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NCT04862650 · ClinicalTrials.gov registry record · Phase 2
Cemiplimab, Low-Dose Paclitaxel and Carboplatin for the Treatment of Recurrent/Metastatic Squamous Cell Carcinoma of the Head and Neck
A Phase 2 study of Metastatic Head-and-neck Squamous-cell Carcinoma and Recurrent Head and Neck Squamous Cell Carcinoma, sponsored by Marcelo Bonomi.
- Active
- Registry status
- Phase 2
- Development phase
- 46
- Enrollment target
- 1
- Study location
NCT04862650: Active Phase 2 study of Metastatic Head-and-neck Squamous-cell Carcinoma and Recurrent Head and Neck Squamous Cell Carcinoma, sponsored by Marcelo Bonomi.
NCT04862650 is a Phase 2 study of Metastatic Head-and-neck Squamous-cell Carcinoma and Recurrent Head and Neck Squamous Cell Carcinoma that is active but no longer recruiting, run by Marcelo Bonomi. The registered enrollment target is 46 participants, below the 125-participant average among 24 other Metastatic 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
NCT04862650, a Phase 2 study of Metastatic Head-and-neck Squamous-cell Carcinoma and Recurrent Head and Neck Squamous Cell Carcinoma, is active but no longer recruiting, sponsored by Marcelo Bonomi.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 2
- Development phase
- 46 participants
- Enrollment target
- 1
- Study location
Study Summary
This phase II trial studies the effect of cemiplimab in combination with low-dose paclitaxel and carboplatin in treating patients with squamous cell carcinoma of the head and neck that has come back (recurrent) or spread to other places in the body (metastatic). Immunotherapy with monoclonal antibodies, such as cemiplimab , may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Chemotherapy drugs, like paclitaxel and carboplatin, work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving cemiplimab in combination with paclitaxel and carboplatin may work better in treating recurrent or metastatic squamous cell carcinoma of the head and neck.
Primary Outcome
ORR defined as the proportion of patients with a documented complete response (CR) + partial response (PR) at week 12 of treatment based on Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 criteria. An ORR of 40% (percent) or higher will be consider a positive result. Simon two-stage optimal design will be used.
Conditions Studied
Interventions
- DRUG Carboplatin
- DRUG Paclitaxel
- BIOLOGICAL Cemiplimab
Study Locations (1)
Ohio
- Ohio State University Comprehensive Cancer Center - Columbus
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 46 participants |
| Start Date | 2021-11-30 |
| Est. Completion | 2026-12-31 |
| Phase | Phase 2 |
What the registry record for NCT04862650 still lists
NCT04862650 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 46 participants, a relatively small participant target, below the 125-participant average among 24 other Metastatic Head-and-neck Squamous-cell Carcinoma trials with a reported enrollment target (63% lower).
The record links to 10 conditions, with Metastatic Head-and-neck Squamous-cell Carcinoma appearing as the primary indexed condition, and to 3 interventions - of which Carboplatin is the first listed.
NCT04862650 reports a single indexed study location in Ohio.
Frequently Asked Questions
What is clinical trial NCT04862650 about?
NCT04862650 is a clinical study titled "Cemiplimab, Low-Dose Paclitaxel and Carboplatin for the Treatment of Recurrent/Metastatic Squamous Cell Carcinoma of the Head and Neck". This phase II trial studies the effect of cemiplimab in combination with low-dose paclitaxel and carboplatin in treating patients with squamous cell carcinoma of the head and neck that has come back (recurrent) or spread to other places in the body (metastatic). Immunotherapy with monoclonal antibod...
What is the current status of trial NCT04862650?
This trial is currently active not recruiting. It is a Phase 2 study. The enrollment target is 46 participants. The study started on 2021-11-30. Estimated completion is 2026-12-31.
What conditions does trial NCT04862650 study?
This clinical trial studies the following conditions: Metastatic Head-and-neck Squamous-cell Carcinoma, Recurrent Head and Neck Squamous Cell Carcinoma, Recurrent Hypopharyngeal Squamous Cell Carcinoma, Recurrent Laryngeal Squamous Cell Carcinoma, Clinical Stage IV HPV-Mediated (p16-Positive) Oropharyngeal Carcinoma AJCC v8.
What interventions are being tested in trial NCT04862650?
The interventions under investigation include: Carboplatin (DRUG), Paclitaxel (DRUG), Cemiplimab (BIOLOGICAL).
Who is sponsoring clinical trial NCT04862650?
This trial is sponsored by Marcelo Bonomi, which has 1 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04862650 being conducted?
This trial has 1 study location across Ohio. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT04862650's enrollment target sits among peer trials
46 13th of 24 higher than 11 of 24 other Metastatic Head-and-neck Squamous-cell Carcinoma trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Metastatic 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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