Study of Pembrolizumab (MK-3475) as Monotherapy in Participants With Previously-Treated Locally Advanced Unresectable or Metastatic Colorectal Cancer (MK-3475-164/KEYNOTE-164)
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|ClinicalTrials.gov Identifier: NCT02460198|
Recruitment Status : Active, not recruiting
First Posted : June 2, 2015
Last Update Posted : November 21, 2019
In this study, participants with previously-treated locally-advanced unresectable or metastatic mismatched repair (MMR) deficient or microsatellite instability-high (MSI-H) colorectal carcinoma (CRC) will be treated with pembrolizumab (MK-3475, KEYTRUDA®) monotherapy.
There will be two cohorts in this study: Cohort A and Cohort B. For Cohort A, participants are required to have been previously treated with standard therapies, which must include fluoropyrimidine, oxaliplatin, and irinotecan. Enrollment into Cohort A has been completed. For Cohort B, participants are required to have been previously treated with at least one line of systemic standard of care therapy: fluoropyrimidine + oxaliplatin or fluoropyrimidine + irinotecan +/ - anti-vascular endothelial growth factor (VEGF)/ epidermal growth factor regulator (EGFR) monoclonal antibody.
|Condition or disease||Intervention/treatment||Phase|
|Colorectal Carcinoma||Biological: Pembrolizumab||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||124 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase II Study of Pembrolizumab (MK-3475) as Monotherapy in Subjects With Previously Treated Locally Advanced Unresectable or Metastatic (Stage IV) Mismatched Repair Deficient or Microsatellite Instability-High Colorectal Carcinoma (KEYNOTE-164)|
|Actual Study Start Date :||August 25, 2015|
|Actual Primary Completion Date :||September 9, 2019|
|Estimated Study Completion Date :||August 10, 2020|
Experimental: Cohort A: Pembrolizumab
Cohort A participants receive pembrolizumab 200 mg intravenously (IV) on Day 1 of every 3-week cycle (Q3W) for up to 35 cycles (up to approximately 2 years).
Experimental: Cohort B: Pembrolizumab
Cohort B participants receive pembrolizumab 200 mg IV on Day 1 Q3W for up to 35 cycles (up to approximately 2 years).
- Objective Response Rate (ORR) per Response Evaluation Criteria in Solid Tumors v 1.1 (RECIST 1.1) assessed by central imaging vendor [ Time Frame: Up to approximately 2 years ]
- Disease Control Rate (DCR) per RECIST 1.1 assessed by central imaging vendor [ Time Frame: Up to approximately 2 years ]
- Duration of Response (DOR) per RECIST 1.1 assessed by central imaging vendor [ Time Frame: Up to approximately 2 years ]
- Progression-Free Survival (PFS) per RECIST 1.1 assessed by central imaging vedor [ Time Frame: Up to approximately 2 years ]
- Overall Survival (OS) [ Time Frame: Up to approximately 2 years ]
- Number of Participants Who Experience an Adverse Event (AE) [ Time Frame: Up to approximately 27 months ]
- Number of Participants Who Discontinue Study Treatment Due to an AE [ Time Frame: Up to approximately 2 years ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02460198
|Study Director:||Medical Director||Merck Sharp & Dohme Corp.|