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

StatusActive, Not Recruiting
PhasePhase 3
Started

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Record History

The 50 most recent of 477 record versions are accounted for below. See every version on ClinicalTrials.gov ↗

  1. Study completion pushed from Sep 26, 2026 to Sep 26, 2027 Show 5 more changesShow less
    • Eligibility criteria expanded, about 45 words
    • Secondary endpoints: details revised at 5 of 6 entries
    • Study description revised
    • Site details revised at 44 of 397 sites
    • Publications: details revised at 4 of 4 entries
  2. Study sites revised (397)v476
  3. Study sites revised (397)v475
  4. Study sites revised (397)v474
  5. Site details revised at 1 of 397 sitesv473
Show 45 earlier versionsHide 45 earlier versions
  1. Study sites revised (397)v472
  2. Study sites revised (397)v471
  3. 26 versions Re-verified since Mar 4, 2026, no change to tracked fieldsv445-v470
  4. Study sites revised (397)v444
  5. Study sites revised (397)v443
  6. Study sites revised (397)v442
  7. Study completion date: May 8, 2026 to Sep 26, 2026v441
  8. Re-verified, no change to tracked fieldsv440
  9. Study sites revised (397)v439
  10. Study completion date: Apr 1, 2029 to May 8, 2026
    • Eligibility criteria shortened, about 6 words
    • Study description shortened, about 1 word
    v438
  11. Study sites revised (397)v437
  12. Study sites revised (397)v436
  13. Results first posted: Mar 18, 2025
    • Start date: Jul 16, 2019 to Aug 22, 2019
    • Secondary endpoints revised (6)
    v435
  14. Secondary endpoints: 7 to 6v434
  15. Enrollment target: 759 to 813
    • Study completion date: May 10, 2024 to Apr 1, 2029
    • Secondary endpoints: 9 to 7
    • Primary endpoint revised
    v433
  16. Study sites revised (397)v432
  17. Enrollment target: estimated 810 to confirmed 759
    • Primary completion date changed from estimate of Jun 30, 2023 to Dec 16, 2022
    • Study completion date: Jun 30, 2023 to May 10, 2024
    v431
  18. Study sites revised (397)v430
  19. 2 versions Re-verified since Apr 21, 2023, no change to tracked fieldsv428-v429
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT03914612
Lead Sponsor National Cancer Institute (NCI)
Collaborators: Canadian Cancer Trials Group, NRG Oncology
Conditions
(from sponsor)		 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 +8 more
Related terms Carcinosarcoma, Endometrial Neoplasms
Enrollment 813 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov