NCT07284849Recruiting
A Study to Evaluate the Efficacy and Safety of Standard-of-Care Chemotherapy and Bevacizumab With or Without INCA33890 in the First-Line Treatment of Metastatic Microsatellite Stable Colorectal Cancer
Summary
The purpose of this study is to evaluate the efficacy and safety of standard-of-care chemotherapy and bevacizumab with or without INCA33890 in the first-line treatment of metastatic microsatellite stable colorectal cancer.
Inclusion criteria
• Stage IV colorectal adenocarcinoma not amenable to curative resection. • No prior systemic treatment for unresectable or metastatic disease. Participants who received adjuvant or neoadjuvant therapy may enroll if there was no recurrence within 12 months of the end of treatment. • Measurable disease per RECIST v1.1. • ECOG performance status of 0 or 1. • Adequate organ function determined by laboratory results.
Exclusion criteria
• MSI-H/dMMR per historical data in the medical record. • BRAF V600E mutation per historical data in the medical record. • Untreated and/or progressing CNS metastases. • History of other malignancy within 2 years. • Treatment with an anti-PD-(L)1 or other immune checkpoint inhibitor for any indication within the last 3 years. • Active autoimmune disease that has required systemic treatment in the past 2 years. • Significant concurrent and/or uncontrolled medical condition. • History of organ transplant, including allogeneic stem cell transplantation. Other protocol-defined inclusion/exclusion criteria apply.
Contacts
The trial team's contact details are shown on request.
See the official trial record- Status
- Recruiting
- Phase
- Phase 3
- Study type
- Interventional
- Countries
- Switzerland, France, Germany, Italy, Austria, United States, Argentina, Australia, Belgium, Brazil, Canada, China, Denmark, Georgia, Japan, Netherlands, Norway, Poland, Puerto Rico, South Korea, Spain, United Kingdom
- Sponsor
- Incyte Corporation(Industry)
- Protocol no.
- INCA033890-303
- Conditions
- CRC (Colorectal Cancer)
- Interventions
- Drug
Treatments studied
- INCA33890
- Placebo
- Bevacizumab
- FOLFOX
Locations · 145
- Bordeaux, FranceChu Bordeaux-Hopital PellegrinRecruiting at this site
- Marseille, FranceHôpital de La TimoneRecruiting at this site
- Paris, FranceHospital Universitaire Pitie-SalpetriereRecruiting at this site
- Poitiers, FranceHospital de La MiletrieRecruiting at this site
- Reims, FranceChu de ReimsRecruiting at this site
- Saint-Etienne, FranceUniversity Hospital of Saint EtienneRecruiting at this site
- Toulouse, FranceChu Toulouse Hopital RangueilRecruiting at this site
- Hamburg, GermanyUniversity Medical Centre Hamburg-Eppendorf Centre of OncologyRecruiting at this site
- Hamburg, GermanyAsklepios Klinik AltonaRecruiting at this site
- München, GermanyKlinikum NeuperlachRecruiting at this site
- Penzberg, GermanyRoche Diagnostics GmbhRecruiting at this site
- Regensburg, GermanyUniversitaetsklinikum RegensburgRecruiting at this site
- Ancona, ItalyAzienda Ospedaliero Universitaria Delle MarcheRecruiting at this site
- Bari, ItalyIstituto Tumori Giovanni Paolo Ii Irccs Ospedale Oncologico BariRecruiting at this site
- Brescia, ItalyFondazione Poliambulanza Istituto OspedalieroRecruiting at this site
- Candiolo, ItalyIstituto Di Candiolo Fondazione Del Piemonte Per L'Oncologia - IrccsRecruiting at this site
- Milan, ItalyComitato Etico Fondazione Irccs Istituto Nazionale Dei Tumori MilanoRecruiting at this site
- Milan, ItalyAsst Grande Ospedale Metropolitano NiguardaRecruiting at this site
- Naples, ItalyAzienda Ospedaliera Universitaria- Università Degli Studi Della Campania "Luigi Vanvitelli"Recruiting at this site
- Padova, ItalyIov - Istituto Oncologico Veneto IrccsRecruiting at this site
- Pisa, ItalyAzienda Ospedaliero Universitaria Pisana - Ospedale S. ChiaraRecruiting at this site
- Ravenna, ItalyOspedale Santa Maria Delle CrociRecruiting at this site
- Reggio Emilia, ItalyArcispedale S. Maria Nuova Azienda Ospedaliera Di Reggio EmiliaRecruiting at this site
- Roma, ItalyAzienda Ospedaliera San Camillo ForlaniniRecruiting at this site
- Rozzano, ItalyIrccs Istituto Clinico HumanitasRecruiting at this site
- San Giovanni Rotondo, ItalyI.R.C.C.S. Casa Sollievo Della SofferenzaRecruiting at this site
- Verona, ItalyCentro Ricerche Cliniche Di VeronaRecruiting at this site
- Linz, AustriaOrdensklinikum Krankenhaus Der Barmherzigen Schwestern LinzRecruiting at this site
- Salzburg, AustriaLkh - Universitatsklinikum Der Pmu SalzburgRecruiting at this site
- Tucson, United StatesThe University of Arizona Cancer CenterRecruiting at this site
In total, worldwide, 145 of the 293 sites listed in the registry are recruiting; the other 148 are not currently recruiting.
Site status per the ClinicalTrials.gov registry (last update posted: October 9, 2026).
This status may have changed and says nothing about your eligibility: before taking any step, check with your oncologist or the site.
+ 115 more locations
Other identifiers
- 2025-523735-19-00 · other registry
- 2025 · NIH grant
See also
Other versions
These results are indicative and do not replace medical advice — discuss them with your doctor.