A Study of Overall Survival in Participants With Metastatic Colorectal Cancer (mCRC)

NCT05420909 | Completed

• 1 other identifier: CA209-7AU
• Study Type: observational
• Target: 124
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to estimate the overall survival (OS) for US participants diagnosed with metastatic colorectal cancer (mCRC) by using Flatiron Health's individual patient level data.

Conditions

Metastatic Colorectal Cancer (mCRC)

Keywords

mCRC; Checkmate-142; Nivolumab

Outcome Measures

Primary Outcomes (2)

• Overall Survival (OS)

  Up to 6 years

• Duration of Systemic Treatment

  Durations were reported for the first line of therapy prior to the second line (2L) therapy of interest, the 2L therapy of interest, the third line of therapy, and the at least fourth line of therapy.

  Up to 6 years

Study Arms (1)

Cohort 1

Participants diagnosed with metastatic colorectal cancer (mCRC) selected from the Flatiron Electronic Health Record database

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

Participants who were diagnosed with mCRC and received 2L therapy of interest were selected from Flatiron Health's data from January 2013 through March 2019. 2L therapies of interest included: * FOLFIRI and bevacizumab * FOLFOX and bevacizumab * CAPEOX and bevacizumab * FOLFIRI and panitumumab * FOLFIRI and ziv-aflibercept * FOLFOX, bevacizumab and other (non I-O) * FOLFIRI, ziv-aflibercept and other (non I-O) * FOLFIRI, bevacizumab and other (non I-O) * Nivolumab monotherapy * Pembrolizumab monotherapy

You may qualify if:

• Metastatic Colorectal Cancer (CRC) participants in the Flatiron database as defined by:
• Diagnosed with CRC (ICD-9 153.x or 154.x or ICD-10 C18x, or C19x, or C20x, or C21x)
• Pathology consistent with CRC
• At least two documented clinical visits on or after January 1, 2013
• Evidence of Stage IV or recurrent metastatic CRC diagnosed on or after January 1, 2013
• Participants with high levels of microsatellite instability (MSI-H) and/or mismatch repair (MMR) protein deficiency (dMMR)
• Participants who received 2L therapy of interest on or after the initial mCRC diagnosis date
• Participants who had at least 1 month medical data during the prior to and post periods; however, participants who died within 1 month after the index date will not be excluded from the study

You may not qualify if:

• Participants \<18 years of age at index date
• Participants who received clinical trial drug during the prior or post periods

Sponsors & Collaborators

• Bristol-Myers Squibb: lead

Study Sites (1)

Local Institution

Princeton, New Jersey, 08543, United States

Location

Related Links

• BMS Clinical Trial Information
• FDA Safety Alerts and Recalls
• Investigator Inquiry Form

MeSH Terms

Conditions

Colorectal Neoplasms

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

Study Officials

• Bristol-Myers Squibb

  Bristol-Myers Squibb

  STUDY DIRECTOR

Study Design

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

Study Record Dates

• First Submitted: June 13, 2022
• First Posted: June 15, 2022
• Study Start: January 28, 2019
• Primary Completion: March 1, 2019
• Study Completion: April 1, 2019
• Last Updated: August 19, 2022

Record last verified: 2022-08

Locations

US (1)