Trials / Terminated
TerminatedNCT04193293
A Study of Duvelisib in Combination With Pembrolizumab in Head and Neck Cancer
A Phase 1b/2 Study of Duvelisib in Combination With Pembrolizumab in Subjects With Recurrent or Metastatic Head and Neck Squamous Cell Cancer
- Status
- Terminated
- Phase
- Phase 1 / Phase 2
- Study type
- Interventional
- Enrollment
- 2 (actual)
- Sponsor
- SecuraBio · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
This study was designed to assess the safety and preliminary efficacy of duvelisib in combination with pembrolizumab in participants with recurrent or metastatic (R/M) head and neck squamous cell carcinoma (HNSCC).
Detailed description
This was a non-randomized, open-label Phase 1b/2 study designed to evaluate safety, tolerability, and preliminary efficacy of duvelisib in combination with pembrolizumab in participants with R/M HNSCC who were eligible for pembrolizumab monotherapy based on the current pembrolizumab prescribing information.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Duvelisib | Phosphoinositide 3-kinase (PI3K) Inhibitor |
| BIOLOGICAL | Pembrolizumab | Immunotherapy (programmed cell death protein 1 \[PD-1\] inhibitor) |
Timeline
- Start date
- 2020-06-01
- Primary completion
- 2020-12-10
- Completion
- 2020-12-10
- First posted
- 2019-12-10
- Last updated
- 2023-09-21
- Results posted
- 2023-04-07
Locations
1 site across 1 country: United States
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT04193293. Inclusion in this directory is not an endorsement.