Suspended

Pembrolizumab, Paclitaxel and Carboplatin for Advanced or Recurrent Endometrial Cancer

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Study Aim

This study aims to evaluate the effectiveness of Pembrolizumab, Paclitaxel and Carboplatin combination in improving progression-free survival in patients with advanced or recurrent endometrial cancer.

What is being tested

Carboplatin

+ Computed Tomography

+ Paclitaxel

DrugProcedureOtherBiological
Who is being recruted

Urogenital Diseases+14

+ Genital Diseases

+ Carcinosarcoma

Over 18 Years
+34 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Treatment Study

Phase 3
Interventional
Study Start: August 2019
See protocol details

Summary

Principal SponsorNational Cancer Institute (NCI)
Last updated: March 25, 2026
Sourced from a government-validated database.Claim as a partner

Study start date: August 22, 2019

Actual date on which the first participant was enrolled.

This study is exploring the effectiveness of a drug called Pembrolizumab (MK-3475) when combined with standard chemotherapy treatments, Paclitaxel and Carboplatin, for women with advanced or recurrent endometrial cancer. The primary goal is to see if adding Pembrolizumab to the standard treatment can improve outcomes for these patients. The study is particularly interested in understanding how this combination therapy works for different types of endometrial cancer, specifically those with mismatch repair protein proficient (pMMR) or mismatch repair deficiency (dMMR). This research is important as it could potentially lead to improved treatments and better quality of life for women with advanced or recurrent endometrial cancer. During the study, participants are randomly assigned to one of two groups. One group receives the standard chemotherapy treatments along with a placebo, while the other group receives the same chemotherapy treatments but with Pembrolizumab instead of the placebo. Both groups receive their treatments every three weeks for six cycles, with the possibility of extending to ten cycles if necessary. After the initial treatment phase, participants enter a maintenance phase where they continue to receive either the placebo or Pembrolizumab every six weeks for up to 14 cycles. Throughout the study, participants undergo regular CT scans to monitor their progress. The study measures the effectiveness of the treatments by looking at progression-free survival rates, the nature and frequency of side effects, and the impact on patients' physical function and quality of life.

Official TitleA 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
NCT03914612
Principal SponsorNational Cancer Institute (NCI)
Last updated: March 25, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

813 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.



Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Female

Biological sex of participants that are eligible to enroll.

Over 18 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Urogenital DiseasesGenital DiseasesCarcinosarcomaFemale Urogenital Diseases and Pregnancy ComplicationsGenital Diseases, FemaleGenital Neoplasms, FemaleNeoplasmsNeoplasms by Histologic TypeNeoplasms by SiteSarcomaUrogenital NeoplasmsUterine DiseasesUterine NeoplasmsEndometrial NeoplasmsNeoplasms, Complex and MixedNeoplasms, Connective and Soft TissueFemale Urogenital Diseases

Criteria

22 inclusion criteria required to participate
Age \>= 18.

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

Pathology report showing results of institutional MMR IHC testing.

Histologic confirmation of the original primary tumor is required (submission of pathology report(s) is required). Patients with the following histologic types are eligible: Endometrioid adenocarcinoma, serous adenocarcinoma, dedifferentiated/undifferentiated carcinoma, clear cell adenocarcinoma, mixed epithelial carcinoma, adenocarcinoma not otherwise specified (N.O.S.).

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12 exclusion criteria prevent from participating
Patients with prior treatment with anti-PD-1, anti-PD-L1 or anti-CTLA-4 therapeutic antibody or other similar agents.

Patients who have a history of a severe hypersensitivity reaction to monoclonal antibody or pembrolizumab (MK-3475) and/or its excipients; and/or a severe hypersensitivity reaction to paclitaxel and/or carboplatin.

Patients who are currently participating and receiving cancer-directed study therapy or have participated in a study of an investigational agent and received cancer-directed study therapy within 4 weeks prior to Step 2 registration.

Patients who have a diagnosis of immunodeficiency or are receiving systemic steroid therapy or any other form of immunosuppressive therapy within 7 days prior to Step 2 registration. * Patients who have received steroids as CT scan contrast premedication may be enrolled. * The use of inhaled or topical corticosteroids is allowed. * The use of mineralocorticoids (e.g., fludrocortisone) for patients with orthostatic hypotension or adrenocortical insufficiency is allowed. * The use of physiologic doses of corticosteroids may be approved after consultation with the study chair.

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Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

2 intervention groups are designated in this study

This study does not include a placebo group 

Treatment Groups

Group I

Active Comparator
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.

Group II

Experimental
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.

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 397 locations

Suspended

University of Alabama at Birmingham Cancer Center

Birmingham, United StatesOpen University of Alabama at Birmingham Cancer Center in Google Maps
Suspended

Alaska Women's Cancer Care

Anchorage, United States
Suspended

CTCA at Western Regional Medical Center

Goodyear, United States
Suspended

NEA Baptist Memorial Hospital and Fowler Family Cancer Center - Jonesboro

Jonesboro, United States
Suspended397 Study Centers