Trial Outcomes & Findings for A Study of Duvelisib in Combination With Pembrolizumab in Head and Neck Cancer (NCT NCT04193293)
NCT ID: NCT04193293
Last Updated: 2023-09-21
Results Overview
TERMINATED
PHASE1/PHASE2
2 participants
4 weeks or 28 days
2023-09-21
Participant Flow
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.
Participant milestones
| Measure |
Duvelisib + 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.
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|---|---|
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Overall Study
STARTED
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0
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Overall Study
COMPLETED
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0
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Overall Study
NOT COMPLETED
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0
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Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
A Study of Duvelisib in Combination With Pembrolizumab in Head and Neck Cancer
Baseline characteristics by cohort
Baseline data not reported
PRIMARY outcome
Timeframe: 4 weeks or 28 daysPopulation: 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.
Outcome measures
Outcome data not reported
PRIMARY outcome
Timeframe: 6 monthsPopulation: 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.
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.
Outcome measures
Outcome data not reported
PRIMARY outcome
Timeframe: Up to 2 yearsPopulation: 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.
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).
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Until documented progressive disease (PD), unacceptable toxicity, discontinuation criteria are met, withdrawal, or death (up to 2 years)Population: 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.
Proportion of participants achieving complete CR or PR according to RECIST v 1.1.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: From first response until documented PD (up to 2 years)Population: 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.
Time from response ≥ PR to documented disease progression according to RECIST v 1.1.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: From start of treatment until documented PD or death (up to 2.5 years)Population: 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.
Time from start of treatment to documented disease progression according to RECIST v 1.1, or death due to any cause.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: From start of treatment until death (up to 2.5 years)Population: 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.
Time from start of treatment to death.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Up to 5 cycles (46 weeks)Population: 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.
Pharmacokinetics (PK) parameters for duvelisib (and metabolite IPI-656) determined using bioanalytical data and Population PK (POPPK) modeling.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Up to 5 cycles (46 weeks)Population: 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.
PK parameters for duvelisib (and metabolite IPI-656) determined using bioanalytical data and POPPK modeling.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 24 monthsPopulation: 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.
Number of participants with TEAEs as assessed by CTCAE v5.0.
Outcome measures
Outcome data not reported
Adverse Events
Duvelisib + Pembrolizumab
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place