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

Part of paid clinical trials in New York, New York.

Sponsor
Memorial Sloan Kettering Cancer Center
Study ID
NCT02437071
Phase
PHASE2
Status
Completed

Conditions

  • Metastatic Colorectal Cancer

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Pembrolizumab — DRUG
    Pembrolizumab will be administered as a 30 minute IV infusion (every effort should be made to target infusion timing to be as close to 30 minutes as possible. However, given the variability of infusion pumps from site to site, a window of -5 minutes and +10 minutes is permitted (i.e., infusion time is 30 minutes: -5 min/+10 min).
  • Radiotherapy — RADIATION
  • Radiofrequency ablation — PROCEDURE

Study Details

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.

Key Dates

Start date
Apr 30, 2015
Status verified
Sep 2024
Primary completion
Sep 20, 2024
Completion
Sep 20, 2024

Study Design

Enrollment
34 participants (actual)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Pembrolizumab Plus Radiotherapy
    pembrolizumab plus RT in subjects with metastatic CRC who are undergoing RT as standard therapy
  • Experimental: Pembrolizumab Plus Ablation
    pembrolizumab plus ablation in subjects with metastatic CRC who are undergoing ablation as standard therapy

Primary Outcome Measure

Number of Participants With Response [ Time Frame: approximately 9 weeks ]

Locations (1)

FacilityCityStateZIPSite coordinators
Memorial Sloan Kettering Cancer CenterNew YorkNew York10065-

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