Study to Explore the Mechanism of Acquired Immune Escape In Participants With Metastatic Cancer Progressing on CPI Therapy

Phase 4

Completed

• Conditions: Neoplasms

• Registration Number: NCT03333655
• Lead Sponsor: Hoffmann-La Roche

Brief Summary

The purpose of this study is to identify mechanisms associated with acquired immune escape by comparing baseline and at-progression tissue samples from participants who derive clinical benefit from CPI treatment of metastatic cancer or hematologic malignancies.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2017-10-04
• Study First Submitted QC: 2017-11-03
• Study First Posted: 2017-11-07
• Study Start: 2018-02-16
• Status Verified: 2022-08
• Primary Completion: 2022-08-04
• Study Completion: 2022-08-04
• Last Update Submitted: 2022-08-10
• Last Update Posted: 2022-08-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 15

Inclusion Criteria

• Response assessment of complete response (CR), partial response (PR), or long-term stable disease (SD) for >6 months with a cancer immunotherapy treatment for metastatic cancer or hematologic malignancies either through a marketed CPI or through participation in a Roche/Genentech CPI clinical trial.
• Availability of tissue sample.

Exclusion Criteria

• Pregnant, lactating, or intending to become pregnant during the study.
• Participants receiving CPI treatment as part of a non-Roche/Genentech clinical trial.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Number of Gene Alterations in at-Progression Biopsy of Patricipants with Acquired Immune Escape	Day 1	Number of Gene Alterations Will Be Evaluated Using NGS Approaches by Comparing At-Progression Biopsy with Pre-Treatment Biopsy

Trial Locations

Locations (11)

UCSF Comp Canc Ctr; 🇺🇸 San Francisco, California, United States

Dana-Farber Cancer Institute; 🇺🇸 Boston, Massachusetts, United States

Washington University School of Medicine; Dept of Medicine/Div of Medical Oncology; 🇺🇸 Saint Louis, Missouri, United States

Herbert Irving Comprehensive Cancer Center; Herbert Irving Pavillion; 🇺🇸 New York, New York, United States

Sarah Cannon Cancer Center; 🇺🇸 Arrington, Tennessee, United States

Institut Universitaire du Cancer - Oncopole Toulouse (IUCT-O); 🇫🇷 Toulouse, France

Seoul National University Hospital; Department of Oncology; 🇰🇷 Seoul, Korea, Republic of

Asan Medical Center, Uni Ulsan Collegemedicine; Dept.Internal Medicine / Divisionhematology/Oncology; 🇰🇷 Seoul, Korea, Republic of

Clinica Universitaria de Navarra; Servicio de oncología; 🇪🇸 Pamplona, Navarra, Spain

Hospital Univ Vall d'Hebron; Servicio de Oncologia; 🇪🇸 Barcelona, Spain

Scroll for more (1 remaining)