- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03333655
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
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
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Toulouse, France, 31059
- Institut Universitaire du Cancer - Oncopole Toulouse (IUCT-O)
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Seoul, Korea, Republic of, 110-744
- Seoul National University Hospital; Department of Oncology
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Seoul, Korea, Republic of, 138-736
- Asan Medical Center, Uni Ulsan Collegemedicine; Dept.Internal Medicine / Divisionhematology/Oncology
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Barcelona, Spain, 08035
- Hospital Univ Vall d'Hebron; Servicio de Oncologia
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Navarra
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Pamplona, Navarra, Spain, 31008
- Clinica Universitaria de Navarra; Servicio de Oncologia
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London, United Kingdom, EC1M 6BQ
- Barts Hospital; Institute of Cancer
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California
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San Francisco, California, United States, 94115
- UCSF Comp Canc Ctr
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Massachusetts
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Boston, Massachusetts, United States, 02215
- Dana-Farber Cancer Institute
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Missouri
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Saint Louis, Missouri, United States, 63108
- Washington University School of Medicine; Dept of Medicine/Div of Medical Oncology
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New York
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New York, New York, United States, 10032
- Herbert Irving Comprehensive Cancer Center; Herbert Irving Pavillion
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Tennessee
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Arrington, Tennessee, United States, 37014
- Sarah Cannon Cancer Center
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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 |
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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.
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Participants who received or are receiving CPI therapy for metastatic cancer or hematologic malignancies.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
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Number of Gene Alterations in at-Progression Biopsy of Patricipants with Acquired Immune Escape
Time Frame: Day 1
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Number of Gene Alterations Will Be Evaluated Using NGS Approaches by Comparing At-Progression Biopsy with Pre-Treatment Biopsy
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Day 1
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
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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