Trial Outcomes & Findings for Study of Imprime PGG and Pembrolizumab in Advanced Melanoma and Triple Negative Breast Cancer (NCT NCT02981303)
NCT ID: NCT02981303
Last Updated: 2024-07-09
Results Overview
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.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
64 participants
Primary outcome timeframe
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.
Results posted on
2024-07-09
Participant Flow
The study included arms with independent Simon 2-stage designs with 29 planned for the melanoma arm (12 subjects in Stage 1 and 17 subjects in Stage 2) and 41 planned for the TNBC arm (12 patients in Stage 1 and 29 patients in Stage 2) for a total of 60 subjects enrolled competitively across US clinical sites.
Participant milestones
| Measure |
Melanoma
4 mg/kg Imprime PGG + 200 mg IV every 3 weeks (Q3W) pembrolizumab in subjects with advanced melanoma
Pembrolizumab: Pembrolizumab is a humanized monoclonal antibody against the programmed death receptor-1 protein. Pembrolizumab will be given at a fixed dose of 200 mg IV over 30 minutes on Day 1 of each 3-week treatment cycle after the Imprime infusion.
|
Triple Negative Breast Cancer
4 mg/kg Imprime PGG + 200 mg IV every 3 weeks (Q3W) pembrolizumab in subjects with metastatic TNBC
Pembrolizumab: Pembrolizumab is a humanized monoclonal antibody against the programmed death receptor-1 protein. Pembrolizumab will be given at a fixed dose of 200 mg IV over 30 minutes on Day 1 of each 3-week treatment cycle after the Imprime infusion.
|
|---|---|---|
|
Overall Study
STARTED
|
20
|
44
|
|
Overall Study
COMPLETED
|
2
|
2
|
|
Overall Study
NOT COMPLETED
|
18
|
42
|
Reasons for withdrawal
| Measure |
Melanoma
4 mg/kg Imprime PGG + 200 mg IV every 3 weeks (Q3W) pembrolizumab in subjects with advanced melanoma
Pembrolizumab: Pembrolizumab is a humanized monoclonal antibody against the programmed death receptor-1 protein. Pembrolizumab will be given at a fixed dose of 200 mg IV over 30 minutes on Day 1 of each 3-week treatment cycle after the Imprime infusion.
|
Triple Negative Breast Cancer
4 mg/kg Imprime PGG + 200 mg IV every 3 weeks (Q3W) pembrolizumab in subjects with metastatic TNBC
Pembrolizumab: Pembrolizumab is a humanized monoclonal antibody against the programmed death receptor-1 protein. Pembrolizumab will be given at a fixed dose of 200 mg IV over 30 minutes on Day 1 of each 3-week treatment cycle after the Imprime infusion.
|
|---|---|---|
|
Overall Study
Progressive Disease
|
17
|
37
|
|
Overall Study
Adverse Event
|
1
|
4
|
|
Overall Study
Withdrawal by Subject
|
0
|
1
|
Baseline Characteristics
Study of Imprime PGG and Pembrolizumab in Advanced Melanoma and Triple Negative Breast Cancer
Baseline characteristics by cohort
| Measure |
Arm 1/ Melanoma
n=20 Participants
Arm 1: 4 mg/kg Imprime PGG + 200 mg IV every 3 weeks (Q3W) pembrolizumab in subjects with advanced melanoma
|
Arm 2/ TNBC
n=44 Participants
Arm 2: 4 mg/kg Imprime PGG + 200 mg IV every 3 weeks (Q3W) pembrolizumab in subjects with metastatic TNBC
|
Total
n=64 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
Demographics Across Arms
|
62.1 years
STANDARD_DEVIATION 8.54 • n=5 Participants
|
51.0 years
STANDARD_DEVIATION 13.37 • n=7 Participants
|
54.4 years
STANDARD_DEVIATION 13.07 • n=5 Participants
|
|
Sex: Female, Male
Demographics Across Arms · Female
|
4 Participants
n=5 Participants
|
43 Participants
n=7 Participants
|
47 Participants
n=5 Participants
|
|
Sex: Female, Male
Demographics Across Arms · Male
|
16 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
17 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
18 Participants
n=5 Participants
|
37 Participants
n=7 Participants
|
55 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
20 Participants
n=5 Participants
|
37 Participants
n=7 Participants
|
57 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
20 participants
n=5 Participants
|
44 participants
n=7 Participants
|
64 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 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.Population: All subjects screened for the study who received at least one dose of study drug (primary population for baseline characteristics and safety analyses and secondary population for efficacy analyses).
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.
