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NCT03650764 · ClinicalTrials.gov registry record · Phase 1
Ramucirumab + Pembrolizumab in Patients With Recurrent/Metastatic Head and Neck Squamous Cell Carcinoma
A Phase 1 study of Head and Neck Squamous Cell Carcinoma, sponsored by Washington University School of Medicine.
- Active
- Registry status
- Phase 1
- Development phase
- 43
- Enrollment target
- 1
- Study location
NCT03650764: Active Phase 1 study of Head and Neck Squamous Cell Carcinoma, sponsored by Washington University School of Medicine.
NCT03650764 is a Phase 1 study of Head and Neck Squamous Cell Carcinoma that is active but no longer recruiting, run by Washington University School of Medicine. The registered enrollment target is 43 participants, below the 117-participant average among 124 other Head and Neck Squamous Cell Carcinoma trials with a reported enrollment target (63% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03650764, a Phase 1 study of Head and Neck Squamous Cell Carcinoma, is active but no longer recruiting, sponsored by Washington University School of Medicine.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 1
- Development phase
- 43 participants
- Enrollment target
- 1
- Study location
Study Summary
The investigators hypothesize that inhibition of angiogenesis and PD-1 will be more effective than inhibition of PD-1 alone. The first step in pursuing proof of this hypothesis is to establish the safety and feasibility of combining ramucirumab with pembrolizumab, therefore the first part of this protocol is a de-escalation phase I trial of the combination of ramucirumab + pembrolizumab. The key objective of the phase I trial is to establish the safety and the recommended phase 2 dose (RP2D) of ramucirumab for this novel combination regimen in patients with recurrent/metastatic head and neck squamous cell carcinoma (RM-HNSCC). The second step in pursuing proof of this hypothesis is to establish the efficacy of ramucirumab (using the RP2D) with pembrolizumab. The second part of this protocol is a single arm phase II trial combining ramucirumab + pembrolizumab. The primary objective of the phase II trial is to determine the tumor response rates (complete response (CR) and partial response (PR)) of the treatment combination given as first line therapy in patients with RM-HNSCC.
Primary Outcome
-The RP2D of ramucirumab is defined as the highest dose level at which fewer than 2 participants of a cohort of three participants experience a dose-limiting toxicity (DLT) during the first cycle.
Conditions Studied
Interventions
- DRUG Pembrolizumab
- DRUG Ramucirumab
- OTHER EORTC QLQ-30
- OTHER FACT H&N
- PROCEDURE Peripheral blood
Study Locations (1)
Missouri
- Washington University School of Medicine - St Louis
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 43 participants |
| Start Date | 2019-05-29 |
| Est. Completion | 2026-06-30 |
| Phase | Phase 1 |
What the registry record for NCT03650764 still lists
NCT03650764 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 43 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 (63% lower).
The record links to 1 condition, with Head and Neck Squamous Cell Carcinoma appearing as the primary indexed condition, and to 5 interventions - of which Pembrolizumab is the first listed.
NCT03650764 reports a single indexed study location in Missouri.
Frequently Asked Questions
What is clinical trial NCT03650764 about?
NCT03650764 is a clinical study titled "Ramucirumab + Pembrolizumab in Patients With Recurrent/Metastatic Head and Neck Squamous Cell Carcinoma". The investigators hypothesize that inhibition of angiogenesis and PD-1 will be more effective than inhibition of PD-1 alone. The first step in pursuing proof of this hypothesis is to establish the safety and feasibility of combining ramucirumab with pembrolizumab, therefore the first part of this pr...
What is the current status of trial NCT03650764?
This trial is currently active not recruiting. It is a Phase 1 study. The enrollment target is 43 participants. The study started on 2019-05-29. Estimated completion is 2026-06-30.
What conditions does trial NCT03650764 study?
This clinical trial studies the following conditions: Head and Neck Squamous Cell Carcinoma.
What interventions are being tested in trial NCT03650764?
The interventions under investigation include: Pembrolizumab (DRUG), Ramucirumab (DRUG), EORTC QLQ-30 (OTHER), FACT H&N (OTHER), Peripheral blood (PROCEDURE).
Who is sponsoring clinical trial NCT03650764?
This trial is sponsored by Washington University School of Medicine, which has 1,502 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03650764 being conducted?
This trial has 1 study location across Missouri. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT03650764's enrollment target sits among peer trials
43 74th of 124 higher than 49 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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