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

August 10, 2022 updated by: Hoffmann-La Roche

A Multicenter Study to Explore the Mechanism of Acquired Immune Escape In Patients With Metastatic Cancer Progressing on Checkpoint Inhibitor Therapy

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 Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

15

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Toulouse, France, 31059
        • Institut Universitaire du Cancer - Oncopole Toulouse (IUCT-O)
  • Korea, Republic of
      • Seoul, Korea, Republic of, 110-744
        • Seoul National University Hospital; Department of Oncology
      • Seoul, Korea, Republic of, 138-736
        • Asan Medical Center, Uni Ulsan Collegemedicine; Dept.Internal Medicine / Divisionhematology/Oncology
  • Spain
      • Barcelona, Spain, 08035
        • Hospital Univ Vall d'Hebron; Servicio de Oncologia
    • Navarra
      • Pamplona, Navarra, Spain, 31008
        • Clinica Universitaria de Navarra; Servicio de Oncologia
  • United Kingdom
      • London, United Kingdom, EC1M 6BQ
        • Barts Hospital; Institute of Cancer
  • United States
    • California
      • San Francisco, California, United States, 94115
        • UCSF Comp Canc Ctr
    • Massachusetts
      • Boston, Massachusetts, United States, 02215
        • Dana-Farber Cancer Institute
    • Missouri
      • Saint Louis, Missouri, United States, 63108
        • Washington University School of Medicine; Dept of Medicine/Div of Medical Oncology
    • New York
      • New York, New York, United States, 10032
        • Herbert Irving Comprehensive Cancer Center; Herbert Irving Pavillion
    • Tennessee
      • Arrington, Tennessee, United States, 37014
        • Sarah Cannon Cancer Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: BASIC_SCIENCE
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: 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.
Procedure: Biopsy
Participants who received or are receiving CPI therapy for metastatic cancer or hematologic malignancies.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Day 1

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hoffmann-La Roche

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 16, 2018

Primary Completion (Actual)

August 4, 2022

Study Completion (Actual)

August 4, 2022

Study Registration Dates

First Submitted

October 4, 2017

First Submitted That Met QC Criteria

November 3, 2017

First Posted (Actual)

November 7, 2017

Study Record Updates

Last Update Posted (Actual)

August 12, 2022

Last Update Submitted That Met QC Criteria

August 10, 2022

Last Verified

August 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ML40108

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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