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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03333655
Other study ID # ML40108
Secondary ID
Status Completed
Phase Phase 4
First received
Last updated
Start date February 16, 2018
Est. completion date August 4, 2022

Study information

Verified date August 2022
Source Hoffmann-La Roche
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 15
Est. completion date August 4, 2022
Est. primary completion date August 4, 2022
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

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

Locations

Country Name City State
France Institut Universitaire du Cancer - Oncopole Toulouse (IUCT-O) Toulouse
Korea, Republic of Asan Medical Center, Uni Ulsan Collegemedicine; Dept.Internal Medicine / Divisionhematology/Oncology Seoul
Korea, Republic of Seoul National University Hospital; Department of Oncology Seoul
Spain Hospital Univ Vall d'Hebron; Servicio de Oncologia Barcelona
Spain Clinica Universitaria de Navarra; Servicio de oncología Pamplona Navarra
United Kingdom Barts Hospital; Institute of Cancer London
United States Sarah Cannon Cancer Center Arrington Tennessee
United States Dana-Farber Cancer Institute Boston Massachusetts
United States Herbert Irving Comprehensive Cancer Center; Herbert Irving Pavillion New York New York
United States Washington University School of Medicine; Dept of Medicine/Div of Medical Oncology Saint Louis Missouri
United States UCSF Comp Canc Ctr San Francisco California

Sponsors (1)

Lead Sponsor Collaborator
Hoffmann-La Roche

Countries where clinical trial is conducted

United States,  France,  Korea, Republic of,  Spain,  United Kingdom, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 Day 1
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