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
The participant (or legally acceptable representative if applicable) provides written informed consent for the trial.
Histologically confirmed diagnosis of squamous cell carcinoma of the penis.
cTxN2-3 or
cTxN1 in case of central nodal necrosis and/or an irregular nodal border, or node >3cm, or
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).
Has received prior systemic anti-cancer therapy including investigational agents, or an investigational device, within 4 weeks prior to registration.
Has received prior radiotherapy within 4 weeks of start of study intervention or radiation-related toxicities requiring corticosteroids.
Has received a live vaccine or live-attenuated vaccine within 30 days before the first dose of study intervention. Administration of killed vaccines is allowed.
The Netherlands Cancer Institute
Lead sponsor
Merck Sharp & Dohme LLC
Collaborator