OncoMatch/Clinical Trials/NCT06302569
Pembrolizumab Plus Enfortumab Vedotin in Collecting Duct and Renal Medullary Carcinoma
Is NCT06302569 recruiting? Yes, currently enrolling (May 2026). This Phase 2 trial studies Pembrolizumab + Enfortumab Vedotin for bellini carcinoma.
Treatment: Pembrolizumab + Enfortumab Vedotin — This is a single-arm, monocentric, phase II trial, enrolling patients with histological diagnosis of collecting duct carcinoma and renal medullary carcinoma with locally advanced or metastatic disease who will be treated with Pembrolizumab plus Enfortumab Vedotin. Approximately, 23 patients will be enrolled. At screening, pre-existing archival primary and metastatic FFPE tumor specimen will be collected and submitted for central pathology review and translational analysis. All participants will undergo baseline screening imaging for clinical staging. Patients will be treated with Pembrolizumab q21 plus Enfortumab Vedotin 1,8q21 for 3 cycles (3 infusion of Pembrolizumab and 6 infusion of Enfortumab Vedotin) then radiological imaging will be repeated and patients with SD, PR or CR will continue pembrolizumab until disease progression, unacceptable toxicities or completion of treatment (17 cycles). Patients with progressive disease after 3 cycles of study intervention will be treated as per clinical practice. Patients who will experience progressive disease during pembrolizumab monotherapy treatment could restart Enfortumab Vedotin. The study will also involve collection of a blood sample taken at the commencement of treatment, at the first cycle, after cycle 3 and at the end of treatment or progression of disease, to be used for research purposes.
Check if I qualifyExtracted eligibility criteria
Disease stage
Metastatic disease required
Performance status
ECOG 0–1(Restricted strenuous activity)
Prior therapy
Cannot have received: anti-PD-1 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, within 2 weeks prior to treatment allocation.
Cannot have received: radiotherapy
Exception: Two weeks or fewer of palliative radiotherapy for non-CNS diseases permitted. The last radiotherapy treatment must have been performed at least 7 days before the first dose of study intervention.
Has received prior radiotherapy within 2 weeks of start of study intervention or radiation-related toxicities requiring corticosteroids.
Cannot have received: investigational agent/device
Has received an investigational agent or has used an investigational device within 4 weeks prior to study intervention administration.
Lab requirements
Blood counts
adequate organ function as defined in Table 4 (not provided in text)
Kidney function
adequate organ function as defined in Table 4 (not provided in text)
Liver function
adequate organ function as defined in Table 4 (not provided in text)
Have adequate organ function as defined in the following table (Table 4). Specimens must be collected within 10 days prior to the start of study intervention.
Structured fields extracted by AI. May contain errors — verify against the official protocol.
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