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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
EU CTIS ID: 2025-523735-19-00
What this study is testing
To evaluate the efficacy of the combination of INCA33890 and SOC therapy versus placebo and SOC therapy.
- Therapeutic confirmatory (Phase III)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Ability to comprehend and willingness to sign a written ICF for the study.
- Aged 18 years or older, inclusive, at the time of signing the ICF.
- Histologically or cytologically confirmed metastatic colorectal adenocarcinoma (Stage IV per the American Joint Committee on Cancer, Cancer Staging Manual, 8th Edition) not amenable to curative resection.
- No prior systemic treatment for unresectable or metastatic CRC. Participants who previously received neoadjuvant and/or adjuvant therapy are allowed to enroll if there was no recurrence of disease within 12 months of last systemic therapy administration.
- Radiographically measurable disease (based on local site investigator/radiology evaluation) per RECIST v1.1 criteria.
- Adequate organ function as defined in the protocol
You likely can't join if
- Cancer History: Known MSI-H/dMMR status per local standard of practice as obtained from historical data in the participant's medical record.
- Medical History: History of organ transplant, including allogeneic stem cell transplantation.
- Active autoimmune disease that has required systemic treatment in the past 2 years (ie, with use of disease-modifying agents, corticosteroids, or immunosuppressive drugs). Replacement therapy is allowed.
- Significant concurrent and/or uncontrolled medical condition as detailed in the protocol
- Uncontrolled active HBV or HCV infection.
- HIV positive, unless all of the following criteria are met: a. CD4+ count ≥ 350 μL. b. Undetectable viral load. c. Receiving highly active antiretroviral therapy.
See the full eligibility criteria
Who can join
- Ability to comprehend and willingness to sign a written ICF for the study.
- Aged 18 years or older, inclusive, at the time of signing the ICF.
- Histologically or cytologically confirmed metastatic colorectal adenocarcinoma (Stage IV per the American Joint Committee on Cancer, Cancer Staging Manual, 8th Edition) not amenable to curative resection.
- No prior systemic treatment for unresectable or metastatic CRC. Participants who previously received neoadjuvant and/or adjuvant therapy are allowed to enroll if there was no recurrence of disease within 12 months of last systemic therapy administration.
- Radiographically measurable disease (based on local site investigator/radiology evaluation) per RECIST v1.1 criteria.
- Adequate organ function as defined in the protocol
- Willingness to avoid pregnancy or fathering children.
What rules you out
- Cancer History: Known MSI-H/dMMR status per local standard of practice as obtained from historical data in the participant's medical record.
- Medical History: History of organ transplant, including allogeneic stem cell transplantation.
- Active autoimmune disease that has required systemic treatment in the past 2 years (ie, with use of disease-modifying agents, corticosteroids, or immunosuppressive drugs). Replacement therapy is allowed.
- Significant concurrent and/or uncontrolled medical condition as detailed in the protocol
- Uncontrolled active HBV or HCV infection.
- HIV positive, unless all of the following criteria are met: a. CD4+ count ≥ 350 μL. b. Undetectable viral load. c. Receiving highly active antiretroviral therapy.
- Medications: 19. Current use of chronic systemic corticosteroids (ie, > 10 mg/day of prednisone or equivalent).
- Received a live vaccine within 28 days before the first dose of study treatment.
- Current use of prohibited medication as defined in the protocol.
- Known complete DPD deficiency as reported in the participant's medical record. Local guidelines and regulations for DPD activity testing and dose adjustments should be applied in case of partial deficiency.
- BRAF V600E mutation as obtained from historical data in the participant's medical record.
- History of other malignancy within 2 years of study entry.
- Untreated and/or progressing CNS metastases (eg, evidence of new or enlarging brain metastasis or new neurological symptoms attributable to brain or CNS metastases).
- Tumor known to invade or encase a major blood vessel or any history of clinically significant bleeding from tumor lesions within 30 days before enrollment.
- Treatment with an anti–PD-(L)1 or anti–CTLA-4 antibody, or any other antibody or drug specifically targeting T-cell costimulation or checkpoint pathways, for any indication within the past 3 years.
- Toxicity from prior therapy that has not recovered to ≤ Grade 1 or baseline. Paresthesia and/or peripheral sensory neuropathy of Grade 2 or higher due to prior chemotherapy (eg, oxaliplatin) are exclusionary.
- Concurrent anticancer therapy other than the therapies being tested in this study.
- Received thoracic radiation of > 30 Gy within 6 months of the first dose of study treatment.
The study team makes the final eligibility decision.
Where it's taking place
- Korea, Republic of
- Argentina
- Puerto Rico
- Switzerland
- Georgia
- United States
- Brazil
- Canada
- Japan
- Australia
- United Kingdom
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 listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18-64 years, 65+ years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Korea, Republic of; Argentina; Puerto Rico; Switzerland; Georgia; United States and 5 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.