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Monoclonal Antibodies

GEN1046 + Anticancer Agents for Endometrial Cancer

Phase 2

Waitlist Available

Research Sponsored by Genmab

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

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.

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 4 years

Awards & highlights

Study Summary

This trial will study a new antibody drug combo to treat incurable endometrial cancer, measuring effectiveness and safety in participants over 39 months.

Who is the study for?

This trial is for individuals with advanced endometrial cancer that's incurable and has failed previous treatments. Participants must have had one or two prior chemotherapy regimens, including platinum-based treatment unless unsuitable. Cohort A includes those new to immune checkpoint inhibitors (CPIs), while Cohort B requires progression after CPI treatment.Check my eligibility

What is being tested?

The study tests acasunlimab combined with pembrolizumab in patients with advanced endometrial cancer. It aims to determine the effectiveness of this combination therapy and monitor side effects over a maximum of 24 months of treatment, within an overall study duration of approximately 39 months.See study design

What are the potential side effects?

Potential side effects from acasunlimab and pembrolizumab may include reactions related to the immune system affecting various organs, infusion-related reactions, fatigue, digestive issues, skin problems, hormonal gland issues like thyroid dysfunction, and increased risk of infections.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My endometrial cancer is advanced and has not responded to initial treatments.

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My tumor is confirmed to have mismatch repair deficiency.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 4 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 4 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 4 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Objective Response Rate (ORR)

Secondary outcome measures

Disease Control Rate (DCR)

Duration of Response (DOR)

Number of Participants with Treatment Emergent Adverse Events (TEAEs) and as Per Severity

+1 more

Trial Design

2Treatment groups

Experimental Treatment

Group I: Cohort B: pembrolizumab + acasunlimabExperimental Treatment2 Interventions

Pembrolizumab will be administered in combination with acasunlimab 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.

Group II: Cohort A: pembrolizumab + acasunlimabExperimental Treatment2 Interventions

Pembrolizumab will be administered in combination with acasunlimab as second-line (2L) or third-line (3L) therapy for dMMR/MSI-H in checkpoint inhibitor (CPI) naïve participants.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Pembrolizumab

2017

Completed Phase 2

~2010

0 / 2Eligibility criteria met

Find a Location

Who is running the clinical trial?

GenmabLead Sponsor

56 Previous Clinical Trials

12,152 Total Patients Enrolled

4 Trials studying Endometrial Cancer

539 Patients Enrolled for Endometrial Cancer

BioNTech SEIndustry Sponsor

64 Previous Clinical Trials

109,101 Total Patients Enrolled

1 Trials studying Endometrial Cancer

468 Patients Enrolled for Endometrial Cancer

Study OfficialStudy DirectorGenmab

9 Previous Clinical Trials

2,549 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are any more individuals being enrolled into this trial at the present?

"According to clinicaltrials.gov, this research is currently accepting enrollees and was initially listed on October 9th 2023 with the latest update taking place two weeks ago on October 2nd of the same year."

Answered by AI

How many participants are currently included in this medical trial?

"Affirmative. According to records hosted on clinicaltrials.gov, this medical trial is currently recruiting patients with the study's initial posting occurring on October 9th 2023 and its last update taking place on October 2nd of the same year. The research requires 80 participants from a single site to move forward."

Answered by AI

Has the combination of Pembrolizumab and GEN1046 been granted authorization from the FDA?

"Our assessment of Cohort A: Pembrolizumab + GEN1046's safety is 2, as there are preliminary safety data but no evidence yet to support its efficacy."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

GEN1046 in Combination With Anticancer Agents for the Treatment of Advanced Endometrial Cancer

2024. "GEN1046 in Combination With Anticancer Agents for the Treatment of Advanced Endometrial Cancer". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06046274.