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Assess the Efficacy of Pembrolizumab Plus Radiotherapy or Ablation in Metastatic Colorectal Cancer Patients | Clinical Trials | Clareo Health

COMPLETEDPHASE2

Assess the Efficacy of Pembrolizumab Plus Radiotherapy or Ablation in Metastatic Colorectal Cancer Patients

Single Arm Phase II Study to Assess the Efficacy of Pembrolizumab Plus Radiotherapy or Ablation in Metastatic Colorectal Cancer Patients

NCT02437071•Memorial Sloan Kettering Cancer Center

View on ClinicalTrials.gov

Summary

The radiation therapy or ablation that the patient received as standard therapy treated only the tumors that were radiated or ablated. Radiation therapy or ablation plus pembrolizumab might lead to a stronger immune response that may control or destroy tumors that did not receive radiation therapy or ablation. The purpose of this study is to find out what effects, good and/or bad, pembrolizumab has on the patient, and the cancer that did not receive radiation therapy or ablation.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Be willing and able to provide written informed consent/assent for the trial.
•Histologically- or cytologically- confirmed CRC.
•Metastatic or recurrent CRC
•Subjects have received two or more standard available therapies known to prolong survival and for which they would be considered eligible. Such therapies should include regimens containing oxaliplatin and irinotecan in combination with a fluoropyrimidine if appropriate (e.g., FOLFOX and FOLFIRI or their variants).
•At least one tumor for which palliative RT is considered appropriate standard therapy (cohort 1); or, at least one tumor for which palliative ablation is considered appropriate standard therapy (cohort 2).
•At least one index lesion that will not undergo RT or ablation, and which is measurable based on RECIST 1.1.
•Be ≥ 18 years of age on day of signing informed consent. Consent for tumor biopsies and blood draws for research purposes.
•Consent for use of available archived tissue for research purposes.
•Have a performance status of 0 or 1 on the ECOG Performance Scale.
•Demonstrate adequate organ function as defined in Table 6.1, all screening labs should be performed within 6 weeks of treatment initiation.
+15 more criteria

Exclusion Criteria

•Is currently participating in or has participated in a study of an investigational agent or using an investigational device within 4 weeks of the first dose of treatment.
•Has a diagnosis of immunodeficiency or is receiving systemic steroid therapy or any other form of immunosuppressive therapy within 7 days prior to the first dose of trial treatment.
•Has had a prior monoclonal antibody within 4 weeks prior to study Day 1 or who has not recovered (i.e., ≤ Grade 1 or at baseline) from adverse events due to agents administered more than 4 weeks earlier.
•Has had prior chemotherapy, targeted small molecule therapy within 2 weeks prior to study Day 1 or who has not recovered (i.e., ≤ Grade 1 or at 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.
•If subject received major surgery, they must have recovered adequately from the toxicity and/or complications from the intervention prior to starting therapy.
•Has a known additional malignancy that is progressing or requires active treatment. Exceptions include basal cell carcinoma of the skin, squamous cell carcinoma of the skin, or in situ cervical cancer that has undergone potentially curative therapy.
•Has known active central nervous system (CNS) 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 four weeks prior to the first dose of trial treatment 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.
•Has an active autoimmune disease requiring systemic treatment within the past 3 months or a documented history of clinically severe autoimmune disease, or a syndrome that requires systemic steroids or immunosuppressive agents. Subjects with vitiligo or resolved childhood asthma/atopy would be an exception to this rule. Subjects that require intermittent use of bronchodilators or local steroid injections would not be excluded from the study. Subjects with hypothyroidism stable on hormone replacement or Sjorgen's syndrome will not be excluded from the study.
•Has evidence of interstitial lung disease or active, non-infectious pneumonitis.
+8 more criteria

Locations (1)

Memorial Sloan Kettering Cancer Center

New York, New York, United States

Key Dates

Start Date

April 1, 2015

Primary Completion Date

September 20, 2024

Completion Date

September 20, 2024

Last Updated

December 5, 2025

Enrollment

ACTUAL participants

Conditions

Metastatic Colorectal Cancer

Interventions

Pembrolizumab

DRUG

Radiotherapy

RADIATION

Radiofrequency ablation

PROCEDURE

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RECRUITINGPHASE1/PHASE2

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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: December 5, 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.

View ClinicalTrials.gov Terms and Conditions

Assess the Efficacy of Pembrolizumab Plus Radiotherapy or Ablation in Metastatic Colorectal Cancer Patients

Inclusion Criteria

Exclusion Criteria

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