A Phase 3 Randomized, Open-label Study of Rinatabart Sesutecan (Rina-S) Versus Treatment of Investigator's Choice (IC) in Patients With Endometrial Cancer After Platinum-Based Chemotherapy and PD(L)-1 Therapy
Summary
The purpose of this study is to compare how well Rina-S (GEN1184) works compared to treatment of physician's choice (paclitaxel or doxorubicin) that are considered standard medical care for the treatment of recurrent or progressive endometrial cancer (EC) following prior therapy. There is an equal (50:50) chance of getting either Rina-S or a chemotherapy agent as treatment in this study. The study duration will be approximately 3 years. The treatment duration will be different for every participant, but an average of 4 to 6 months is expected. All participants will receive active drug; no one will be given placebo. Participation in the study will require visits to the study site(s).
Detailed description
This is a global, open-label, randomized Phase 3 study in approximately 660 participants with recurrent or progressive EC following prior therapy. Participants will be randomized in a 1:1 ratio to receive treatment with Rina-S vs investigator's choice (IC) (paclitaxel or doxorubicin). Investigators must select one of the IC treatment options for each participant prior to randomization so that this may be used for treatment assignment if the participant is randomized to the IC arm.
Arms & interventions
- DrugRina-S
Intravenous (IV) infusion.
- DrugIC
* Paclitaxel: IV infusion * Doxorubicin: IV bolus injection/infusion
Outcome measures
Primary
Progression-free Survival (PFS) per Response Criteria in Solid Tumors (RECIST) v1.1, as Determined by Blinded Independent Central Review (BICR)
Time frame: Up to approximately 3 years
Overall Survival (OS)
Time frame: Up to approximately 3 years
Secondary
Objective Response Rate (ORR), per RECIST v1.1, as Determined by BICR
Time frame: Up to approximately 3 years
PFS, per RECIST v1.1, as Determined by Investigator Assessment
Time frame: Up to approximately 3 years
ORR, per RECIST v1.1, as Determined by Investigator Assessment
Time frame: Up to approximately 3 years
Duration of Objective Response (DOR), per RECIST v1.1, as Determined by Investigator Assessment
Time frame: Up to approximately 3 years
DOR, per RECIST v1.1, as Determined by BICR
Time frame: Up to approximately 3 years
Number of Participants with Treatment-emergent Adverse Events (TEAEs)
Time frame: Up to approximately 3 years
Change from Baseline in Global Health Status/Quality of Life (GHS/Qol)
Time frame: Baseline up to approximately 3 years
Time to Deterioration (TTD) in GHS/Qol
Time frame: Up to approximately 3 years
Eligibility criteria
Study locations (43)
MedStar Washington Hospital
Washington D.C., District of Columbia, 20010
SMH - Sarasota - Main Campus
Sarasota, Florida, 34239
Women's Care - 9th Ave
St. Petersburg, Florida, 33713
Emory Winship Cancer Inst.
Atlanta, Georgia, 30308
Emory Winship Cancer Inst.
Atlanta, Georgia, 30322
Emory Winship Cancer Inst./Emory Decatur Hospital
Decatur, Georgia, 30033
Trials365, LLC
Shreveport, Louisiana, 71103
Sinai Hospital
Baltimore, Maryland, 21215
William Kahlert Reg. Can. Ctr
Westminster, Maryland, 21157
USOR - Minnesota Oncology-Coon Rapids Clinic
Coon Rapids, Minnesota, 55433
USOR - Minnesota Oncology/ Coon Rapids Clinic
Coon Rapids, Minnesota, 55433
USOR - Minnesota Oncology - Edina Clinic
Edina, Minnesota, 55435
USOR - Minnesota Oncology/Edina Clinic
Edina, Minnesota, 55435
USOR - Minnesota Oncology/ Maple Grove Clinic
Maple Grove, Minnesota, 55369
USOR - Minnesota Oncology-Maplewood Clinic
Maplewood, Minnesota, 55109
USOR - Minnesota Oncology/ Maplewood Clinic
Maplewood, Minnesota, 55109
USOR - Minnesota Oncology/ Minneapolis Clinic
Minneapolis, Minnesota, 55404
USOR - Minnesota Oncology
Minneapolis, Minnesota, 55404
USOR - Minnesota Oncology/ Woodbury Clinic
Woodbury, Minnesota, 55125
Washington University School of Medicine
St Louis, Missouri, 63110
University of Cincinnati Medical Center
Cincinnati, Ohio, 45219
Willamette Valley Cancer Institute and Research Center - Eugene
Eugene, Oregon, 97401
NW Cancer Specs. P.C.
Happy Valley, Oregon, 97015
USOR - NW Cancer Specs P.C.
Portland, Oregon, 97227
USOR - NW Cancer Specs. P.C.
Tigard, Oregon, 97223
TX Onc - Arlington North
Arlington, Texas, 76012
USOR - Texas Oncology
Austin, Texas, 78731
USOR - Texas Oncology
Austin, Texas, 78745
USOR - Texas Oncology- Austin North
Austin, Texas, 78758
TX Onc - Bedford
Bedford, Texas, 76022
TX Onc - Methodist Dallas
Dallas, Texas, 75203
TX Onc - Presbyterian Dallas
Dallas, Texas, 75231
TX Onc - Methodist Charlton
Dallas, Texas, 75237
TX Onc - Sammons
Dallas, Texas, 75246
USOR - Texas Oncology - Dallas Fort Worth (DFW)
Fort Worth, Texas, 76104
USOR - Texas Oncology
Harlingen, Texas, 78550
USOR - Texas Oncology
McAllen, Texas, 78503
USOR - TX Oncology - SA NE
San Antonio, Texas, 78217
NEXT San Antonio
San Antonio, Texas, 78240
USOR - Texas Oncology- Horizon Circle
Waco, Texas, 76712
USOR - Texas Oncology- Waco
Waco, Texas, 76712
USOR - Texas Oncology
Weslaco, Texas, 78596
USOR - NW Cancer Specs P.C.
Vancouver, Washington, 98684