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NCT02981303 · ClinicalTrials.gov registry record · Phase 2
Study of Imprime PGG and Pembrolizumab in Advanced Melanoma and Triple Negative Breast Cancer
A Phase 2 study, sponsored by HiberCell.
- Completed
- Registry status
- Phase 2
- Development phase
- 64
- Enrollment target
NCT02981303: Completed Phase 2 study, sponsored by HiberCell.
NCT02981303 is a Phase 2 study that has completed, run by HiberCell. The registered enrollment target is 64 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (52% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02981303, a Phase 2 study, has completed, sponsored by HiberCell.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 64 participants
- Enrollment target
Study Summary
Objective: To determine the Overall Response Rate (ORR) to Imprime PGG + pembrolizumab in subjects with advanced melanoma or metastatic TNBC Safety: To characterize the safety of Imprime PGG + pembrolizumab given in combination Hypothesis: Restore (for melanoma) or enhance (for TNBC) sensitivity to checkpoint inhibitors (CPI) by appropriate and effective stimulation of the subject's innate and adaptive immune systems in those subjects who have failed 1st line therapy The study will incorporate Simon's optimal 2-stage design with sample size fixed at 12 subjects each in Stage 1 for advanced melanoma and for Triple Negative Breast Cancer (TNBC) subjects. The safety criterion of ≤ 4 (or ≤ 33%) subjects with Grade 3/4 adverse events in Cycle 1 within either tumor type must be met in order to proceed to Stage 2. The starting dose is 4 mg/kg for Imprime PGG. In the event there are a total of \> 4 (or \> 33%) of subjects with Grade 3/4 adverse events in Cycle 1, the dose of Imprime PGG will be reduced to 2 mg/kg, and Stage 1 will be repeated at a dose of 2 mg/kg with an additional cohort of n=12 subjects. For the dose that meets the safety criterion in Stage 1, at least 1 response in melanoma subjects and 2 responses in TNBC subjects amongst the 12 subjects within each tumor type must be observed in order to proceed to Stage 2. Stage 2 will enroll an additional 17 subjects with melanoma, and 30 subjects with TNBC. For the dose that meets the Stage 1 safety criterion, success will be declared if at least 4 amongst the total of up to 29 subjects with melanoma, and 13 amongst the total of up to 42 subjects with TNBC achieve an objective response.
Primary Outcome
The best response was defined as the best response recorded from the start of study treatment until the first PD based on RECIST v1.1 or start of new cancer therapy, whichever occurred earlier. Response assessment occurred every 6 weeks after the first dose of study drug.
Interventions
- DRUG Pembrolizumab
- BIOLOGICAL Imprime PGG
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 64 participants |
| Start Date | 2017-02-22 |
| Est. Completion | 2020-12-31 |
| Phase | Phase 2 |
What the finished NCT02981303 record still lists
NCT02981303 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 64 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (52% lower).
The record links to 0 conditions, and to 2 interventions - of which Pembrolizumab is the first listed.
NCT02981303 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02981303 about?
NCT02981303 is a clinical study titled "Study of Imprime PGG and Pembrolizumab in Advanced Melanoma and Triple Negative Breast Cancer". Objective: To determine the Overall Response Rate (ORR) to Imprime PGG + pembrolizumab in subjects with advanced melanoma or metastatic TNBC Safety: To characterize the safety of Imprime PGG + pembrolizumab given in combination Hypothesis: Restore (for melanoma) or enhance (for TNBC) sensitivity t...
What is the current status of trial NCT02981303?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 64 participants. The study started on 2017-02-22. Estimated completion is 2020-12-31.
What interventions are being tested in trial NCT02981303?
The interventions under investigation include: Pembrolizumab (DRUG), Imprime PGG (BIOLOGICAL).
Who is sponsoring clinical trial NCT02981303?
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 NCT02981303's enrollment target sits among peer trials
64 996th of 2000 higher than 992 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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