Pembrolizumab + Chemotherapy for Endometrial Cancer

Recruiting at 406 trial locations

Overseen by Ramez N Eskander

Age: 18+

Sex: Female

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 3

Waitlist Available

Sponsor: National Cancer Institute (NCI)

No Placebo Group

Pivotal Trial (Near Approval)

Prior Safety Data

Breakthrough Therapy

Trial Summary

What is the purpose of this trial?

This phase III trial studies how well the combination of pembrolizumab, paclitaxel and carboplatin works compared with paclitaxel and carboplatin alone in treating patients with endometrial cancer that is stage III or IV, or has come back after a period of improvement (recurrent). Immunotherapy with monoclonal antibodies, such as pembrolizumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Paclitaxel and carboplatin are chemotherapy drugs used as part of the usual treatment approach for this type of cancer. This study aims to assess if adding immunotherapy to these drugs is better or worse than the usual approach for treatment of this cancer.

Research Team

Ramez N Eskander

Principal Investigator

NRG Oncology

Eligibility Criteria

This trial is for adults with stage III-IV or recurrent endometrial cancer. Eligible participants may have had prior hormonal therapy, but not chemotherapy for this cancer within the last year, and no previous treatment with certain immunotherapy drugs. They must not be pregnant, agree to use contraception if of childbearing potential, and cannot have severe allergies to the study drugs or significant health conditions that could affect safety.

Inclusion Criteria

My endometrial cancer is at stage III, IVA, IVB, or is recurrent.

I am HIV positive, on treatment, and my viral load is undetectable.

For patients of child bearing potential: negative urine or serum pregnancy test. If the urine test is positive or cannot be confirmed as negative, a serum pregnancy test is required

Exclusion Criteria

My hepatitis B virus load is undetectable with treatment.

I have not taken steroids or immunosuppressants in the last 7 days.

I do not have any severe illnesses that could interfere with the study.

Treatment Details

Interventions

• Carboplatin (Alkylating agents)
• Paclitaxel (Anti-metabolites)
• Pembrolizumab (Monoclonal Antibodies)

Trial Overview The trial tests adding pembrolizumab (an immunotherapy drug) to the usual chemotherapy regimen of paclitaxel and carboplatin in treating advanced or recurrent endometrial cancer. It aims to see if this combination improves outcomes compared to chemotherapy alone.

Participant Groups

Group I: Arm II (pembrolizumab, paclitaxel, carboplatin) Experimental Treatment 6 Interventions

COMBINATION PHASE: Patients receive pembrolizumab IV over 30 minutes on day 1 of each cycle, paclitaxel IV over 3 hours on day 1 of each cycle, and carboplatin IV over 30 minutes on day 1 of each cycle. Treatment repeats every 3 weeks for 6 cycles in the absence of disease progression or unacceptable toxicity. Patients with SD or PR who still have measurable disease may continue treatment for up to a total of 10 cycles (if deemed necessary by the treating physician) in the absence of disease progression or unacceptable toxicity. MAINTENANCE PHASE: Patients receive pembrolizumab IV over 30-60 minutes on day 1 of each cycle. Treatment repeats every 6 weeks for up to 14 cycles in the absence of disease progression or unacceptable toxicity. Patients undergo CT scan throughout the study.

Group II: Arm I (placebo, paclitaxel, carboplatin) Active Control 6 Interventions

COMBINATION PHASE: Patients receive placebo IV over 30 minutes on day 1 of each cycle, paclitaxel IV over 3 hours on day 1 of each cycle, and carboplatin IV over 30-60 minutes on day 1 of each cycle. Treatment repeats every 3 weeks for 6 cycles in the absence of disease progression or unacceptable toxicity. Patients with SD or PR who still have measurable disease may continue treatment for up to a total of 10 cycles (if deemed necessary by the treating physician) in the absence of disease progression or unacceptable toxicity. MAINTENANCE PHASE: Patients receive placebo IV over 30 minutes on day 1 of each cycle. Treatment repeats every 6 weeks for up to 14 cycles in the absence of disease progression or unacceptable toxicity. Patients undergo CT scan throughout the study. On February 6, 2023, all patient treatment assignments were unblinded. Patients randomized to Arm 1 will not receive additional placebo infusions.

Carboplatin is already approved in Canada for the following indications:

Approved in Canada as Carboplatin for:

• Ovarian cancer
• Small cell lung cancer
• Testicular cancer

Who Is Running the Clinical Trial?

National Cancer Institute (NCI)

Lead Sponsor

Trials

14,080

Recruited

41,180,000+

Dr. Douglas R. Lowy

National Cancer Institute (NCI)

Chief Executive Officer since 2023

MD from New York University School of Medicine

Dr. Monica Bertagnolli

National Cancer Institute (NCI)

Chief Medical Officer since 2022

MD from Harvard Medical School

Canadian Cancer Trials Group

Collaborator

Trials

135

Recruited

70,300+

Dr. Janet Dancey

Canadian Cancer Trials Group

Chief Medical Officer since 2014

MD, FRCPC

Susan Marlin

Canadian Cancer Trials Group

Chief Executive Officer since 2012

BSc (Hons) from Dalhousie University, MSc in Community Health and Epidemiology from Queen’s University

NRG Oncology

Collaborator

Trials

242

Recruited

105,000+

Stephanie Gaillard

NRG Oncology

Chief Medical Officer

MD from Johns Hopkins University

Norman Wolmark

NRG Oncology

Chief Executive Officer since 2023

MD from Harvard Medical School