drugset / Trial / NCT03575234
Nivolumab & IRX-2 With Surgery for Resectable Stage III-IVA Oral Cavity Cancer or HPV-Positive Oropharyngeal Cancer
Phase 1
Withdrawn
Emory University
Bristol-Myers Squibb · collabBrooklyn ImmunoTherapeutics, LLC · collab
NaSingle-groupOpen-labelTreatment
Summary
This phase I trial studies the side effects of nivolumab and IRX-2 and how well they work in treating participants with stage III-IVA oral cavity cancer or human papillomavirus (HPV)-positive oropharyngeal cancer that can be removed by surgery. Monoclonal antibodies, such as nivolumab, may interfere with the ability of tumor cells to grow and spread. IRX-2 may "turn on" the immune system and stimulate an immune response against tumor cells. Giving nivolumab and IRX-2 followed by surgery may work better at treating oral cavity and oropharyngeal cancer.
Timeline
- Start
- 2020-07-01
- Primary completion
- 2026-01-31
- Completion
- 2026-01-31
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | IRX-2 | Protein / enzyme biologic | — | Subcutaneous |
| Subject | Nivolumab | Monoclonal antibody | — | Intravenous |
| Background | Cyclophosphamide | Other / unclassified | — | Intravenous |