Back to resultsStudy to Explore the Mechanism of Acquired Immune Escape In Participants With Metastatic Cancer Progressing on CPI Therapy
Primary Purpose
Neoplasms
Status
Completed
Phase
Phase 4
Locations
International
Study Type
Interventional
Intervention
Biopsy
Sponsored by
About this trial
This is an interventional basic science trial for Neoplasms focused on measuring Metastatic Cancer
Eligibility Criteria
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.
Sites / Locations
- UCSF Comp Canc Ctr
- Dana-Farber Cancer Institute
- Washington University School of Medicine; Dept of Medicine/Div of Medical Oncology
- Herbert Irving Comprehensive Cancer Center; Herbert Irving Pavillion
- Sarah Cannon Cancer Center
- Institut Universitaire du Cancer - Oncopole Toulouse (IUCT-O)
- Seoul National University Hospital; Department of Oncology
- Asan Medical Center, Uni Ulsan Collegemedicine; Dept.Internal Medicine / Divisionhematology/Oncology
- Clinica Universitaria de Navarra; Servicio de oncología
- Hospital Univ Vall d'Hebron; Servicio de Oncologia
- Barts Hospital; Institute of Cancer
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
Checkpoint Inhibitor Therapy
Arm 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.
Outcomes
Primary Outcome Measures
Number of Gene Alterations in at-Progression Biopsy of Patricipants with Acquired Immune Escape
Number of Gene Alterations Will Be Evaluated Using NGS Approaches by Comparing At-Progression Biopsy with Pre-Treatment Biopsy
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03333655
Brief Title
Study to Explore the Mechanism of Acquired Immune Escape In Participants With Metastatic Cancer Progressing on CPI Therapy
Official Title
A Multicenter Study to Explore the Mechanism of Acquired Immune Escape In Patients With Metastatic Cancer Progressing on Checkpoint Inhibitor Therapy
Study Type
Interventional
2. Study Status
Record Verification Date
August 2022
Overall Recruitment Status
Completed
Study Start Date
February 16, 2018 (Actual)
Primary Completion Date
August 4, 2022 (Actual)
Study Completion Date
August 4, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hoffmann-La Roche
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Neoplasms
Keywords
Metastatic Cancer
7. Study Design
Primary Purpose
Basic Science
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
15 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Checkpoint Inhibitor Therapy
Arm Type
Other
Arm 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.
Intervention Type
Procedure
Intervention Name(s)
Biopsy
Intervention Description
Participants who received or are receiving CPI therapy for metastatic cancer or hematologic malignancies.
Primary Outcome Measure Information:
Title
Number of Gene Alterations in at-Progression Biopsy of Patricipants with Acquired Immune Escape
Description
Number of Gene Alterations Will Be Evaluated Using NGS Approaches by Comparing At-Progression Biopsy with Pre-Treatment Biopsy
Time Frame
Day 1
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Clinical Trials
Organizational Affiliation
Hoffmann-La Roche
Official's Role
Study Chair
Facility Information:
Facility Name
UCSF Comp Canc Ctr
City
San Francisco
State/Province
California
ZIP/Postal Code
94115
Country
United States
Facility Name
Dana-Farber Cancer Institute
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02215
Country
United States
Facility Name
Washington University School of Medicine; Dept of Medicine/Div of Medical Oncology
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63108
Country
United States
Facility Name
Herbert Irving Comprehensive Cancer Center; Herbert Irving Pavillion
City
New York
State/Province
New York
ZIP/Postal Code
10032
Country
United States
Facility Name
Sarah Cannon Cancer Center
City
Arrington
State/Province
Tennessee
ZIP/Postal Code
37014
Country
United States
Facility Name
Institut Universitaire du Cancer - Oncopole Toulouse (IUCT-O)
City
Toulouse
ZIP/Postal Code
31059
Country
France
Facility Name
Seoul National University Hospital; Department of Oncology
City
Seoul
ZIP/Postal Code
110-744
Country
Korea, Republic of
Facility Name
Asan Medical Center, Uni Ulsan Collegemedicine; Dept.Internal Medicine / Divisionhematology/Oncology
City
Seoul
ZIP/Postal Code
138-736
Country
Korea, Republic of
Facility Name
Clinica Universitaria de Navarra; Servicio de oncología
City
Pamplona
State/Province
Navarra
ZIP/Postal Code
31008
Country
Spain
Facility Name
Hospital Univ Vall d'Hebron; Servicio de Oncologia
City
Barcelona
ZIP/Postal Code
08035
Country
Spain
Facility Name
Barts Hospital; Institute of Cancer
City
London
ZIP/Postal Code
EC1M 6BQ
Country
United Kingdom
12. IPD Sharing Statement
Learn more about this trial
Study to Explore the Mechanism of Acquired Immune Escape In Participants With Metastatic Cancer Progressing on CPI Therapy
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