Summary

Eligibility
for people ages 18 years and up (full criteria)
Location
at UCLA
Dates
study started
study ends around

Description

Summary

The purpose of this study is to evaluate the efficacy and safety of standard-of-care chemotherapy and bevacizumab with or without INCA33890 in the first-line treatment of metastatic microsatellite stable colorectal cancer.

Official Title

A Randomized, Double-Blind, Phase 3 Study of Standard-of-Care Chemotherapy and Bevacizumab With or Without INCA33890 in the First-Line Treatment of Metastatic Microsatellite Stable Colorectal Cancer

Keywords

CRC (Colorectal Cancer), Metastatic Colorectal Cancer, Colon Cancer, INCA33890, Colorectal Neoplasms, Colonic Neoplasms, Bevacizumab, Folfox protocol, FOLFOX

Eligibility

You can join if…

Open to people ages 18 years and up

  • Stage IV colorectal adenocarcinoma not amenable to curative resection.
  • No prior systemic treatment for unresectable or metastatic disease. Participants who received adjuvant or neoadjuvant therapy may enroll if there was no recurrence within 12 months of the end of treatment.
  • Measurable disease per RECIST v1.1.
  • ECOG performance status of 0 or 1.
  • Adequate organ function determined by laboratory results.

You CAN'T join if...

  • MSI-H/dMMR per historical data in the medical record.
  • BRAF V600E mutation per historical data in the medical record.
  • Untreated and/or progressing CNS metastases.
  • History of other malignancy within 2 years.
  • Treatment with an anti-PD-(L)1 or other immune checkpoint inhibitor for any indication within the last 3 years.
  • Active autoimmune disease that has required systemic treatment in the past 2 years.
  • Significant concurrent and/or uncontrolled medical condition.
  • History of organ transplant, including allogeneic stem cell transplantation.

Other protocol-defined inclusion/exclusion criteria apply.

Locations

  • University of California Los Angeles Health not yet accepting patients
    Los Angeles California 90095 United States
  • Providence Medical Foundation not yet accepting patients
    Fullerton California 92835 United States
  • Pan American Center For Oncology Trials Llc Dorado Office accepting new patients
    Dorado 00646 Puerto Rico

Details

Status
accepting new patients at some sites,
but this study is not currently recruiting here
Start Date
Completion Date
(estimated)
Sponsor
Incyte Corporation
Links
A Study to Evaluate the Efficacy and Safety of Standard-of-Care Chemotherapy and Bevacizumab With or Without INCA33890 in the First-Line Treatment of Metastatic Microsatellite Stable Colorectal Cancer
ID
NCT07284849
Phase
Phase 3 research study
Study Type
Interventional
Participants
Expecting 700 study participants
Last Updated