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NCT04144517 · ClinicalTrials.gov registry record · Phase 2
A Study of ALKS 4230 (Nemvaleukin Alfa) With Pembrolizumab in Head and Neck Cancer
A Phase 2 study of Squamous Cell Carcinoma of Head and Neck, sponsored by Mural Oncology.
- Completed
- Registry status
- Phase 2
- Development phase
- 14
- Enrollment target
- 7
- Study locations
NCT04144517: Completed Phase 2 study of Squamous Cell Carcinoma of Head and Neck, sponsored by Mural Oncology.
NCT04144517 is a Phase 2 study of Squamous Cell Carcinoma of Head and Neck that has completed, run by Mural Oncology. The registered enrollment target is 14 participants, below the 170-participant average among 37 other Squamous Cell Carcinoma of Head and Neck trials with a reported enrollment target (92% lower). The trial reports 7 study locations across 6 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04144517, a Phase 2 study of Squamous Cell Carcinoma of Head and Neck, has completed, sponsored by Mural Oncology.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 14 participants
- Enrollment target
- 7
- Study locations
Study 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.
Primary Outcome
ORR was defined as percentage of participants with complete response (CR) or PR as assessed by investigator based on response evaluation criteria in solid tumors (RECIST) version (v) 1.1. CR was defined as the disappearance of all target and non-target lesions (non-lymph nodes). All pathological lymph nodes (whether target or non-target) must have a reduction in their short axis less than (\<) 10 millimeters (mm). PR was defined as at least a 30 percent (%) decrease in the sum of diameter (SOD)
Conditions Studied
Interventions
- DRUG Pembrolizumab
- DRUG Nemvaleukin Alfa
Study Locations (7)
New York
- Mural Oncology Investigational Site - New York
- Mural Oncology Investigational Site - New York
Florida
- Mural Oncology Investigational Site - Miami
Georgia
- Mural Oncology Investigational Site - Atlanta
Minnesota
- Mural Oncology Investigational Site - Minneapolis
Ohio
- Mural Oncology Investigational Site - Cleveland
Texas
- Mural Oncology Investigational Site - Austin
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 14 participants |
| Start Date | 2020-02-05 |
| Est. Completion | 2022-01-07 |
| Phase | Phase 2 |
What the finished NCT04144517 record still lists
NCT04144517 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 14 participants, a relatively small participant target, below the 170-participant average among 37 other Squamous Cell Carcinoma of Head and Neck trials with a reported enrollment target (92% lower).
The record links to 1 condition, with Squamous Cell Carcinoma of Head and Neck appearing as the primary indexed condition, and to 2 interventions - of which Pembrolizumab is the first listed.
NCT04144517 lists 7 locations in 6 states (New York, Florida, Georgia).
Frequently Asked Questions
What is clinical trial NCT04144517 about?
NCT04144517 is a clinical study titled "A Study of ALKS 4230 (Nemvaleukin Alfa) With Pembrolizumab in Head and Neck Cancer". 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.
What is the current status of trial NCT04144517?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 14 participants. The study started on 2020-02-05. Estimated completion is 2022-01-07.
What conditions does trial NCT04144517 study?
This clinical trial studies the following conditions: Squamous Cell Carcinoma of Head and Neck.
What interventions are being tested in trial NCT04144517?
The interventions under investigation include: Pembrolizumab (DRUG), Nemvaleukin Alfa (DRUG).
Who is sponsoring clinical trial NCT04144517?
This trial is sponsored by Mural Oncology, which has 6 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04144517 being conducted?
This trial has 7 study locations across Florida, Georgia, Minnesota, New York, Ohio. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Where NCT04144517's enrollment target sits among peer trials
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participants (enrollment target), bucketed by value
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