Metastatic Colorectal Cancer study: Ivonescimab Injection vs Bevacizumab Injection
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 Ivonescimab Injection?
An investigational injectable medicine being studied as a potential treatment for metastatic colorectal cancer.
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
- The study aims to find out whether ivonescimab combined with standard chemotherapy works as well as, or better than, the usual bevacizumab combo, and to compare safety of the two treatments.
- Who it's for
- Adults who have newly diagnosed metastatic colorectal cancer and have not yet received treatment for the spread.
- What's involved
- Participants will receive IV infusions of either ivonescimab or bevacizumab together with the chemotherapy regimen FOLFOX, plus regular check‑ups, blood tests and imaging scans.
- Time commitment
- Treatment is given every two weeks for up to about six months, with clinic visits for infusions and periodic scans throughout the study.
- 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 is enrolling
- 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
- Oakland, California, United States
- Orange, California, United States
- Pasadena, California, United States
- Roseville, California, United States
- San Francisco, California, United States
- Santa Clara, California, United States
- Stanford, California, United States
- Torrance, California, United States
+ 191 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, but 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?
This study is enrolling now at 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 205 more locations. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.