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

Phase 4

Completed

• Conditions: Neoplasms
• Interventions: Procedure: Biopsy

• 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

Arm && Interventions

Group	Intervention	Description
Checkpoint Inhibitor Therapy	Biopsy	Pre-treatment (archival) and at progression biopsy for participants with a demonstrated clinical benefit on CPI therapy will be asked to participate in the study. In addition, retrospective enrollment of patients who progressed on CPI therapy after documented response and for whom an at-progression biopsy is available, is also possible.

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)

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

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

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

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

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

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

Barts Hospital; Institute of Cancer; 🇬🇧 London, United Kingdom

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