drugset / Trial / NCT04688658
Duvelisib in Combination With Nivolumab in Patients With Advanced Unresectable Melanoma
Phase 1/2
Terminated
13 enrolled
John Kirkwood
Bristol-Myers Squibb · collabSecura Bio, Inc. · collab
NaSingle-groupOpen-labelTreatment
Summary
This trial is a Phase I/II study in which a combination of duvelisib and nivolumab will be used to treat a total of patients diagnosed with advanced unresectable melanoma who have progressed on anti-PD1 therapy. The Recommended Phase II Dose of oral duvelisib will be determined and administered with intravenous nivolumab 480mg for up to 1 year or until the patient's disease does not progress or the patient experiences unacceptable side effects to treatment.
Timeline
- Start
- 2021-10-06
- Primary completion
- 2024-02-22
- Completion
- 2025-02-01
Outcome
Outcome not reported
Stopped: “Secura Bio, Inc. discontinued support of the trial.”
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Duvelisib | Small molecule | 15 mg | Oral |
| Subject | Duvelisib | Small molecule | 25 mg | Oral |
| Subject | Nivolumab | Monoclonal antibody | 480 mg | Intravenous |