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

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ClinicalTrials.gov Identifier: NCT03333655
Recruitment Status : Recruiting
First Posted : November 7, 2017
Last Update Posted : November 26, 2019
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Neoplasms Procedure: Biopsy Phase 4

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: A Multicenter Study to Explore the Mechanism of Acquired Immune Escape In Patients With Metastatic Cancer Progressing on Checkpoint Inhibitor Therapy
Actual Study Start Date : February 16, 2018
Estimated Primary Completion Date : April 20, 2020
Estimated Study Completion Date : April 20, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Biopsy

Arm Intervention/treatment
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.




Primary Outcome Measures :
  1. 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



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Response assessment of complete response (CR), partial response (PR), long stable disease (SD) for >3 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 tumor biopsy material extracted and preserved by the investigating site.

Exclusion Criteria:

  • Participants taking CPI combination therapies with chemotherapy are not permitted.
  • Pregnant, lactating, or intending to become pregnant during the study.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03333655


Contacts
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Contact: Reference Study ID Number: ML40108 www.roche.com/about_roche/roche_worldwide.htm +1 888-662-6728 global-roche-genentech-trials@gene.com

Locations
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United States, California
UCSF Comp Canc Ctr Recruiting
San Francisco, California, United States, 94115
United States, Massachusetts
Dana-Farber Cancer Institute Recruiting
Boston, Massachusetts, United States, 02215
United States, Missouri
Washington University School of Medicine; Dept of Medicine/Div of Medical Oncology Recruiting
Saint Louis, Missouri, United States, 63108
United States, New York
Herbert Irving Comprehensive Cancer Center; Herbert Irving Pavillion Recruiting
New York, New York, United States, 10032
United States, Tennessee
Sarah Cannon Cancer Center Recruiting
Arrington, Tennessee, United States, 37014
France
Centre Leon Berard; Service Oncologie Medicale Withdrawn
Lyon, France, 69008
Institut Universitaire du Cancer - Oncopole Toulouse (IUCT-O) Recruiting
Toulouse, France, 31059
Korea, Republic of
Seoul National University Hospital; Department of Oncology Recruiting
Seoul, Korea, Republic of, 110-744
Asan Medical Center, Uni Ulsan Collegemedicine; Dept.Internal Medicine / Divisionhematology/Oncology Recruiting
Seoul, Korea, Republic of, 138-736
Spain
Clinica Universitaria de Navarra; Servicio de oncología Recruiting
Pamplona, Navarra, Spain, 31008
Hospital Univ Vall d'Hebron; Servicio de Oncologia Recruiting
Barcelona, Spain, 08035
United Kingdom
Barts Hospital; Institute of Cancer Recruiting
London, United Kingdom, EC1M 6BQ
Sponsors and Collaborators
Hoffmann-La Roche
Investigators
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Study Chair: Clinical Trials Hoffmann-La Roche

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Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT03333655     History of Changes
Other Study ID Numbers: ML40108
First Posted: November 7, 2017    Key Record Dates
Last Update Posted: November 26, 2019
Last Verified: November 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Hoffmann-La Roche:
Metastatic Cancer
Additional relevant MeSH terms:
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Neoplasm Metastasis
Neoplastic Processes
Neoplasms
Pathologic Processes