Ivonescimab versus bevacizumab with FOLFOX for first-line metastatic colorectal cancer

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a randomized, double-blind, active-controlled, multicenter Phase 3 trial that will enroll about 600 patients with metastatic colorectal cancer who have not received prior systemic therapy for metastatic disease. Participants will be assigned 1:1 to receive either ivonescimab plus mFOLFOX6 or bevacizumab plus mFOLFOX6, given by intravenous infusion every two weeks for up to eight cycles. After combination therapy, patients may continue maintenance treatment with the assigned antibody plus 5-fluorouracil and leucovorin every two weeks for up to two years. The study compares clinical outcomes and safety between the two antibody-containing regimens.

Why it matters

Who can join: the full rules

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

Where it's running

• Clinical Study Site
  Mobile, Alabama, United States Recruiting
• Clinical Study Site
  Tuscaloosa, Alabama, United States Recruiting
• Clinical Study Site
  Goodyear, Arizona, United States Recruiting
• Clinical Study Site
  Beverly Hills, California, United States Recruiting
• Clinical Study Site
  Beverly Hills, California, United States Recruiting
• Clinical Study Site
  Cerritos, California, United States Recruiting

+193 more sites. See ClinicalTrials.gov for the full list.

Study contacts

• Study coordinator: Ning Chang, MD
• Email: medicalaffairs@summitplc.com
• Phone: 1-833-256-0522

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• SAR445877 with FOLFOX6 and bevacizumab as first-line treatment for MSS metastatic colorectal cancer

  This study tests whether giving SAR445877 together with FOLFOX6 and bevacizumab is safe and tolerable as a first-line treatment for adults with MSS metastatic colorectal cancer.

  Recruiting Phase 1 M.D. Anderson Cancer Center · Houston, Texas · NCT07500298

• Irinotecan plus cetuximab rechallenge versus trifluridine/tipiracil plus bevacizumab in metastatic colorectal cancer

  This phase 2 trial tests whether giving irinotecan with cetuximab again helps patients with metastatic colorectal cancer whose disease progressed after standard therapies, compared with the current standard third-line treatment of trifluridine/tipiracil plus bevacizumab, using blood-based molecular profiling to select

  Recruiting at 19 sites Phase 2 Gruppo Oncologico Italia Meridionale · Alessandria and 25 other locations · NCT07381764

• Combining node-sparing radiotherapy with chemotherapy and immunotherapy for metastatic colorectal cancer

  This study is testing a new treatment that combines a special type of radiation with chemotherapy and immunotherapy to see if it can help people with metastatic colorectal cancer live longer and feel better.

  Recruiting Phase 2/3 Sixth Affiliated Hospital, Sun Yat-sen University · Guangzhou, Guangdong · NCT06958419

• Nelmastobart plus trifluridine/tipiracil and bevacizumab for metastatic or recurrent colorectal cancer

  This trial tests whether adding nelmastobart to trifluridine/tipiracil and bevacizumab helps adults with metastatic or recurrent colorectal cancer who cannot use oxaliplatin or irinotecan.

  Recruiting Phase 1/2 STCube, Inc. · Seongnam-si, Gyeonggi-do and 4 other locations · NCT06873763

• Combining TAS-102 and Bevacizumab with Local Treatment for Advanced Colorectal Cancer

  This study is testing a new combination of medications and local treatment for patients with advanced colorectal cancer who didn't get better with their first treatment to see if it works better than the usual second-line therapy.

  Recruiting Phase 2 Fudan University · Shanghai, Shanghai Municipality · NCT06856187

• KRAS Inhibitor ETX-929 in advanced solid tumors

  This trial tests ETX-929, alone or with cetuximab, in people whose cancers have KRAS mutations and have progressed after prior therapy.

  Recruiting Phase 1/2 Ensem Therapeutics · Fairfax, Virginia · NCT07912593

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.