Outcome measures
| Measure |
Melanoma
n=20 Participants
4 mg/kg Imprime PGG + 200 mg IV every 3 weeks (Q3W) pembrolizumab in subjects with advanced melanoma
Pembrolizumab: Pembrolizumab is a humanized monoclonal antibody against the programmed death receptor-1 protein. Pembrolizumab will be given at a fixed dose of 200 mg IV over 30 minutes on Day 1 of each 3-week treatment cycle after the Imprime infusion.
|
Triple Negative Breast Cancer
n=44 Participants
4 mg/kg Imprime PGG + 200 mg IV every 3 weeks (Q3W) pembrolizumab in subjects with metastatic TNBC
Pembrolizumab: Pembrolizumab is a humanized monoclonal antibody against the programmed death receptor-1 protein. Pembrolizumab will be given at a fixed dose of 200 mg IV over 30 minutes on Day 1 of each 3-week treatment cycle after the Imprime infusion.
|
|---|---|---|
|
The Primary Efficacy Endpoint Was ORR, Defined as the Proportion of Subjects Demonstrating CR or PR Based on RECIST v1.1 Criteria.
Complete Response
|
1 Participants
|
1 Participants
|
|
The Primary Efficacy Endpoint Was ORR, Defined as the Proportion of Subjects Demonstrating CR or PR Based on RECIST v1.1 Criteria.
Partial Response
|
0 Participants
|
5 Participants
|
|
The Primary Efficacy Endpoint Was ORR, Defined as the Proportion of Subjects Demonstrating CR or PR Based on RECIST v1.1 Criteria.
Stable Disease
|
8 Participants
|
17 Participants
|
|
The Primary Efficacy Endpoint Was ORR, Defined as the Proportion of Subjects Demonstrating CR or PR Based on RECIST v1.1 Criteria.
Confirmed Progressive Disease
|
10 Participants
|
19 Participants
|
|
The Primary Efficacy Endpoint Was ORR, Defined as the Proportion of Subjects Demonstrating CR or PR Based on RECIST v1.1 Criteria.
Not Evaluable
|
1 Participants
|
2 Participants
|
SECONDARY outcome
Timeframe: 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).
Outcome measures
| Measure |
Melanoma
n=1 Participants
4 mg/kg Imprime PGG + 200 mg IV every 3 weeks (Q3W) pembrolizumab in subjects with advanced melanoma
Pembrolizumab: Pembrolizumab is a humanized monoclonal antibody against the programmed death receptor-1 protein. Pembrolizumab will be given at a fixed dose of 200 mg IV over 30 minutes on Day 1 of each 3-week treatment cycle after the Imprime infusion.
|
Triple Negative Breast Cancer
n=6 Participants
4 mg/kg Imprime PGG + 200 mg IV every 3 weeks (Q3W) pembrolizumab in subjects with metastatic TNBC
Pembrolizumab: Pembrolizumab is a humanized monoclonal antibody against the programmed death receptor-1 protein. Pembrolizumab will be given at a fixed dose of 200 mg IV over 30 minutes on Day 1 of each 3-week treatment cycle after the Imprime infusion.
|
|---|---|---|
|
Time to Response (TTR) Using RECIST v1.1 Criteria
|
9.66 months
Interval 9.66 to 9.66
|
2.86 months
Interval 1.25 to 5.39
|
SECONDARY outcome
Timeframe: 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
Outcome measures
| Measure |
Melanoma
n=20 Participants
4 mg/kg Imprime PGG + 200 mg IV every 3 weeks (Q3W) pembrolizumab in subjects with advanced melanoma
Pembrolizumab: Pembrolizumab is a humanized monoclonal antibody against the programmed death receptor-1 protein. Pembrolizumab will be given at a fixed dose of 200 mg IV over 30 minutes on Day 1 of each 3-week treatment cycle after the Imprime infusion.
|
Triple Negative Breast Cancer
n=44 Participants
4 mg/kg Imprime PGG + 200 mg IV every 3 weeks (Q3W) pembrolizumab in subjects with metastatic TNBC
Pembrolizumab: Pembrolizumab is a humanized monoclonal antibody against the programmed death receptor-1 protein. Pembrolizumab will be given at a fixed dose of 200 mg IV over 30 minutes on Day 1 of each 3-week treatment cycle after the Imprime infusion.
|
|---|---|---|
|
Complete Response Rate (CRR)
|
5.3 percentage of patients
Interval 0.1 to 26.0
|
2.4 percentage of patients
Interval 0.1 to 12.6
|
SECONDARY outcome
Timeframe: 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.
