A Study of Duvelisib in Combination With Pembrolizumab in Head and Neck Cancer

• ClinicalTrials.gov Identifier: NCT04193293
• Recruitment Status: Terminated
• First Posted: December 10, 2019
• Results First Posted: April 7, 2023
• Last Update Posted: April 7, 2023
• Sponsor: SecuraBio
• Information provided by (Responsible Party): SecuraBio

• Study Type: Interventional
• Study Design: Allocation: N/A; Intervention Model: Single Group Assignment; Masking: None (Open Label); Primary Purpose: Treatment
• Condition: Head and Neck Squamous Cell Carcinoma
• Interventions: Drug: Duvelisib; Biological: Pembrolizumab
• Enrollment: 2

Participant Flow

Recruitment Details
Pre-assignment Details	The study was terminated 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.

Arm/Group Title	Duvelisib + Pembrolizumab
Arm/Group Description	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.
Period Title: Overall Study
Started	0
Completed	0
Not Completed	0

Baseline Characteristics

Arm/Group Title		Duvelisib + Pembrolizumab
Arm/Group Description		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.
Overall Number of Baseline Participants		0
Baseline Analysis Population Description		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.
Age, Continuous	Number Analyzed	0 participants
Sex: Female, Male
	Number Analyzed	0 participants
	Female
	Male
Ethnicity (NIH/OMB)
	Number Analyzed	0 participants
	Hispanic or Latino
	Not Hispanic or Latino
	Unknown or Not Reported
Race (NIH/OMB)
	Number Analyzed	0 participants
	American Indian or Alaska Native
	Asian
	Native Hawaiian or Other Pacific Islander
	Black or African American
	White
	More than one race
	Unknown or Not Reported

Outcome Measures

1. Primary Outcome

Title	Stage 1: Number of Participants With Dose-limiting Toxicities
Description	[Not Specified]
Time Frame	4 weeks or 28 days

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	Duvelisib + Pembrolizumab
Arm/Group Description:	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.
Overall Number of Participants Analyzed	0

No data displayed because Outcome Measure has zero total analyzed.

2. Primary Outcome

Title	Stage 1: Number of Participants With Treatment-emergent Adverse Events (TEAEs)
Description	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.
Time Frame	6 months

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	Duvelisib + Pembrolizumab
Arm/Group Description:	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.
Overall Number of Participants Analyzed	0

No data displayed because Outcome Measure has zero total analyzed.

3. Primary Outcome

Title	Stage 1 and 2: Overall Response Rate (ORR)
Description	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).
Time Frame	Up to 2 years

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	Duvelisib + Pembrolizumab
Arm/Group Description:	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.
Overall Number of Participants Analyzed	0

No data displayed because Outcome Measure has zero total analyzed.

4. Secondary Outcome

Title	Stage 1: ORR
Description	Proportion of participants achieving complete CR or PR according to RECIST v 1.1.
Time Frame	Until documented progressive disease (PD), unacceptable toxicity, discontinuation criteria are met, withdrawal, or death (up to 2 years)

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	Duvelisib + Pembrolizumab
Arm/Group Description:	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.
Overall Number of Participants Analyzed	0

No data displayed because Outcome Measure has zero total analyzed.

5. Secondary Outcome

Title	Stage 1 and 2: Duration of Response (DOR)
Description	Time from response ≥ PR to documented disease progression according to RECIST v 1.1.
Time Frame	From first response until documented PD (up to 2 years)

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	Duvelisib + Pembrolizumab
Arm/Group Description:	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.
Overall Number of Participants Analyzed	0

No data displayed because Outcome Measure has zero total analyzed.

6. Secondary Outcome

Title	Stage 1 and 2: Progression-free Survival (PFS)
Description	Time from start of treatment to documented disease progression according to RECIST v 1.1, or death due to any cause.
Time Frame	From start of treatment until documented PD or death (up to 2.5 years)

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	Duvelisib + Pembrolizumab
Arm/Group Description:	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.
Overall Number of Participants Analyzed	0

No data displayed because Outcome Measure has zero total analyzed.

7. Secondary Outcome

Title	Stage 1 and 2: Overall Survival
Description	Time from start of treatment to death.
Time Frame	From start of treatment until death (up to 2.5 years)

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	Duvelisib + Pembrolizumab
Arm/Group Description:	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.
Overall Number of Participants Analyzed	0

No data displayed because Outcome Measure has zero total analyzed.

8. Secondary Outcome

Title	Stage 1 and 2: Maximum Observed Concentration [Cmax]
Description	Pharmacokinetics (PK) parameters for duvelisib (and metabolite IPI-656) determined using bioanalytical data and Population PK (POPPK) modeling.
Time Frame	Up to 5 cycles (46 weeks)

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	Duvelisib + Pembrolizumab
Arm/Group Description:	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.
Overall Number of Participants Analyzed	0

No data displayed because Outcome Measure has zero total analyzed.

9. Secondary Outcome

Title	Stage 1 and 2: Area Under the Curve [AUC]
Description	PK parameters for duvelisib (and metabolite IPI-656) determined using bioanalytical data and POPPK modeling.
Time Frame	Up to 5 cycles (46 weeks)

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	Duvelisib + Pembrolizumab
Arm/Group Description:	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.
Overall Number of Participants Analyzed	0

No data displayed because Outcome Measure has zero total analyzed.

10. Secondary Outcome

Title	Stage 1 and 2: Number of Participants With TEAEs
Description	Number of participants with TEAEs as assessed by CTCAE v5.0.
Time Frame	24 months

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	Duvelisib + Pembrolizumab
Arm/Group Description:	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.
Overall Number of Participants Analyzed	0

No data displayed because Outcome Measure has zero total analyzed.

Adverse Events

Time Frame	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.
Adverse Event Reporting Description	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.
Arm/Group Title	Duvelisib + Pembrolizumab
Arm/Group Description	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.
All-Cause Mortality
	Duvelisib + Pembrolizumab
	Affected / at Risk (%)
Total	0/0
Serious Adverse Events
	Duvelisib + Pembrolizumab
	Affected / at Risk (%)
Total	0/0
Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events	0%
	Duvelisib + Pembrolizumab
	Affected / at Risk (%)
Total	0/0

Limitations and Caveats

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.

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

Results Point of Contact

• Name/Title: Study Director
• Organization: SecuraBio
• Phone: 1-858-251-1414
• EMail: dkatz@securabio.com

• Responsible Party: SecuraBio
• ClinicalTrials.gov Identifier: NCT04193293
• Other Study ID Numbers: VS-0145-130
• First Submitted: December 4, 2019
• First Posted: December 10, 2019
• Results First Submitted: March 14, 2023
• Results First Posted: April 7, 2023
• Last Update Posted: April 7, 2023