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

Summary

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.

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

Interventions

DRUG

Carboplatin

Given IV

PROCEDURE

Computed Tomography

Undergo CT scan

DRUG

Paclitaxel

Given IV

BIOLOGICAL

Pembrolizumab

Given IV

OTHER

Placebo Administration

Given IV

OTHER

Quality-of-Life Assessment

Ancillary studies

OTHER

Questionnaire Administration

Ancillary studies

Sponsors & Collaborators

• Canadian Cancer Trials Group

  collaborator NETWORK

• NRG Oncology

  collaborator OTHER

• National Cancer Institute (NCI)

  lead NIH

Principal Investigators

• Ramez N Eskander · NRG Oncology

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

FEMALE

Healthy Volunteers

No

Timeline & Regulatory

Start

2019-08-22

Primary Completion

2022-12-16

Completion

2026-09-26

FDA Drug

Yes

Countries

• United States
• Canada
• Japan
• Puerto Rico
• South Korea

Study Locations