Testing the Addition of the Immunotherapy Drug Pembrolizumab to the Usual Chemotherapy Treatment (Paclitaxel and Carboplatin) in Stage III-IV or Recurrent Endometrial Cancer

Conditions

• Endometrial Clear Cell Adenocarcinoma
• Endometrial Dedifferentiated Carcinoma
• Endometrial Endometrioid Adenocarcinoma
• Endometrial Mixed Cell Adenocarcinoma
• Endometrial Serous Adenocarcinoma
• Endometrial Undifferentiated Carcinoma
• Recurrent Endometrial Adenocarcinoma
• Recurrent Endometrial Carcinoma
• Recurrent Endometrial Clear Cell Adenocarcinoma
• Recurrent Endometrial Dedifferentiated Carcinoma
• Recurrent Endometrial Endometrioid Adenocarcinoma
• Recurrent Endometrial Mixed Cell Adenocarcinoma
• Recurrent Endometrial Serous Adenocarcinoma
• Recurrent Endometrial Undifferentiated Carcinoma
• Stage III Uterine Corpus Carcinoma or Carcinosarcoma AJCC v8
• Stage IV Uterine Corpus Carcinoma or Carcinosarcoma AJCC v8

Eligibility Criteria

Sex

FEMALE

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Carboplatin — DRUG
  Given IV
• Computed Tomography — PROCEDURE
  Undergo CT scan
• Paclitaxel — DRUG
  Given IV
• Pembrolizumab — BIOLOGICAL
  Given IV
• Placebo Administration — OTHER
  Given IV
• Quality-of-Life Assessment — OTHER
  Ancillary studies
• Questionnaire Administration — OTHER
  Ancillary studies

Study Details

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.

Key Dates

Start date

Aug 22, 2019

Status verified

Mar 2026

Primary completion

Dec 16, 2022

Completion

Sep 26, 2026

Study Design

Enrollment

813 participants (actual)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Active Comparator: Arm I (placebo, paclitaxel, carboplatin)
  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.
• Experimental: Arm II (pembrolizumab, paclitaxel, carboplatin)
  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.

Primary Outcome Measure

Progression-free Survival (PFS) [ Time Frame: Duration of time from study entry to time of progression per RECIST criteria or death due to any cause, whichever occurs first. The interquartile range for follow-up was (6.37 months, 30.62 months). The maximum for follow-up was 37.85 months. ]

Locations (370)

Related coverage on Hipa.ai

• Pembrolizumab Extends PFS in pMMR Endometrial Cancer Trial
  Pembrolizumab · Mar 18, 2025 · ClinicalTrials.gov

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