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NCT03655444 · ClinicalTrials.gov registry record · Phase 1
Abemaciclib + Nivolumab in Patients With Recurrent/Metastatic Head and Neck Squamous Cell Carcinoma That Progressed or Recurred Within Six Months After Platinum-based Chemotherapy
A Phase 1 study, sponsored by Washington University School of Medicine.
- Terminated
- Registry status
- Phase 1
- Development phase
- 6
- Enrollment target
NCT03655444 is a Phase 1 study that was terminated before completion, run by Washington University School of Medicine. The registered enrollment target is 6 participants.
The verdict
NCT03655444, a Phase 1 study, was terminated before completion, sponsored by Washington University School of Medicine.
- TERMINATED
- Registry status
- Phase 1
- Development phase
- 6 participants
- Enrollment target
Study Summary
In phase I of the trial, the investigators aim to explore the safety and feasibility of abemaciclib in combination with nivolumab in patients with recurrent/metatstatic head and neck squamous cell carcinoma (RM-HNSCC). A dose de-escalation study design will be used to determine the recommended phase II dose (RP2D) of abemaciclib given with the standard dose of nivolumab. In phase II of the trial, the investigators aim to determine if abemaciclib and nivolumab will improve the one year survival from 36% (historical comparison with nivolumab) to 60% (abemaciclib + nivolumab) in patients with RM-HNSCC that had progressed or recurred within six months after platinum-based chemotherapy. Patients will be treated with abemaciclib at the recommended phase 2 dose (RP2D) in combination with standard doses of nivolumab. If this aim is met, genome sequencing, bulk and single cell RNAseq, and selected protein expression and deep cellular phenotyping will be performed on tumor tissue and blood obtained before and during treatment with abemaciclib and nivolumab. These biomarker data will be correlated with survival and tumor response to abemaciclib and nivolumab.
Interventions
- DRUG Nivolumab
- DRUG Abemaciclib
- PROCEDURE Tumor biopsy
- OTHER EORTC QLQ-30
- PROCEDURE Peripheral blood
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 6 participants |
| Start Date | 2019-05-29 |
| Est. Completion | 2020-08-24 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03655444
The ClinicalTrials.gov registry entry for NCT03655444 describes a study currently listed as terminated, categorized as Phase 1. The registered enrollment target is 6 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Washington University School of Medicine, which has 1,502 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 5 interventions - of which Nivolumab is the first listed.
NCT03655444 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT03655444 about?
NCT03655444 is a clinical study titled "Abemaciclib + Nivolumab in Patients With Recurrent/Metastatic Head and Neck Squamous Cell Carcinoma That Progressed or Recurred Within Six Months After Platinum-based Chemotherapy". In phase I of the trial, the investigators aim to explore the safety and feasibility of abemaciclib in combination with nivolumab in patients with recurrent/metatstatic head and neck squamous cell carcinoma (RM-HNSCC). A dose de-escalation study design will be used to determine the recommended phase...
What is the current status of trial NCT03655444?
This trial is currently terminated. It is a Phase 1 study. The enrollment target is 6 participants. The study started on 2019-05-29. Estimated completion is 2020-08-24.
What interventions are being tested in trial NCT03655444?
The interventions under investigation include: Nivolumab (DRUG), Abemaciclib (DRUG), Tumor biopsy (PROCEDURE), EORTC QLQ-30 (OTHER), Peripheral blood (PROCEDURE).
Who is sponsoring clinical trial NCT03655444?
This trial is sponsored by Washington University School of Medicine, which has 1,502 total clinical trials registered on ClinicalTrials.gov.
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