OncoMatch/Clinical Trials/NCT06353906
Carboplatin/Paclitaxel + Pembrolizumab for Locoregionally Advanced Penile Cancer
Is NCT06353906 recruiting? Yes, currently enrolling (Jun 2026). This Phase 2 trial studies multiple treatments including Carboplatin/Paclitaxel and Pembrolizumab for urologic neoplasms.
Treatment: Carboplatin/Paclitaxel · Pembrolizumab — This is a single-armed, single-centre, non-blinded phase II trial to assess efficacy of induction chemo-immunotherapy for resectable node-positive squamous cell carcinoma of the penis
Check if I qualifyExtracted eligibility criteria
Treatments studied
Immunotherapy
Chemotherapy
Cancer type
Penile Carcinoma
Disease stage
Required: Stage CTXN2-3, CTXN1 IN CASE OF CENTRAL NODAL NECROSIS AND/OR AN IRREGULAR NODAL BORDER, OR NODE >3CM, INGUINAL OR PELVIC LYMPH NODE RECURRENCE THAT IS POTENTIALLY RESECTABLE (clinical (cTNM))
Patients have one of the following disease stages: * cTxN2-3 or * cTxN1 in case of central nodal necrosis and/or an irregular nodal border, or node >3cm, or * Inguinal or pelvic lymph node recurrence that is potentially resectable. Any of the disease stages above, in combination with oligometastatic disease with a maximum of 2 distant metastases is allowed, as long as these metastases can be treated by resection or radiotherapy.
Performance status
ECOG 0–1(Restricted strenuous activity)
Demographics
Prior therapy
Cannot have received: anti-PD-1/PD-L1/PD-L2 or co-inhibitory T-cell receptor therapy
Has received prior therapy with an anti-PD-1, anti-PD-L1, or anti-PD-L2 agent or with an agent directed to another stimulatory or co-inhibitory T-cell receptor (eg, CTLA-4, OX-40, CD137).
Cannot have received: systemic anti-cancer therapy
Has received prior systemic anti-cancer therapy including investigational agents, or an investigational device, within 4 weeks prior to registration.
Cannot have received: radiotherapy
Has received prior radiotherapy within 4 weeks of start of study intervention or radiation-related toxicities requiring corticosteroids.
Lab requirements
Blood counts
absolute neutrophil count (ANC) ≥1.5 10e9 /L, platelets ≥100 10e9/L; hemoglobin ≥9.0 g/dL or ≥5.6 mmol/L
Kidney function
creatinine ≤1.5 × ULN OR GFR>30 ml/min as per Cockcroft-Gault formula in patients with creatinine levels > 1.5x institutional ULN
Liver function
total bilirubin 1.5 ×ULN OR direct bilirubin ≤ULN for participants with total bilirubin levels >1.5 × ULN; AST (SGOT) and ALT (SGPT) ≤2.5 × ULN
Have adequate organ function defined as: absolute neutrophil count (ANC) ≥1.5 10e9 /L, platelets ≥100 10e9/L; hemoglobin ≥9.0 g/dL or ≥5.6 mmol/L; creatinine ≤1.5 × ULN OR GFR>30 ml/min as per Cockcroft-Gault formula in patients with creatinine levels > 1.5x institutional ULN; total bilirubin 1.5 ×ULN OR direct bilirubin ≤ULN for participants with total bilirubin levels >1.5 × ULN; AST (SGOT) and ALT (SGPT) ≤2.5 × ULN; International normalized ratio (INR), prothrombin time (PT) OR activated partial thromboplastin time (aPTT) ≤1.5 × ULN unless participant is receiving anticoagulant therapy as long as PT or aPTT is within therapeutic range of intended use of anticoagulants.
Structured fields extracted by AI. May contain errors — verify against the official protocol.
Frequently asked questions
Is NCT06353906 currently recruiting?
Yes, this trial is currently recruiting patients.
Are there prior therapy exclusions?
Yes. Prior anti-PD-1/PD-L1/PD-L2 or co-inhibitory T-cell receptor therapy, systemic anti-cancer therapy, radiotherapy disqualifies patients from enrollment.
What disease stage is eligible?
Stage CTXN2-3 or CTXN1 IN CASE OF CENTRAL NODAL NECROSIS AND/OR AN IRREGULAR NODAL BORDER, OR NODE >3CM or INGUINAL OR PELVIC LYMPH NODE RECURRENCE THAT IS POTENTIALLY RESECTABLE is required.
Is this trial open to female patients?
No. This trial enrolls male patients only.
Could you qualify for this trial?
Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.
Check if I qualifyRelated pages