Outcome measures
| Measure |
Melanoma
n=1 Participants
4 mg/kg Imprime PGG + 200 mg IV every 3 weeks (Q3W) pembrolizumab in subjects with advanced melanoma
Pembrolizumab: Pembrolizumab is a humanized monoclonal antibody against the programmed death receptor-1 protein. Pembrolizumab will be given at a fixed dose of 200 mg IV over 30 minutes on Day 1 of each 3-week treatment cycle after the Imprime infusion.
|
Triple Negative Breast Cancer
n=6 Participants
4 mg/kg Imprime PGG + 200 mg IV every 3 weeks (Q3W) pembrolizumab in subjects with metastatic TNBC
Pembrolizumab: Pembrolizumab is a humanized monoclonal antibody against the programmed death receptor-1 protein. Pembrolizumab will be given at a fixed dose of 200 mg IV over 30 minutes on Day 1 of each 3-week treatment cycle after the Imprime infusion.
|
|---|---|---|
|
Duration of Overall Response (DoR) Using RECIST v1.1 Criteria
|
12.68 Months
|
15.24 Months
Interval 4.11 to 20.96
|
SECONDARY outcome
Timeframe: 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.
Outcome measures
| Measure |
Melanoma
n=20 Participants
4 mg/kg Imprime PGG + 200 mg IV every 3 weeks (Q3W) pembrolizumab in subjects with advanced melanoma
Pembrolizumab: Pembrolizumab is a humanized monoclonal antibody against the programmed death receptor-1 protein. Pembrolizumab will be given at a fixed dose of 200 mg IV over 30 minutes on Day 1 of each 3-week treatment cycle after the Imprime infusion.
|
Triple Negative Breast Cancer
n=44 Participants
4 mg/kg Imprime PGG + 200 mg IV every 3 weeks (Q3W) pembrolizumab in subjects with metastatic TNBC
Pembrolizumab: Pembrolizumab is a humanized monoclonal antibody against the programmed death receptor-1 protein. Pembrolizumab will be given at a fixed dose of 200 mg IV over 30 minutes on Day 1 of each 3-week treatment cycle after the Imprime infusion.
|
|---|---|---|
|
Progression-Free Survival (PFS) Per RECISTv1.1
|
1.76 Months
Interval 1.31 to 2.79
|
2.35 Months
Interval 1.35 to 3.98
|
SECONDARY outcome
Timeframe: 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.
Outcome measures
| Measure |
Melanoma
n=20 Participants
4 mg/kg Imprime PGG + 200 mg IV every 3 weeks (Q3W) pembrolizumab in subjects with advanced melanoma
Pembrolizumab: Pembrolizumab is a humanized monoclonal antibody against the programmed death receptor-1 protein. Pembrolizumab will be given at a fixed dose of 200 mg IV over 30 minutes on Day 1 of each 3-week treatment cycle after the Imprime infusion.
|
Triple Negative Breast Cancer
n=44 Participants
4 mg/kg Imprime PGG + 200 mg IV every 3 weeks (Q3W) pembrolizumab in subjects with metastatic TNBC
Pembrolizumab: Pembrolizumab is a humanized monoclonal antibody against the programmed death receptor-1 protein. Pembrolizumab will be given at a fixed dose of 200 mg IV over 30 minutes on Day 1 of each 3-week treatment cycle after the Imprime infusion.
|
|---|---|---|
|
Overall Survival (OS)
|
8.80 Months
Interval 3.61 to 15.67
|
16.36 Months
Interval 11.1 to 19.22
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 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.
Outcome measures
| Measure |
Melanoma
n=20 Participants
4 mg/kg Imprime PGG + 200 mg IV every 3 weeks (Q3W) pembrolizumab in subjects with advanced melanoma
Pembrolizumab: Pembrolizumab is a humanized monoclonal antibody against the programmed death receptor-1 protein. Pembrolizumab will be given at a fixed dose of 200 mg IV over 30 minutes on Day 1 of each 3-week treatment cycle after the Imprime infusion.
|
Triple Negative Breast Cancer
n=44 Participants
4 mg/kg Imprime PGG + 200 mg IV every 3 weeks (Q3W) pembrolizumab in subjects with metastatic TNBC
Pembrolizumab: Pembrolizumab is a humanized monoclonal antibody against the programmed death receptor-1 protein. Pembrolizumab will be given at a fixed dose of 200 mg IV over 30 minutes on Day 1 of each 3-week treatment cycle after the Imprime infusion.
|
|---|---|---|
|
Progression Free Survival Based on irRECIST
|
1.76 months
Interval 1.31 to 2.99
|
2.86 months
Interval 1.81 to 4.11
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 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.
