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NCT03049618 · ClinicalTrials.gov registry record · Phase 2
Recombinant EphB4-HSA Fusion Protein and Pembrolizumab, MK-3475
A Phase 2 study of Head and Neck Squamous Cell Carcinoma and Stage IIIA Non-Small Cell Lung Cancer, sponsored by University of Southern California.
- Completed
- Registry status
- Phase 2
- Development phase
- 42
- Enrollment target
- 1
- Study location
NCT03049618: Completed Phase 2 study of Head and Neck Squamous Cell Carcinoma and Stage IIIA Non-Small Cell Lung Cancer, sponsored by University of Southern California.
NCT03049618 is a Phase 2 study of Head and Neck Squamous Cell Carcinoma and Stage IIIA Non-Small Cell Lung Cancer that has completed, run by University of Southern California. The registered enrollment target is 42 participants, below the 117-participant average among 124 other Head and Neck Squamous Cell Carcinoma trials with a reported enrollment target (64% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03049618, a Phase 2 study of Head and Neck Squamous Cell Carcinoma and Stage IIIA Non-Small Cell Lung Cancer, has completed, sponsored by University of Southern California.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 42 participants
- Enrollment target
- 1
- Study location
Study Summary
This phase IIa trial studies how well recombinant EphB4-HSA fusion protein and pembrolizumab work in treating patients with non-small cell lung cancer that has spread to other places in the body or head and neck squamous cell cancer that has come back or spread to other places in the body. Recombinant EphB4-HSA fusion protein may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Monoclonal antibodies, such as pembrolizumab, may interfere with the ability of cancer cells to grow and spread. Giving recombinant EphB4-HSA fusion protein and pembrolizumab may work better in treating patients with non-small cell lung or head and neck squamous cell cancer.
Primary Outcome
Calculated based on the evaluable population of patients who received at least 1 dose of therapy. Overall response rate (ORR) is complete response (CR) + partial response (PR) recorded from study entry until disease progression based on RECIST v1.1 criteria. Per RECIST 1.1 for target lesions: CR is complete disappearance of all target lesions and PR is at least a 30% decrease in the sum of longest diameter (LD) of target lesions, taking as reference baseline sum LD. PR or better overall response
Conditions Studied
Interventions
- BIOLOGICAL Pembrolizumab
- OTHER Laboratory Biomarker Analysis
- BIOLOGICAL Recombinant EphB4-HSA Fusion Protein
Study Locations (1)
California
- USC / Norris Comprehensive Cancer Center - Los Angeles
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 42 participants |
| Start Date | 2017-03-10 |
| Est. Completion | 2024-09-04 |
| Phase | Phase 2 |
What the finished NCT03049618 record still lists
NCT03049618 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 42 participants, a relatively small participant target, below the 117-participant average among 124 other Head and Neck Squamous Cell Carcinoma trials with a reported enrollment target (64% lower).
The record links to 10 conditions, with Head and Neck Squamous Cell Carcinoma appearing as the primary indexed condition, and to 3 interventions - of which Pembrolizumab is the first listed.
NCT03049618 reports a single indexed study location in California.
Frequently Asked Questions
What is clinical trial NCT03049618 about?
NCT03049618 is a clinical study titled "Recombinant EphB4-HSA Fusion Protein and Pembrolizumab, MK-3475". This phase IIa trial studies how well recombinant EphB4-HSA fusion protein and pembrolizumab work in treating patients with non-small cell lung cancer that has spread to other places in the body or head and neck squamous cell cancer that has come back or spread to other places in the body. Recombina...
What is the current status of trial NCT03049618?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 42 participants. The study started on 2017-03-10. Estimated completion is 2024-09-04.
What conditions does trial NCT03049618 study?
This clinical trial studies the following conditions: Head and Neck Squamous Cell Carcinoma, Stage IIIA Non-Small Cell Lung Cancer, EGFR Gene Mutation, Metastatic Head and Neck Carcinoma, Recurrent Non-Small Cell Lung Carcinoma.
What interventions are being tested in trial NCT03049618?
The interventions under investigation include: Pembrolizumab (BIOLOGICAL), Laboratory Biomarker Analysis (OTHER), Recombinant EphB4-HSA Fusion Protein (BIOLOGICAL).
Who is sponsoring clinical trial NCT03049618?
This trial is sponsored by University of Southern California, which has 617 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03049618 being conducted?
This trial has 1 study location across California. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT03049618's enrollment target sits among peer trials
42 77th of 124 higher than 48 of 124 other Head and Neck Squamous Cell Carcinoma trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Head and Neck Squamous Cell Carcinoma trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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