18 and older, any sex, with Advanced Melanoma or Triple-Negative Breast Cancer. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
The Primary Efficacy Endpoint Was ORR, Defined as the Proportion of Subjects Demonstrating CR or PR Based on RECIST v1.1 Criteria.Primary· From the start of study treatment until the first PD based on RECIST v1.1 or start of new cancer therapy, whichever occurred earlier, up to 24 months.
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.
Group
Value
95% CI
Melanoma
1
Triple Negative Breast Cancer
1
Melanoma
0
Triple Negative Breast Cancer
5
Melanoma
8
Triple Negative Breast Cancer
17
Melanoma
10
Triple Negative Breast Cancer
19
Time to Response (TTR) Using RECIST v1.1 CriteriaSecondary· TTR was defined as time from the date of the first dose to the first response, up to 24 months.
For the subset of subjects with a confirmed CR or PR (RECIST v1.1), TTR was defined as time from the date of the first dose to the first response (the CR/PR prior to the confirmation).
Group
Value
95% CI
Melanoma
9.66
9.66 – 9.66
Triple Negative Breast Cancer
2.86
1.25 – 5.39
Complete Response Rate (CRR)Secondary· The time from the date of the first dose to the first response (CR), up to 24 months.
Complete response rate (CRR) using RECIST v1.1 criteria
Group
Value
95% CI
Melanoma
5.3
0.1 – 26.0
Triple Negative Breast Cancer
2.4
0.1 – 12.6
Duration of Overall Response (DoR) Using RECIST v1.1 CriteriaSecondary· time from the first documented evidence of CR or PR (the response prior to the confirmation) until the time of documented PD (based on radiological assessments per RECIST v1.1) or death due to any cause, whichever occurred earlier.
For the subset of subjects with a confirmed CR or PR (RECIST v1.1), DoR was defined as the time from the first documented evidence of CR or PR (the response prior to the confirmation) until the time of documented PD (based on radiological assessments per RECIST v1.1) or death due to any cause, whichever occurred earlier.
Group
Value
95% CI
Melanoma
12.68
Triple Negative Breast Cancer
15.24
4.11 – 20.96
Progression-Free Survival (PFS) Per RECISTv1.1Secondary· time from the date of the first dose until the first PD or death due to any cause, whichever occurred first.
Progression free survival was defined as the time from the date of the first dose until the first PD or death due to any cause, whichever occurred first.
Group
Value
95% CI
Melanoma
1.76
1.31 – 2.79
Triple Negative Breast Cancer
2.35
1.35 – 3.98
Overall Survival (OS)Secondary· Time from date of study day 1 until date of death due to any cause.
Overall survival was defined as the time from the date of the first dose until the date of death due to any causes.
Group
Value
95% CI
Melanoma
8.80
3.61 – 15.67
Triple Negative Breast Cancer
16.36
11.10 – 19.22
Progression Free Survival Based on irRECISTSecondary· time from the date of the first dose until the first PD or death due to any cause, whichever occurred first.
Progression free survival was defined as the time from the date of the first dose until the first PD or death due to any cause, whichever occurred first.
Group
Value
95% CI
Melanoma
1.76
1.31 – 2.99
Triple Negative Breast Cancer
2.86
1.81 – 4.11
ORR Based on irRECISTSecondary· the best response recorded from the start of study treatment until PD (PD per RECIST v1.1 or PD confirmed by irRECIST, whichever was later) or start of new anticancer therapy, whichever occurred earlier; up to 24 months.
The best response based on irRECIST was the best response recorded from the start of study treatment until PD (PD per RECIST v1.1 or PD confirmed by irRECIST, whichever was later) or start of new anticancer therapy, whichever occurred earlier.
Group
Value
95% CI
Melanoma
1
Triple Negative Breast Cancer
1
Melanoma
0
Triple Negative Breast Cancer
6
Melanoma
8
Triple Negative Breast Cancer
17
Melanoma
2
Triple Negative Breast Cancer
0
Summary of Overall Response Rate in Subgroup of TNBC Subjects Who Had Received Prior Hormone TherapySecondary· The time from the date of the first dose to the first response (CR), up to 24 months.
proportion of subjects demonstrating complete response (CR) or partial response (PR) based on RECIST v1.1 thru end of study
Group
Value
95% CI
Triple Negative Breast Cancer
5
Adverse events — posted to ClinicalTrials.gov
Time frame: From first dose of study drug through 30 days post last dose of study drug, up to 25 months..
Reporting threshold: 5%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
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.
Publications & conference data
8 peer-reviewed publications reference this trial (live from Europe PMC):
NCT05159778 — Phase 2 Study of Imprime PGG and Pembrolizumab in Patients With HR+/HER2- Metastatic Breast Cancer (mBCA)
· Phase 2
· completed
NCT04995094 — Study of Neoadjuvant Imprime PGG and Pembrolizumab for Stage III, Resectable Melanoma
· Phase 2
· withdrawn
NCT03555149 — A Study Evaluating the Efficacy and Safety of Multiple Immunotherapy-Based Treatment Combinations in Patients With Metas
· Phase 1, PHASE2
· terminated
NCT03246685 — Phase 2 Study of Imprime PGG & Pembrolizumab in Subjects With Adv SCCHN Who Failed Pembro Monotherapy or Experiencing SD
· Phase 2
· terminated
NCT03003468 — Pembrolizumab + Imprime PGG for Metastatic Non-small Cell Lung Cancer After Progression on First-Line Therapy: Big Ten C
· Phase 1, PHASE2
· completed
Other recruiting trials for Advanced Melanoma
Currently open trials in the same condition.
NCT07310784 — A Phase II Trial of LM103 in Advanced Melanoma
· Phase 2
· recruiting
NCT07099430 — A Trial of LBL-024 Monotherapy, LBL-024 Combined With LBL-007 or Toripalimab in Patients With Advanced Melanoma
· Phase 1, PHASE2
· recruiting
NCT05629546 — Memory-Like Natural Killer Cells With Nivolumab and Relatlimab in Advanced or Metastatic Melanoma After Progression on C
· Phase 1
· recruiting
NCT06264180 — VO and Nivolumab vs Physician's Choice in Advanced Melanoma That Progressed on Anti-PD-1 & Anti-CTLA-4 Drugs [IGNYTE-3]
· Phase 3
· recruiting
NCT06298734 — High-Intensity Exercise and High-Fiber Diet for Immunotherapy Outcomes in Melanoma Patients: The DUO Trial
· NA
· recruiting
Other HiberCell, Inc. trials
Trials by the same sponsor.
NCT05484011 — A Maintenance Therapy Study of Odetiglucan With CDX-1140 in Patients With Metastatic Pancreatic Ductal Adenocarcinoma
· Phase 1
· terminated
NCT05121948 — A Study of HC-7366 to Establish the Maximum Tolerated Dose (MTD) and Recommended Phase 2 Dose (RP2D)
· Phase 1
· terminated
NCT05159778 — Phase 2 Study of Imprime PGG and Pembrolizumab in Patients With HR+/HER2- Metastatic Breast Cancer (mBCA)
· Phase 2
· completed
NCT04995094 — Study of Neoadjuvant Imprime PGG and Pembrolizumab for Stage III, Resectable Melanoma
· Phase 2
· withdrawn
NCT04834778 — A Study of HC-5404-FU to Establish the Maximum Tolerated Dose (MTD)
· Phase 1
· completed
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by HiberCell, Inc.
Last refreshed: 9 July 2024
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT02981303.