Outcome measures
| Measure |
Melanoma
n=20 Participants
4 mg/kg Imprime PGG + 200 mg IV every 3 weeks (Q3W) pembrolizumab in subjects with advanced melanoma
Pembrolizumab: Pembrolizumab is a humanized monoclonal antibody against the programmed death receptor-1 protein. Pembrolizumab will be given at a fixed dose of 200 mg IV over 30 minutes on Day 1 of each 3-week treatment cycle after the Imprime infusion.
|
Triple Negative Breast Cancer
n=44 Participants
4 mg/kg Imprime PGG + 200 mg IV every 3 weeks (Q3W) pembrolizumab in subjects with metastatic TNBC
Pembrolizumab: Pembrolizumab is a humanized monoclonal antibody against the programmed death receptor-1 protein. Pembrolizumab will be given at a fixed dose of 200 mg IV over 30 minutes on Day 1 of each 3-week treatment cycle after the Imprime infusion.
|
|---|---|---|
|
ORR Based on irRECIST
Complete Response
|
1 Participants
|
1 Participants
|
|
ORR Based on irRECIST
Partial Response
|
0 Participants
|
6 Participants
|
|
ORR Based on irRECIST
Stable Disease
|
8 Participants
|
17 Participants
|
|
ORR Based on irRECIST
Confirmed Progressive Disease
|
2 Participants
|
0 Participants
|
|
ORR Based on irRECIST
Unconfirmed Progressive Disease
|
8 Participants
|
18 Participants
|
|
ORR Based on irRECIST
Not Evaluable
|
1 Participants
|
2 Participants
|
POST_HOC outcome
Timeframe: The time from the date of the first dose to the first response (CR), up to 24 months.Population: Evaluable subjects who received prior hormone therapy
proportion of subjects demonstrating complete response (CR) or partial response (PR) based on RECIST v1.1 thru end of study
Outcome measures
| Measure |
Melanoma
n=11 Participants
4 mg/kg Imprime PGG + 200 mg IV every 3 weeks (Q3W) pembrolizumab in subjects with advanced melanoma
Pembrolizumab: Pembrolizumab is a humanized monoclonal antibody against the programmed death receptor-1 protein. Pembrolizumab will be given at a fixed dose of 200 mg IV over 30 minutes on Day 1 of each 3-week treatment cycle after the Imprime infusion.
|
Triple Negative Breast Cancer
4 mg/kg Imprime PGG + 200 mg IV every 3 weeks (Q3W) pembrolizumab in subjects with metastatic TNBC
Pembrolizumab: Pembrolizumab is a humanized monoclonal antibody against the programmed death receptor-1 protein. Pembrolizumab will be given at a fixed dose of 200 mg IV over 30 minutes on Day 1 of each 3-week treatment cycle after the Imprime infusion.
|
|---|---|---|
|
Summary of Overall Response Rate in Subgroup of TNBC Subjects Who Had Received Prior Hormone Therapy
|
5 Participants
|
—
|
Adverse Events
Melanoma
Serious events: 3 serious events
Other events: 20 other events
Deaths: 1 deaths
Triple Negative Breast Cancer
Serious events: 9 serious events
Other events: 44 other events
Deaths: 2 deaths
Serious adverse events
| Measure |
Melanoma
n=20 participants at risk
4 mg/kg Imprime PGG + 200 mg IV every 3 weeks (Q3W) pembrolizumab in subjects with advanced melanoma
Pembrolizumab: Pembrolizumab is a humanized monoclonal antibody against the programmed death receptor-1 protein. Pembrolizumab will be given at a fixed dose of 200 mg IV over 30 minutes on Day 1 of each 3-week treatment cycle after the Imprime infusion.
|
Triple Negative Breast Cancer
n=44 participants at risk
4 mg/kg Imprime PGG + 200 mg IV every 3 weeks (Q3W) pembrolizumab in subjects with metastatic TNBC
Pembrolizumab: Pembrolizumab is a humanized monoclonal antibody against the programmed death receptor-1 protein. Pembrolizumab will be given at a fixed dose of 200 mg IV over 30 minutes on Day 1 of each 3-week treatment cycle after the Imprime infusion.
|
|---|---|---|
|
Vascular disorders
Hypertension
|
0.00%
0/20 • From first dose of study drug through 30 days post last dose of study drug, up to 25 months.
|
2.3%
1/44 • Number of events 1 • From first dose of study drug through 30 days post last dose of study drug, up to 25 months.
|
|
Nervous system disorders
Haemorrhage intracranial
|
5.0%
1/20 • Number of events 1 • From first dose of study drug through 30 days post last dose of study drug, up to 25 months.
|
0.00%
0/44 • From first dose of study drug through 30 days post last dose of study drug, up to 25 months.
|
|
Cardiac disorders
Myocarditis
|
0.00%
0/20 • From first dose of study drug through 30 days post last dose of study drug, up to 25 months.
|
2.3%
1/44 • Number of events 1 • From first dose of study drug through 30 days post last dose of study drug, up to 25 months.
