NCT03333655

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.

Trial Health

93
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
15

participants targeted

Target at below P25 for phase_4

Timeline
Completed

Started Feb 2018

Longer than P75 for phase_4

Geographic Reach
5 countries

11 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 4, 2017

Completed
1 month until next milestone

First Posted

Study publicly available on registry

November 7, 2017

Completed
3 months until next milestone

Study Start

First participant enrolled

February 16, 2018

Completed
4.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 4, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 4, 2022

Completed
Last Updated

August 12, 2022

Status Verified

August 1, 2022

Enrollment Period

4.5 years

First QC Date

October 4, 2017

Last Update Submit

August 10, 2022

Conditions

Neoplasms

Keywords

Metastatic Cancer

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (1)

Checkpoint Inhibitor Therapy

OTHER

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

Interventions

BiopsyPROCEDURE

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

Checkpoint Inhibitor Therapy

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • Pregnant, lactating, or intending to become pregnant during the study.
  • Participants receiving CPI treatment as part of a non-Roche/Genentech clinical trial.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (11)

UCSF Comp Canc Ctr

San Francisco, California, 94115, United States

Location

Dana-Farber Cancer Institute

Boston, Massachusetts, 02215, United States

Location

Washington University School of Medicine; Dept of Medicine/Div of Medical Oncology

St Louis, Missouri, 63108, United States

Location

Herbert Irving Comprehensive Cancer Center; Herbert Irving Pavillion

New York, New York, 10032, United States

Location

Sarah Cannon Cancer Center

Arrington, Tennessee, 37014, United States

Location

Institut Universitaire du Cancer - Oncopole Toulouse (IUCT-O)

Toulouse, 31059, France

Location

Seoul National University Hospital; Department of Oncology

Seoul, 110-744, South Korea

Location

Asan Medical Center, Uni Ulsan Collegemedicine; Dept.Internal Medicine / Divisionhematology/Oncology

Seoul, 138-736, South Korea

Location

Clinica Universitaria de Navarra; Servicio de oncología

Pamplona, Navarre, 31008, Spain

Location

Hospital Univ Vall d'Hebron; Servicio de Oncologia

Barcelona, 08035, Spain

Location

Barts Hospital; Institute of Cancer

London, EC1M 6BQ, United Kingdom

Location

MeSH Terms

Conditions

NeoplasmsNeoplasm Metastasis

Interventions

Biopsy

Condition Hierarchy (Ancestors)

Neoplastic ProcessesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

CytodiagnosisCytological TechniquesClinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisSpecimen HandlingDiagnostic Techniques, SurgicalSurgical Procedures, OperativeInvestigative Techniques

Study Officials

  • Clinical Trials

    Hoffmann-La Roche

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NA
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 4, 2017

First Posted

November 7, 2017

Study Start

February 16, 2018

Primary Completion

August 4, 2022

Study Completion

August 4, 2022

Last Updated

August 12, 2022

Record last verified: 2022-08

Locations

ES(2)FR(1)KR(2)GB(1)US(5)