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

Sponsor

Hoffmann-La Roche (Industry)

Overall Status

Completed

CT.gov ID

NCT03333655

Collaborator

(none)

Enrollment

Locations

Arm

53.6

Actual Duration (Months)

1.4

Patients Per Site

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Neoplasms	Procedure: Biopsy	Phase 4

Study Design

Study Type:

Interventional

Actual Enrollment :

15 participants

Allocation:

N/A

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 :

Feb 16, 2018

Actual Primary Completion Date :

Aug 4, 2022

Actual Study Completion Date :

Aug 4, 2022

Arms and Interventions

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.

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.

Outcome Measures

Primary Outcome Measures

Number of Gene Alterations in at-Progression Biopsy of Patricipants with Acquired Immune Escape [Day 1]
Number of Gene Alterations Will Be Evaluated Using NGS Approaches by Comparing At-Progression Biopsy with Pre-Treatment Biopsy

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.

Contacts and Locations

Locations

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

Sponsors and Collaborators

Hoffmann-La Roche

Investigators

Study Chair: Clinical Trials, Hoffmann-La Roche

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Hoffmann-La Roche

ClinicalTrials.gov Identifier:

NCT03333655

Other Study ID Numbers:

ML40108

First Posted:

Nov 7, 2017

Last Update Posted:

Aug 12, 2022

Last Verified:

Aug 1, 2022

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Hoffmann-La Roche

Metastatic Cancer

Additional relevant MeSH terms:

Neoplasm Metastasis

Study Results

No Results Posted as of Aug 12, 2022