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Alkylating agents

Pembrolizumab + Chemotherapy for Endometrial Cancer

Phase 3

Waitlist Available

Led By Ramez N Eskander

Research Sponsored by National Cancer Institute (NCI)

Eligibility Criteria Checklist

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

Must have

Measurable stage III, measurable stage IVA, stage IVB (with or without measurable disease) or recurrent (with or without measurable disease) endometrial cancer.

Performance status of 0, 1 or 2

Must not have

For patients with evidence of chronic hepatitis B virus (HBV) infection, the HBV viral load must be undetectable on suppressive therapy, if indicated

Uncontrolled intercurrent illness including, but not limited to: ongoing or active infection (except for uncomplicated urinary tract infection), interstitial lung disease or active, non-infectious pneumonitis, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 5 years

Awards & highlights

Pivotal Trial

Summary

This trial is studying the combination of pembrolizumab, paclitaxel, and carboplatin to treat endometrial cancer.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

Pembrolizumab can cause immune-related side effects such as inflammation in various organs, skin reactions, hormone gland problems (like thyroid issues), and infusion-related reactions. Chemotherapy with paclitaxel and carboplatin may lead to hair loss, nausea, fatigue, increased risk of infection due to low blood cell counts.

Eligibility Criteria

Inclusion Criteria

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

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

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I can take care of myself and perform daily activities.

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

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My cancer's type has been confirmed by a pathology report.

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My cancer can be measured by scans and has a visible tumor or enlarged lymph node.

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I cannot have surgery to reduce my tumor size after starting this trial until my disease progresses.

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I cannot have surgery to reduce my tumor after starting this trial until my disease progresses.

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My pathology report includes MMR protein testing results.

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I am 18 years old or older.

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My cancer type is confirmed and matches one of the specified types.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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My hepatitis B virus load is undetectable with treatment.

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

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I have had pneumonitis treated with steroids or have it now.

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I do not have significant liver disease like hepatitis or cirrhosis.

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I have or had an autoimmune disease that could worsen or needs steroids.

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I have been treated with specific immune therapy drugs before.

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I had hepatitis C but am cured, or I'm being treated with no detectable virus.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 5 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~5 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and 5 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Progression-free survival (PFS)

Secondary study objectives

Association between PD-L1 IHC and MMR status

Concordance between Institutional Mismatch repair (MMR) immunohistochemistry (IHC) testing and centralized MMR IHC

Duration of objective response

+5 more

Awards & Highlights

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Arm II (pembrolizumab, paclitaxel, carboplatin)Experimental Treatment6 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 Control6 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.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Computed Tomography

2017

Completed Phase 2

~2790

Paclitaxel

2011

Completed Phase 4

~5450