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
0.00%
0/20 • From first dose of study drug through 30 days post last dose of study drug, up to 25 months.
|
2.3%
1/44 • Number of events 1 • From first dose of study drug through 30 days post last dose of study drug, up to 25 months.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/20 • From first dose of study drug through 30 days post last dose of study drug, up to 25 months.
|
2.3%
1/44 • Number of events 1 • From first dose of study drug through 30 days post last dose of study drug, up to 25 months.
|
|
Psychiatric disorders
Mental status change
|
0.00%
0/20 • From first dose of study drug through 30 days post last dose of study drug, up to 25 months.
|
2.3%
1/44 • Number of events 1 • From first dose of study drug through 30 days post last dose of study drug, up to 25 months.
|
|
Injury, poisoning and procedural complications
Femur Fracture
|
5.0%
1/20 • Number of events 1 • From first dose of study drug through 30 days post last dose of study drug, up to 25 months.
|
0.00%
0/44 • From first dose of study drug through 30 days post last dose of study drug, up to 25 months.
|
|
Injury, poisoning and procedural complications
Infusion Related Reactions
|
5.0%
1/20 • Number of events 1 • From first dose of study drug through 30 days post last dose of study drug, up to 25 months.
|
2.3%
1/44 • Number of events 1 • From first dose of study drug through 30 days post last dose of study drug, up to 25 months.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary Embolism
|
5.0%
1/20 • Number of events 1 • From first dose of study drug through 30 days post last dose of study drug, up to 25 months.
|
0.00%
0/44 • From first dose of study drug through 30 days post last dose of study drug, up to 25 months.
|
|
Vascular disorders
Hypotension
|
5.0%
1/20 • Number of events 1 • From first dose of study drug through 30 days post last dose of study drug, up to 25 months.
|
0.00%
0/44 • From first dose of study drug through 30 days post last dose of study drug, up to 25 months.
|
|
Infections and infestations
Candida Infection
|
0.00%
0/20 • From first dose of study drug through 30 days post last dose of study drug, up to 25 months.
|
2.3%
1/44 • Number of events 1 • From first dose of study drug through 30 days post last dose of study drug, up to 25 months.
|
|
Infections and infestations
Cellulitis
|
0.00%
0/20 • From first dose of study drug through 30 days post last dose of study drug, up to 25 months.
|
2.3%
1/44 • Number of events 1 • From first dose of study drug through 30 days post last dose of study drug, up to 25 months.
|
|
Infections and infestations
Pneumonia
|
0.00%
0/20 • From first dose of study drug through 30 days post last dose of study drug, up to 25 months.
|
2.3%
1/44 • Number of events 1 • From first dose of study drug through 30 days post last dose of study drug, up to 25 months.
|
|
Gastrointestinal disorders
Pancreatitis
|
0.00%
0/20 • From first dose of study drug through 30 days post last dose of study drug, up to 25 months.
|
4.5%
2/44 • Number of events 2 • From first dose of study drug through 30 days post last dose of study drug, up to 25 months.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/20 • From first dose of study drug through 30 days post last dose of study drug, up to 25 months.
|
2.3%
1/44 • Number of events 1 • From first dose of study drug through 30 days post last dose of study drug, up to 25 months.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural Effusion
|
0.00%
0/20 • From first dose of study drug through 30 days post last dose of study drug, up to 25 months.
|
2.3%
1/44 • Number of events 1 • From first dose of study drug through 30 days post last dose of study drug, up to 25 months.
|
|
Cardiac disorders
Acute myocardial infarction
|
0.00%
0/20 • From first dose of study drug through 30 days post last dose of study drug, up to 25 months.
|
2.3%
1/44 • Number of events 1 • From first dose of study drug through 30 days post last dose of study drug, up to 25 months.
|
Other adverse events
| Measure |
Melanoma
n=20 participants at risk
4 mg/kg Imprime PGG + 200 mg IV every 3 weeks (Q3W) pembrolizumab in subjects with advanced melanoma
Pembrolizumab: Pembrolizumab is a humanized monoclonal antibody against the programmed death receptor-1 protein. Pembrolizumab will be given at a fixed dose of 200 mg IV over 30 minutes on Day 1 of each 3-week treatment cycle after the Imprime infusion.
