Trial Outcomes & Findings for Tadalafil and Pembrolizumab in Recurrent or Metastatic Head and Neck Cancer (NCT NCT03993353)
NCT ID: NCT03993353
Last Updated: 2026-02-12
Results Overview
Rate of dose limiting toxicity at least possibly attributable to study treatment
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
7 participants
Primary outcome timeframe
2 years
Results posted on
2026-02-12
Participant Flow
Participant milestones
| Measure |
Tadalafil and Pembrolizumab
Tadalafil for up to 12 months and pembrolizumab for up to 24 months.
Pembrolizumab: 200 mg intravenously every 3 weeks
Tadalafil: 10 mg by mouth daily
|
|---|---|
|
Overall Study
STARTED
|
7
|
|
Overall Study
COMPLETED
|
6
|
|
Overall Study
NOT COMPLETED
|
1
|
Reasons for withdrawal
| Measure |
Tadalafil and Pembrolizumab
Tadalafil for up to 12 months and pembrolizumab for up to 24 months.
Pembrolizumab: 200 mg intravenously every 3 weeks
Tadalafil: 10 mg by mouth daily
|
|---|---|
|
Overall Study
Screen Failure
|
1
|
Baseline Characteristics
Tadalafil and Pembrolizumab in Recurrent or Metastatic Head and Neck Cancer
Baseline characteristics by cohort
| Measure |
Tadalafil and Pembrolizumab
n=6 Participants
Tadalafil for up to 12 months and pembrolizumab for up to 24 months.
Pembrolizumab: 200 mg intravenously every 3 weeks
Tadalafil: 10 mg by mouth daily
|
|---|---|
|
Age, Continuous
|
59.67 years
STANDARD_DEVIATION 6.62 • n=41 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=41 Participants
|
|
Sex: Female, Male
Male
|
6 Participants
n=41 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
2 Participants
n=41 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
4 Participants
n=41 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=41 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=41 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=41 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=41 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=41 Participants
|
|
Race (NIH/OMB)
White
|
3 Participants
n=41 Participants
|
|
Race (NIH/OMB)
More than one race
|
2 Participants
n=41 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=41 Participants
|
|
Cancer Type
Hypopharynx
|
1 Participants
n=41 Participants
|
|
Cancer Type
Larynx
|
2 Participants
n=41 Participants
|
|
Cancer Type
Oral cavity
|
2 Participants
n=41 Participants
|
|
Cancer Type
Oropharynx
|
1 Participants
n=41 Participants
|
PRIMARY outcome
Timeframe: 2 yearsRate of dose limiting toxicity at least possibly attributable to study treatment
Outcome measures
| Measure |
Tadalafil and Pembrolizumab
n=6 Participants
Tadalafil for up to 12 months and pembrolizumab for up to 24 months.
Pembrolizumab: 200 mg intravenously every 3 weeks
Tadalafil: 10 mg by mouth daily
|
|---|---|
|
Rate of Dose Limiting Toxicity (DLT)
|
1 Participants
|
PRIMARY outcome
Timeframe: 12 monthsOverall survival at 12 months post-enrollment
Outcome measures
| Measure |
Tadalafil and Pembrolizumab
n=6 Participants
Tadalafil for up to 12 months and pembrolizumab for up to 24 months.
Pembrolizumab: 200 mg intravenously every 3 weeks
Tadalafil: 10 mg by mouth daily
|
|---|---|
|
Overall Survival (OS)
|
3 Participants
|
SECONDARY outcome
Timeframe: 12 monthsResponse measured by RECIST 1.1
Outcome measures
| Measure |
Tadalafil and Pembrolizumab
n=3 Participants
Tadalafil for up to 12 months and pembrolizumab for up to 24 months.
Pembrolizumab: 200 mg intravenously every 3 weeks
Tadalafil: 10 mg by mouth daily
|
|---|---|
|
Response Measured by RECIST 1.1
|
1 Participants
|
SECONDARY outcome
Timeframe: 2 yearsProgression free survival
Outcome measures
| Measure |
Tadalafil and Pembrolizumab
n=3 Participants
Tadalafil for up to 12 months and pembrolizumab for up to 24 months.
Pembrolizumab: 200 mg intravenously every 3 weeks
Tadalafil: 10 mg by mouth daily
|
|---|---|
|
Progression Free Survival
|
21.56 months
Standard Deviation 22.98
|
SECONDARY outcome
Timeframe: 2 yearsAdverse event rates
Outcome measures
| Measure |
Tadalafil and Pembrolizumab
n=6 Participants
Tadalafil for up to 12 months and pembrolizumab for up to 24 months.
Pembrolizumab: 200 mg intravenously every 3 weeks
Tadalafil: 10 mg by mouth daily
|
|---|---|
|
Adverse Event Rates
|
6 Participants
|
Adverse Events
Tadalafil and Pembrolizumab
Serious events: 1 serious events
Other events: 6 other events
Deaths: 3 deaths
Serious adverse events
| Measure |
Tadalafil and Pembrolizumab
n=6 participants at risk
Tadalafil for up to 12 months and pembrolizumab for up to 24 months.
Pembrolizumab: 200 mg intravenously every 3 weeks
Tadalafil: 10 mg by mouth daily
|
|---|---|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
16.7%
1/6 • Number of events 1 • 2 years
|
Other adverse events
| Measure |
Tadalafil and Pembrolizumab
n=6 participants at risk
Tadalafil for up to 12 months and pembrolizumab for up to 24 months.
Pembrolizumab: 200 mg intravenously every 3 weeks
Tadalafil: 10 mg by mouth daily
|
|---|---|
|
Endocrine disorders
Endocrine disorders
|
16.7%
1/6 • Number of events 2 • 2 years
|
|
Eye disorders
Eye disorders
|
16.7%
1/6 • Number of events 1 • 2 years
|
|
Gastrointestinal disorders
Gastrointestinal disorders
|
50.0%
3/6 • Number of events 9 • 2 years
|
|
General disorders
General disorders and administration site conditions
|
66.7%
4/6 • Number of events 7 • 2 years
|
|
Infections and infestations
Infections and infestations
|
50.0%
3/6 • Number of events 3 • 2 years
|
|
Investigations
Investigations
|
16.7%
1/6 • Number of events 2 • 2 years
|
|
Metabolism and nutrition disorders
Metabolism and nutrition disorders
|
50.0%
3/6 • Number of events 4 • 2 years
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal and connective tissue disorders
|
16.7%
1/6 • Number of events 2 • 2 years
|
|
Psychiatric disorders
Psychiatric disorders
|
16.7%
1/6 • Number of events 1 • 2 years
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory, thoracic and mediastinal disorders
|
83.3%
5/6 • Number of events 7 • 2 years
|
|
Skin and subcutaneous tissue disorders
Skin and subcutaneous tissue disorders
|
66.7%
4/6 • Number of events 5 • 2 years
|
|
Vascular disorders
Vascular disorders
|
16.7%
1/6 • Number of events 1 • 2 years
|
Additional Information
Dr. Joseph Califano
University of California, San Diego
Phone: (858) 822-5354
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place