Trial Outcomes & Findings for Pembrolizumab + Poly-ICLC in MRP Colon Cancer (NCT NCT02834052)
NCT ID: NCT02834052
Last Updated: 2024-06-07
Results Overview
A minimum of 3 participants will be treated at dose level 1 (1mg). * If 0 out of 3 participants experience dose limiting toxicities (DLT), then dose escalation will proceed to dose level 2 (2mg). * If 1 out of 3 participants experience DLT, a cohort of additional 3 participants will be assigned to the same dose level (1mg). * If 2 or more participants of 3 (or 6) experience DLT at dose level 1, then enrollment of participants will be stopped.
Recruitment status
COMPLETED
Study phase
PHASE1/PHASE2
Target enrollment
42 participants
Primary outcome timeframe
12 months
Results posted on
2024-06-07
Participant Flow
Participant milestones
| Measure |
Phase 1: Poly-ICLC: 1mg
Cohort 1: Participants were administrated 1mg Poly-ICLC intramuscularly (IM) twice weekly. Pembrolizumab was administrated 200 mg intravenously (IV) every 3 weeks (q3W)
|
Phase 1: Poly-ICLC 2mg
Cohort 2: Participants were administrated 2mg Poly-ICLC intramuscularly (IM) twice weekly. Pembrolizumab was administrated 200 mg intravenously (IV) every 3 weeks (q3W)
|
Phase 2: Poly-ICLC: 2mg
Cohort 3: Participants were administrated 2mg Poly-ICLC intramuscularly (IM) twice weekly. Pembrolizumab was administrated 200 mg intravenously (IV) every 3 weeks (q3W)
|
|---|---|---|---|
|
Overall Study
STARTED
|
8
|
10
|
24
|
|
Overall Study
COMPLETED
|
0
|
0
|
0
|
|
Overall Study
NOT COMPLETED
|
8
|
10
|
24
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Pembrolizumab + Poly-ICLC in MRP Colon Cancer
Baseline characteristics by cohort
| Measure |
Phase 1: Poly-ICLC: 1mg
n=8 Participants
Cohort 1: Participants were administrated 1mg Poly-ICLC intramuscularly (IM) twice weekly. Pembrolizumab was administrated 200 mg intravenously (IV) every 3 weeks (q3W)
|
Phase 1: Poly-ICLC: 2mg
n=10 Participants
Cohort 2: Participants were administrated 2mg Poly-ICLC intramuscularly (IM) twice weekly. Pembrolizumab was administrated 200 mg intravenously (IV) every 3 weeks (q3W)
|
Phase 2: Poly-ICLC: 2mg
n=24 Participants
Cohort 3: Participants were administrated 2mg Poly-ICLC intramuscularly (IM) twice weekly. Pembrolizumab was administrated 200 mg intravenously (IV) every 3 weeks (q3W)
|
Total
n=42 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
6 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
24 Participants
n=4 Participants
|
|
Age, Categorical
>=65 years
|
2 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
13 Participants
n=5 Participants
|
18 Participants
n=4 Participants
|
|
Sex: Female, Male
Female
|
6 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
15 Participants
n=5 Participants
|
26 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
2 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
16 Participants
n=4 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 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
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Black or African American
|
5 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
17 Participants
n=4 Participants
|
|
Race (NIH/OMB)
White
|
3 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
14 Participants
n=5 Participants
|
24 Participants
n=4 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
PRIMARY outcome
Timeframe: 12 monthsPopulation: The safety population for this trial includes all participants who received at least one dose of the investigational product and excludes any participants who were screen fails.
A minimum of 3 participants will be treated at dose level 1 (1mg). * If 0 out of 3 participants experience dose limiting toxicities (DLT), then dose escalation will proceed to dose level 2 (2mg). * If 1 out of 3 participants experience DLT, a cohort of additional 3 participants will be assigned to the same dose level (1mg). * If 2 or more participants of 3 (or 6) experience DLT at dose level 1, then enrollment of participants will be stopped.
