Trial Outcomes & Findings for Imiquimod and Pembrolizumab in Treating Patients With Stage IIIB-IV Melanoma (NCT NCT03276832)
NCT ID: NCT03276832
Last Updated: 2026-03-19
Results Overview
Defined as percentage of patients whose objective disease status meets the criteria for Response Evaluation Criteria in Solid Tumors (RECIST) criteria for partial or complete response on two consecutive disease evaluations.
Recruitment status
COMPLETED
Study phase
EARLY_PHASE1
Target enrollment
7 participants
Primary outcome timeframe
16 months
Results posted on
2026-03-19
Participant Flow
Participant milestones
| Measure |
Treatment (Pembrolizumab, Imiquimod)
Patients receive pembrolizumab IV on day 1 and apply imiquimod cutaneously on days 1-5 (Monday - Friday). Cycles repeat every 21 days for up to 2 years (approximately 35 courses) in the absence of disease progression or unacceptable toxicity. Patients undergo biopsy at baseline, 6 weeks, and 12 weeks and CT, PET/CT, or MRI throughout the trial.
Imiquimod: Applied cutaneously
Biopsy: Undergo biopsy
Pembrolizumab: Given IV
Computed Tomography: Undergo CT or PET/CT
Positron Emission Tomography: Undergo PET/CT
Magnetic Resonance Imaging: Undergo MRI
|
|---|---|
|
Overall Study
STARTED
|
7
|
|
Overall Study
COMPLETED
|
7
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Imiquimod and Pembrolizumab in Treating Patients With Stage IIIB-IV Melanoma
Baseline characteristics by cohort
| Measure |
Treatment (Pembrolizumab, Imiquimod)
n=7 Participants
Patients receive pembrolizumab IV on day 1 and apply imiquimod cutaneously on days 1-5 (Monday - Friday). Cycles repeat every 21 days for up to 2 years (approximately 35 courses) in the absence of disease progression or unacceptable toxicity. Patients undergo biopsy at baseline, 6 weeks, and 12 weeks and CT, PET/CT, or MRI throughout the trial.
Imiquimod: Applied cutaneously
Biopsy: Undergo biopsy
Pembrolizumab: Given IV
Computed Tomography: Undergo CT or PET/CT
Positron Emission Tomography: Undergo PET/CT
Magnetic Resonance Imaging: Undergo MRI
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=110 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
1 Participants
n=110 Participants
|
|
Age, Categorical
>=65 years
|
6 Participants
n=110 Participants
|
|
Age, Continuous
|
80 years
n=110 Participants
|
|
Sex: Female, Male
Female
|
2 Participants
n=110 Participants
|
|
Sex: Female, Male
Male
|
5 Participants
n=110 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=110 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
6 Participants
n=110 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=110 Participants
|
|
Region of Enrollment
United States
|
7 participants
n=110 Participants
|
PRIMARY outcome
Timeframe: 16 monthsDefined as the time from response to disease progression.
Outcome measures
| Measure |
Treatment (Pembrolizumab, Imiquimod)
n=4 Participants
Patients receive pembrolizumab IV on day 1 and apply imiquimod cutaneously on days 1-5 (Monday - Friday). Cycles repeat every 21 days for up to 2 years (approximately 35 courses) in the absence of disease progression or unacceptable toxicity. Patients undergo biopsy at baseline, 6 weeks, and 12 weeks and CT, PET/CT, or MRI throughout the trial.
Imiquimod: Applied cutaneously
Biopsy: Undergo biopsy
Pembrolizumab: Given IV
Computed Tomography: Undergo CT or PET/CT
Positron Emission Tomography: Undergo PET/CT
Magnetic Resonance Imaging: Undergo MRI
|
|---|---|
|
Duration of Response
|
8.1 months
Interval 5.2 to 11.6
|
PRIMARY outcome
Timeframe: 16 monthsAEs are graded using Common Terminology Criteria for Adverse Events version 4.0
Outcome measures
| Measure |
Treatment (Pembrolizumab, Imiquimod)
n=7 Participants
Patients receive pembrolizumab IV on day 1 and apply imiquimod cutaneously on days 1-5 (Monday - Friday). Cycles repeat every 21 days for up to 2 years (approximately 35 courses) in the absence of disease progression or unacceptable toxicity. Patients undergo biopsy at baseline, 6 weeks, and 12 weeks and CT, PET/CT, or MRI throughout the trial.
Imiquimod: Applied cutaneously
Biopsy: Undergo biopsy
Pembrolizumab: Given IV
Computed Tomography: Undergo CT or PET/CT
Positron Emission Tomography: Undergo PET/CT
Magnetic Resonance Imaging: Undergo MRI
|
|---|---|
|
Incidence of Adverse Events (AEs)
Allergic reaction
|
2 Participants
|
|
Incidence of Adverse Events (AEs)
Anemia
|
3 Participants
|
|
Incidence of Adverse Events (AEs)
Arthralgia
|
2 Participants
|
|
Incidence of Adverse Events (AEs)
Aspartate aminotransferase increase
|
1 Participants
|
|
Incidence of Adverse Events (AEs)
Blood bilirubin increase
|
3 Participants
|
|
Incidence of Adverse Events (AEs)
Fatigue
|
5 Participants
|
|
Incidence of Adverse Events (AEs)
Nausea
|
1 Participants
|
PRIMARY outcome
Timeframe: 21 monthsDefined as the time from registration to death due to any cause. Will be estimated using the Kaplan-Meier method. The 21 month OS rate was calculated here.
