpoint, Idaho, United States, 83864
- Recruiting
- Kootenai Clinic Cancer Services - Sandpoint
-
Principal Investigator:
- John M. Schallenkamp
-
Contact:
- Site Public Contact
- Phone Number: 406-969-6060
- Email: mccinfo@mtcancer.org
-
-
Illinois
-
Chicago, Illinois, United States, 60611
- Recruiting
- Northwestern University
-
Contact:
- Site Public Contact
- Phone Number: 312-695-1301
- Email: cancer@northwestern.edu
-
Principal Investigator:
- Emma Barber
-
Chicago, Illinois, United States, 60612
- Recruiting
- Rush MD Anderson Cancer Center
-
Principal Investigator:
- Alexander C. Cohen
-
Contact:
- Site Public Contact
- Phone Number: 312-226-2371
- Email: Cancer_Studies@rush.edu
-
DeKalb, Illinois, United States, 60115
- Recruiting
- Northwestern Medicine Cancer Center Kishwaukee
-
Contact:
- Site Public Contact
- Phone Number: 630-352-5360
- Email: Donald.Smith3@nm.org
-
Principal Investigator:
- Emma Barber
-
Decatur, Illinois, United States, 62526
- Recruiting
- Cancer Care Specialists of Illinois - Decatur
-
Principal Investigator:
- Bryan A. Faller
-
Contact:
- Site Public Contact
- Phone Number: 217-876-4762
- Email: morganthaler.jodi@mhsil.com
-
Decatur, Illinois, United States, 62526
- Recruiting
- Decatur Memorial Hospital
-
Principal Investigator:
- Bryan A. Faller
-
Contact:
- Site Public Contact
- Phone Number: 217-876-4762
- Email: morganthaler.jodi@mhsil.com
-
Geneva, Illinois, United States, 60134
- Recruiting
- Northwestern Medicine Cancer Center Delnor
-
Contact:
- Site Public Contact
- Phone Number: 630-352-5360
- Email: Donald.Smith3@nm.org
-
Principal Investigator:
- Emma Barber
-
Oak Brook, Illinois, United States, 60523
- Recruiting
- Northwestern Medicine Oak Brook
-
Principal Investigator:
- Emma Barber
-
Contact:
- Site Public Contact
- Email: nctnprogram_rhlccc@northwestern.edu
-
Oak Park, Illinois, United States, 60304
- Recruiting
- Rush MD Anderson Cancer Center at Rush Oak Park
-
Principal Investigator:
- Alexander C. Cohen
-
Contact:
- Site Public Contact
- Phone Number: 312-226-2371
- Email: Cancer_Studies@rush.edu
-
Orland Park, Illinois, United States, 60462
- Recruiting
- Northwestern Medicine Orland Park
-
Principal Investigator:
- Emma Barber
-
Contact:
- Site Public Contact
- Email: nctnprogram_rhlccc@northwestern.edu
-
Peoria, Illinois, United States, 61637
- Recruiting
- OSF Saint Francis Medical Center
-
Contact:
- Site Public Contact
- Phone Number: 309-243-3605
- Email: andersonj@illinoiscancercare.com
-
Principal Investigator:
- Bryan A. Faller
-
Springfield, Illinois, United States, 62702
- Recruiting
- Southern Illinois University School of Medicine
-
Principal Investigator:
- Bryan A. Faller
-
Contact:
- Site Public Contact
- Phone Number: 217-545-7929
-
Springfield, Illinois, United States, 62702
- Recruiting
- Springfield Clinic
-
Principal Investigator:
- Bryan A. Faller
-
Contact:
- Site Public Contact
- Phone Number: 800-444-7541
-
Springfield, Illinois, United States, 62781
- Recruiting
- Springfield Memorial Hospital
-
Principal Investigator:
- Bryan A. Faller
-
Contact:
- Site Public Contact
- Phone Number: 217-528-7541
- Email: pallante.beth@mhsil.com
-
Warrenville, Illinois, United States, 60555
- Recruiting
- Northwestern Medicine Cancer Center Warrenville
-
Contact:
- Site Public Contact
- Phone Number: 630-352-5360
- Email: Donald.Smith3@nm.org
-
Principal Investigator:
- Emma Barber
-
-
Indiana
-
Goshen, Indiana, United States, 46526
- Recruiting
- Goshen Center for Cancer Care
-
Contact:
- Site Public Contact
- Phone Number: 574-364-2973
- Email: cccois@goshenhealth.com
-
Principal Investigator:
- Pamela J. Stone
-
South Bend, Indiana, United States, 46601
- Recruiting
- Memorial Hospital of South Bend
-
Contact:
- Site Public Contact
- Phone Number: 800-284-7370
-
Principal Investigator:
- LaToya J. Perry
-
-
Iowa
-
Ankeny, Iowa, United States, 50023
- Recruiting
- UI Health Care Mission Cancer and Blood - Ankeny Clinic
-
Contact:
- Site Public Contact
- Phone Number: 515-241-3305
-
Principal Investigator:
- Seema Harichand-Herdt
-
Carroll, Iowa, United States, 51401
- Recruiting
- Saint Anthony Regional Hospital
-
Contact:
- Site Public Contact
- Phone Number: 515-689-7658
- Email: sbenson@iora.org
-
Principal Investigator:
- Seema Harichand-Herdt
-
Cedar Rapids, Iowa, United States, 52403
- Recruiting
- Mercy Hospital
-
Contact:
- Site Public Contact
- Phone Number: 319-365-4673
-
Principal Investigator:
- Deborah W. Wilbur
-
Cedar Rapids, Iowa, United States, 52403
- Recruiting
- Oncology Associates at Mercy Medical Center
-
Principal Investigator:
- Deborah W. Wilbur
-
Contact:
- Site Public Contact
- Phone Number: 319-363-2690
-
Clive, Iowa, United States, 50325
- Recruiting
- UI Health Care Mission Cancer and Blood - West Des Moines Clinic
-
Contact:
- Site Public Contact
- Phone Number: 515-241-3305
-
Principal Investigator:
- Seema Harichand-Herdt
-
Des Moines, Iowa, United States, 50314
- Recruiting
- Broadlawns Medical Center
-
Contact:
- Site Public Contact
- Phone Number: 515-282-2200
-
Principal Investigator:
- Seema Harichand-Herdt
-
Des Moines, Iowa, United States, 50314
- Recruiting
- Mercy Medical Center - Des Moines
-
Contact:
- Site Public Contact
- Phone Number: 515-241-3305
-
Principal Investigator:
- Richard L. Deming
-
Des Moines, Iowa, United States, 50309
- Recruiting
- Iowa Methodist Medical Center
-
Contact:
- Site Public Contact
- Phone Number: 515-241-6727
-
Principal Investigator:
- Seema Harichand-Herdt
-
Des Moines, Iowa, United States, 50309
- Recruiting
- UI Health Care Mission Cancer and Blood - Des Moines Clinic
-
Contact:
- Site Public Contact
- Phone Number: 515-241-3305
-
Principal Investigator:
- Seema Harichand-Herdt
-
Des Moines, Iowa, United States, 50314
- Recruiting
- UI Health Care Mission Cancer and Blood - Laurel Clinic
-
Contact:
- Site Public Contact
- Phone Number: 515-241-3305
-
Principal Investigator:
- Seema Harichand-Herdt
-
Fort Dodge, Iowa, United States, 50501
- Recruiting
- UI Healthcare Mission Cancer and Blood - Fort Dodge
-
Principal Investigator:
- Seema Harichand-Herdt
-
Contact:
- Site Public Contact
- Phone Number: 515-282-2921
- Email: trials@missioncancer.com
-
Iowa City, Iowa, United States, 52242
- Recruiting
- University of Iowa/Holden Comprehensive Cancer Center
-
Contact:
- Site Public Contact
- Phone Number: 800-237-1225
-
Principal Investigator:
- David P. Bender
-
Waukee, Iowa, United States, 50263
- Recruiting
- UI Health Care Mission Cancer and Blood - Waukee Clinic
-
Contact:
- Site Public Contact
- Phone Number: 515-241-3305
-
Principal Investigator:
- Seema Harichand-Herdt
-
-
Kentucky
-
Lexington, Kentucky, United States, 40536
- Recruiting
- University of Kentucky/Markey Cancer Center
-
Contact:
- Site Public Contact
- Phone Number: 859-257-3379
-
Principal Investigator:
- Rachel W. Miller
-
-
Louisiana
-
Marrero, Louisiana, United States, 70072
- Recruiting
- West Jefferson Medical Center
-
