Trial · NCT07110038
DEPECA-1 - A Phase II Study to Evaluate a First-line Systemic Therapy With Enfortumab Vedotin Plus Avelumab for Advanced and Metastatic Penile Carcinoma
NCT07110038, Phase 2, Recruiting, Institut für Klinische Krebsforschung IKF GmbH at Krankenhaus Nordwest
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. DEPECA-1 - A Phase II Study to Evaluate a First-line Systemic Therapy With Enfortumab Vedotin Plus Avelumab for Advanced and Metastatic Penile Carcinoma. Trials, record NCT07110038. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT07110038
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- DEPECA-1 - A Phase II Study to Evaluate a First-line Systemic Therapy With Enfortumab Vedotin Plus Avelumab for Advanced and Metastatic Penile Carcinoma
- NCT number
- NCT07110038
- Status
- Recruiting
- Phases
- Phase 2
- Enrollment
- 25 participants, estimated
- Lead sponsor
- Institut für Klinische Krebsforschung IKF GmbH at Krankenhaus Nordwest
- Conditions
- Penile Squamous Cell Carcinoma (PSCC)
- Interventions
- Avelumab, enfortumab vedotin
- First posted
- 2025-08-07
- Last updated
- 2026-10-13
Source ClinicalTrials.gov
Registered outcomes8
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Objective Response Rate (ORR) | Up to 24 months. | Objective Response Rate (ORR) in 1st line as assessed by investigators, defined as the proportion of patients achieving a complete response (CR) or partial response (PR) according to RECIST 1.1 criteria. |
| Secondary | Progression-free survival (PFS) | Up to 5 years. | Progression-free survival (PFS), defined as the time from the start of treatment to the first documented disease progression acc. to RECIST 1.1 criteria or death from any cause, whichever occurs first. |
| Secondary | Overall Survival (OS) | Up to 5 years. | Time from the start of treatment to death from any cause. |
| Secondary | Duration of Response (DoR) | Up to 5 years. | Time from the first documented response (CR or PR) to disease progression or death from any cause (whichever occurs first). |
| Secondary | Disease Control Rate (DCR) | Up to 27 months. | Disease Control Rate (DCR), defined as the proportion of patients achieving CR, PR, or stable disease (SD) according to RECIST 1.1 criteria. |
| Secondary | Incidence and severity of (serious) adverse events | Up to 27 months | Incidence and severity of adverse events (AEs) and serious adverse events (SAEs), graded according to the Common Terminology Criteria for Adverse Events (CTCAE) version 5.0. |
| Secondary | Quality of life (QoL) using EQ-5D-5L questionnaire | Up to 24 months. | Changes in patient-reported quality of life, using EQ-5D-5L questionnaire and a set of bolt-on questions will be collected. |
| Secondary | Quality of life (QoL) using EQ-HWB-S questionnaire | Up to 24 months. | Changes in patient-reported quality of life, using EQ-HWB-S questionnaire and a set of bolt-on questions will be collected. |
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/NCT07110038
GET https://conductscience.org/api/trials/v1/NCT07110038/registered