Trial · NCT02837042
Trial of Pembrolizumab for Advanced Penile Squamous Cell Carcinoma
NCT02837042, Phase 2, Terminated, University of Alabama at Birmingham; results first posted 2022-06-21
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Trial of Pembrolizumab for Advanced Penile Squamous Cell Carcinoma. Trials, record NCT02837042. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02837042
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Trial of Pembrolizumab for Advanced Penile Squamous Cell Carcinoma
- NCT number
- NCT02837042
- Status
- Terminated
- Phases
- Phase 2
- Enrollment
- 6 participants, actual
- Lead sponsor
- University of Alabama at Birmingham
- Conditions
- Penile Squamous Cell Carcinoma
- Interventions
- Pembrolizumab
- First posted
- 2016-07-19
- Last updated
- 2022-06-21
- Results first posted
- 2022-06-21
Source ClinicalTrials.gov
Registered outcomes4
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Objective Tumor Response Rate | Baseline up to two years | 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. |
| Secondary | Progression-free Survival (PFS) | Baseline up to two years | The duration of time from the start of treatment to the first documentation of tumor progression. |
| Secondary | Overall Survival | 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 | Length of subject survival after starting study treatment |
| Secondary | Number of Patients With Adverse Events | 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. |
Source ClinicalTrials.gov
Outcomes4
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Objective Tumor Response Rate | Baseline up to two years | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Progression-free Survival (PFS) | Baseline up to two years | 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. | days | MEDIAN |
| SECONDARY | Overall Survival | 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 | 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. | days | MEDIAN |
| SECONDARY | Number of Patients With Adverse Events | Baseline up to two years | Participants | COUNT_OF_PARTICIPANTS |
Source ClinicalTrials.gov
Results by group4
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Objective Tumor Response Rate | Pembrolizumab 200 mg | 1 | Participants | ||
| Progression-free Survival (PFS) | Pembrolizumab 200 mg | 91 | Inter-Quartile Range NA to NA | days | |
| Overall Survival | Pembrolizumab 200 mg | 307 | Inter-Quartile Range NA to NA | days | |
| Number of Patients With Adverse Events | Pembrolizumab 200 mg | 4 | Participants |
Source ClinicalTrials.gov
Participant flow3
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Pembrolizumab 200 mg | 6 | |
| Overall Study | COMPLETED | Pembrolizumab 200 mg | 6 | |
| Overall Study | NOT COMPLETED | Pembrolizumab 200 mg | 0 |
Source ClinicalTrials.gov
Adverse events4
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Fever | Infections and infestations | Pembrolizumab 200 mg | 1 | 6 | 1 |
| other | Hyponatremia | Renal and urinary disorders | Pembrolizumab 200 mg | 1 | 6 | 1 |
| serious | Hypoalbuminemia | Hepatobiliary disorders | Pembrolizumab 200 mg | 1 | 6 | 1 |
| serious | Constipation | Gastrointestinal disorders | Pembrolizumab 200 mg | 1 | 6 | 1 |
Source ClinicalTrials.gov
Adverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Pembrolizumab 200 mg | 0 | 6 |
| Total, other adverse events | Pembrolizumab 200 mg | 2 | 6 |
| Total, serious adverse events | Pembrolizumab 200 mg | 2 | 6 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT02837042
GET https://conductscience.org/api/trials/v1/NCT02837042/registered