Clinical trial · Interventional
Combination Study of Urelumab and Cetuximab in Patients With Advanced/Metastatic Colorectal Cancer or Advanced/Metastatic Head and Neck Cancer
A Phase 1b, Open-label, Multicenter Study of Urelumab (BMS-663513) in Combination With Cetuximab in Subjects With Advanced/Metastatic Colorectal Cancer or Advanced/Metastatic Squamous Cell Carcinoma of the Head and Neck
NCT02110082CI-TRIAL-00027082completedPhase 1ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The purpose of the study is to determine the safety, tolerability and maximum tolerated dose of Urelumab in combination with Cetuximab in patients with Advanced/Metastatic Colorectal Cancer or Advanced/Metastatic Squamous Cell Carcinoma of the Head and Neck.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Colorectal Cancer | Malignant Colorectal Neoplasm | CURATED_BROADER | 0.80 |
| Head and Neck Cancer | Malignant Head and Neck Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Cetuximab | Biological | Cetuximab | ALIAS |
| Urelumab | Biological | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Cohort 1: Urelumab + Cetuximab
- description
- Urelumab every 3 weeks with Cetuximab weekly through Intravenous infusion
- interventionNames
- Biological: Urelumab
- Biological: Cetuximab
- type
- EXPERIMENTAL
- label
- Cohort 2: Urelumab + Cetuximab
- description
- Urelumab every 3 weeks with Cetuximab weekly through Intravenous infusion
- interventionNames
- Biological: Urelumab
- Biological: Cetuximab
Primary outcomes (1)
- measure
- The primary safety endpoint is the incidence, potential significance, and clinical importance of adverse events
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
For more information regarding BMS clinical trial participation, please visit www.BMSStudyConnect.com Inclusion Criteria: * Subjects with advanced/metastatic Colorectal Cancer(CRC) who have failed or been intolerant to both irinotecan- and oxaliplatin- based regimens * Subjects with advanced/metastatic Squamous cell carcinoma of the head and neck (SCCHN) who are without options for curative treatment * Subjects must have measurable disease per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 criteria * Men and women 18 and older * Women of childbearing potential (WOCBP) and men must use highly effective methods of contraception * Eastern Cooperative Oncology Group (ECOG) of 0 or 1 * Subjects must have a life expectancy of at least 3 months Exclusion Criteria: * Active or progressing brain metastases * Other concomitant malignancies (with some exceptions per protocol) * Nasopharyngeal carcinoma * Active or history of autoimmune disease * Positive test for Human Immunodeficiency Virus (HIV) 1\&2 or known AIDS * History of any hepatitis (A,B or C) * Known current drug or alcohol abuse * Active Tuberculosis (TB) * Use of anti-cancer treatments within 28 days * Prior therapy with anti-CD137 antibody Other protocol defined inclusion/exclusion criteria could apply
References
Publications (1)
- DERIVEDKhushalani NI, Ott PA, Ferris RL, Cascone T, Schadendorf D, Le DT, Sharma MR, Barlesi F, Sharfman W, Luke JJ, Melero I, Lathers D, Neely J, Suryawanshi S, Sanyal A, Holloway JL, Suryawanshi R, Ely S, Segal NH. Final results of urelumab, an anti-CD137 agonist monoclonal antibody, in combination with cetuximab or nivolumab in patients with advanced solid tumors. J Immunother Cancer. 2024 Mar 7;12(3):e007364. doi: 10.1136/jitc-2023-007364. PMID 38458639