Retrospective Study on the Use of Immunotherapy in Patients With MSI-H Metastatic Colorectal Cancer

NCT04612309 | Active Not Recruiting FDA Drug

• 1 other identifier: GOIRC-07-2019
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

An increasing number of patients with metastatic colorectal cancer (mCRC) are able to receive 3 or more lines of therapy. In this setting, can be recognize treatments such as regorafenib (an oral multikinase inhibitor), trifluridine/tipiracil hydrochloride (TAS-102), an antineoplastic nucleoside analogue, and antibodies anti-epidermal growth factor receptor (EGFR) in patients with RAS wild-type tumors (if no prior exposure to antibodies). Maintaining quality of life is an essential goal for third- and later-line treatments for patients. The anti-programmed cell death protein 1 (anti-PD-1) immune checkpoint inhibitors, pembrolizumab and nivolumab, were approved in the US by the FDA in 2017, and the combination nivolumab plus ipilimumab (anti CTLA-4) was recently approved by the FDA in 2018, all in the second and later-line setting for patients with microsatellite instability-high (MSI-H) or deficient DNA mismatch repair mCRC whose disease has progressed despite treatment with fluoropyrimidine-, oxaliplatin-, and irinotecan-based chemotherapy. At present, these agents are not approved in Europe for mCRC patients with MSI-H. Clinical trial results and scientific data supported evidence that immunotherapies provide benefit but are limited to the small proportion (\< 5%) of patients with MSI-H tumors, in whom they are highly effective. Therefore, patients with MSI-H disease should be referred as expeditiously as possible to receive immune checkpoint inhibitors. The aim the study is to retrospectively collect data of patients treated with immunotherapy in the context of real clinical practice, in order to describe the real impact in terms of clinical outcomes and tolerability of treatment in common clinical practice.

Conditions

Colorectal Cancer

Keywords

H-MSI; immunotherapy

Outcome Measures

Primary Outcomes (1)

• effectiveness

  survival rate of patients

  6 months after the start of immunotherapy

Study Arms (1)

Treated

Patient with colorectal cancer already treated with immunotherapy

Drug: Immunotherapy

Interventions

Immunotherapy DRUG

patient treated with at least 1 immunotherapy administration

Treated

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with colorectal cancer treated with at least one administration of immunotherapy prior to 30 June 2020

You may qualify if:

• Signed informed consent for alive patients
• Patients with diagnosis of colorectal cancer with MSI-H
• Patient treated with at least one administration of antibody anti PD-1 for colorectal cancer prior to 30 June 2020 outside clinical trials.
• Availability of the tumor tissue from the primary tumor or a metastatic site for molecular analyses. The availability of tumor tissue is recommended but not mandatory.

You may not qualify if:

• Patients who received immunotherapy during a clinical trial.

Sponsors & Collaborators

• Gruppo Oncologico Italiano di Ricerca Clinica: lead

Study Sites (1)

Ospedale Ramazzini

Carpi, Modena, Italy

Location

MeSH Terms

Conditions

Colorectal Neoplasms

Interventions

Immunotherapy

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases

Intervention Hierarchy (Ancestors)

Immunomodulation; Biological Therapy; Therapeutics

Study Officials

• Carmine Pinto, MD

  Gruppo Oncologico Italiano di Ricerca Clinica

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 30, 2020
• First Posted: November 2, 2020
• Study Start: October 28, 2020
• Primary Completion: June 30, 2023
• Study Completion: June 30, 2025
• Last Updated: March 13, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will share

Locations

IT (1)