Contact:
- Site Public Contact
- Phone Number: 504-210-3539
- Email: emede1@lsuhsc.edu
-
Principal Investigator:
- Tara Castellano
-
Metairie, Louisiana, United States, 70006
- Recruiting
- East Jefferson General Hospital
-
Contact:
- Site Public Contact
- Phone Number: 504-210-3539
- Email: emede1@lsuhsc.edu
-
Principal Investigator:
- Tara Castellano
-
Metairie, Louisiana, United States, 70006
- Recruiting
- LSU Healthcare Network / Metairie Multi-Specialty Clinic
-
Contact:
- Site Public Contact
- Phone Number: 504-210-3539
- Email: emede1@lsuhsc.edu
-
Principal Investigator:
- Tara Castellano
-
New Orleans, Louisiana, United States, 70112
- Recruiting
- University Medical Center New Orleans
-
Contact:
- Site Public Contact
- Phone Number: 504-210-3539
- Email: emede1@lsuhsc.edu
-
Principal Investigator:
- Tara Castellano
-
-
Maine
-
Scarborough, Maine, United States, 04074
- Recruiting
- MaineHealth Maine Medical Center- Scarborough
-
Principal Investigator:
- Leslie S. Bradford
-
Contact:
- Site Public Contact
- Phone Number: 207-396-8670
- Email: clinicalresearch@mainehealth.org
-
-
Maryland
-
Baltimore, Maryland, United States, 21287
- Recruiting
- Johns Hopkins University/Sidney Kimmel Cancer Center
-
Contact:
- Site Public Contact
- Phone Number: 410-955-8804
- Email: jhcccro@jhmi.edu
-
Principal Investigator:
- Amanda N. Fader
-
-
Massachusetts
-
Boston, Massachusetts, United States, 02215
- Recruiting
- Dana-Farber Cancer Institute
-
Contact:
- Site Public Contact
- Phone Number: 877-442-3324
-
Principal Investigator:
- Susana M. Campos
-
-
Michigan
-
Ann Arbor, Michigan, United States, 48109
- Recruiting
- University of Michigan Rogel Cancer Center
-
Contact:
- Site Public Contact
- Phone Number: 800-865-1125
- Email: CancerAnswerLine@med.umich.edu
-
Principal Investigator:
- Zhen Ni Zhou
-
Battle Creek, Michigan, United States, 49017
- Recruiting
- Bronson Battle Creek
-
Contact:
- Site Public Contact
- Phone Number: 616-391-1230
- Email: crcwm-regulatory@crcwm.org
-
Principal Investigator:
- Kathleen Y. Butler
-
Brighton, Michigan, United States, 48114
- Recruiting
- Trinity Health IHA Medical Group Hematology Oncology - Brighton
-
Contact:
- Site Public Contact
- Phone Number: 734-712-7251
- Email: MCRCwebsitecontactform@stjoeshealth.org
-
Principal Investigator:
- J. R. Liu
-
Brighton, Michigan, United States, 48116
- Recruiting
- University of Michigan - Brighton Center for Specialty Care
-
Contact:
- Site Public Contact
- Phone Number: 800-865-1125
-
Principal Investigator:
- Zhen Ni Zhou
-
Canton, Michigan, United States, 48188
- Recruiting
- Trinity Health IHA Medical Group Hematology Oncology - Canton
-
Contact:
- Site Public Contact
- Phone Number: 734-712-7251
- Email: MCRCwebsitecontactform@stjoeshealth.org
-
Principal Investigator:
- J. R. Liu
-
Chelsea, Michigan, United States, 48118
- Recruiting
- Trinity Health IHA Medical Group Hematology Oncology - Chelsea Hospital
-
Contact:
- Site Public Contact
- Phone Number: 734-712-7251
- Email: MCRCwebsitecontactform@stjoeshealth.org
-
Principal Investigator:
- J. R. Liu
-
Escanaba, Michigan, United States, 49829
- Recruiting
- OSF Saint Francis Hospital and Medical Group
-
Principal Investigator:
- Matthew L. Ryan
-
Contact:
- Site Public Contact
- Phone Number: 920-433-8889
- Email: wi_research_admin@hshs.org
-
Flint, Michigan, United States, 48503
- Recruiting
- Genesys Hurley Cancer Institute
-
Contact:
- Site Public Contact
- Phone Number: 810-762-8038
- Email: wstrong@ghci.org
-
Principal Investigator:
- J. R. Liu
-
Flint, Michigan, United States, 48503
- Recruiting
- Hurley Medical Center
-
Contact:
- Site Public Contact
- Phone Number: 810-762-8038
- Email: wstrong@ghci.org
-
Principal Investigator:
- J. R. Liu
-
Grand Rapids, Michigan, United States, 49503
- Recruiting
- Trinity Health Grand Rapids Hospital
-
Contact:
- Site Public Contact
- Phone Number: 616-391-1230
- Email: crcwm-regulatory@crcwm.org
-
Principal Investigator:
- Kathleen Y. Butler
-
Grand Rapids, Michigan, United States, 49503
- Recruiting
- Corewell Health Grand Rapids Hospitals - Butterworth Hospital
-
Contact:
- Site Public Contact
- Phone Number: 616-391-1230
- Email: crcwm-regulatory@crcwm.org
-
Principal Investigator:
- Kathleen Y. Butler
-
Kalamazoo, Michigan, United States, 49007
- Recruiting
- Bronson Methodist Hospital
-
Contact:
- Site Public Contact
- Phone Number: 616-391-1230
- Email: crcwm-regulatory@crcwm.org
-
Principal Investigator:
- Kathleen Y. Butler
-
Kalamazoo, Michigan, United States, 49007
- Recruiting
- West Michigan Cancer Center
-
Contact:
- Site Public Contact
- Phone Number: 616-391-1230
- Email: crcwm-regulatory@crcwm.org
-
Principal Investigator:
- Kathleen Y. Butler
-
Kalamazoo, Michigan, United States, 49009
- Recruiting
- Beacon Kalamazoo Cancer Center
-
Principal Investigator:
- Kathleen Y. Butler
-
Contact:
- Site Public Contact
- Phone Number: 574-647-7370
-
Livonia, Michigan, United States, 48154
- Recruiting
- Trinity Health Saint Mary Mercy Livonia Hospital
-
Contact:
- Site Public Contact
- Phone Number: 734-712-7251
- Email: MCRCwebsitecontactform@stjoeshealth.org
-
Principal Investigator:
- J. R. Liu
-
Muskegon, Michigan, United States, 49444
- Recruiting
- Trinity Health Muskegon Hospital
-
Contact:
- Site Public Contact
- Phone Number: 616-391-1230
- Email: crcwm-regulatory@crcwm.org
-
Principal Investigator:
- Kathleen Y. Butler
-
Niles, Michigan, United States, 49120
- Recruiting
- Corewell Health Lakeland Hospitals - Niles Hospital
-
Contact:
- Site Public Contact
- Phone Number: 616-391-1230
-
Principal Investigator:
- Kathleen Y. Butler
-
Norton Shores, Michigan, United States, 49444
- Recruiting
- Cancer and Hematology Centers of Western Michigan - Norton Shores
-
Contact:
- Site Public Contact
- Phone Number: 616-391-1230
- Email: connie.szczepanek@crcwm.org
-
Principal Investigator:
- Kathleen Y. Butler
-
Pontiac, Michigan, United States, 48341
- Recruiting
- Trinity Health Saint Joseph Mercy Oakland Hospital
-
Contact:
- Site Public Contact
- Phone Number: 734-712-7251
- Email: MCRCwebsitecontactform@stjoeshealth.org
-
Principal Investigator:
- J. R. Liu
-
Reed City, Michigan, United States, 49677
- Recruiting
- Corewell Health Reed City Hospital
-
Contact:
- Site Public Contact
- Phone Number: 616-391-1230
- Email: crcwm-regulatory@crcwm.org
-
Principal Investigator:
- Kathleen Y. Butler
-
Saint Joseph, Michigan, United States, 49085
- Recruiting
- Corewell Health Lakeland Hospitals - Marie Yeager Cancer Center
-
Contact:
- Site Public Contact
- Phone Number: 616-391-1230
- Email: crcwm-regulatory@crcwm.org
-
Principal Investigator:
- Kathleen Y. Butler
-
Saint Joseph, Michigan, United States, 49085
- Recruiting
- Corewell Health Lakeland Hospitals - Saint Joseph Hospital
-
Contact:
- Site Public Contact
- Phone Number: 616-391-1230
- Email: crcwm-regulatory@crcwm.org
-
Principal Investigator:
- Kathleen Y. Butler
-
Traverse City, Michigan, United States, 49684
