At a glance
ClinicalIndex Comparison Record- ✓Measurable stage III, stage IVA, stage IVB (with or without measurable disease), or recurrent endometrial cancer (with or without measurable disease)
- ✓Institutional MMR IHC testing results documented in pathology report
- ✓Histologically confirmed endometrioid, serous, dedifferentiated, clear cell, mixed epithelial, or NOS adenocarcinoma
- ✓ECOG performance status 0, 1, or 2
- ✕Prior anti-PD-1, anti-PD-L1, or anti-CTLA-4 therapy
- ✕Severe hypersensitivity to monoclonal antibodies, pembrolizumab, paclitaxel, or carboplatin
- ✕Active cancer-directed investigational study therapy within 4 weeks prior to registration
- ✕Immunodeficiency or systemic immunosuppressive therapy within 7 days prior to registration (except inhaled/topical steroids or physiologic doses)
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Phase III Randomized, Placebo-Controlled Study of Pembrolizumab (MK-3475, NSC #776864) in Addition to Paclitaxel and Carboplatin for Measurable Stage III or IVA, Stage IVB or Recurrent Endometrial Cancer
In Brief
A Phase 3 clinical trial evaluating Carboplatin, Computed Tomography, and 5 other interventions for Endometrial Clear Cell Adenocarcinoma and 15 related conditions. Active but no longer recruiting, targeting 813 participants across 397 sites in 5 countries.
Signals
Detailed 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.
Study Details
Timeline
Arms & 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.
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.
Interventions
Given IV
Undergo CT scan
Given IV
Given IV
Given IV
Ancillary studies
Ancillary studies