Trial Outcomes & Findings for Trial of Pembrolizumab for Advanced Penile Squamous Cell Carcinoma (NCT NCT02837042)

Last Updated: 2022-06-21

Results Overview

The response rate will be evaluated every 3 weeks using the criteria proposed by the Response Evaluation Criteria in Solid Tumors (RECIST 1.1) in addition to immune related criteria based on patterns of response.

Recruitment status

TERMINATED

Study phase

PHASE2

Target enrollment

6 participants

Primary outcome timeframe

Baseline up to two years

Results posted on

2022-06-21

Participant Flow

Participant milestones

Participant milestones
Measure	Pembrolizumab 200 mg Once eligibility is confirmed, the patient will start treatment cycles with Pembrolizumab at 200 mg given intravenously on the first day of each cycle. Each cycle corresponds to a duration of 3 weeks. Pembrolizumab: Pembrolizumab will be administered intravenously every 3 weeks.
Overall Study STARTED	6
Overall Study COMPLETED	6
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Trial of Pembrolizumab for Advanced Penile Squamous Cell Carcinoma

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Pembrolizumab 200 mg n=6 Participants Once eligibility is confirmed, the patient will start treatment cycles with Pembrolizumab at 200 mg given intravenously on the first day of each cycle. Each cycle corresponds to a duration of 3 weeks. Pembrolizumab: Pembrolizumab will be administered intravenously every 3 weeks.
Age, Continuous	65 years n=5 Participants
Sex: Female, Male Female	0 Participants n=5 Participants
Sex: Female, Male Male	6 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	6 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants
Race (NIH/OMB) White	6 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Region of Enrollment United States	6 participants n=5 Participants

PRIMARY outcome

Timeframe: Baseline up to two years

Outcome measures

Outcome measures
Measure	Pembrolizumab 200 mg n=6 Participants Once eligibility is confirmed, the patient will start treatment cycles with Pembrolizumab at 200 mg given intravenously on the first day of each cycle. Each cycle corresponds to a duration of 3 weeks. Pembrolizumab: Pembrolizumab will be administered intravenously every 3 weeks.
Objective Tumor Response Rate	1 Participants

SECONDARY outcome

Timeframe: Baseline up to two years

Population: Since the trial stopped due to poor accrual, and more censored patients, the 95% CI for median PFS and OS could not be determined. We are reporting median values without CI.

The duration of time from the start of treatment to the first documentation of tumor progression.

Outcome measures

Outcome measures
Measure	Pembrolizumab 200 mg n=6 Participants Once eligibility is confirmed, the patient will start treatment cycles with Pembrolizumab at 200 mg given intravenously on the first day of each cycle. Each cycle corresponds to a duration of 3 weeks. Pembrolizumab: Pembrolizumab will be administered intravenously every 3 weeks.
Progression-free Survival (PFS)	91 days The study was ended prematurely due to poor accrual and only two patients progressed while the rest were lost to follow up. The statistical analysis will not give a reliable range except median based on two findings

SECONDARY outcome

Timeframe: From date of randomization until the date of first documented progression or date of death from any cause, whichever comes first, assessed up to 100 months

Population: Due to poor accrual, low sample size, and higher number of patients censored, the 95% CI for median OS and PFS could not be determined.

Length of subject survival after starting study treatment

Outcome measures

Outcome measures
Measure	Pembrolizumab 200 mg n=6 Participants Once eligibility is confirmed, the patient will start treatment cycles with Pembrolizumab at 200 mg given intravenously on the first day of each cycle. Each cycle corresponds to a duration of 3 weeks. Pembrolizumab: Pembrolizumab will be administered intravenously every 3 weeks.
Overall Survival	307 days The study was ended prematurely due to poor accrual and only two patients progressed while the rest were lost to follow up. The statistical analysis will not give a reliable range except median based on two findings

SECONDARY outcome

Timeframe: Baseline up to two years

Adverse events reporting will be graded following the National Cancer Institute of Common Terminology Criteria for Adverse Events (NCI CTCAE) version 4.0.

Outcome measures

Outcome measures
Measure	Pembrolizumab 200 mg n=6 Participants Once eligibility is confirmed, the patient will start treatment cycles with Pembrolizumab at 200 mg given intravenously on the first day of each cycle. Each cycle corresponds to a duration of 3 weeks. Pembrolizumab: Pembrolizumab will be administered intravenously every 3 weeks.
Number of Patients With Adverse Events	4 Participants

Adverse Events

Pembrolizumab 200 mg

Serious events: 2 serious events

Other events: 2 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Pembrolizumab 200 mg n=6 participants at risk Once eligibility is confirmed, the patient will start treatment cycles with Pembrolizumab at 200 mg given intravenously on the first day of each cycle. Each cycle corresponds to a duration of 3 weeks. Pembrolizumab: Pembrolizumab will be administered intravenously every 3 weeks.
Hepatobiliary disorders Hypoalbuminemia	16.7% 1/6 • Number of events 1 • From baseline through one year after the end of the study, up to 2 years. The study was closed prematurely due to poor accrual and substantial loss to follow-up of patients.
Gastrointestinal disorders Constipation	16.7% 1/6 • Number of events 1 • From baseline through one year after the end of the study, up to 2 years. The study was closed prematurely due to poor accrual and substantial loss to follow-up of patients.

Other adverse events

Other adverse events
Measure	Pembrolizumab 200 mg n=6 participants at risk Once eligibility is confirmed, the patient will start treatment cycles with Pembrolizumab at 200 mg given intravenously on the first day of each cycle. Each cycle corresponds to a duration of 3 weeks. Pembrolizumab: Pembrolizumab will be administered intravenously every 3 weeks.
Infections and infestations Fever	16.7% 1/6 • Number of events 1 • From baseline through one year after the end of the study, up to 2 years. The study was closed prematurely due to poor accrual and substantial loss to follow-up of patients.
Renal and urinary disorders Hyponatremia	16.7% 1/6 • Number of events 1 • From baseline through one year after the end of the study, up to 2 years. The study was closed prematurely due to poor accrual and substantial loss to follow-up of patients.

Additional Information

Gurudatta Naik, Scientist 3

UAB

Phone: 205-996-5530

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place