Outcome measures
| Measure |
Treatment (Pembrolizumab, Imiquimod)
n=7 Participants
Patients receive pembrolizumab IV on day 1 and apply imiquimod cutaneously on days 1-5 (Monday - Friday). Cycles repeat every 21 days for up to 2 years (approximately 35 courses) in the absence of disease progression or unacceptable toxicity. Patients undergo biopsy at baseline, 6 weeks, and 12 weeks and CT, PET/CT, or MRI throughout the trial.
Imiquimod: Applied cutaneously
Biopsy: Undergo biopsy
Pembrolizumab: Given IV
Computed Tomography: Undergo CT or PET/CT
Positron Emission Tomography: Undergo PET/CT
Magnetic Resonance Imaging: Undergo MRI
|
|---|---|
|
Overall Survival
|
6 Participants
|
PRIMARY outcome
Timeframe: 7 monthsDefined as the time from registration to documentation of first disease progression or death due to any cause. Will be estimated using the Kaplan-Meier method. The 7 month PFS rate was calculated.
Outcome measures
| Measure |
Treatment (Pembrolizumab, Imiquimod)
n=7 Participants
Patients receive pembrolizumab IV on day 1 and apply imiquimod cutaneously on days 1-5 (Monday - Friday). Cycles repeat every 21 days for up to 2 years (approximately 35 courses) in the absence of disease progression or unacceptable toxicity. Patients undergo biopsy at baseline, 6 weeks, and 12 weeks and CT, PET/CT, or MRI throughout the trial.
Imiquimod: Applied cutaneously
Biopsy: Undergo biopsy
Pembrolizumab: Given IV
Computed Tomography: Undergo CT or PET/CT
Positron Emission Tomography: Undergo PET/CT
Magnetic Resonance Imaging: Undergo MRI
|
|---|---|
|
Progression Free Survival
|
4 Participants
|
PRIMARY outcome
Timeframe: 16 monthsDefined as percentage of patients whose objective disease status meets the criteria for Response Evaluation Criteria in Solid Tumors (RECIST) criteria for partial or complete response on two consecutive disease evaluations.
Outcome measures
| Measure |
Treatment (Pembrolizumab, Imiquimod)
n=7 Participants
Patients receive pembrolizumab IV on day 1 and apply imiquimod cutaneously on days 1-5 (Monday - Friday). Cycles repeat every 21 days for up to 2 years (approximately 35 courses) in the absence of disease progression or unacceptable toxicity. Patients undergo biopsy at baseline, 6 weeks, and 12 weeks and CT, PET/CT, or MRI throughout the trial.
Imiquimod: Applied cutaneously
Biopsy: Undergo biopsy
Pembrolizumab: Given IV
Computed Tomography: Undergo CT or PET/CT
Positron Emission Tomography: Undergo PET/CT
Magnetic Resonance Imaging: Undergo MRI
|
|---|---|
|
Tumor Response Rate
Complete Response
|
3 Participants
|
|
Tumor Response Rate
Partial Response
|
1 Participants
|
|
Tumor Response Rate
Stable Disease
|
2 Participants
|
|
Tumor Response Rate
Disease progression
|
1 Participants
|
Adverse Events
Treatment (Pembrolizumab, Imiquimod)
Serious events: 0 serious events
Other events: 7 other events
Deaths: 1 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Treatment (Pembrolizumab, Imiquimod)
n=7 participants at risk
Patients receive pembrolizumab IV on day 1 and apply imiquimod cutaneously on days 1-5 (Monday - Friday). Cycles repeat every 21 days for up to 2 years (approximately 35 courses) in the absence of disease progression or unacceptable toxicity. Patients undergo biopsy at baseline, 6 weeks, and 12 weeks and CT, PET/CT, or MRI throughout the trial.
Imiquimod: Applied cutaneously
Biopsy: Undergo biopsy
Pembrolizumab: Given IV
Computed Tomography: Undergo CT or PET/CT
Positron Emission Tomography: Undergo PET/CT
Magnetic Resonance Imaging: Undergo MRI
|
|---|---|
|
Immune system disorders
Allergic reaction
|
28.6%
2/7 • Adverse events were followed for 16 months and mortality was followed for 21 months.
|
|
Blood and lymphatic system disorders
Anemia
|
42.9%
3/7 • Adverse events were followed for 16 months and mortality was followed for 21 months.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
28.6%
2/7 • Adverse events were followed for 16 months and mortality was followed for 21 months.
|
|
Hepatobiliary disorders
Aspartate aminotransferase increase
|
14.3%
1/7 • Adverse events were followed for 16 months and mortality was followed for 21 months.
|
|
Hepatobiliary disorders
Bilirubin increase
|
42.9%
3/7 • Adverse events were followed for 16 months and mortality was followed for 21 months.
|
|
General disorders
Fatigue
|
71.4%
5/7 • Adverse events were followed for 16 months and mortality was followed for 21 months.
|
|
Gastrointestinal disorders
Nausea
|
14.3%
1/7 • Adverse events were followed for 16 months and mortality was followed for 21 months.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place