Clinical Trials Logo
  1. Home
  2. Neoplasms
  3. NCT03333655
  4. Details
NCT03333655 Clinical Trial

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

Neoplasms Clinical Trial

Official title:
A Multicenter Study to Explore the Mechanism of Acquired Immune Escape In Patients With Metastatic Cancer Progressing on Checkpoint Inhibitor Therapy

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
See also
  Status Clinical Trial Phase
Completed NCT03826043 - THrombo-Embolic Event in Onco-hematology N/A
Terminated NCT03166631 - A Trial to Find the Safe Dose for BI 891065 Alone and in Combination With BI 754091 in Patients With Incurable Tumours or Tumours That Have Spread Phase 1
Completed NCT01938846 - BI 860585 Dose Escalation Single Agent and in Combination With Exemestane or With Paclitaxel in Patients With Various Advanced and/or Metastatic Solid Tumors Phase 1
Recruiting NCT06058312 - Individual Food Preferences for the Mediterranean Diet in Cancer Patients N/A
Completed NCT03308942 - Effects of Single Agent Niraparib and Niraparib Plus Programmed Cell Death-1 (PD-1) Inhibitors in Non-Small Cell Lung Cancer Participants Phase 2
Recruiting NCT06018311 - Exercising Together for Hispanic Prostate Cancer Survivor-Caregiver Dyads N/A
Withdrawn NCT05431439 - Omics of Cancer: OncoGenomics
Completed NCT01343043 - A Pilot Study of Genetically Engineered NY-ESO-1 Specific NY-ESO-1ᶜ²⁵⁹T in HLA-A2+ Patients With Synovial Sarcoma Phase 1
Completed NCT01938638 - Open Label Phase I Dose Escalation Study With BAY1143572 in Patients With Advanced Cancer Phase 1
Recruiting NCT05514444 - Study of MK-4464 as Monotherapy and in Combination With Pembrolizumab in Participants With Advanced/Metastatic Solid Tumors (MK-4464-001) Phase 1
Recruiting NCT02292641 - Beyond TME Origins N/A
Terminated NCT00954512 - Study of Robatumumab (SCH 717454, MK-7454) in Combination With Different Treatment Regimens in Participants With Advanced Solid Tumors (P04722, MK-7454-004) Phase 1/Phase 2
Recruiting NCT04958239 - A Study to Test Different Doses of BI 765179 Alone and in Combination With Ezabenlimab in Patients With Advanced Cancer (Solid Tumors) Phase 1
Recruiting NCT04627376 - Multimodal Program for Cancer Related Cachexia Prevention N/A
Completed NCT01222728 - Using Positron Emission Tomography to Predict Intracranial Tumor Growth in Neurofibromatosis Type II Patients
Recruiting NCT06004440 - Real World Registry for Use of the Ion Endoluminal System
Active, not recruiting NCT05636696 - COMPANION: A Couple Intervention Targeting Cancer-related Fatigue N/A
Not yet recruiting NCT06035549 - Resilience in East Asian Immigrants for Advance Care Planning Discussions N/A
Recruiting NCT06004466 - Noninvasive Internal Jugular Venous Oximetry
Completed NCT03190811 - Anti-PD-1 Alone or Combined With Autologous DC-CIK Cell Therapy in Advanced Solid Tumors Phase 1/Phase 2