Outcome measures
| Measure |
Phase 1: Poly-ICLC: 1 and 2 mg
n=14 Participants
Cohort 1: Participants were administrated 1mg Poly-ICLC intramuscularly (IM) twice weekly. Pembrolizumab was administrated 200 mg intravenously (IV) every 3 weeks (q3W)
Cohort 2: Participants were administrated 2mg Poly-ICLC intramuscularly (IM) twice weekly. Pembrolizumab was administrated 200 mg intravenously (IV) every 3 weeks (q3W)
|
Phase 1: Poly-ICLC 2mg
Cohort 2: Participants were administrated 2mg Poly-ICLC intramuscularly (IM) twice weekly. Pembrolizumab was administrated 200 mg intravenously (IV) every 3 weeks (q3W)
|
Phase 2: Poly-ICLC: 2mg
Cohort 3: Participants were administrated 2mg Poly-ICLC intramuscularly (IM) twice weekly. Pembrolizumab was administrated 200 mg intravenously (IV) every 3 weeks (q3W)
|
|---|---|---|---|
|
Phase 1: Determine the Maximum Tolerated Dose of Poly-ICLC That Can be Combined With Pembrolizumab
|
2 mg
|
—
|
—
|
PRIMARY outcome
Timeframe: From baseline to disease progression (Expected 12-24 months)Population: The analysis population is the number of patients who received treatment. The outcome measure population below is determined by the number of patients within each dataset (each cohort) with complete response (CR) or partial response (PR) defined by RECIST criteria.
Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.
Outcome measures
| Measure |
Phase 1: Poly-ICLC: 1 and 2 mg
n=7 Participants
Cohort 1: Participants were administrated 1mg Poly-ICLC intramuscularly (IM) twice weekly. Pembrolizumab was administrated 200 mg intravenously (IV) every 3 weeks (q3W)
Cohort 2: Participants were administrated 2mg Poly-ICLC intramuscularly (IM) twice weekly. Pembrolizumab was administrated 200 mg intravenously (IV) every 3 weeks (q3W)
|
Phase 1: Poly-ICLC 2mg
n=7 Participants
Cohort 2: Participants were administrated 2mg Poly-ICLC intramuscularly (IM) twice weekly. Pembrolizumab was administrated 200 mg intravenously (IV) every 3 weeks (q3W)
|
Phase 2: Poly-ICLC: 2mg
n=17 Participants
Cohort 3: Participants were administrated 2mg Poly-ICLC intramuscularly (IM) twice weekly. Pembrolizumab was administrated 200 mg intravenously (IV) every 3 weeks (q3W)
|
|---|---|---|---|
|
Phase 1 and 2: Determine the Response Rate of Metastatic MRP Colon Cancer (That Has Progressed Following Two Lines of Therapy in the Metastatic Setting) to the Combination of Pembrolizumab and Poly-ICLC
|
0 Participants
|
0 Participants
|
1 Participants
|
PRIMARY outcome
Timeframe: From baseline to disease progression (up to 24 months)The overall survival rate of response to the combination of pembrolizumab and poly-ICLC administered at the Recommended Phase 2 Dose (RP2D) will be estimated along with the correspondent 95% confidence interval.
Outcome measures
| Measure |
Phase 1: Poly-ICLC: 1 and 2 mg
n=8 Participants
Cohort 1: Participants were administrated 1mg Poly-ICLC intramuscularly (IM) twice weekly. Pembrolizumab was administrated 200 mg intravenously (IV) every 3 weeks (q3W)
Cohort 2: Participants were administrated 2mg Poly-ICLC intramuscularly (IM) twice weekly. Pembrolizumab was administrated 200 mg intravenously (IV) every 3 weeks (q3W)
|
Phase 1: Poly-ICLC 2mg
n=10 Participants
Cohort 2: Participants were administrated 2mg Poly-ICLC intramuscularly (IM) twice weekly. Pembrolizumab was administrated 200 mg intravenously (IV) every 3 weeks (q3W)
|
Phase 2: Poly-ICLC: 2mg
n=24 Participants
Cohort 3: Participants were administrated 2mg Poly-ICLC intramuscularly (IM) twice weekly. Pembrolizumab was administrated 200 mg intravenously (IV) every 3 weeks (q3W)
|
|---|---|---|---|
|
Determine the Overall Survival Rate for Recurrent Metastatic MRP Colon Cancer Response to the Combination of Pembrolizumab and Poly-ICLC
|
0 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: 12 monthsPopulation: The percentage of participants that experienced severe adverse events.
