ivo versus Nivo/Ipi or versus other chemotherapies to treat colorectal cancer

Phase 1

• Conditions: Microsatellite Instability High (MSI-H) or Mismatch Repair DeficientMetastatic Colorectal Cancer (dMMR); MedDRA version: 21.0Level: LLTClassification code 10052362Term: Metastatic colorectal cancerSystem Organ Class: 100000004864; Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2018-000040-26-GB
• Lead Sponsor: Bristol-Myers Squibb International Corporation

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2019-11-01
• Last Update Posted: 28 September 2020

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 974

Inclusion Criteria

- Histologically confirmed recurrent or metastatic colorectal cancer
(CRC) irrespective of prior treatment history with chemotherapy and/or
targeted agents not
amenable to surgery (Applicable only during Part 1 enrollment of the
study)
-Histologically confirmed recurrent or metastatic CRC with no prior
treatment history with chemotherapy and/or targeted agents for
metastatic disease and not
amenable to surgery (Applicable during Part 2 enrollment of the study)
- Known tumor MSI-H or dMMR status per local standard of practice
- Eastern cooperative oncology group (ECOG) performance status lower
than or equal to 1
- Other protocol-defined inclusion/exclusion criteria apply
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 682
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 292

Exclusion Criteria

- Participants with an active, known or suspected autoimmune disease
- History of interstitial lung disease or pneumonitis
- Known history of positive test for human immunodeficiency virus (HIV)
or known acquired immunodeficiency syndrome (AIDS)
- Other protocol-defined inclusion/exclusion criteria apply

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified