RightFit
RecruitingPhase 3

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

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

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years and older
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

Not stated in the study description — ask the study team about visits and procedures.

Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tests how well standard chemotherapy and bevacizumab work, and how safe they are, with or without INCA33890. It is for people starting treatment for colon or rectal cancer that has spread and is microsatellite stable, meaning it does not have certain changes in its DNA.

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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Have stage IV colorectal adenocarcinoma, a cancer of the colon or rectum that has spread and cannot be cured with surgery.
  • Have not had whole-body drug treatment for cancer that has spread or cannot be removed by surgery. Earlier treatment before or after surgery is allowed if the cancer did not return within 12 months after treatment ended.
  • Have cancer that can be measured using the study’s rules.
  • Be fully active or able to do light work, even if hard physical activity is limited.
  • Have lab results showing that your organs work well enough.

Who can't join

  • Medical records show MSI-H or dMMR, signs of certain problems with how cancer cells repair DNA.
  • Medical records show a BRAF V600E change in a cancer gene.
  • Have cancer that has spread to the brain or spinal cord and is untreated or getting worse.
  • Have had another cancer within the past 2 years.
  • Have taken an immune checkpoint inhibitor, a drug that helps the immune system fight cancer, for any reason within the past 3 years.
  • Have an active autoimmune disease, where the immune system attacks the body, that needed whole-body treatment in the past 2 years.
  • Have another serious or uncontrolled medical condition.
  • Have had an organ transplant or a stem cell transplant from a donor.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility criteria

Inclusion Criteria: * 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. Exclusion Criteria: * 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.

Study sites (75)

AL

AZ

CA

CO

CT

DC

FL

GA

HI

IA

ID

IL

IN

MA

MD

MI

MO

NC

NJ

NM

NY

OH

PA

SD

TN

TX

VA

WA

WI

WV