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U.S. Department of Health and Human Services

Post-Approval Studies (PAS) Database

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The FDA has the authority to require sponsors to perform a post-approval study (or studies) at the time of approval of a premarket approval (PMA), humanitarian device exemption (HDE), or product development protocol (PDP) application. Post-approval studies can provide patients, health care professionals, the device industry, the FDA and other stakeholders information on the continued safety and effectiveness (or continued probable benefit, in the case of an HDE) of approved medical devices. This database allows you to search Post-Approval Study information by applicant or device information.

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Study Status Study Pending
Application Number /
Requirement Number
P210001 S001/ PAS001
Date Original Protocol Accepted 05/20/2022
Date Current Protocol Accepted  
Device Name VENTANA MMR RxDx Panel
General Study Protocol Parameters
Study Design Prospective & Retrospective Study
Data Source Sponsor Registry
Comparison Group Historical Control
Analysis Type Descriptive
Study Population Transit. Adolescent B (as adults) : 18-21 yrs, Adult: >21
Detailed Study Protocol Parameters
Study Objectives The purpose of this study is to confirm in a post marketing setting the clinical effectiveness of the MMR RxDx as a companion diagnostic in identifying dMMR solid tumor patients for treatment with pembrolizumab.
The primary objective of this study is to estimate the objective response rate (ORR) for pembrolizumab treatment among clinical study subjects whose archived solid tumor specimens are dMMR as determined by retrospective testing with the MMR RxDx (CDx).
The study design includes two cohorts of patients with solid tumors treated with pembrolizumab:
- 34 patients from the original approval cohort (KEYNOTE-158, Cohort K) which previously did not have a full 26-weeks of follow-up, were not included in the original data set, had archival tissue available for CDx testing
- Up to 30 patients prospectively enrolled in the ongoing Cohort L underway in China that have been tested with the CDx
Study Population The study consists of 34 participants from KN-158 Cohort K and 30 participants from KN-158 Cohort K in KN158 is an ongoing multicenter, global, open-label, single-arm cohort of pembrolizumab in participants with any advanced MSI-H/dMMR solid tumor (except CRC) that was incurable and for which prior standard first-line treatment had failed. Participants were eligible for enrollment into Cohort K based on local testing for dMMR/MSI-H status (referred to as the clinical trial assay (CTA).
The sPMA dataset (P210001/S001, approved on March 21, 2022) included data from 321 KEYNOTE-158 Cohort K participants with at least 26 weeks of follow-up by the data cutoff date on October 5, 2020. Since then, an additional 34 participants enrolled in that cohort now have 26 weeks of follow-up. Data from these 34 participants are part of this proposed study. Samples from these participants have been tested with the CDx. The proposed study will evaluate the response to pembrolizumab treatment in these 34 participants based on their CDx MMR status.
The tumor types represented in these 34 participants include anal (1), breast (2), cervical (1), endometrial, gastric (9), glioma (4), ovarian (1), and small intestine (1). Among these 34 participants, enrolled based on dMMR/MSI-H status per the CTA, whose samples were tested by the CDx, 26 had CDx-positive status and 8 had CDx-negative status.
Cohort L in KN158 is an ongoing study cohort enrolling 30 participants who are from mainland China and are of Chinese descent with any advanced solid tumor (including CRC) that is dMMR/MSI-H determined by the CDx (VENTANA MMR RxDx) and Promega PCR, respectively. KN-158 Cohort L is still enrolling, and the tumor types will be included in the report.
Sample Size 34 patients from KEYNOTE-158 Cohort K will be included, 26 of which are CDx positive and 8 are CDx negative. The sample size is limited by the subjects available for inclusion.
Up to 30 additional patients from KEYNOTE-158 Cohort L will be evaluated. The sample size is limited by the subjects available for inclusion.
Key Study Endpoints The primary study endpoint is the objective response rate (ORR) based on partial or complete response among patients whose tumors are dMMR by the CDx.
Duration of response (DOR) will be reported as an additional endpoint. For Cohort K, the ORR observed in CDx-negative patients will also be reported
Follow-up Visits and Length of Follow-up Patients with 26-weeks of follow-up are included in the study.

KEYTRUDA PAS Reporting Schedule

Reporting Schedule
Date Due
FDA Receipt
Applicant's Reporting Status
6 month report 09/19/2022   Overdue
1 year report 03/21/2023    
18 month report 09/19/2023    
2 year report 03/20/2024    
3 year report 03/20/2025    

Contact Us

Mandated Studies Program
Food and Drug Administration
10903 New Hampshire Ave.
Silver Spring, MD 20993-0002
Email: MandatedStudiesPrograms@fda.hhs.gov

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