- Recruiting
- Munson Medical Center
-
Contact:
- Site Public Contact
- Phone Number: 616-391-1230
- Email: crcwm-regulatory@crcwm.org
-
Principal Investigator:
- Kathleen Y. Butler
-
Wyoming, Michigan, United States, 49519
- Recruiting
- University of Michigan Health - West
-
Contact:
- Site Public Contact
- Phone Number: 616-391-1230
- Email: crcwm-regulatory@crcwm.org
-
Principal Investigator:
- Kathleen Y. Butler
-
Ypsilanti, Michigan, United States, 48197
- Recruiting
- Trinity Health IHA Medical Group Hematology Oncology Ann Arbor Campus
-
Contact:
- Site Public Contact
- Phone Number: 734-712-7251
- Email: MCRCwebsitecontactform@stjoeshealth.org
-
Principal Investigator:
- J. R. Liu
-
-
Minnesota
-
Brainerd, Minnesota, United States, 56401
- Recruiting
- Essentia Health Saint Joseph's Medical Center
-
Contact:
- Site Public Contact
- Phone Number: 218-786-3308
- Email: CancerTrials@EssentiaHealth.org
-
Principal Investigator:
- Bret E. Friday
-
Coon Rapids, Minnesota, United States, 55433
- Recruiting
- Mercy Hospital
-
Contact:
- Site Public Contact
- Phone Number: 952-993-1517
- Email: mmcorc@healthpartners.com
-
Principal Investigator:
- Yan Ji
-
Deer River, Minnesota, United States, 56636
- Recruiting
- Essentia Health - Deer River Clinic
-
Contact:
- Site Public Contact
- Phone Number: 218-786-3308
- Email: CancerTrials@EssentiaHealth.org
-
Principal Investigator:
- Bret E. Friday
-
Duluth, Minnesota, United States, 55805
- Recruiting
- Essentia Health Cancer Center
-
Contact:
- Site Public Contact
- Phone Number: 218-786-3308
- Email: CancerTrials@EssentiaHealth.org
-
Principal Investigator:
- Bret E. Friday
-
Edina, Minnesota, United States, 55435
- Recruiting
- Fairview Southdale Hospital
-
Contact:
- Site Public Contact
- Phone Number: 952-993-1517
- Email: mmcorc@healthpartners.com
-
Principal Investigator:
- Yan Ji
-
Hibbing, Minnesota, United States, 55746
- Recruiting
- Essentia Health Hibbing Clinic
-
Principal Investigator:
- Bret E. Friday
-
Contact:
- Site Public Contact
- Phone Number: 218-786-3308
-
Minneapolis, Minnesota, United States, 55407
- Recruiting
- Abbott-Northwestern Hospital
-
Contact:
- Site Public Contact
- Phone Number: 952-993-1517
- Email: mmcorc@healthpartners.com
-
Principal Investigator:
- Yan Ji
-
Saint Louis Park, Minnesota, United States, 55416
- Recruiting
- Park Nicollet Clinic - Saint Louis Park
-
Contact:
- Site Public Contact
- Phone Number: 952-993-1517
- Email: mmcorc@healthpartners.com
-
Principal Investigator:
- Yan Ji
-
Saint Paul, Minnesota, United States, 55101
- Recruiting
- Regions Hospital
-
Contact:
- Site Public Contact
- Phone Number: 952-993-1517
- Email: mmcorc@healthpartners.com
-
Principal Investigator:
- Yan Ji
-
Saint Paul, Minnesota, United States, 55102
- Recruiting
- United Hospital
-
Contact:
- Site Public Contact
- Phone Number: 952-993-1517
- Email: mmcorc@healthpartners.com
-
Principal Investigator:
- Yan Ji
-
Sandstone, Minnesota, United States, 55072
- Recruiting
- Essentia Health Sandstone
-
Contact:
- Site Public Contact
- Phone Number: 218-786-3308
- Email: CancerTrials@EssentiaHealth.org
-
Principal Investigator:
- Bret E. Friday
-
Virginia, Minnesota, United States, 55792
- Recruiting
- Essentia Health Virginia Clinic
-
Contact:
- Site Public Contact
- Phone Number: 218-786-3308
- Email: CancerTrials@EssentiaHealth.org
-
Principal Investigator:
- Bret E. Friday
-
Woodbury, Minnesota, United States, 55125
- Recruiting
- Minnesota Oncology Hematology PA-Woodbury
-
Contact:
- Site Public Contact
- Phone Number: 952-993-1517
- Email: mmcorc@healthpartners.com
-
Principal Investigator:
- Yan Ji
-
-
Missouri
-
Springfield, Missouri, United States, 65804
- Recruiting
- Mercy Hospital Springfield
-
Principal Investigator:
- Jay W. Carlson
-
Contact:
- Site Public Contact
- Phone Number: 417-269-4520
-
Springfield, Missouri, United States, 65807
- Recruiting
- CoxHealth South Hospital
-
Principal Investigator:
- Jay W. Carlson
-
Contact:
- Site Public Contact
- Phone Number: 417-269-4520
-
-
Montana
-
Anaconda, Montana, United States, 59711
- Recruiting
- Community Hospital of Anaconda
-
Principal Investigator:
- John M. Schallenkamp
-
Contact:
- Site Public Contact
- Phone Number: 406-969-6060
- Email: mccinfo@mtcancer.org
-
Billings, Montana, United States, 59101
- Recruiting
- Billings Clinic Cancer Center
-
Principal Investigator:
- John M. Schallenkamp
-
Contact:
- Site Public Contact
- Phone Number: 800-996-2663
- Email: research@billingsclinic.org
-
Bozeman, Montana, United States, 59715
- Recruiting
- Bozeman Health Deaconess Hospital
-
Principal Investigator:
- John M. Schallenkamp
-
Contact:
- Site Public Contact
- Phone Number: 406-969-6060
- Email: mccinfo@mtcancer.org
-
Great Falls, Montana, United States, 59405
- Recruiting
- Benefis Sletten Cancer Institute
-
Principal Investigator:
- John M. Schallenkamp
-
Contact:
- Site Public Contact
- Phone Number: 406-969-6060
- Email: mccinfo@mtcancer.org
-
Kalispell, Montana, United States, 59901
- Recruiting
- Logan Health Medical Center
-
Principal Investigator:
- John M. Schallenkamp
-
Contact:
- Site Public Contact
- Phone Number: 406-969-6060
- Email: mccinfo@mtcancer.org
-
Missoula, Montana, United States, 59804
- Recruiting
- Community Medical Center
-
Principal Investigator:
- John M. Schallenkamp
-
Contact:
- Site Public Contact
- Phone Number: 406-969-6060
- Email: mccinfo@mtcancer.org
-
-
Nebraska
-
Bellevue, Nebraska, United States, 68123
- Recruiting
- Nebraska Medicine-Bellevue
-
Contact:
- Site Public Contact
- Phone Number: 402-559-6941
- Email: unmcrsa@unmc.edu
-
Principal Investigator:
- Lindsey A. McAlarnen
-
Kearney, Nebraska, United States, 68845
- Recruiting
- Fred and Pamela Buffett Cancer Center - Kearney
-
Contact:
- Site Public Contact
- Phone Number: 402-559-6941
- Email: unmcrsa@unmc.edu
-
Principal Investigator:
- Lindsey A. McAlarnen
-
Omaha, Nebraska, United States, 68198
- Recruiting
- University of Nebraska Medical Center
-
Contact:
- Site Public Contact
- Phone Number: 402-559-6941
- Email: unmcrsa@unmc.edu
-
Principal Investigator:
- Lindsey A. McAlarnen
-
Omaha, Nebraska, United States, 68114
- Recruiting
- Nebraska Methodist Hospital
-
Contact:
- Site Public Contact
- Phone Number: 402-354-5144
-
Principal Investigator:
- Brent J. Tierney
-
Omaha, Nebraska, United States, 68118
- Recruiting
- Nebraska Medicine-Village Pointe
-
Contact:
- Site Public Contact
- Phone Number: 402-559-5600
-
Principal Investigator:
- Lindsey A. McAlarnen
-
-
Nevada
-
Las Vegas, Nevada, United States, 89106
- Recruiting
- Women's Cancer Center of Nevada
-
Principal Investigator:
- Nicola M. Spirtos
-
Contact:
- Site Public Contact
- Phone Number: 702-851-4672
-
-
New Jersey
-
Basking Ridge, New Jersey, United States, 07920
- Recruiting
- Memorial Sloan Kettering Basking Ridge
-
Contact:
- Site Public Contact
- Phone Number: 212-639-7592
-
Principal Investigator:
- Carol Aghajanian