|
Triple Negative Breast Cancer
n=44 participants at risk
4 mg/kg Imprime PGG + 200 mg IV every 3 weeks (Q3W) pembrolizumab in subjects with metastatic TNBC
Pembrolizumab: Pembrolizumab is a humanized monoclonal antibody against the programmed death receptor-1 protein. Pembrolizumab will be given at a fixed dose of 200 mg IV over 30 minutes on Day 1 of each 3-week treatment cycle after the Imprime infusion.
|
|---|---|---|
|
General disorders
Fatigue
|
55.0%
11/20 • From first dose of study drug through 30 days post last dose of study drug, up to 25 months.
|
31.8%
14/44 • From first dose of study drug through 30 days post last dose of study drug, up to 25 months.
|
|
General disorders
Chills
|
20.0%
4/20 • From first dose of study drug through 30 days post last dose of study drug, up to 25 months.
|
29.5%
13/44 • From first dose of study drug through 30 days post last dose of study drug, up to 25 months.
|
|
General disorders
Axillary pain
|
10.0%
2/20 • From first dose of study drug through 30 days post last dose of study drug, up to 25 months.
|
0.00%
0/44 • From first dose of study drug through 30 days post last dose of study drug, up to 25 months.
|
|
Gastrointestinal disorders
Nausea
|
40.0%
8/20 • From first dose of study drug through 30 days post last dose of study drug, up to 25 months.
|
45.5%
20/44 • From first dose of study drug through 30 days post last dose of study drug, up to 25 months.
|
|
Gastrointestinal disorders
Abdominal pain
|
20.0%
4/20 • From first dose of study drug through 30 days post last dose of study drug, up to 25 months.
|
11.4%
5/44 • From first dose of study drug through 30 days post last dose of study drug, up to 25 months.
|
|
Gastrointestinal disorders
Dyspepsia
|
20.0%
4/20 • From first dose of study drug through 30 days post last dose of study drug, up to 25 months.
|
0.00%
0/44 • From first dose of study drug through 30 days post last dose of study drug, up to 25 months.
|
|
Gastrointestinal disorders
Constipation
|
15.0%
3/20 • From first dose of study drug through 30 days post last dose of study drug, up to 25 months.
|
22.7%
10/44 • From first dose of study drug through 30 days post last dose of study drug, up to 25 months.
|
|
Gastrointestinal disorders
Vomiting
|
15.0%
3/20 • From first dose of study drug through 30 days post last dose of study drug, up to 25 months.
|
27.3%
12/44 • From first dose of study drug through 30 days post last dose of study drug, up to 25 months.
|
|
Gastrointestinal disorders
Diarrhoea
|
10.0%
2/20 • From first dose of study drug through 30 days post last dose of study drug, up to 25 months.
|
29.5%
13/44 • From first dose of study drug through 30 days post last dose of study drug, up to 25 months.
|
|
Gastrointestinal disorders
Dry Mouth
|
10.0%
2/20 • From first dose of study drug through 30 days post last dose of study drug, up to 25 months.
|
9.1%
4/44 • From first dose of study drug through 30 days post last dose of study drug, up to 25 months.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
30.0%
6/20 • From first dose of study drug through 30 days post last dose of study drug, up to 25 months.
|
38.6%
17/44 • From first dose of study drug through 30 days post last dose of study drug, up to 25 months.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
20.0%
4/20 • From first dose of study drug through 30 days post last dose of study drug, up to 25 months.
|
31.8%
14/44 • From first dose of study drug through 30 days post last dose of study drug, up to 25 months.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
15.0%
3/20 • From first dose of study drug through 30 days post last dose of study drug, up to 25 months.
|
22.7%
10/44 • From first dose of study drug through 30 days post last dose of study drug, up to 25 months.
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
10.0%
2/20 • From first dose of study drug through 30 days post last dose of study drug, up to 25 months.
|
6.8%
3/44 • From first dose of study drug through 30 days post last dose of study drug, up to 25 months.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
10.0%
2/20 • From first dose of study drug through 30 days post last dose of study drug, up to 25 months.
|
22.7%
10/44 • From first dose of study drug through 30 days post last dose of study drug, up to 25 months.
|
|
Investigations
Blood bilirubin increased
|
20.0%
4/20 • From first dose of study drug through 30 days post last dose of study drug, up to 25 months.
|
0.00%
0/44 • From first dose of study drug through 30 days post last dose of study drug, up to 25 months.
|
|
Investigations
Aspartate aminotransferase increased
|
15.0%
3/20 • From first dose of study drug through 30 days post last dose of study drug, up to 25 months.
|
18.2%
8/44 • From first dose of study drug through 30 days post last dose of study drug, up to 25 months.
