Study to Assess the Efficacy and Safety of Rina-S Compared to Treatment of Investigator's Choice in Participants With Endometrial Cancer
18 Years and older, Male and Female
GCT1184-03 (primary)
NCI-2025-08516
2024-519818-31
ENGOT-en31
GEICO-158-E
GOG-3128
jRCT2031250494
MOH_2026-03-29_015739
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).
Objectives
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.
Eligibility
- Participants must have histologically or cytologically confirmed recurrent or progressive endometrial cancer (EC; any subtype excluding neuroendocrine tumors, carcinosarcoma, or endometrial sarcoma) following prior therapy.
- Participants must have received at least 1, but not more than 3, prior lines of therapy:
- Participants must have received prior platinum-based chemotherapy and a programmed death (ligand)-1 (PD(L)-1) inhibitor, either separately or in combination
- If the tumor recurred more than 12 months after completion of platinum-based chemotherapy, additional platinum-based chemotherapy must be administered for recurrent disease unless the participant is ineligible for further platinum-based chemotherapy, in which case the reason for ineligibility must be documented.
- Note: If Immunotherapy-based treatment is administered in the advanced/recurrent setting, then platinum rechallenge is not required, regardless of the duration of the platinum-free interval from prior platinum-based chemotherapy. In such cases, the reason for ineligibility for platinum-based chemotherapy must be documented.
- Prior induction plus maintenance is considered 1 line of therapy
- Hormonal therapy alone (i.e., without chemotherapy) will not be counted as a separate line of therapy.
- Therapy changed due to toxicity in the absence of progression will be considered part of the same line of therapy (i.e., will not be counted independently as a separate line of therapy)
- Participants must have progressed radiographically on or after their most recent line of therapy Key
Treatment Sites in Georgia
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