The adverse event profile will be presented by dose level of the combination treatment for the phase I portion
Outcome measures
| Measure |
Phase 1: Poly-ICLC: 1 and 2 mg
n=8 Participants
Cohort 1: Participants were administrated 1mg Poly-ICLC intramuscularly (IM) twice weekly. Pembrolizumab was administrated 200 mg intravenously (IV) every 3 weeks (q3W)
Cohort 2: Participants were administrated 2mg Poly-ICLC intramuscularly (IM) twice weekly. Pembrolizumab was administrated 200 mg intravenously (IV) every 3 weeks (q3W)
|
Phase 1: Poly-ICLC 2mg
n=10 Participants
Cohort 2: Participants were administrated 2mg Poly-ICLC intramuscularly (IM) twice weekly. Pembrolizumab was administrated 200 mg intravenously (IV) every 3 weeks (q3W)
|
Phase 2: Poly-ICLC: 2mg
n=24 Participants
Cohort 3: Participants were administrated 2mg Poly-ICLC intramuscularly (IM) twice weekly. Pembrolizumab was administrated 200 mg intravenously (IV) every 3 weeks (q3W)
|
|---|---|---|---|
|
Determine the Adverse Event Profile and Dose Limiting Toxicities of the Combination of Pembrolizumab and Poly-ICLC
|
87.5 percentage of participants
|
70 percentage of participants
|
70.83 percentage of participants
|
SECONDARY outcome
Timeframe: 20 weeksPopulation: Progression is defined using Response Evaluation Criteria in Solid Tumors (RECIST v1.1) as any tumor enlargement greater than 20% and 5mm from baseline. The number of patients analyzed were the patients who received treatment. The outcome measure describes the count of patients who did not progress.
The 20-week progression free survival rate for the combination of pembrolizumab and poly-ICLC administered at the Recommended Phase 2 Dose (RP2D) will be estimated along with the correspondent 95% confidence interval.
Outcome measures
| Measure |
Phase 1: Poly-ICLC: 1 and 2 mg
n=7 Participants
Cohort 1: Participants were administrated 1mg Poly-ICLC intramuscularly (IM) twice weekly. Pembrolizumab was administrated 200 mg intravenously (IV) every 3 weeks (q3W)
Cohort 2: Participants were administrated 2mg Poly-ICLC intramuscularly (IM) twice weekly. Pembrolizumab was administrated 200 mg intravenously (IV) every 3 weeks (q3W)
|
Phase 1: Poly-ICLC 2mg
n=7 Participants
Cohort 2: Participants were administrated 2mg Poly-ICLC intramuscularly (IM) twice weekly. Pembrolizumab was administrated 200 mg intravenously (IV) every 3 weeks (q3W)
|
Phase 2: Poly-ICLC: 2mg
n=17 Participants
Cohort 3: Participants were administrated 2mg Poly-ICLC intramuscularly (IM) twice weekly. Pembrolizumab was administrated 200 mg intravenously (IV) every 3 weeks (q3W)
|
|---|---|---|---|
|
Determine the 20-week Progression Free Survival Rate of Recurrent Metastatic MRP Colon Cancer to the Combination of Pembrolizumab and Poly-ICLC
|
0 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: From baseline to disease progression (up to 24 months)Population: Only one participant on this trial responded to the study treatment, so the 95% confidence interval could not be calculated.
The duration of response to the combination of pembrolizumab and poly-ICLC administered at the Recommended Phase 2 Dose (RP2D) will be estimated along with the correspondent 95% confidence interval.
