GEN1046 in Combination With Anticancer Agents for the Treatment of Advanced Endometrial Cancer
Advanced Endometrial Cancer
About this trial
This is an interventional treatment trial for Advanced Endometrial Cancer
Eligibility Criteria
Inclusion Criteria: Have a histologically confirmed diagnosis of advanced (unresectable, recurrent, and/or metastatic) endometrial carcinoma that is incurable and for which prior standard first-line treatment has failed. Prior to Cycle 1 Day 1 (C1D1), documentation of tumor dMMR/MSI-H status must be available based on local testing. Must have progressed on or after at least 1 (but no more than 2) prior line(s) of a systemic chemotherapy regimen for unresectable and/or metastatic endometrial cancer of which at least 1 regimen of platinum-based treatment unless participant is ineligible for or intolerant to platinum. Cohort A only: Must be treatment naive for CPIs including PD-1 or PD-L1 inhibitors and other immune CPIs (eg, anti-CTLA-4, anti-LAG3, anti-TIGIT). Cohort B only: Must have received and progressed on or after prior treatment with a PD-1/PD-L1 inhibitor alone or in combination. Moreover, the participant's duration of CPI containing treatment and best overall response (BOR) is known, and participant has received a minimum of 2 cycles of CPI. Exclusion Criteria: Histological diagnosis of carcinosarcoma, malignant mixed Műllerian tumor, endometrial leiomyosarcoma, or endometrial stromal sarcomas. Any prior treatment with any type of antitumor vaccine, or autologous cell immunotherapy. Radiotherapy within 14 days before the planned first dose of trial treatment with exception of palliative radiotherapy to bone lesions. Treatment with an anticancer agent, including investigational vaccines within 28 days before or 5 times t1/2, whichever is shorter, prior to the planned first dose of trial treatment or is currently enrolled in an interventional trial. Prior treatment with live, attenuated vaccines within 30 days prior to initiation of trial treatment. Received granulocyte colony-stimulating factor (G-CSF) or granulocyte-macrophage colony-stimulating factor (GM-CSF) support within 4 weeks before the planned first dose of trial treatment. Cohort A only: Prior exposure to immune CPIs other than anti-PD-1/anti-PD-L1 (eg, anti-CTLA-4, anti-LAG3, anti-TIGIT) or agents directed at costimulatory T-cell receptors (eg, 4-1BB, OX40) Cohort B only: Known history of Grade 3 or higher immune-related adverse events (irAEs) that led to treatment discontinuation of a prior immunotherapy treatment Exposure to any of the following prior therapies/treatments within the specified timeframes: Prior exposure to immune CPIs other than anti-PD-1/anti-PD-L1 (eg, anti-CTLA-4, anti-LAG3, anti-TIGIT) or agents directed at costimulatory T-cell receptors (eg, 4-1BB, OX40) PD-1/PD-L1 antibody within 28 days before the planned first dose of trial treatment NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.
Sites / Locations
- Orlando Health Cancer InstituteRecruiting
Arms of the Study
Arm 1
Arm 2
Experimental
Experimental
Cohort A: Pembrolizumab + GEN1046
Cohort B: Pembrolizumab + GEN1046
Pembrolizumab will be administered in combination with GEN1046 as second-line (2L) or third-line (3L) therapy for dMMR/MSI-H in checkpoint inhibitor (CPI) naive participants.
Pembrolizumab will be administered in combination with GEN1046 as 2L or 3L therapy for mismatch repair deficient/ microsatellite instability-high (dMMR/MSI-H) participants who had prior exposure to programmed cell death protein/ programmed death ligand 1 (PD-1/PD-L1) inhibitors.