|
|
Investigations
Blood alkaline phosphatase increased
|
10.0%
2/20 • From first dose of study drug through 30 days post last dose of study drug, up to 25 months.
|
9.1%
4/44 • From first dose of study drug through 30 days post last dose of study drug, up to 25 months.
|
|
Nervous system disorders
Dizziness
|
10.0%
2/20 • From first dose of study drug through 30 days post last dose of study drug, up to 25 months.
|
11.4%
5/44 • From first dose of study drug through 30 days post last dose of study drug, up to 25 months.
|
|
Nervous system disorders
Neuropathy peripheral
|
10.0%
2/20 • From first dose of study drug through 30 days post last dose of study drug, up to 25 months.
|
0.00%
0/44 • From first dose of study drug through 30 days post last dose of study drug, up to 25 months.
|
|
Nervous system disorders
Syncope
|
10.0%
2/20 • From first dose of study drug through 30 days post last dose of study drug, up to 25 months.
|
0.00%
0/44 • From first dose of study drug through 30 days post last dose of study drug, up to 25 months.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
10.0%
2/20 • From first dose of study drug through 30 days post last dose of study drug, up to 25 months.
|
22.7%
10/44 • From first dose of study drug through 30 days post last dose of study drug, up to 25 months.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
10.0%
2/20 • From first dose of study drug through 30 days post last dose of study drug, up to 25 months.
|
0.00%
0/44 • From first dose of study drug through 30 days post last dose of study drug, up to 25 months.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
20.0%
4/20 • From first dose of study drug through 30 days post last dose of study drug, up to 25 months.
|
20.5%
9/44 • From first dose of study drug through 30 days post last dose of study drug, up to 25 months.
|
|
Injury, poisoning and procedural complications
Infusion related reaction
|
25.0%
5/20 • From first dose of study drug through 30 days post last dose of study drug, up to 25 months.
|
22.7%
10/44 • From first dose of study drug through 30 days post last dose of study drug, up to 25 months.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
20.0%
4/20 • From first dose of study drug through 30 days post last dose of study drug, up to 25 months.
|
13.6%
6/44 • From first dose of study drug through 30 days post last dose of study drug, up to 25 months.
|
|
Blood and lymphatic system disorders
Anaemia
|
15.0%
3/20 • From first dose of study drug through 30 days post last dose of study drug, up to 25 months.
|
6.8%
3/44 • From first dose of study drug through 30 days post last dose of study drug, up to 25 months.
|
|
Psychiatric disorders
Insomnia
|
10.0%
2/20 • From first dose of study drug through 30 days post last dose of study drug, up to 25 months.
|
9.1%
4/44 • From first dose of study drug through 30 days post last dose of study drug, up to 25 months.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumour pain
|
10.0%
2/20 • From first dose of study drug through 30 days post last dose of study drug, up to 25 months.
|
0.00%
0/44 • From first dose of study drug through 30 days post last dose of study drug, up to 25 months.
|
|
Vascular disorders
Hypotension
|
10.0%
2/20 • From first dose of study drug through 30 days post last dose of study drug, up to 25 months.
|
9.1%
4/44 • From first dose of study drug through 30 days post last dose of study drug, up to 25 months.
|
|
Gastrointestinal disorders
Abdominal distension
|
0.00%
0/20 • From first dose of study drug through 30 days post last dose of study drug, up to 25 months.
|
6.8%
3/44 • From first dose of study drug through 30 days post last dose of study drug, up to 25 months.
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
0.00%
0/20 • From first dose of study drug through 30 days post last dose of study drug, up to 25 months.
|
6.8%
3/44 • From first dose of study drug through 30 days post last dose of study drug, up to 25 months.
|
|
General disorders
Pyrexia
|
0.00%
0/20 • From first dose of study drug through 30 days post last dose of study drug, up to 25 months.
|
29.5%
13/44 • From first dose of study drug through 30 days post last dose of study drug, up to 25 months.
|
|
General disorders
Chest discomfort
|
0.00%
0/20 • From first dose of study drug through 30 days post last dose of study drug, up to 25 months.
|
9.1%
4/44 • From first dose of study drug through 30 days post last dose of study drug, up to 25 months.
|
|
General disorders
Oedema peripheral
|
0.00%
0/20 • From first dose of study drug through 30 days post last dose of study drug, up to 25 months.
|
9.1%
4/44 • From first dose of study drug through 30 days post last dose of study drug, up to 25 months.
|
|
General disorders
Pain
|
0.00%
0/20 • From first dose of study drug through 30 days post last dose of study drug, up to 25 months.
|
9.1%
4/44 • From first dose of study drug through 30 days post last dose of study drug, up to 25 months.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
|
0.00%
0/20 • From first dose of study drug through 30 days post last dose of study drug, up to 25 months.
|
9.1%
4/44 • From first dose of study drug through 30 days post last dose of study drug, up to 25 months.
