Immunotherapy vs Chemotherapy for Endometrial Cancer

Recruiting in Palo Alto (17 mi)

+196 other locations

Age: 18+

Sex: Female

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 3

Waitlist Available

Sponsor: Merck Sharp & Dohme Corp.

No Placebo Group

Pivotal Trial (Near Approval)

Prior Safety Data

Breakthrough Therapy

Trial Summary

What is the purpose of this trial?The purpose of this study is to assess the safety and efficacy of treatment with pembrolizumab (MK-3475) compared to a combination of carboplatin and paclitaxel in women with mismatch repair deficient (dMMR) advanced or recurrent endometrial carcinoma who have not previously been treated with prior systemic chemotherapy. The primary study hypotheses are that pembrolizumab is superior to the combination of carboplatin and paclitaxel with respect to Progression Free Survival (PFS) per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) as assessed by Blinded Independent Central Review (BICR) and Overall Survival (OS).

Eligibility Criteria

This trial is for women with advanced or recurrent endometrial carcinoma that's mismatch repair deficient (dMMR) and who haven't had systemic chemotherapy before. They should be in good physical condition, not pregnant, willing to use contraception, and able to provide a tumor tissue sample. Those with active CNS metastases, recent major surgeries, other cancers within 3 years (except certain skin cancers), active infections requiring therapy, HIV infection or autoimmune diseases treated in the last 2 years can't join.

Inclusion Criteria

I am positive for Hepatitis B but have been treated and now have an undetectable viral load.

My cancer can be seen and measured on scans.

I have esophageal cancer and have only had specific prior treatments like chemotherapy, radiation, or hormonal therapy.

+6 more

Exclusion Criteria

Is currently participating in or has participated in certain types of studies or used investigational devices within specified timeframes before the first dose of study intervention.

I have had treatment for advanced or metastatic endometrial cancer.

I am still recovering from a major surgery.

+14 more

Participant Groups

The study compares the safety and effectiveness of pembrolizumab against standard chemotherapy (carboplatin and paclitaxel). The goal is to see if pembrolizumab improves progression-free survival and overall survival better than the chemo combination. Participants will be randomly assigned to one of these treatments.

2Treatment groups

Experimental Treatment

Active Control

Group I: PembrolizumabExperimental Treatment1 Intervention

Participants receive pembrolizumab 400 mg via IV infusion on Day 1 of each 6-week cycle (Q6W) for up to 18 cycles (up to approximately 2 years).

Group II: Carboplatin+paclitaxelActive Control4 Interventions

Participants receive a combination of paclitaxel 175 mg/m\^2 on Day 1 of each 3-week cycle (Q3W) and carboplatin AUC 5 or 6 on Day 1 Q3W for 6 cycles (up to approximately 4 months). Participants who experience a severe hypersensitivity reaction to paclitaxel or an adverse event (AE) requiring discontinuation of paclitaxel may receive docetaxel 75 mg/m\^2 in place of paclitaxel on Day 1 Q3W after Sponsor consultation. Participants who experience a severe hypersensitivity reaction to carboplatin or an AE requiring discontinuation of carboplatin may receive cisplatin 75 mg/m\^2 in place of carboplatin on Day 1 Q3W after Sponsor consultation.

Carboplatin is already approved in United States, European Union, Canada for the following indications:

🇺🇸 Approved in United States as Paraplatin for: