A Study of Duvelisib in Combination With Pembrolizumab in Head and Neck Cancer
- Conditions
- Head and Neck Squamous Cell Carcinoma
- Interventions
- Biological: Pembrolizumab
- Registration Number
- NCT04193293
- Lead Sponsor
- SecuraBio
- Brief 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.
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 2
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Duvelisib + Pembrolizumab Pembrolizumab Stage 1: Duvelisib twice daily (BID) for 1 week followed by combination therapy with duvelisib BID + pembrolizumab every 3 weeks (q3w) (Cycle 1 was 4 weeks consisting of the 1-week duvelisib monotherapy lead-in period followed by 1 dose of pembrolizumab in combination with 3 additional weeks of continuous dosing of duvelisib; subsequent cycles were 3 weeks). Stage 2: Duvelisib BID + pembrolizumab q3w in 3-week cycles. Duvelisib + Pembrolizumab Duvelisib Stage 1: Duvelisib twice daily (BID) for 1 week followed by combination therapy with duvelisib BID + pembrolizumab every 3 weeks (q3w) (Cycle 1 was 4 weeks consisting of the 1-week duvelisib monotherapy lead-in period followed by 1 dose of pembrolizumab in combination with 3 additional weeks of continuous dosing of duvelisib; subsequent cycles were 3 weeks). Stage 2: Duvelisib BID + pembrolizumab q3w in 3-week cycles.
- Primary Outcome Measures
Name Time Method Stage 1: Number of Participants With Dose-limiting Toxicities 4 weeks or 28 days Stage 1 and 2: Overall Response Rate (ORR) Up to 2 years Proportion of participants achieving complete response (CR) or partial response (PR) according to Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v 1.1).
Stage 1: Number of Participants With Treatment-emergent Adverse Events (TEAEs) 6 months Number of participants with TEAEs as assessed by the Common Terminology Criteria for Adverse Events version 5 (CTCAE v5) as a measure of safety and tolerability of duvelisib in combination with pembrolizumab.
- Secondary Outcome Measures
Name Time Method Stage 1 and 2: Progression-free Survival (PFS) From start of treatment until documented PD or death (up to 2.5 years) Time from start of treatment to documented disease progression according to RECIST v 1.1, or death due to any cause.
Stage 1 and 2: Area Under the Curve [AUC] Up to 5 cycles (46 weeks) PK parameters for duvelisib (and metabolite IPI-656) determined using bioanalytical data and POPPK modeling.
Stage 1 and 2: Overall Survival From start of treatment until death (up to 2.5 years) Time from start of treatment to death.
Stage 1 and 2: Duration of Response (DOR) From first response until documented PD (up to 2 years) Time from response ≥ PR to documented disease progression according to RECIST v 1.1.
Stage 1 and 2: Number of Participants With TEAEs 24 months Number of participants with TEAEs as assessed by CTCAE v5.0.
Stage 1: ORR Until documented progressive disease (PD), unacceptable toxicity, discontinuation criteria are met, withdrawal, or death (up to 2 years) Proportion of participants achieving complete CR or PR according to RECIST v 1.1.
Stage 1 and 2: Maximum Observed Concentration [Cmax] Up to 5 cycles (46 weeks) Pharmacokinetics (PK) parameters for duvelisib (and metabolite IPI-656) determined using bioanalytical data and Population PK (POPPK) modeling.
Trial Locations
- Locations (1)
UPMC Hillman Cancer Center
🇺🇸Pittsburgh, Pennsylvania, United States