-
Middletown, New Jersey, United States, 07748
- Recruiting
- Memorial Sloan Kettering Monmouth
-
Contact:
- Site Public Contact
- Phone Number: 212-639-7592
-
Principal Investigator:
- Carol Aghajanian
-
Montvale, New Jersey, United States, 07645
- Recruiting
- Memorial Sloan Kettering Bergen
-
Contact:
- Site Public Contact
- Phone Number: 212-639-7592
-
Principal Investigator:
- Carol Aghajanian
-
New Brunswick, New Jersey, United States, 08903
- Recruiting
- Rutgers Cancer Institute of New Jersey
-
Contact:
- Site Public Contact
- Phone Number: 732-235-7356
-
Principal Investigator:
- Eugenia Girda
-
Newark, New Jersey, United States, 07101
- Recruiting
- Rutgers New Jersey Medical School
-
Contact:
- Site Public Contact
- Phone Number: 732-235-7356
-
Principal Investigator:
- Eugenia Girda
-
Paramus, New Jersey, United States, 07652
- Recruiting
- The Valley Hospital - Luckow Pavilion
-
Principal Investigator:
- Eleonora Teplinsky
-
Contact:
- Site Public Contact
- Phone Number: 201-634-5792
- Email: clinicaltrialsresearch@valleyhealth.com
-
Ridgewood, New Jersey, United States, 07450
- Recruiting
- Valley Health System Ridgewood Campus
-
Principal Investigator:
- Eleonora Teplinsky
-
Contact:
- Site Public Contact
- Phone Number: 201-634-5792
- Email: clinicaltrialsresearch@valleyhealth.com
-
Sewell, New Jersey, United States, 08080
- Recruiting
- Sidney Kimmel Cancer Center Washington Township
-
Contact:
- Site Public Contact
- Phone Number: 215-600-9151
- Email: ONCTrialNow@jefferson.edu
-
Principal Investigator:
- Jessa Suhner
-
-
New Mexico
-
Albuquerque, New Mexico, United States, 87106
- Recruiting
- University of New Mexico Cancer Center
-
Contact:
- Site Public Contact
- Phone Number: 505-925-0348
- Email: HSC-ClinicalTrialInfo@salud.unm.edu
-
Principal Investigator:
- Amaranta D. Craig
-
-
New York
-
Bay Shore, New York, United States, 11706
- Recruiting
- Northwell Health Imbert Cancer Center
-
Principal Investigator:
- Veena S. John
-
Contact:
- Site Public Contact
- Phone Number: 516-734-8896
-
Commack, New York, United States, 11725
- Recruiting
- Memorial Sloan Kettering Commack
-
Contact:
- Site Public Contact
- Phone Number: 212-639-7592
-
Principal Investigator:
- Carol Aghajanian
-
Flushing, New York, United States, 11354
- Recruiting
- Northwell Health Physician Partners at Flushing
-
Principal Investigator:
- Veena S. John
-
Contact:
- Site Public Contact
- Phone Number: 718-559-3600
- Email: nhppflushing@northwell.edu
-
Greenlawn, New York, United States, 11740
- Recruiting
- Northwell Health Cancer Institute at Huntington
-
Principal Investigator:
- Veena S. John
-
Contact:
- Site Public Contact
- Phone Number: 516-734-8896
-
Harrison, New York, United States, 10604
- Recruiting
- Memorial Sloan Kettering Westchester
-
Contact:
- Site Public Contact
- Phone Number: 212-639-7592
-
Principal Investigator:
- Carol Aghajanian
-
Lake Success, New York, United States, 11042
- Recruiting
- Northwell Health/Center for Advanced Medicine
-
Principal Investigator:
- Veena S. John
-
Contact:
- Site Public Contact
- Phone Number: 516-734-8896
-
New York, New York, United States, 10065
- Recruiting
- Memorial Sloan Kettering Cancer Center
-
Contact:
- Site Public Contact
- Phone Number: 212-639-7592
-
Principal Investigator:
- Carol Aghajanian
-
New York, New York, United States, 10075
- Recruiting
- Lenox Hill Hospital
-
Principal Investigator:
- Veena S. John
-
Contact:
- Site Public Contact
- Phone Number: 516-734-8896
-
New York, New York, United States, 10065
- Recruiting
- Manhattan Eye Ear and Throat Hospital
-
Principal Investigator:
- Veena S. John
-
Contact:
- Site Public Contact
- Phone Number: 212-434-4460
-
Rego Park, New York, United States, 11374
- Recruiting
- Queens Cancer Center
-
Principal Investigator:
- Veena S. John
-
Contact:
- Site Public Contact
- Phone Number: 718-312-3446
-
Sleepy Hollow, New York, United States, 10591
- Recruiting
- Phelps Memorial Hospital Center
-
Principal Investigator:
- Veena S. John
-
Contact:
- Site Public Contact
- Phone Number: 914-366-1600
-
Staten Island, New York, United States, 10305
- Recruiting
- Staten Island University Hospital
-
Principal Investigator:
- Veena S. John
-
Contact:
- Site Public Contact
- Phone Number: 718-226-8888
-
Stony Brook, New York, United States, 11794
- Recruiting
- Stony Brook University Medical Center
-
Contact:
- Site Public Contact
- Phone Number: 800-862-2215
-
Principal Investigator:
- Susan M. Lang
-
The Bronx, New York, United States, 10461
- Recruiting
- Montefiore Medical Center-Einstein Campus
-
Contact:
- Site Public Contact
- Phone Number: 718-379-6866
- Email: eskwak@montefiore.org
-
Principal Investigator:
- Nicole S. Nevadunsky
-
The Bronx, New York, United States, 10467
- Recruiting
- Montefiore Medical Center - Moses Campus
-
Contact:
- Site Public Contact
- Phone Number: 718-379-6866
- Email: eskwak@montefiore.org
-
Principal Investigator:
- Nicole S. Nevadunsky
-
The Bronx, New York, United States, 10461
- Recruiting
- Montefiore Medical Center-Weiler Hospital
-
Contact:
- Site Public Contact
- Phone Number: 718-379-6866
- Email: eskwak@montefiore.org
-
Principal Investigator:
- Nicole S. Nevadunsky
-
Uniondale, New York, United States, 11553
- Recruiting
- Memorial Sloan Kettering Nassau
-
Contact:
- Site Public Contact
- Phone Number: 212-639-7592
-
Principal Investigator:
- Carol Aghajanian
-
-
North Carolina
-
Chapel Hill, North Carolina, United States, 27599
- Recruiting
- UNC Lineberger Comprehensive Cancer Center
-
Contact:
- Site Public Contact
- Phone Number: 877-668-0683
- Email: cancerclinicaltrials@med.unc.edu
-
Principal Investigator:
- Olivia D. Lara
-
Clinton, North Carolina, United States, 28328
- Recruiting
- Southeastern Medical Oncology Center-Clinton
-
Contact:
- Site Public Contact
- Phone Number: 919-587-9084
- Email: jfields@cancersmoc.com
-
Principal Investigator:
- Samer S. Kasbari
-
Durham, North Carolina, United States, 27710
- Recruiting
- Duke University Medical Center
-
Principal Investigator:
- Angeles A. Secord
-
Contact:
- Site Public Contact
- Phone Number: 888-275-3853
-
Goldsboro, North Carolina, United States, 27534
- Recruiting
- Southeastern Medical Oncology Center-Goldsboro
-
Contact:
- Site Public Contact
- Phone Number: 919-587-9084
- Email: jfields@cancersmoc.com
-
Principal Investigator:
- Samer S. Kasbari
-
Jacksonville, North Carolina, United States, 28546
- Recruiting
- Southeastern Medical Oncology Center-Jacksonville
-
Principal Investigator:
- Samer S. Kasbari
-
Contact:
- Site Public Contact
- Phone Number: 910-587-9084
- Email: jfields@cancersmoc.com
-
Raleigh, North Carolina, United States, 27607
- Recruiting
- Duke Women's Cancer Care Raleigh
-
Principal Investigator:
- Angeles A. Secord
-
Contact:
- Site Public Contact
- Phone Number: 919-785-4878
-
-
North Dakota
-
Fargo, North Dakota, United States, 58103
- Recruiting
- Essentia Health Cancer Center-South University Clinic