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
0.00%
0/20 • From first dose of study drug through 30 days post last dose of study drug, up to 25 months.
|
6.8%
3/44 • From first dose of study drug through 30 days post last dose of study drug, up to 25 months.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/20 • From first dose of study drug through 30 days post last dose of study drug, up to 25 months.
|
20.5%
9/44 • From first dose of study drug through 30 days post last dose of study drug, up to 25 months.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.00%
0/20 • From first dose of study drug through 30 days post last dose of study drug, up to 25 months.
|
6.8%
3/44 • From first dose of study drug through 30 days post last dose of study drug, up to 25 months.
|
|
Nervous system disorders
Headache
|
0.00%
0/20 • From first dose of study drug through 30 days post last dose of study drug, up to 25 months.
|
29.5%
13/44 • From first dose of study drug through 30 days post last dose of study drug, up to 25 months.
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
0.00%
0/20 • From first dose of study drug through 30 days post last dose of study drug, up to 25 months.
|
6.8%
3/44 • From first dose of study drug through 30 days post last dose of study drug, up to 25 months.
|
|
Investigations
Alanine aminotransferase increased
|
0.00%
0/20 • From first dose of study drug through 30 days post last dose of study drug, up to 25 months.
|
13.6%
6/44 • From first dose of study drug through 30 days post last dose of study drug, up to 25 months.
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/20 • From first dose of study drug through 30 days post last dose of study drug, up to 25 months.
|
9.1%
4/44 • From first dose of study drug through 30 days post last dose of study drug, up to 25 months.
|
|
Infections and infestations
Pneumonia
|
0.00%
0/20 • From first dose of study drug through 30 days post last dose of study drug, up to 25 months.
|
6.8%
3/44 • From first dose of study drug through 30 days post last dose of study drug, up to 25 months.
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
0.00%
0/20 • From first dose of study drug through 30 days post last dose of study drug, up to 25 months.
|
6.8%
3/44 • From first dose of study drug through 30 days post last dose of study drug, up to 25 months.
|
|
Metabolism and nutrition disorders
Hypomagnesaemia
|
0.00%
0/20 • From first dose of study drug through 30 days post last dose of study drug, up to 25 months.
|
9.1%
4/44 • From first dose of study drug through 30 days post last dose of study drug, up to 25 months.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
0.00%
0/20 • From first dose of study drug through 30 days post last dose of study drug, up to 25 months.
|
6.8%
3/44 • From first dose of study drug through 30 days post last dose of study drug, up to 25 months.
|
|
Vascular disorders
Hot flush
|
0.00%
0/20 • From first dose of study drug through 30 days post last dose of study drug, up to 25 months.
|
6.8%
3/44 • From first dose of study drug through 30 days post last dose of study drug, up to 25 months.
|
|
Vascular disorders
Hypertension
|
0.00%
0/20 • From first dose of study drug through 30 days post last dose of study drug, up to 25 months.
|
6.8%
3/44 • From first dose of study drug through 30 days post last dose of study drug, up to 25 months.
|
|
Psychiatric disorders
Anxiety
|
0.00%
0/20 • From first dose of study drug through 30 days post last dose of study drug, up to 25 months.
|
6.8%
3/44 • From first dose of study drug through 30 days post last dose of study drug, up to 25 months.
|
|
Eye disorders
Vision blurred
|
0.00%
0/20 • From first dose of study drug through 30 days post last dose of study drug, up to 25 months.
|
9.1%
4/44 • From first dose of study drug through 30 days post last dose of study drug, up to 25 months.
|
|
Cardiac disorders
Tachycardia
|
0.00%
0/20 • From first dose of study drug through 30 days post last dose of study drug, up to 25 months.
|
6.8%
3/44 • From first dose of study drug through 30 days post last dose of study drug, up to 25 months.
|
|
Ear and labyrinth disorders
Vertigo
|
0.00%
0/20 • From first dose of study drug through 30 days post last dose of study drug, up to 25 months.
|
6.8%
3/44 • From first dose of study drug through 30 days post last dose of study drug, up to 25 months.
|
|
Endocrine disorders
Hypothyroidism
|
0.00%
0/20 • From first dose of study drug through 30 days post last dose of study drug, up to 25 months.
|
6.8%
3/44 • From first dose of study drug through 30 days post last dose of study drug, up to 25 months.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place