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NCT03019003 · ClinicalTrials.gov registry record · Phase 1
Oral Decitabine (ASTX727) and Durvalumab in Recurrent and/or Metastatic Head and Neck Cancer Patients
A Phase 1 study, sponsored by Massachusetts General Hospital.
- Completed
- Registry status
- Phase 1
- Development phase
- 13
- Enrollment target
NCT03019003: Completed Phase 1 study, sponsored by Massachusetts General Hospital.
NCT03019003 is a Phase 1 study that has completed, run by Massachusetts General Hospital. The registered enrollment target is 13 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03019003, a Phase 1 study, has completed, sponsored by Massachusetts General Hospital.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 13 participants
- Enrollment target
Study Summary
This is a non-randomized, open-label, Phase Ib study to assess the safety and efficacy of a DNA methyltransferase inhibitor and immune checkpoint inhibitor(s) (durvalumab and/or tremelimumab) combination therapy in the treatment of patients with recurrent and/or metastatic squamous cell carcinoma of the head and neck (SCCHN) who have progressed during or after treatment with anti-PD-1, anti-PD-L1, or anti-CTLA-4 monotherapy for recurrent and/or metastatic disease. The clinical trial is studying drugs that can boost the participant's immune system against the cancer cells as a possible treatment for head and neck cancer. The study interventions involved in this study are: * Oral Decitabine (ASTX 727) and 5' Azacytidine * Durvalumab (MEDI4736) and Tremelimumab
Interventions
- DRUG Durvalumab
- DRUG Tremelimumab
- DRUG Oral Decitabine
- DRUG 5' Azacitidine
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 13 participants |
| Start Date | 2017-03-20 |
| Est. Completion | 2024-09-24 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03019003
The ClinicalTrials.gov registry entry for NCT03019003 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 13 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Massachusetts General Hospital, which has 2,032 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 4 interventions - of which Durvalumab is the first listed.
NCT03019003 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT03019003 about?
NCT03019003 is a clinical study titled "Oral Decitabine (ASTX727) and Durvalumab in Recurrent and/or Metastatic Head and Neck Cancer Patients". This is a non-randomized, open-label, Phase Ib study to assess the safety and efficacy of a DNA methyltransferase inhibitor and immune checkpoint inhibitor(s) (durvalumab and/or tremelimumab) combination therapy in the treatment of patients with recurrent and/or metastatic squamous cell carcinoma of...
What is the current status of trial NCT03019003?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 13 participants. The study started on 2017-03-20. Estimated completion is 2024-09-24.
What interventions are being tested in trial NCT03019003?
The interventions under investigation include: Durvalumab (DRUG), Tremelimumab (DRUG), Oral Decitabine (DRUG), 5' Azacitidine (DRUG).
Who is sponsoring clinical trial NCT03019003?
This trial is sponsored by Massachusetts General Hospital, which has 2,032 total clinical trials registered on ClinicalTrials.gov.
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