-
Contact:
- Site Public Contact
- Phone Number: 218-786-3308
- Email: CancerTrials@EssentiaHealth.org
-
Principal Investigator:
- Bret E. Friday
-
-
Ohio
-
Athens, Ohio, United States, 45701
- Recruiting
- OhioHealth O'Bleness Hospital
-
Principal Investigator:
- Aine E. Clements
-
Contact:
- Site Public Contact
- Phone Number: 614-788-3860
- Email: Jennifer.Sexton@ohiohealth.com
-
Beachwood, Ohio, United States, 44122
- Recruiting
- UHHS-Chagrin Highlands Medical Center
-
Contact:
- Site Public Contact
- Phone Number: 800-641-2422
- Email: CTUReferral@UHhospitals.org
-
Principal Investigator:
- Amy Armstrong
-
Chardon, Ohio, United States, 44024
- Recruiting
- Geauga Hospital
-
Contact:
- Site Public Contact
- Phone Number: 800-641-2422
- Email: CTUReferral@UHhospitals.org
-
Principal Investigator:
- Amy Armstrong
-
Cleveland, Ohio, United States, 44106
- Recruiting
- Case Western Reserve University
-
Contact:
- Site Public Contact
- Phone Number: 800-641-2422
- Email: CTUReferral@UHhospitals.org
-
Principal Investigator:
- Amy Armstrong
-
Columbus, Ohio, United States, 43214
- Recruiting
- Columbus Oncology and Hematology Associates Inc
-
Principal Investigator:
- Aine E. Clements
-
Contact:
- Site Public Contact
- Phone Number: 614-788-3860
- Email: Jennifer.Sexton@ohiohealth.com
-
Columbus, Ohio, United States, 43214
- Recruiting
- Riverside Methodist Hospital
-
Principal Investigator:
- Aine E. Clements
-
Contact:
- Site Public Contact
- Phone Number: 614-788-3860
- Email: Jennifer.Sexton@ohiohealth.com
-
Columbus, Ohio, United States, 43215
- Recruiting
- Grant Medical Center
-
Principal Investigator:
- Aine E. Clements
-
Contact:
- Site Public Contact
- Phone Number: 614-788-3860
- Email: Jennifer.Sexton@ohiohealth.com
-
Columbus, Ohio, United States, 43228
- Recruiting
- Doctors Hospital
-
Principal Investigator:
- Aine E. Clements
-
Contact:
- Site Public Contact
- Phone Number: 614-788-3860
- Email: Jennifer.Sexton@ohiohealth.com
-
Columbus, Ohio, United States, 43210
- Recruiting
- Ohio State University Comprehensive Cancer Center
-
Contact:
- Site Public Contact
- Phone Number: 800-293-5066
- Email: Jamesline@osumc.edu
-
Principal Investigator:
- Floor Backes
-
Delaware, Ohio, United States, 43015
- Recruiting
- Delaware Health Center-Grady Cancer Center
-
Principal Investigator:
- Aine E. Clements
-
Contact:
- Site Public Contact
- Phone Number: 614-788-3860
- Email: Jennifer.Sexton@ohiohealth.com
-
Delaware, Ohio, United States, 43015
- Recruiting
- Grady Memorial Hospital
-
Principal Investigator:
- Aine E. Clements
-
Contact:
- Site Public Contact
- Phone Number: 614-788-3860
- Email: Jennifer.Sexton@ohiohealth.com
-
Dublin, Ohio, United States, 43016
- Recruiting
- Columbus Oncology and Hematology Associates
-
Principal Investigator:
- Aine E. Clements
-
Contact:
- Site Public Contact
- Phone Number: 614-788-3860
- Email: Jennifer.Sexton@ohiohealth.com
-
Dublin, Ohio, United States, 43016
- Recruiting
- Dublin Methodist Hospital
-
Principal Investigator:
- Aine E. Clements
-
Contact:
- Site Public Contact
- Phone Number: 614-788-3860
- Email: Jennifer.Sexton@ohiohealth.com
-
Mansfield, Ohio, United States, 44903
- Recruiting
- OhioHealth Mansfield Hospital
-
Principal Investigator:
- Aine E. Clements
-
Contact:
- Site Public Contact
- Phone Number: 614-788-3860
- Email: Jennifer.Sexton@ohiohealth.com
-
Marion, Ohio, United States, 43302
- Recruiting
- OhioHealth Marion General Hospital
-
Principal Investigator:
- Aine E. Clements
-
Contact:
- Site Public Contact
- Phone Number: 614-788-3860
- Email: Jennifer.Sexton@ohiohealth.com
-
Mentor, Ohio, United States, 44060
- Recruiting
- UH Seidman Cancer Center at Lake Health Mentor Campus
-
Contact:
- Site Public Contact
- Phone Number: 800-641-2422
- Email: CTUReferral@UHhospitals.org
-
Principal Investigator:
- Amy Armstrong
-
Parma, Ohio, United States, 44129
- Recruiting
- University Hospitals Parma Medical Center
-
Contact:
- Site Public Contact
- Phone Number: 800-641-2422
- Email: CTUReferral@UHhospitals.org
-
Principal Investigator:
- Amy Armstrong
-
Pickerington, Ohio, United States, 43147
- Recruiting
- OhioHealth Pickerington Methodist Hospital
-
Principal Investigator:
- Aine E. Clements
-
Contact:
- Site Public Contact
- Phone Number: 614-788-3860
- Email: Jennifer.Sexton@ohiohealth.com
-
Sylvania, Ohio, United States, 43560
- Recruiting
- ProMedica Flower Hospital
-
Contact:
- Site Public Contact
- Phone Number: 419-824-1842
- Email: PCIOncResearch@promedica.org
-
Principal Investigator:
- Anjalika Gandhi
-
Westerville, Ohio, United States, 43082
- Recruiting
- OhioHealth Westerville Medical Campus/Westerville Cancer Center
-
Principal Investigator:
- Aine E. Clements
-
Contact:
- Site Public Contact
- Phone Number: 610-788-3860
- Email: Jennifer.Sexton@ohiohealth.com
-
Westlake, Ohio, United States, 44145
- Recruiting
- UH Seidman Cancer Center at Saint John Medical Center
-
Contact:
- Site Public Contact
- Phone Number: 800-641-2422
- Email: CTUReferral@UHhospitals.org
-
Principal Investigator:
- Amy Armstrong
-
-
Oklahoma
-
Oklahoma City, Oklahoma, United States, 73104
- Recruiting
- University of Oklahoma Health Sciences Center
-
Contact:
- Site Public Contact
- Phone Number: 405-271-8777
- Email: ou-clinical-trials@ouhsc.edu
-
Principal Investigator:
- Grace Duininck
-
-
Oregon
-
Portland, Oregon, United States, 97213
- Recruiting
- Providence Portland Medical Center
-
Principal Investigator:
- Dan S. Zuckerman
-
Contact:
- Site Public Contact
- Phone Number: 503-215-2614
- Email: CanRsrchStudies@providence.org
-
Portland, Oregon, United States, 97225
- Recruiting
- Providence Saint Vincent Medical Center
-
Principal Investigator:
- Dan S. Zuckerman
-
Contact:
- Site Public Contact
- Phone Number: 503-215-2614
- Email: CanRsrchStudies@providence.org
-
Portland, Oregon, United States, 97210
- Recruiting
- Legacy Good Samaritan Hospital and Medical Center
-
Contact:
- Site Public Contact
- Phone Number: 800-220-4937
- Email: cancer@lhs.org
-
Principal Investigator:
- Julia Fehniger
-
Tualatin, Oregon, United States, 97062
- Recruiting
- Legacy Meridian Park Hospital
-
Contact:
- Site Public Contact
- Phone Number: 503-413-1742
-
Principal Investigator:
- Julia Fehniger
-
-
Pennsylvania
-
Erie, Pennsylvania, United States, 16505
- Recruiting
- UPMC Hillman Cancer Center Erie
-
Principal Investigator:
- Sarah E. Taylor
-
Contact:
- Site Public Contact
- Phone Number: 412-864-7716
- Email: ClinicalResearchServices@upmc.edu
-
Greensburg, Pennsylvania, United States, 15601
- Recruiting
- UPMC Cancer Centers - Arnold Palmer Pavilion
-
Contact:
- Site Public Contact
- Phone Number: 724-838-1900
-
Principal Investigator:
- Sarah E. Taylor
-
Mechanicsburg, Pennsylvania, United States, 17050
- Recruiting
- UPMC Hillman Cancer Center at Rocco And Nancy Ortenzio Cancer Pavilion
-
Contact:
- Site Public Contact
- Phone Number: 412-389-5208
- Email: haneydl@upmc.edu
-
