Symptoms and General Pathology

All Conditions

Neoplasms

Recurrence

Carcinoma

Carcinoma, Squamous Cell

Squamous Cell Carcinoma of Head and Neck

Head and Neck Neoplasms

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Neoplasms, Squamous Cell

Antineoplastic Agents

All Drugs and Chemicals

Pembrolizumab

Immunomodulating Agents

Immune Checkpoint Inhibitors

Antineoplastic Agents, Immunological

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.

Phosphoinositide 3-kinase (PI3K) Inhibitor

Duvelisib

Immunotherapy (programmed cell death protein 1 \[PD-1\] inhibitor)

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).

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.

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

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.

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).

Proportion of participants achieving complete CR or PR according to RECIST v 1.1.

Time from response ≥ PR to documented disease progression according to RECIST v 1.1.

Time from start of treatment to documented disease progression according to RECIST v 1.1, or death due to any cause.

Pharmacokinetics (PK) parameters for duvelisib (and metabolite IPI-656) determined using bioanalytical data and Population PK (POPPK) modeling.

PK parameters for duvelisib (and metabolite IPI-656) determined using bioanalytical data and POPPK modeling.

Number of participants with TEAEs as assessed by CTCAE v5.0.

SecuraBio

This study was terminated by the Sponsor. Due to study termination and only 2 participants receiving treatment, there are concerns regarding participant confidentiality, therefore no data are being reported.

Stage 1: Duvelisib BID for 1 week followed by combination therapy with duvelisib BID + pembrolizumab 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

Age, Continuous

Sex: Female, Male

Ethnicity (NIH/OMB)

Race (NIH/OMB)

The study was terminated early by the Sponsor due to low enrollment. Due to study termination and only 2 participants receiving treatment, there are concerns regarding participant confidentiality, therefore no data are being reported.

Spots Global Cancer Trial Database for A Study of Duvelisib in Combination With Pembrolizumab in Head and Neck Cancer

Trial Identification

Conditions

Interventions

Study Description

Keywords

Eligibility

Locations

Contact Details

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