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MK-3475 Immunotherapy in Endometrial Carcinoma | Clinical Trials | Clareo Health

COMPLETEDPHASE1

MK-3475 Immunotherapy in Endometrial Carcinoma

Immunotherapy With MK-3475 in Surgically Resectable Endometrial Carcinoma

NCT02630823•Washington University School of Medicine

Summary

Due to the high expression of PD-L1 in endometrial cancers as well as in ovarian cancers which are molecularly similar to uterine serous cancers, using pembrolizumab should be beneficial in this patient population. Since the investigators are able to get a pre-treatment research- related endometrial biopsy as well as the surgical specimen post two cycles of pembrolizumab, the investigators will be able to evaluate the mechanism of action of this drug on the endometrial cancer tumor environment.

Eligibility

Age

18 - No limit years

Sex

FEMALE

Healthy Volunteers

Inclusion Criteria

•Diagnosis of FIGO grade 3 endometrioid cancer, serous, clear cell, or mixed high grade endometrial cancer with confirmation on research-related endometrial biopsy.
•Radiographically confirmed endometrial adenocarcinoma of stages III-IV requiring adjuvant therapy. If stage III disease is suspected, there should be multiple pelvic and/or lymph nodes involved.
•Measurable disease defined as lesions that can be accurately measured in at least one dimension (longest diameter to be recorded) as \>10 mm with CT scan, as \>20 mm by chest x-ray, or \>10 mm with calipers by clinical exam by RECIST 1.1.
•Treatment plan must include primary site biopsy followed by resection of the primary tumor site and any metastatic sites at time of surgery.
•At least 18 years of age.
•GOG performance status ≤ 2
•Normal bone marrow and organ function as defined below:
•* Absolute neutrophil count ≥ 1,500/mcl
•* Platelets ≥ 100,000/mcl
•* Hemoglobin ≥ 9 g/dL
+7 more criteria

Exclusion Criteria

•FIGO grade 1 or 2 endometrioid cancer.
•Radiographic imaging demonstrating uterine cancer that is probably stage I or II.
•Prior treatment for endometrial cancer.
•Prior treatment with an anti-PD-1, anti-PD-L1, or anti-PD-L2 agent.
•Prior anti-cancer monoclonal antibody (mAb) within 4 weeks prior to first dose of MK-3475 or has not recovered (i.e., to ≤ grade 1 or baseline) from adverse events due to agents administered more than 4 weeks earlier.
•Prior chemotherapy, targeted small molecule therapy, or radiation therapy within 2 weeks prior to the first dose of MK-3475 or has not recovered (i.e., to ≤ grade 1 or baseline) from adverse events due to a previously administered agent. Note, subjects with ≤ grade 2 neuropathy are an exception to this criterion and may qualify for the study. Note, if a subject received major surgery, she must have recovered adequately from the toxicity and/or complications from the intervention prior to starting therapy.
•Received a live vaccine within 30 days prior to the first dose of MK-3475. Examples of live vaccines include, but are not limited to, the following: measles, mumps, rubella, varicella/zoster (chicken pox), yellow fever, rabies, Bacillus Calmette-Guérin (BCG), and typhoid vaccine. Seasonal influenza vaccines for injection are generally killed virus vaccines and are allowed; however, intranasal influenza vaccines (e.g. FluMist) are live attenuated vaccines and are not allowed.
•A history of other malignancy ≤ 5 years previous with the exception of basal cell or squamous cell carcinoma of the skin which were treated with local resection only.
•Known active central nervous system metastases and/or carcinomatous meningitis. Subjects with previously treated brain metastases may participate provided they are stable (without evidence of progression by imaging for at least 4 weeks prior to the first dose of MK-3475 and any neurologic symptoms have returned to baseline), have no evidence of new or enlarging brain metastases, and are not using steroids for at least 7 days prior to trial treatment. This exception does not include carcinomatous meningitis which is excluded regardless of clinical stability.
•Diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy in dosing exceeding 10 mg daily of prednisone or equivalent) or any other form of immunosuppressive therapy within 7 days prior to the first dose of MK-3475.
+9 more criteria

Locations (1)

Washington University School of Medicine

St Louis, Missouri, United States

Key Dates

Start Date

February 5, 2016

Primary Completion Date

January 1, 2019

Completion Date

October 3, 2020

Last Updated

January 3, 2025

Enrollment

ACTUAL participants

Conditions

Endometrial CancerEndometrial CarcinomaNeoplasms, Endometrial

Interventions

MK-3475

DRUG

Surgical resection (standard of care)

PROCEDURE

Paclitaxel (standard of care)

DRUG

Carboplatin (standard of care)

DRUG

Radiation (standard of care)

RADIATION

Endometrial biopsy

PROCEDURE

Peripheral blood draw

PROCEDURE

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: January 3, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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MK-3475 Immunotherapy in Endometrial Carcinoma

Inclusion Criteria

Exclusion Criteria

IACS-6274 With or Without Bevacizumab and Paclitaxel for the Treatment of Advanced Solid Tumors

Testing the Combination of Two Anti-cancer Drugs, DS-8201a and AZD6738, for The Treatment of Advanced Solid Tumors Expressing the HER2 Protein or Gene, The DASH Trial

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Immune Checkpoint Inhibitor Response in Solid Tumors Using a Live Tumor Diagnostic Platform