Principal Investigator:
- Sarah E. Taylor
-
Philadelphia, Pennsylvania, United States, 19107
- Recruiting
- Thomas Jefferson University Hospital
-
Contact:
- Site Public Contact
- Phone Number: 215-600-9151
- Email: ONCTrialNow@jefferson.edu
-
Principal Investigator:
- Jessa Suhner
-
Philadelphia, Pennsylvania, United States, 19114
- Recruiting
- Jefferson Torresdale Hospital
-
Contact:
- Site Public Contact
- Phone Number: 215-600-9151
- Email: ONCTrialNow@jefferson.edu
-
Principal Investigator:
- Jessa Suhner
-
Pittsburgh, Pennsylvania, United States, 15213
- Recruiting
- UPMC-Magee Womens Hospital
-
Contact:
- Site Public Contact
- Phone Number: 412-647-2811
-
Principal Investigator:
- Sarah E. Taylor
-
Pittsburgh, Pennsylvania, United States, 15237
- Recruiting
- UPMC-Passavant Hospital
-
Contact:
- Site Public Contact
- Phone Number: 412-367-6454
-
Principal Investigator:
- Sarah E. Taylor
-
Washington, Pennsylvania, United States, 15301
- Recruiting
- UPMC Cancer Center-Washington
-
Contact:
- Site Public Contact
- Phone Number: 412-339-5294
- Email: Roster@nrgoncology.org
-
Principal Investigator:
- Sarah E. Taylor
-
Willow Grove, Pennsylvania, United States, 19090
- Recruiting
- Asplundh Cancer Pavilion
-
Contact:
- Site Public Contact
- Phone Number: 215-600-9151
- Email: ONCTrialNow@jefferson.edu
-
Principal Investigator:
- Jessa Suhner
-
-
Rhode Island
-
Providence, Rhode Island, United States, 02905
- Recruiting
- Women and Infants Hospital
-
Contact:
- Site Public Contact
- Phone Number: 401-274-1122
-
Principal Investigator:
- Paul A. DiSilvestro
-
-
Tennessee
-
Nashville, Tennessee, United States, 37232
- Recruiting
- Vanderbilt University/Ingram Cancer Center
-
Contact:
- Site Public Contact
- Phone Number: 800-811-8480
-
Principal Investigator:
- Alaina J. Brown
-
-
Utah
-
Salt Lake City, Utah, United States, 84106
- Recruiting
- University of Utah Sugarhouse Health Center
-
Contact:
- Site Public Contact
- Phone Number: 888-424-2100
- Email: cancerinfo@hci.utah.edu
-
Principal Investigator:
- Talicia Savage
-
Salt Lake City, Utah, United States, 84112
- Recruiting
- Huntsman Cancer Institute/University of Utah
-
Contact:
- Site Public Contact
- Phone Number: 888-424-2100
- Email: cancerinfo@hci.utah.edu
-
Principal Investigator:
- Talicia Savage
-
South Jordan, Utah, United States, 84009
- Recruiting
- South Jordan Health Center
-
Contact:
- Site Public Contact
- Phone Number: 888-424-2100
- Email: cancerinfo@hci.utah.edu
-
Principal Investigator:
- Talicia Savage
-
-
Virginia
-
Charlottesville, Virginia, United States, 22908
- Recruiting
- University of Virginia Cancer Center
-
Contact:
- Site Public Contact
- Phone Number: 434-243-6303
- Email: uvacancertrials@hscmail.mcc.virginia.edu
-
Principal Investigator:
- Linda R. Duska
-
Richmond, Virginia, United States, 23298
- Recruiting
- VCU Massey Comprehensive Cancer Center
-
Principal Investigator:
- Jaclyn Wall
-
Contact:
- Site Public Contact
- Phone Number: 804-628-6430
- Email: CTOclinops@vcu.edu
-
-
Washington
-
Edmonds, Washington, United States, 98026
- Recruiting
- Swedish Cancer Institute-Edmonds
-
Principal Investigator:
- Dan S. Zuckerman
-
Contact:
- Site Public Contact
- Phone Number: 206-215-2343
- Email: PCRC-NCORP@Swedish.org
-
Issaquah, Washington, United States, 98029
- Recruiting
- Swedish Cancer Institute-Issaquah
-
Principal Investigator:
- Dan S. Zuckerman
-
Contact:
- Site Public Contact
- Phone Number: 206-215-2343
- Email: PCRC-NCORP@Swedish.org
-
Seattle, Washington, United States, 98122
- Recruiting
- Swedish Medical Center-First Hill
-
Principal Investigator:
- Dan S. Zuckerman
-
Contact:
- Site Public Contact
- Phone Number: 206-215-2343
- Email: PCRC-NCORP@Swedish.org
-
Vancouver, Washington, United States, 98686
- Recruiting
- Legacy Salmon Creek Hospital
-
Contact:
- Site Public Contact
- Phone Number: 503-413-2150
-
Principal Investigator:
- Julia Fehniger
-
-
West Virginia
-
Bridgeport, West Virginia, United States, 26330
- Recruiting
- United Hospital Center
-
Contact:
- Site Public Contact
- Phone Number: 304-293-7374
- Email: cancertrialsinfo@hsc.wvu.edu
-
Principal Investigator:
- Krista S. Pfaendler
-
Charleston, West Virginia, United States, 25304
- Recruiting
- West Virginia University Charleston Division
-
Contact:
- Site Public Contact
- Phone Number: 304-388-9944
-
Principal Investigator:
- Stephen H. Bush
-
Martinsburg, West Virginia, United States, 25401
- Recruiting
- WVUH-Berkely Medical Center
-
Contact:
- Site Public Contact
- Phone Number: 304-293-7374
- Email: cancertrialsinfo@hsc.wvu.edu
-
Principal Investigator:
- Krista S. Pfaendler
-
Morgantown, West Virginia, United States, 26506
- Recruiting
- West Virginia University Healthcare
-
Contact:
- Site Public Contact
- Phone Number: 304-293-7374
- Email: cancertrialsinfo@hsc.wvu.edu
-
Principal Investigator:
- Krista S. Pfaendler
-
Parkersburg, West Virginia, United States, 26101
- Recruiting
- Camden Clark Medical Center
-
Contact:
- Site Public Contact
- Phone Number: 304-293-7374
- Email: cancertrialsinfo@hsc.wvu.edu
-
Principal Investigator:
- Krista S. Pfaendler
-
-
Wisconsin
-
Ashland, Wisconsin, United States, 54806
- Recruiting
- Duluth Clinic Ashland
-
Contact:
- Site Public Contact
- Phone Number: 218-786-3308
- Email: CancerTrials@EssentiaHealth.org
-
Principal Investigator:
- Bret E. Friday
-
Green Bay, Wisconsin, United States, 54301
- Recruiting
- Saint Vincent Hospital Cancer Center Green Bay
-
Principal Investigator:
- Matthew L. Ryan
-
Contact:
- Site Public Contact
- Phone Number: 920-433-8889
- Email: wi_research_admin@hshs.org
-
Green Bay, Wisconsin, United States, 54303
- Recruiting
- Saint Vincent Hospital Cancer Center at Saint Mary's
-
Principal Investigator:
- Matthew L. Ryan
-
Contact:
- Site Public Contact
- Phone Number: 920-433-8889
- Email: wi_research_admin@hshs.org
-
La Crosse, Wisconsin, United States, 54601
- Recruiting
- Gundersen Lutheran Medical Center
-
Contact:
- Site Public Contact
- Phone Number: 608-775-2385
- Email: cancerctr@gundersenhealth.org
-
Principal Investigator:
- Kurt Oettel
-
Oconto Falls, Wisconsin, United States, 54154
- Recruiting
- Saint Vincent Hospital Cancer Center at Oconto Falls
-
Principal Investigator:
- Matthew L. Ryan
-
Contact:
- Site Public Contact
- Phone Number: 920-433-8889
- Email: wi_research_admin@hshs.org
-
Sheboygan, Wisconsin, United States, 53081
- Recruiting
- Saint Vincent Hospital Cancer Center at Sheboygan
-
Principal Investigator:
- Matthew L. Ryan
-
Contact:
- Site Public Contact
- Phone Number: 920-433-8889
- Email: wi_research_admin@hshs.org
-
Sheboygan, Wisconsin, United States, 53081
- Recruiting
- Sheboygan Physicians Group
-
Principal Investigator:
- Matthew L. Ryan
-
Contact:
- Site Public Contact
- Phone Number: 920-433-8889
- Email: wi_research_admin@hshs.org
-
Spooner, Wisconsin, United States, 54801
- Recruiting
- Essentia Health-Spooner Clinic
-
Contact:
- Site Public Contact
