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

Roche

Status and phase: Completed; Phase 4

Conditions: Neoplasms

Treatments: Procedure: Biopsy

Study type: Interventional

Funder types: Industry

Identifiers

NCT03333655

ML40108

Details and patient eligibility

About

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.

Enrollment: 15 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Basic Science

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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15 participants in 1 patient group

Checkpoint Inhibitor Therapy

Other group

Description:

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.

Treatment:

Procedure: Biopsy