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New treatment option for Metastatic Colorectal Cancer (CRC)
Official title Phase III Study of Ivonescimab or Bevacizumab Combined With FOLFOX in Patients With Metastatic Colorectal Cancer
ClinicalTrials.gov ID: NCT07228832
What this study is testing
What is Drug: Ivonescimab Injection?
Drug: Ivonescimab Injection is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for metastatic colorectal cancer (crc).
Also referred to as Oxaliplatin, Leucovorin.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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)
- Phase 3: a large, late-stage study
- Time commitment: about 2 years
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- ECOG performance status score of 0 or 1
- Expected life expectancy ≥ 6 months
- Patients with histologically or cytologically confirmed metastatic CRC
- No prior systemic therapy for metastatic CRC
- At least 1 measurable noncerebral lesion
You likely can't join if
- Microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) disease
- Known BRAF V600E mutant status
- Current presence of significant radiographic or clinical manifestations of gastrointestinal (GI) obstruction
- Ascites requiring paracentesis within last 30 days
- Patients who have received prior immunotherapy or anti-angiogenic therapy for colorectal cancer
- Active or prior history of inflammatory bowel disease (eg, Crohn's disease, ulcerative colitis, or chronic diarrhea)
See the full eligibility criteria
- ECOG performance status score of 0 or 1
- Expected life expectancy ≥ 6 months
- Patients with histologically or cytologically confirmed metastatic CRC
- No prior systemic therapy for metastatic CRC
- At least 1 measurable noncerebral lesion
- Microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) disease
- Known BRAF V600E mutant status
- Current presence of significant radiographic or clinical manifestations of gastrointestinal (GI) obstruction
- Ascites requiring paracentesis within last 30 days
- Patients who have received prior immunotherapy or anti-angiogenic therapy for colorectal cancer
- Active or prior history of inflammatory bowel disease (eg, Crohn's disease, ulcerative colitis, or chronic diarrhea)
- Resectable disease
The study team makes the final eligibility decision.
Where it's taking place
- Mobile, Alabama, United States
- Tuscaloosa, Alabama, United States
- Goodyear, Arizona, United States
- Beverly Hills, California, United States
- Cerritos, California, United States
- Corona, California, United States
- Duarte, California, United States
- Fountain Valley, California, United States
- Huntington Beach, California, United States
- Irvine, California, United States
- Los Angeles, California, United States
- Murrieta, California, United States
- Orange, California, United States
- Pasadena, California, United States
- Torrance, California, United States
- Upland, California, United States
- West Hollywood, California, United States
- Hartford, Connecticut, United States
- New Haven, Connecticut, United States
- Norwich, Connecticut, United States
+ 103 more site(s).
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The study runs about 2 years per participant, based on its public description. The team confirms the exact schedule and number of visits before you enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Mobile, Alabama, United States; Tuscaloosa, Alabama, United States; Goodyear, Arizona, United States; Beverly Hills, California, United States; Cerritos, California, United States; Corona, California, United States and 117 more location(s). Enter your location above to see the nearest site and check your eligibility.
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BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.