At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 14 enrolled
Drug / intervention
Nemvaleukin Alfa +1 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Phase 2 Study of ALKS 4230 in Combination With Anti-PD-1 (Pembrolizumab) in Patients With Advanced or Recurrent Head and Neck Squamous Cell Cancer Currently on Treatment With Anti-PD-(L)1 Without Having Achieved a Complete Remission
In Brief
A Phase 2 clinical trial evaluating Nemvaleukin Alfa and Pembrolizumab for Squamous Cell Carcinoma of Head and Neck. Completed, enrolled 14 participants across 7 sites.
Detailed Summary
The primary objective of this study was to estimate the response rate to ALKS 4230 in combination with pembrolizumab in patients with HNSCC who had previously received anti-PD-(L)1 therapy but who had not achieved a CR.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsSquamous Cell Carcinoma of Head and Neck
CountriesUnited States
CollaboratorsImmune Oncology Network (ION)
Timeline
Phase 2CompletedFinished
2020202120222023202420252026
First PostedOct 2019
Enrollment StartFeb 2020
Primary CompletionOct 2021
Study CompletionJan 2022
TodayJul 2026
First PostedOct 30, 2019
Enrollment StartFeb 5, 2020
Primary CompletionOct 8, 2021
Study CompletionJan 7, 2022
TodayJul 2, 2026
Enrollment to primary: 1.7 yearsPosted 6.7 years ago
Interventions
Nemvaleukin Alfadrug
Nemvaleukin alfa IV infusion.
Pembrolizumabdrug
Pembrolizumab IV infusion.