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Pembrolizumab Plus Enfortumab Vedotin in Collecting Duct and Renal Medullary Carcinoma

NCT06302569 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 23

Last updated 2025-09-09

No results posted yet for this study

Summary

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.

Conditions

  • Bellini Carcinoma
  • Collecting Duct Carcinoma
  • Renal Medullary Carcinoma

Interventions

DRUG

Pembrolizumab + Enfortumab Vedotin

* Pembrolizumab will be given for a maximum of 2 years i.e. a total of 35 cycles of pembrolizumab with the q3 week dosing. Participants who complete study intervention after 2 years of pembrolizumab are eligible for up to 1 year of additional pembrolizumab (second course) upon experiencing disease progression. * Enfortumab Vedotin will be given for a maximum of 3 cycles on day 1 and day 3 each 3 weeks. EV treatment could be re-started in case of Progressive Disease RECIST v1.1 during pembrolizumab monotherapy treatment.

Sponsors & Collaborators

  • Giuseppe Procopio

    lead OTHER

Principal Investigators

  • Giuseppe Procopio, MD · Fondazione IRCCS Istituto Nazionale dei Tumori di Milano, Milan, Italy

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-05-30
Primary Completion
2027-10-31
Completion
2029-05-31

Countries

  • Italy

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06302569 on ClinicalTrials.gov