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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: Clinical Trial Phase 2 study, sponsored by HiberCell.
NCT03246685 is a Phase 2 study that was terminated before completion, run by HiberCell. The registered enrollment target is 1 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (99% lower). According to ClinicalTrials.gov, the official US trial registry.
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 |
Why NCT03246685 stopped before completion
NCT03246685 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 1 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (99% lower).
The record links to 0 conditions, and to 2 interventions - of which Pembrolizumab is the first listed.
NCT03246685 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03246685's enrollment target sits among peer trials
1 2001st of 2000 the lowest of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 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.
Source ClinicalTrials.gov registry export · 2026-08-08
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