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NCT03246685 · ClinicalTrials.gov registry record · Phase 2
Phase 2 Study of Imprime PGG & Pembrolizumab in Subjects With Adv SCCHN Who Failed Pembro Monotherapy or Experiencing SD
A Phase 2 study, sponsored by HiberCell.
- Terminated
- Registry status
- Phase 2
- Development phase
- 1
- Enrollment target
NCT03246685 is a Phase 2 study that was terminated before completion, run by HiberCell. The registered enrollment target is 1 participants.
The verdict
NCT03246685, a Phase 2 study, was terminated before completion, sponsored by HiberCell.
- TERMINATED
- Registry status
- Phase 2
- Development phase
- 1 participants
- Enrollment target
Study Summary
Objective: To determine the Overall Response Rate (ORR) to Imprime PGG + pembrolizumab in subjects with advanced Squamous Cell Carcinoma of the Head and Neck (SCCHN) Safety: To characterize the safety of Imprime PGG + pembrolizumab given in combination Hypothesis: Restore (for subjects who have failed pembrolizumab mono therapy) or enhance (for subjects who actively experiencing SD) sensitivity to checkpoint inhibitors (CPI) by appropriate and effective stimulation of the subject's innate and adaptive immune systems by combining Imprime PGG with pembrolizumab. The study will require documenting at least 5 objective responses among the 38 subjects enrolled who have failed prior pembrolizumab monotherapy and at least 17 objective responses among the 49 subjects enrolled who are actively experiencing stable disease following at least 4 cycles (but no more than 8 cycles) of pembrolizumab monotherapy.
Interventions
- DRUG Pembrolizumab
- BIOLOGICAL Imprime PGG
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 1 participants |
| Start Date | 2017-11-08 |
| Est. Completion | 2018-04-13 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03246685
The ClinicalTrials.gov registry entry for NCT03246685 describes a study currently listed as terminated, categorized as Phase 2. The registered enrollment target is 1 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is HiberCell, which has 11 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Pembrolizumab is the first listed.
NCT03246685 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT03246685 about?
NCT03246685 is a clinical study titled "Phase 2 Study of Imprime PGG & Pembrolizumab in Subjects With Adv SCCHN Who Failed Pembro Monotherapy or Experiencing SD". Objective: To determine the Overall Response Rate (ORR) to Imprime PGG + pembrolizumab in subjects with advanced Squamous Cell Carcinoma of the Head and Neck (SCCHN) Safety: To characterize the safety of Imprime PGG + pembrolizumab given in combination Hypothesis: Restore (for subjects who have fail...
What is the current status of trial NCT03246685?
This trial is currently terminated. It is a Phase 2 study. The enrollment target is 1 participants. The study started on 2017-11-08. Estimated completion is 2018-04-13.
What interventions are being tested in trial NCT03246685?
The interventions under investigation include: Pembrolizumab (DRUG), Imprime PGG (BIOLOGICAL).
Who is sponsoring clinical trial NCT03246685?
This trial is sponsored by HiberCell, which has 11 total clinical trials registered on ClinicalTrials.gov.
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