- Phone Number: 218-786-3308
- Email: CancerTrials@EssentiaHealth.org
-
Principal Investigator:
- Bret E. Friday
-
Sturgeon Bay, Wisconsin, United States, 54235-1495
- Recruiting
- Saint Vincent Hospital Cancer Center at Sturgeon Bay
-
Principal Investigator:
- Matthew L. Ryan
-
Contact:
- Site Public Contact
- Phone Number: 920-433-8889
- Email: wi_research_admin@hshs.org
-
Superior, Wisconsin, United States, 54880
- Recruiting
- Essentia Health Saint Mary's Hospital - Superior
-
Principal Investigator:
- Bret E. Friday
-
Contact:
- Site Public Contact
- Phone Number: 701-364-6272
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
Documentation of disease:
- Stage III and stage IVA endometrial cancers (with measurable disease),
- Stage IVB endometrial cancer (with or without measurable disease), or
- Recurrent endometrial cancer (with or without measurable disease)
- In patients with measurable disease, lesions will be defined and monitored by RECIST 1.1. Measurable disease (RECIST 1.1) is defined as at least one lesion that can be accurately measured in at least one dimension (longest diameter to be recorded). Each lesion must be ≥ 10 mm when measured by CT or MRI. Lymph nodes must be ≥ 15 mm in short axis when measured by CT or MRI
- Histologic confirmation of the original primary tumor is required (submission of pathology report[s] is required). Patients with the following histologic types are eligible: endometrioid, serous, dedifferentiated/undifferentiated, clear cell, mixed epithelial, carcinosarcoma, adenocarcinoma not otherwise specified (N.O.S.)
Patients must have:
- Tumoral mismatch repair proficient (pMMR) disease as assessed by immunohistochemistry (IHC) AND
- P53 IHC with aberrant staining pattern (aberrant p53 expression is consistent with mutant TP53). TP53 mutation by next-generation sequencing will also be accepted
- A pathology report demonstrating results of institutional MMR IHC and p53 IHC and/or TP53 by next-generation sequencing
Patients may have received:
- NO prior chemotherapy for treatment of endometrial cancer OR
- Prior adjuvant chemotherapy (e.g., paclitaxel/carboplatin alone or as a component of concurrent chemotherapy and radiation therapy [with or without cisplatin]) provided adjuvant chemotherapy was completed ≥ 12 months prior to registration
- Patients may have received prior radiation therapy for treatment of endometrial cancer. Prior radiation therapy may have included pelvic radiation therapy, extended field pelvic/para-aortic radiation therapy, intravaginal brachytherapy, and/or palliative radiation therapy. All radiation therapy must be completed at least 4 weeks prior to registration. For patients with recent radiation, they must have RECIST-evaluable disease outside of the radiation field and have recovered their marrow function
- Patients may have received prior hormonal (endocrine) therapy. All hormonal (endocrine) therapy must have been completed at least 1 week prior to registration
- NO prior pembrolizumab (or other anti-PD1, anti-PDL1 or anti-CTLA4 therapy) or bevacizumab (or other antiangiogenic therapy)
- Interval or cytoreductive surgery, after start of treatment on this trial, and prior to documentation of disease progression, is NOT permitted
- Patients with treated brain metastases are eligible if follow-up brain imaging after central nervous system (CNS)-directed therapy shows no evidence of disease progression. Patients with brain metastases must have follow up imaging demonstrating no evidence of disease progression and that the disease is stable off of steroids
- Age ≥ 18
- Eastern Cooperative Oncology Group (ECOG) performance status of ≤ 2
- Not pregnant and not nursing
- Absolute neutrophil count (ANC) ≥ 1,500 cells/mm^3
- Platelets ≥ 100,000 cells/mm^3
- Hemoglobin ≥ 8 g/dl
- Creatinine clearance (CrCl) of ≥ 30 mL/min by the Cockcroft-Gault formula
- Total bilirubin ≤ 1.5 x institutional upper limit of normal (ULN) (patients with known Gilbert's disease who have bilirubin level ≤ 3 x institutional ULN may be enrolled)
- Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 3 x institutional ULN
- 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 Classification. To be eligible for this trial, patients should be class II or better
- No active infection requiring parenteral antibiotics
- No current evidence of intra-abdominal abscess, abdominal/pelvic fistula (not diverted), gastrointestinal perforation, gastrointestinal (GI) obstruction, and/or need for drainage nasogastric or gastrostomy tube
- No clinically significant bleeding within 28 days prior to registration
- No uncontrolled hypertension, defined as systolic ≥ 160 mm Hg or diastolic ≥ 100 mm Hg
- No major surgery within 28 days of initiation of bevacizumab
No active autoimmune disease or history of autoimmune disease that might recur, which may affect vital organ function or require immune suppressive treatment including corticosteroids. This includes, but is not limited to, patients with a history of immune related neurologic disease, multiple sclerosis, autoimmune (demyelinating) neuropathy, Guillain-Barre syndrome, myasthenia gravis; systemic autoimmune disease such as systemic lupus erythematosus (SLE), connective tissue diseases, scleroderma, inflammatory bowel disease (IBD), Crohn's, ulcerative colitis, hepatitis; and patients with a history of toxic epidermal necrolysis (TEN), Stevens-Johnson syndrome, or phospholipid syndrome because of the risk of recurrence or exacerbation of disease
- Patients with vitiligo, endocrine deficiencies including type I diabetes mellitus, thyroiditis managed with replacement hormones including physiologic corticosteroids are eligible
- Topical or inhaled steroids are allowed
- Patients with rheumatoid arthritis and other arthropathies, Sjogren's syndrome and psoriasis controlled with topical medication and patients with positive serology, such as antinuclear antibodies (ANA), and anti-thyroid antibodies should be evaluated with the presence of target organ involvement and potential need for systemic treatment but should otherwise be eligible
- No history of (non-infectious) pneumonitis that required steroids, or current pneumonitis
- No history of stem cell or solid organ transplant
- No history of allergic reaction to the study agent(s) or compounds of similar chemical or biologic composition to the study agent(s) (or any of its excipients)
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: Arm 1 (paclitaxel, carboplatin, pembrolizumab)
Patients receive paclitaxel IV over 3 hours, carboplatin IV and pembrolizumab IV over 30 minutes on day 1 of each cycle.
Cycles repeat every 3 weeks for up to 6-10 cycles in the absence of disease progression or unacceptable toxicity.
Starting 3 weeks after last combination phase cycle, patients may continue to receive maintenance pembrolizumab IV over 30 minutes on day 1 of each cycle.
Cycles repeat every 6 weeks for up to an additional 14 cycles.
