RightFit
RecruitingPhase 3

Phase III Study of Ivonescimab or Bevacizumab Combined With FOLFOX in Patients With Metastatic Colorectal Cancer

A Randomized, Active-Controlled, Double-blind, Multicenter, Phase 3 Clinical Study of Ivonescimab in Combination With FOLFOX Versus Bevacizumab in Combination With FOLFOX for the First-line Treatment of Metastatic 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

  • Time periods mentioned: 2 years
  • Procedures mentioned: Infusions

Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.

Show the study's own words
  • "Each enrolled subject will receive an intravenous infusion of the Ivonescimab/Bevacizumab Plus mFOLFOX6 (Q2W, up to 8 cycles) in treatment periods per the randomization schedule."
  • "Afterward, Ivonescimab/ Bevacizumab Plus 5-Fluorouracil and Leucovorin will be used for maintenance treatment (administered on Day 1 of each cycle, Q2W) for up to 2 years."
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 compares ivonescimab plus FOLFOX chemotherapy with bevacizumab plus FOLFOX chemotherapy. It is for people with colon or rectal cancer that has spread to other parts of the body and has not yet been treated with medicines that work throughout the body.

A Randomized, Active-Controlled, Double-blind, Multicenter, Phase 3 Clinical Study of Ivonescimab in Combination with mFOLFOX6 (Oxaliplatin, Leucovorin and 5-Fluorouracil) versus Bevacizumab in Combination with FOLFOX for the First-line Treatment of Metastatic Colorectal Cancer(HARMONi-GI3)

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

Eligibility

Who can join

  • You can do all your usual activities, or you can do light work but not hard physical activity.
  • You are expected to live at least 6 months.
  • Tests of tissue or cells confirm colon or rectal cancer that has spread.
  • You have not had medicines that work throughout the body to treat the cancer after it spread.
  • You have at least one tumor outside the brain that can be measured.

Who can't join

  • Your cancer has MSI-H or dMMR, signs of problems with how cancer cells repair their DNA.
  • Your cancer has a known gene change called BRAF V600E.
  • Scans or symptoms show a major blockage in your stomach or intestines.
  • You needed fluid drained from your belly with a needle in the past 30 days.
  • You have had immune-based treatment or drugs that block blood vessel growth for colon or rectal cancer.
  • You have or have had inflammatory bowel disease, such as Crohn’s disease or ulcerative colitis, or long-lasting diarrhea.
  • Your cancer can be removed with surgery.

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

Official eligibility criteria

Inclusion Criteria: 1. ECOG performance status score of 0 or 1 2. Expected life expectancy ≥ 6 months 3. Patients with histologically or cytologically confirmed metastatic CRC 4. No prior systemic therapy for metastatic CRC 5. At least 1 measurable noncerebral lesion Exclusion Criteria: 1. Microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) disease 2. Known BRAF V600E mutant status 3. Current presence of significant radiographic or clinical manifestations of gastrointestinal (GI) obstruction 4. Ascites requiring paracentesis within last 30 days 5. Patients who have received prior immunotherapy or anti-angiogenic therapy for colorectal cancer 6. Active or prior history of inflammatory bowel disease (eg, Crohn's disease, ulcerative colitis, or chronic diarrhea) 7. Resectable disease

Study sites (112)

AL

AZ

CA

CO

CT

DE

FL

GA

IL

IN

KS

KY

LA

MA

MD

MI

MN

MO

MT

NC

NE

NH

NJ

NY

OH

OK

PA

RI

SC

TN

TX

UT

VA

VT

WA

WI

WV