Outcome measures
| Measure |
Phase 1: Poly-ICLC: 1 and 2 mg
Cohort 1: Participants were administrated 1mg Poly-ICLC intramuscularly (IM) twice weekly. Pembrolizumab was administrated 200 mg intravenously (IV) every 3 weeks (q3W)
Cohort 2: Participants were administrated 2mg Poly-ICLC intramuscularly (IM) twice weekly. Pembrolizumab was administrated 200 mg intravenously (IV) every 3 weeks (q3W)
|
Phase 1: Poly-ICLC 2mg
Cohort 2: Participants were administrated 2mg Poly-ICLC intramuscularly (IM) twice weekly. Pembrolizumab was administrated 200 mg intravenously (IV) every 3 weeks (q3W)
|
Phase 2: Poly-ICLC: 2mg
n=1 Participants
Cohort 3: Participants were administrated 2mg Poly-ICLC intramuscularly (IM) twice weekly. Pembrolizumab was administrated 200 mg intravenously (IV) every 3 weeks (q3W)
|
|---|---|---|---|
|
Determine the Duration of Response of Recurrent Metastatic MRP Colon Cancer to the Combination of Pembrolizumab and Poly-ICLC
|
—
|
—
|
36 weeks
|
Adverse Events
Phase 1: Poly-ICLC: 1mg
Serious events: 7 serious events
Other events: 0 other events
Deaths: 8 deaths
Phase 1: Poly-ICLC: 2mg
Serious events: 7 serious events
Other events: 0 other events
Deaths: 10 deaths
Phase 2: Poly-ICLC: 2mg
Serious events: 17 serious events
Other events: 0 other events
Deaths: 23 deaths
Serious adverse events
| Measure |
Phase 1: Poly-ICLC: 1mg
n=8 participants at risk
Cohort 1: Participants were administrated 1mg Poly-ICLC intramuscularly (IM) twice weekly. Pembrolizumab was administrated 200 mg intravenously (IV) every 3 weeks (q3W)
|
Phase 1: Poly-ICLC: 2mg
n=10 participants at risk
Cohort 2: Participants were administrated 2mg Poly-ICLC intramuscularly (IM) twice weekly. Pembrolizumab was administrated 200 mg intravenously (IV) every 3 weeks (q3W)
|
Phase 2: Poly-ICLC: 2mg
n=24 participants at risk
Cohort 3: Participants were administrated 2mg Poly-ICLC intramuscularly (IM) twice weekly. Pembrolizumab was administrated 200 mg intravenously (IV) every 3 weeks (q3W)
|
|---|---|---|---|
|
Gastrointestinal disorders
Abdominal Distention
|
12.5%
1/8 • Number of events 1 • 3 years
|
0.00%
0/10 • 3 years
|
4.2%
1/24 • Number of events 1 • 3 years
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
37.5%
3/8 • Number of events 3 • 3 years
|
10.0%
1/10 • Number of events 1 • 3 years
|
8.3%
2/24 • Number of events 2 • 3 years
|
|
Gastrointestinal disorders
Small Bowel Obstruction
|
12.5%
1/8 • Number of events 1 • 3 years
|
0.00%
0/10 • 3 years
|
0.00%
0/24 • 3 years
|
|
Blood and lymphatic system disorders
Leukocytosis
|
0.00%
0/8 • 3 years
|
10.0%
1/10 • Number of events 1 • 3 years
|
4.2%
1/24 • Number of events 1 • 3 years
|
|
General disorders
Death
|
12.5%
1/8 • Number of events 1 • 3 years
|
10.0%
1/10 • Number of events 1 • 3 years
|
8.3%
2/24 • Number of events 2 • 3 years
|
|
Infections and infestations
Sepsis
|
0.00%
0/8 • 3 years
|
0.00%
0/10 • 3 years
|
4.2%
1/24 • Number of events 1 • 3 years
|
|
Nervous system disorders
Intracranial Hemorrhage
|
0.00%
0/8 • 3 years
|
0.00%
0/10 • 3 years
|
4.2%
1/24 • Number of events 1 • 3 years
|
|
