A Multicenter Study to Explore the Mechanism of Acquired Immune Escape In Patients With Metastatic Cancer Progressing on Checkpoint Inhibitor Therapy
Trial Snapshot
- Phase
- Phase 4
- Status
- Completed
- Sponsor
- Hoffmann-La Roche
- Enrollment
- 15
- Locations
- 11
- Primary Endpoint
- Number of Gene Alterations in at-Progression Biopsy of Patricipants with Acquired Immune Escape
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Basic Science
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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.
Arms & Interventions
Checkpoint Inhibitor Therapy
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.
Intervention: Biopsy (Procedure)
Outcomes
Primary Outcomes
Number of Gene Alterations in at-Progression Biopsy of Patricipants with Acquired Immune Escape
Time Frame: Day 1
Number of Gene Alterations Will Be Evaluated Using NGS Approaches by Comparing At-Progression Biopsy with Pre-Treatment Biopsy
Secondary Outcomes
No secondary outcomes reported