Trial · NCT06353906
Carboplatin/Paclitaxel + Pembrolizumab for Locoregionally Advanced Penile Cancer
NCT06353906, Phase 2, Recruiting, The Netherlands Cancer Institute
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Carboplatin/Paclitaxel + Pembrolizumab for Locoregionally Advanced Penile Cancer. Trials, record NCT06353906. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT06353906
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Carboplatin/Paclitaxel + Pembrolizumab for Locoregionally Advanced Penile Cancer
- NCT number
- NCT06353906
- Status
- Recruiting
- Phases
- Phase 2
- Enrollment
- 27 participants, estimated
- Lead sponsor
- The Netherlands Cancer Institute
- Conditions
- Urologic Neoplasms, Urogenital Neoplasms, Male Urogenital Diseases, Penile Cancer, Penile Squamous Cell Carcinoma, Locally Advanced Penile Carcinoma
- Interventions
- Carboplatin/Paclitaxel, Pembrolizumab, Partial or total penectomy with inguinal and/or pelvic lymph node dissection
- First posted
- 2024-04-09
- Last updated
- 2025-12-08
Source ClinicalTrials.gov
Registered outcomes8
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Pathological complete response (pCR) | Immediately after surgery | Pathological complete response defined as pT0N0 in all evaluable patients |
| Secondary | Drug toxicity | Drug-related serious adverse events will be noted from day of registration until 90 days after the last protocol treatment/administration. | Safety in terms of chemotherapy and immunotherapy-related adverse events of grade 3 or higher according to version 5.0 of the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) criteria. |
| Secondary | Progression-free survival (PFS) | Through study completion, at a minimum of 24 months | PFS is defined as time from start of therapy until an event. Events include: * Histologically or cytologically established recurrence after surgery * Omission of surgery as a result of progressive disease. * Unequivocal radiological progression. In case of equivocal results, radiological evaluation may continue. When unequivocal progression is established, the event date will be the first tumor assessment where new lesions were noted. * Switch to another systemic therapy. Note: in case a radiologically responding patient refuses surgery and elects other locoregional therapy (e.g. (chemo)radiotherapy), this is not considered a progression event. PFS will be estimated using the Kaplan-Meier method. The median PFS and 95% confidence interval will be reported. |
| Secondary | Overall survival (OS) | Through study completion, at a minimum of 24 months | OS is defined as the time between the date of enrollment and the date of death. OS will be estimated using the Kaplan-Meier method. The median OS and 95% confidence interval will be reported. |
| Secondary | Assessment of correlation between clinical endpoints and tumor characteristics | Tumor tissue will be collected at baseline and during resection procedure. Clinical endpoints of pCR, PFS and OS will be determined as mentioned above | Tumor tissue gathered from patients at baseline via biopsy and, in case of non complete response, at surgery will be tested via a comprehensive analysis of the tumor microenvironment (TME) using state of the art multiparameter techniques to determine the TME composition and activation status in responders vs non-responders. Additional analyses on clinical endpoints (i.e. pCR, PFS and OS) will be carried out between patient groups defined by tumor characteristics. |
| Secondary | Tumor tissue HPV status in relation to treatment response | 12 weeks after last patient first visit | HPV, or human papilloma virus, status of pre-treatment (baseline) tumor tissue will be determined. Tumor tissue will be tested for HPV status (present or not) to determine a possible (prior) infection with a "high-risk" HPV serotype. High-risk meaning a serotype associated with a higher risk for developing neoplasms. High-risk HPV status will be related to pCR, PFS and OS as they are described above. Baseline tumor tissue will be requested from a referring hospital or gathered from each individual patient during screening. |
| Secondary | Tumor tissue PD-L1 expression in relation to treatment response | 12 weeks after last patient first visit | PD-L1 expression of pre-treatment (baseline) tumor tissue will be determined. PD-L1 tumor proportion score (TPS; 0%-100%) will be assessed via immunohistochemical staining of tumor tissue. PD-L1 TPS ≥50% will be related to pCR, PFS and OS as they are described above. Baseline tumor tissue will be requested from a referring hospital or gathered from each individual patient during screening. |
| Secondary | Evaluation of changes in patient reported outcome regarding Quality of Life (QoL) | From screening until end of treatment visit (30 days after last adjuvant treatment) | QoL will be measured by the European Organization for the Research and Treatement of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) in all patients who were registered for the study and started treatment. This questionnaire will be used to evaluate changes from baseline in QoL, with patient-reported QoL scored in various domains on a scale of 0-100. |
Source ClinicalTrials.gov
Outcomes0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
None in this release.
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow0
How many started, completed or left each group, period by period.
None in this release.
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals0
The totals the trial posted for each group.
None in this release.
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/NCT06353906
GET https://conductscience.org/api/trials/v1/NCT06353906/registered