Additionally, patients undergo urine and blood sample collection and CT or MRI throughout the study.
|
Given IV
Other Names:
Undergo MRI
Other Names:
Given IV
Other Names:
Undergo CT
Other Names:
Given IV
Other Names:
Undergo urine and blood sample collection
Other Names:
|
|
Experimental: Arm 2 (paclitaxel, carboplatin, bevacizumab)
Patients receive paclitaxel IV over 3 hours, carboplatin IV, and bevacizumab IV or anti-VEGF antibody biosimilar on day 1 of each cycle.
Cycles repeat every 3 weeks for up to 6-10 cycles in the absence of disease progression or unacceptable toxicity.
Starting 3 weeks after last combination phase cycle, patients may continue to receive maintenance bevacizumab IV on day 1 of each cycle.
Treatment repeats every 3 weeks for up to an additional 28 doses.
Additionally, patients undergo urine and blood sample collection and CT or MRI throughout the study.
|
Given IV
Other Names:
Undergo MRI
Other Names:
Given IV
Other Names:
Undergo CT
Other Names:
Given IV
Other Names:
Undergo urine and blood sample collection
Other Names:
|
|
Experimental: Arm 3 (paclitaxel, carboplatin, pembrolizumab, bevacizumab)
Patients receive paclitaxel IV over 3 hours, carboplatin IV, pembrolizumab IV over 30 minutes, and bevacizumab IV or anti-VEGF antibody biosimilar on day 1 of each cycle.
Cycles repeat every 3 weeks for up to 6-10 cycles in the absence of disease progression or unacceptable toxicity.
Starting 3 weeks after last combination phase cycle, patients may continue to receive maintenance pembrolizumab IV over 30 minutes every 6 weeks for up to an additional 14 cycles and bevacizumab IV every 3 weeks for up to an additional 28 doses.
Additionally, patients undergo urine and blood sample collection and CT or MRI throughout the study.
|
Given IV
Other Names:
Undergo MRI
Other Names:
Given IV
Other Names:
Undergo CT
Other Names:
Given IV
Other Names:
Given IV
Other Names:
Undergo urine and blood sample collection
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Progression-free survival (PFS)
Time Frame: From study entry to time of progression or death, whichever occurs first, or date of last contact if neither progression nor death has occurred, assessed up to 5 years
|
Will be defined using Response Evaluation Criteria in Solid Tumors version (v) 1.1.
Will be tested using one-sided log-rank tests with α-levels stratified by factors used in the randomization.
Patients will be grouped by their randomized treatment assignment for intention-to-treat (ITT) analyses, supported by patients in ITT population.
Treatment hazard ratios and their 95% confidence intervals will be estimated using a Cox proportional hazards models specified with a main effect for the randomized treatment assignment and stratified using the stratification factors applied at randomization.
|
From study entry to time of progression or death, whichever occurs first, or date of last contact if neither progression nor death has occurred, assessed up to 5 years
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Overall survival (OS)
Time Frame: From study entry to time of death from any cause, assessed up to 5 years
|
Will be assessed with proportional hazards modeling stratified for stratification factors at baseline.
Hazard ratios and corresponding 2-sided 95% confidence intervals will be estimated for treatment (with Arm 1 as the reference arm).
|
From study entry to time of death from any cause, assessed up to 5 years
|
|
Prognostic and predictive associations of type of TP53 mutation status with PFS
Time Frame: Up to 5 years
|
Will be assessed with proportional hazards modeling stratified for stratification factors at baseline and adjusted by randomized treatment arm assignment.
Hazard ratios and corresponding 2-sided 95% confidence intervals will be estimated for TP53 status as well as treatment hazard ratios (with Arm 1 as the reference arm) within TP53 subgroups.
|
Up to 5 years
|
|
Prognostic and predictive associations of type of TP53 mutation status with OS
Time Frame: Up to 5 years
|
Will be assessed with proportional hazards modeling stratified for stratification factors at baseline and adjusted by randomized treatment arm assignment.
Hazard ratios and corresponding 2-sided 95% confidence intervals will be estimated for TP53 status as well as treatment hazard ratios (with Arm 1 as the reference arm) within TP53 subgroups.
|
Up to 5 years
|
|
Incidence of adverse events (AEs) in treatment with bevacizumab when combined with carboplatin, paclitaxel, and pembrolizumab
Time Frame: Up to 90 days after last dose of study treatment
|
The nature, frequency, and degree of toxicity will be tabulated at the system organ class and AE-specific term levels using Common Terminology Criteria for Adverse Events v 5.0.
Each patient will be represented according to maximum grade observed for each term.
Tabulations will show the number and percentage of patients by maximum grade, within the treatment group received, regardless of the randomized treatment assignment.
No specific hypothesis test is pre-specified.
|
Up to 90 days after last dose of study treatment
|
|
Objective response rate
Time Frame: Within 12 months of initiating therapy
|
Will be defined as the binomial proportion of evaluable patients with a best overall response of complete response or partial response.
Will be supported by their 2-sided, 95% Wilson-Score confidence intervals.
The relative odds of response in each experimental group (vs the reference group) will be estimated using a multivariable logistic regression model specified with main effects for the treatment groups and stratified by the stratification factors reported at baseline.
|
Within 12 months of initiating therapy
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
PFS
Time Frame: From study entry to time of progression or death, whichever occurs first, or date of last contact if neither progression nor death has occurred, assessed up to 5 years
|
Will estimate the PFS treatment effect and the corresponding 95% confidence intervals by sex.
|
From study entry to time of progression or death, whichever occurs first, or date of last contact if neither progression nor death has occurred, assessed up to 5 years
|
|
PFS
Time Frame: From study entry to time of progression or death, whichever occurs first, or date of last contact if neither progression nor death has occurred, assessed up to 5 years
|
Will estimate the PFS treatment effect and the corresponding 95% confidence intervals by race.
|
From study entry to time of progression or death, whichever occurs first, or date of last contact if neither progression nor death has occurred, assessed up to 5 years
|
|
PFS
Time Frame: From study entry to time of progression or death, whichever occurs first, or date of last contact if neither progression nor death has occurred, assessed up to 5 years
|
Will estimate the PFS treatment effect and the corresponding 95% confidence intervals by ethnicity.
|
From study entry to time of progression or death, whichever occurs first, or date of last contact if neither progression nor death has occurred, assessed up to 5 years
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Amanda N Fader, NRG Oncology
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Urogenital Diseases
- Genital Diseases
- Urogenital Neoplasms
- Neoplasms by Site
- Neoplasms
- Female Urogenital Diseases
- Female Urogenital Diseases and Pregnancy Complications
- Uterine Diseases
- Genital Diseases, Female
- Genital Neoplasms, Female
- Uterine Neoplasms
- Endometrial Neoplasms
- Amino Acids, Peptides, and Proteins
- Proteins
- Sulfur Compounds
- Organic Chemicals
- Investigative Techniques
- Clinical Laboratory Techniques
- Diagnostic Techniques and Procedures
- Diagnosis
- Hydrocarbons
- Cycloparaffins
- Hydrocarbons, Alicyclic
- Hydrocarbons, Cyclic
- Terpenes
- Antibodies, Monoclonal, Humanized
- Antibodies, Monoclonal
- Antibodies
- Immunoglobulins
- Immunoproteins
- Blood Proteins
- Serum Globulins
- Globulins
- Inorganic Chemicals
- Coordination Complexes
- Taxoids
- Cyclodecanes
- Diterpenes
- Health Care Economics and Organizations
- Chemistry Techniques, Analytical
- Spectrum Analysis
- Immunoglobulin Isotypes
- Sulfides
- Anions
- Ions
- Electrolytes
- Hydrogen Sulfide
- Economics
- Bevacizumab
- Carboplatin
- Paclitaxel
- Immunoglobulin G
- Specimen Handling
- pembrolizumab
- Magnetic Resonance Spectroscopy
- Disulfides
- Taxes
Other Study ID Numbers
- NCI-2025-06974 (Registry Identifier: CTRP (Clinical Trial Reporting Program))
- U10CA180868 (U.S. NIH Grant/Contract)
- NRG-GY035 (Other Identifier: CTEP)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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Sun Yat-sen UniversityNot yet recruiting
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National Cancer Institute (NCI)CompletedBreast Cancer | Ovarian CancerUnited States
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Tang-Du HospitalRecruitingHead & Neck CancerChina
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Shuangyue LiuNot yet recruiting