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

NCT ID: NCT03333655

Last Updated: 2022-08-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

15 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-02-16

Study Completion Date

2022-08-04

Brief Summary

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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

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Conditions

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Neoplasms

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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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.

Group Type OTHER

Biopsy

Intervention Type PROCEDURE

Participants who received or are receiving CPI therapy for metastatic cancer or hematologic malignancies.

Interventions

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Biopsy

Participants who received or are receiving CPI therapy for metastatic cancer or hematologic malignancies.

Intervention Type PROCEDURE

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Hoffmann-La Roche

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Clinical Trials

Role: STUDY_CHAIR

Hoffmann-La Roche

Locations

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UCSF Comp Canc Ctr

San Francisco, California, United States

Site Status

Dana-Farber Cancer Institute

Boston, Massachusetts, United States

Site Status

Washington University School of Medicine; Dept of Medicine/Div of Medical Oncology

St Louis, Missouri, United States

Site Status

Herbert Irving Comprehensive Cancer Center; Herbert Irving Pavillion

New York, New York, United States

Site Status

Sarah Cannon Cancer Center

Arrington, Tennessee, United States

Site Status

Institut Universitaire du Cancer - Oncopole Toulouse (IUCT-O)

Toulouse, , France

Site Status

Seoul National University Hospital; Department of Oncology

Seoul, , South Korea

Site Status

Asan Medical Center, Uni Ulsan Collegemedicine; Dept.Internal Medicine / Divisionhematology/Oncology

Seoul, , South Korea

Site Status

Clinica Universitaria de Navarra; Servicio de oncología

Pamplona, Navarre, Spain

Site Status

Hospital Univ Vall d'Hebron; Servicio de Oncologia

Barcelona, , Spain

Site Status

Barts Hospital; Institute of Cancer

London, , United Kingdom

Site Status

Countries

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United States France South Korea Spain United Kingdom

Other Identifiers

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ML40108

Identifier Type: -

Identifier Source: org_study_id

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