Renal and urinary disorders
Acute Kidney Injury
|
12.5%
1/8 • Number of events 1 • 3 years
|
10.0%
1/10 • Number of events 1 • 3 years
|
4.2%
1/24 • Number of events 1 • 3 years
|
|
Gastrointestinal disorders
Nausea/Vomitting
|
0.00%
0/8 • 3 years
|
10.0%
1/10 • Number of events 2 • 3 years
|
8.3%
2/24 • Number of events 2 • 3 years
|
|
Cardiac disorders
Thrombolytic Event
|
0.00%
0/8 • 3 years
|
0.00%
0/10 • 3 years
|
4.2%
1/24 • Number of events 1 • 3 years
|
|
Metabolism and nutrition disorders
Hyperkalemia
|
12.5%
1/8 • Number of events 1 • 3 years
|
0.00%
0/10 • 3 years
|
0.00%
0/24 • 3 years
|
|
Renal and urinary disorders
Hyperuricemia
|
12.5%
1/8 • Number of events 1 • 3 years
|
0.00%
0/10 • 3 years
|
0.00%
0/24 • 3 years
|
|
General disorders
Tumor Lysis Syndrome
|
12.5%
1/8 • Number of events 1 • 3 years
|
0.00%
0/10 • 3 years
|
0.00%
0/24 • 3 years
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
12.5%
1/8 • Number of events 1 • 3 years
|
0.00%
0/10 • 3 years
|
0.00%
0/24 • 3 years
|
|
General disorders
Fever
|
12.5%
1/8 • Number of events 1 • 3 years
|
0.00%
0/10 • 3 years
|
4.2%
1/24 • Number of events 1 • 3 years
|
|
General disorders
Malaise
|
12.5%
1/8 • Number of events 1 • 3 years
|
0.00%
0/10 • 3 years
|
8.3%
2/24 • Number of events 2 • 3 years
|
|
General disorders
Fatigue
|
12.5%
1/8 • Number of events 1 • 3 years
|
10.0%
1/10 • Number of events 1 • 3 years
|
0.00%
0/24 • 3 years
|
|
Cardiac disorders
Pulmonary Edema
|
0.00%
0/8 • 3 years
|
10.0%
1/10 • Number of events 1 • 3 years
|
0.00%
0/24 • 3 years
|
|
Cardiac disorders
Hypotension
|
0.00%
0/8 • 3 years
|
10.0%
1/10 • Number of events 1 • 3 years
|
0.00%
0/24 • 3 years
|
|
Blood and lymphatic system disorders
Hypoglycemia
|
0.00%
0/8 • 3 years
|
10.0%
1/10 • Number of events 1 • 3 years
|
0.00%
0/24 • 3 years
|
|
Nervous system disorders
Acute Encephalopathy
|
0.00%
0/8 • 3 years
|
10.0%
1/10 • Number of events 1 • 3 years
|
0.00%
0/24 • 3 years
|
|
Metabolism and nutrition disorders
Hyponatrenia
|
0.00%
0/8 • 3 years
|
10.0%
1/10 • Number of events 1 • 3 years
|
0.00%
0/24 • 3 years
|
|
General disorders
Dehydration
|
0.00%
0/8 • 3 years
|
10.0%
1/10 • Number of events 1 • 3 years
|
4.2%
1/24 • Number of events 1 • 3 years
|
|
Blood and lymphatic system disorders
Blood Biliruben Increased
|
0.00%
0/8 • 3 years
|
0.00%
0/10 • 3 years
|
8.3%
2/24 • Number of events 2 • 3 years
|
|
General disorders
Hydrocephalis
|
0.00%
0/8 • 3 years
|
0.00%
0/10 • 3 years
|
4.2%
1/24 • Number of events 1 • 3 years
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonia
|
0.00%
0/8 • 3 years
|
0.00%
0/10 • 3 years
|
8.3%
2/24 • Number of events 2 • 3 years
|
|
General disorders
Abdominal Pain
|
0.00%
0/8 • 3 years
|
0.00%
0/10 • 3 years
|
4.2%
1/24 • Number of events 1 • 3 years
|
|
General disorders
Kidney Infection
|
0.00%
0/8 • 3 years
|
0.00%
0/10 • 3 years
|
4.2%
1/24 • Number of events 1 • 3 years
|
|
General disorders
Ascites
|
0.00%
0/8 • 3 years
|
0.00%
0/10 • 3 years
|
4.2%
1/24 • Number of events 1 • 3 years
|
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place