Study of Pembrolizumab (MK-3475) in Participants With Advanced Solid Tumors (MK-3475-158/KEYNOTE-158)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT02628067|
Recruitment Status : Recruiting
First Posted : December 11, 2015
Last Update Posted : February 21, 2021
|Condition or disease||Intervention/treatment||Phase|
|Advanced Cancer Anal Carcinoma Anal Cancer Biliary Cancer Cholangiocarcinoma Bile Duct Cancer Neuroendocrine Tumor Carcinoid Tumor Endometrial Carcinoma Endometrial Cancer Cervical Carcinoma Cervical Cancer Vulvar Carcinoma Vulvar Cancer Small Cell Lung Carcinoma Small Cell Lung Cancer (SCLC) Mesothelioma Thyroid Carcinoma Thyroid Cancer Salivary Gland Carcinoma Salivary Gland Cancer Salivary Cancer Parotid Gland Cancer Advanced Solid Tumors Colorectal Carcinoma||Biological: pembrolizumab||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||1595 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Clinical Trial of Pembrolizumab (MK-3475) Evaluating Predictive Biomarkers in Subjects With Advanced Solid Tumors (KEYNOTE 158)|
|Actual Study Start Date :||December 18, 2015|
|Estimated Primary Completion Date :||June 18, 2026|
|Estimated Study Completion Date :||June 18, 2026|
Experimental: Pembrolizumab 200 mg
Participants receive pembrolizumab 200 mg intravenously on Day 1 of each 3-week cycle for up to 35 administrations (up to approximately 2 years of treatment).
Experimental: Pembrolizumab 400 mg
Participants with any advanced solid tumor that has failed at least one line of therapy and is Tumor- Mutational Burden-High (TMB-H), excluding participants with mismatch repair deficient (dMMR/MSI-H) tumors. The dosing regimen for this cohort will be 400 mg every 6 weeks (Q6W) for up to 18 administrations (up to approximately 2 years of treatment).
- Objective Response Rate (ORR) [ Time Frame: Up to approximately 2 years ]ORR is defined as the percentage of participants who have a Complete Response (CR: Disappearance of all target lesions) or a Partial Response (PR: At least a 30% decrease in the sum of diameters of target lesions) per RECIST 1.1 modified to follow a maximum of 10 target lesions and a maximum of 5 target lesions per organ at any time during the trial. Responses will be determined by independent central radiologic review, with confirmatory assessment as required per RECIST 1.1. Participants with unknown or missing response information will be treated as non-responders. The percentage of participants who experience a CR or PR based on modified RECIST 1.1 will be presented.
- Duration of Response (DOR) [ Time Frame: Up to approximately 2 years ]DOR, defined in the subset of participants with a CR or PR, based on RECIST 1.1 as assessed by independent central radiologic review, as the time from first documented evidence of CR or PR until the first documented sign of disease progression or death due to any cause, whichever occurs first. A Complete Response (CR: Disappearance of all target lesions) or a Partial Response (PR: At least a 30% decrease in the sum of diameters of target lesions) per RECIST 1.1 modified to follow a maximum of 10 target lesions and a maximum of 5 target lesions per organ. Participants who are alive, have not progressed, have not initiated new anti-cancer treatment, and have not been determined to be lost to follow-up are considered ongoing responders at the time of analysis.
- Progression Free Survival (PFS) [ Time Frame: Up to approximately 2 years ]PFS is defined as the time from allocation to the first documented disease progression according to RECIST 1.1 as assessed by independent central radiologic review, or death due to any cause, whichever occurs first. Per RECIST 1.1, PD is defined as ≥20% increase in the sum of diameters of target lesions. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of ≥5 mm. Note: The appearance of one or more new lesions is also considered PD. If a participant does not have a documented date of progression or death, PFS will be censored at the date of the last adequate assessment.
- Overall Survival (OS) [ Time Frame: Up to approximately 2 years ]OS was defined as the time from randomization to death due to any cause. OS is presented. Censoring will be performed using the date of last known contact for those who are alive at the time of analysis.
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): NCT02628067
|Contact: Toll Free Number||1-888-577-8839|
|Study Director:||Medical Director||Merck Sharp & Dohme Corp.|