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NCT04030455 · ClinicalTrials.gov registry record · Phase 2
Cisplatin, Docetaxel, and Pembrolizumab in Treating Patients With Stage II-III Laryngeal Cancer
A Phase 2 study of Laryngeal Squamous Cell Carcinoma and Stage III Laryngeal Cancer AJCC v8, sponsored by M.D. Anderson Cancer Center.
- Active
- Registry status
- Phase 2
- Development phase
- 28
- Enrollment target
- 1
- Study location
NCT04030455: Active Phase 2 study of Laryngeal Squamous Cell Carcinoma and Stage III Laryngeal Cancer AJCC v8, sponsored by M.D. Anderson Cancer Center.
NCT04030455 is a Phase 2 study of Laryngeal Squamous Cell Carcinoma and Stage III Laryngeal Cancer AJCC v8 that is active but no longer recruiting, run by M.D. Anderson Cancer Center. The registered enrollment target is 28 participants, below the 94-participant average among 5 other Laryngeal Squamous Cell Carcinoma trials with a reported enrollment target (70% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04030455, a Phase 2 study of Laryngeal Squamous Cell Carcinoma and Stage III Laryngeal Cancer AJCC v8, is active but no longer recruiting, sponsored by M.D. Anderson Cancer Center.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 2
- Development phase
- 28 participants
- Enrollment target
- 1
- Study location
Study Summary
This phase II trial studies how well cisplatin, docetaxel, and pembrolizumab work in treating patients with stage II-III laryngeal cancer. Drugs used in chemotherapy, such as cisplatin and docetaxel, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Immunotherapy with monoclonal antibodies, such as pembrolizumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Giving cisplatin, docetaxel, and pembrolizumab may help to control the disease.
Primary Outcome
To determine the clinical benefit rate (CBR) of patients with stage II or III larynx squamous cell carcinoma (SCC) after 2 cycles of pembrolizumab, cisplatin and docetaxel (PCD), and the pathologic complete response (pCR) rate after 4 cycles of PCD. The CBR rate of patients with stage II or III larynx SCC after 2 cycles of PCD is 100%, excluding one patient (measurable data not available). The pCR rate after 4 cycles of PCD is 75.0%. Per Response Evaluation Criteria in Solid Tumors Criteria (REC
Conditions Studied
Interventions
- BIOLOGICAL Pembrolizumab
- DRUG Carboplatin
- DRUG Docetaxel
- DRUG Cisplatin
Study Locations (1)
Texas
- M D Anderson Cancer Center - Houston
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 28 participants |
| Start Date | 2019-08-07 |
| Est. Completion | 2026-09-17 |
| Phase | Phase 2 |
What the registry record for NCT04030455 still lists
NCT04030455 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 28 participants, a relatively small participant target, below the 94-participant average among 5 other Laryngeal Squamous Cell Carcinoma trials with a reported enrollment target (70% lower).
The record links to 3 conditions, with Laryngeal Squamous Cell Carcinoma appearing as the primary indexed condition, and to 4 interventions - of which Pembrolizumab is the first listed.
NCT04030455 reports a single indexed study location in Texas.
Frequently Asked Questions
What is clinical trial NCT04030455 about?
NCT04030455 is a clinical study titled "Cisplatin, Docetaxel, and Pembrolizumab in Treating Patients With Stage II-III Laryngeal Cancer". This phase II trial studies how well cisplatin, docetaxel, and pembrolizumab work in treating patients with stage II-III laryngeal cancer. Drugs used in chemotherapy, such as cisplatin and docetaxel, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping t...
What is the current status of trial NCT04030455?
This trial is currently active not recruiting. It is a Phase 2 study. The enrollment target is 28 participants. The study started on 2019-08-07. Estimated completion is 2026-09-17.
What conditions does trial NCT04030455 study?
This clinical trial studies the following conditions: Laryngeal Squamous Cell Carcinoma, Stage III Laryngeal Cancer AJCC v8, Stage II Laryngeal Cancer AJCC v8.
What interventions are being tested in trial NCT04030455?
The interventions under investigation include: Pembrolizumab (BIOLOGICAL), Carboplatin (DRUG), Docetaxel (DRUG), Cisplatin (DRUG).
Who is sponsoring clinical trial NCT04030455?
This trial is sponsored by M.D. Anderson Cancer Center, which has 2,692 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04030455 being conducted?
This trial has 1 study location across Texas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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