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

Colorectal Cancer Clinical Trial

— C-MSI  

Official title:

Retrospective Observational Study on the Use of Immunotherapy With Anti PD-1 Antibodies in Patients With MSI-H Metastatic Colorectal Cancer

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04612309
• Other study ID #: GOIRC-07-2019
• Status: Recruiting
• Start date: October 28, 2020
• Est. completion date: June 30, 2023

Study information

• Verified date: August 2022
• Source: Gruppo Oncologico Italiano di Ricerca Clinica
• Contact: Carmine Pinto, MD
• Phone: 0522295181
• Email: carmine.pinto[@]ausl.re.it
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: June 30, 2023
• Est. primary completion date: December 31, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 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.

Exclusion Criteria:

• Patients who received immunotherapy during a clinical trial.

Related Conditions & MeSH terms

• Colorectal Cancer
• Colorectal Neoplasms

Intervention

Drug:
• Immunotherapy
patient treated with at least 1 immunotherapy administration

Locations

Country	Name	City	State
Italy	Ospedale Ramazzini	Carpi	Modena

Sponsors (1)

Lead Sponsor	Collaborator
Gruppo Oncologico Italiano di Ricerca Clinica

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	effectiveness	survival rate of patients	6 months after the start of immunotherapy