Trial · NCT07518979
EGFR-ADC (Becotatug Vedotin) Combined With PD-1 Inhibitor (Pucotenlimab) in Neoadjuvant Treatment of Advanced Penile Cancer
NCT07518979, Phase 2, Recruiting, Jiyan Liu
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. EGFR-ADC (Becotatug Vedotin) Combined With PD-1 Inhibitor (Pucotenlimab) in Neoadjuvant Treatment of Advanced Penile Cancer. Trials, record NCT07518979. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT07518979
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- EGFR-ADC (Becotatug Vedotin) Combined With PD-1 Inhibitor (Pucotenlimab) in Neoadjuvant Treatment of Advanced Penile Cancer
- NCT number
- NCT07518979
- Status
- Recruiting
- Phases
- Phase 2
- Enrollment
- 60 participants, estimated
- Lead sponsor
- Jiyan Liu
- Conditions
- Penile Cancer
- Interventions
- Becotatug Vedotin, Pucotenlimab
- First posted
- 2026-04-09
- Last updated
- 2026-07-29
Source ClinicalTrials.gov
Registered outcomes9
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Surgical Resection Rate | Up to 6 months after the start of neoadjuvant therapy (after completion of 4-6 cycles of treatment and MDT evaluation). | Proportion of patients who achieve R0 resection (no residual tumor cells at margins) after neoadjuvant therapy, confirmed by surgical records and postoperative pathological reports. |
| Secondary | Objective Response Rate (ORR) | Every 6 weeks during neoadjuvant therapy, up to 6 months. | Proportion of patients with complete response (CR) + partial response (PR) per RECIST 1.1, evaluated by imaging. |
| Secondary | Downstaging Rate | After completion of neoadjuvant therapy (up to 6 months). | Proportion of patients with reduced tumor stage (focus on inguinal lymph node stage) after neoadjuvant therapy. |
| Secondary | Pathological Complete Response (pCR) Rate | Within 1 month after surgery. | Proportion of patients with no residual viable tumor cells (0% RVT) in primary tumor and sampled lymph nodes, confirmed by central pathology. |
| Secondary | Major Pathological Response (MPR) Rate | Within 1 month after surgery. | Proportion of patients with residual viable tumor cells ≤10% in primary tumor and sampled lymph nodes, confirmed by central pathology. |
| Secondary | Tumor Regression Grade (TRG) | Within 1 month after surgery. | Semi-quantitative grading of tumor regression (Miller-Payne or RCB system) by central pathology. |
| Secondary | Event-Free Survival (EFS) | From first dose to 2 years after study completion, assessed every 3 months. | Time from first neoadjuvant therapy to first event (disease progression, recurrence, metastasis, death from any cause). |
| Secondary | Disease-Free Survival (DFS) | From surgery to 2 years after study completion, assessed every 3 months. | Time from R0 resection to first recurrence (local/regional/distant), metastasis, or death from any cause. |
| Secondary | Safety Profile | From signing informed consent to 28 days after last dose. | Incidence and severity of adverse events (AEs) per CTCAE 5.0; changes in vital signs, physical examination, laboratory tests, electrocardiogram. |
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.
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 42757773 | DERIVED |
Source PubMed
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/NCT07518979
GET https://conductscience.org/api/trials/v1/NCT07518979/registered