Neoadjuvant Pucotenlimab and Becotatug Vedotin for Locally Advanced Penile Cancer
Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexMale
Age18-75
SponsorSun Yat-sen University
About this trial
This is an open-label, multicenter, single-arm Phase 2 clinical trial evaluating neoadjuvant pucotenlimab (anti-PD-1 immunotherapy) combined with becotatug vedotin (EGFR-targeted antibody-drug conjugate, ADC) for adults with locally advanced penile squamous cell carcinoma. Eligible patients have high-risk disease defined as T4 primary tumor with any nodal status or any T stage with N2-N3 lymph node metastasis and no distant metastasis.
All participants receive up to 4 cycles of combination neoadjuvant therapy every 3 weeks. After treatment completion, a multidisciplinary team will assess if consolidative surgery can be performed. Patients who undergo surgery will continue single-agent pucotenlimab adjuvant treatment for 17 additional cycles (approximately 1 year).
The primary goal is to measure the pathological complete response (pCR) rate. Secondary goals include objective response rate (ORR), progression-free survival (PFS),overall survival (OS) and safty profiles. Blood and tumor tissue samples will be collected to explore biomarkers that may predict treatment response and drug resistance. A total of 29 male patients will be enrolled.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Aged 18-75 years, biologically male.
Histologically confirmed penile squamous cell carcinoma, stage T4 any N M0 or any T N2-N3 M0 without distant metastasis.
Treatment-naive; or relapsed patients with ≥12 months interval from last prior systemic therapy.
At least one measurable target lesion per RECIST 1.1.
Disqualifiers
Pre-existing grade ≥2 peripheral neuropathy interfering daily activities.
Prior neoadjuvant therapy for penile cancer; previous use of PD-1/PD-L1 inhibitors or EGFR ADCs including becotatug vedotin.
Known hypersensitivity to pucotenlimab, becotatug vedotin or excipients.
Active malignancy within 5 years (excluding cured basal cell skin carcinoma and low-risk prostate cancer).
Trial design
Design model
Single group
Treatments tested in this trial
Pucotenlimab plus Becotatug Vedotin
DrugNeoadjuvant PD-1 inhibitor pucotenlimab (HX008) combine with EGFR ADC becotatug vedotin (MRG003) for locally advanced penile squamous cell carcinoma. Up to 4 Q3W neoadjuvant cycles; surgical patients receive 17-cycle adjuvant pucotenlimab.
Treatment groups
29 Participants
are divided into 1 treatment groupGroup A: TreatmentExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Pathological Complete Remission (pCR) Rate
Percentage of patients achieving pathological complete remission, defined as no residual invasive tumor cells in primary penile lesion and resected regional lymph nodes after neoadjuvant therapy and consolidative surgery.
Time frame
Within 4 weeks after consolidative surgerySecondary outcomes
1
Objective Response Rate (ORR)
Percentage of patients with Complete Response (CR) or Partial Response (PR) per RECIST 1.1 after neoadjuvant therapy.
Time frame
Evaluation at the end of Cycle 2 or 4 (each cycle is 21 days) of neoadjuvant treatment2
Progression-Free Survival (PFS)
Time from study enrollment to first tumor progression or all-cause death.
Time frame
From the date of study enrollment until the date of first documented tumor progression or death from any cause (whichever occurs first), assessed up to 12 months3
Overall Survival (OS)
Time from study enrollment to death from any cause.
Time frame
From the date of study enrollment to death from any cause, assessed up to 12 months4
Incidence of Treatment-Related Adverse Events (TRAEs)
All-grade and Grade ≥3 TRAE incidence, type and severity graded by CTCAE v5.0.
Time frame
From enrollment to 28 days after last study treatmentSponsors and contacts
Click on the lead sponsor to view all of their trials.
Sun Yat-sen University
Lead sponsor
The First Affiliated Hospital of Nanchang University
Collaborator
Jiangsu Cancer Institute & Hospital
Collaborator
Tianjin Medical University Cancer Institute and Hospital
Collaborator
Hunan Cancer Hospital
Collaborator
The Affiliated Tumor Hospital of Xinjiang Medical University
Collaborator
West China Hospital
Collaborator
Qilu Hospital of Shandong University
Collaborator
Tongji Hospital
Collaborator
Source ClinicalTrials.gov
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