Actively Recruiting
Pembrolizumab Plus Enfortumab Vedotin in Collecting Duct and Renal Medullary Carcinoma
Led by Giuseppe Procopio · Updated on 2025-09-09
23
Participants Needed
1
Research Sites
204 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official Title
Pembrolizumab Plus Enfortumab Vedotin in Collecting Duct and Renal Medullary Carcinoma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male or female participants aged 18 years or older with histologically confirmed metastatic or advanced Collecting Duct Carcinoma or Medullary Renal Cell Carcinoma
- Written informed consent provided by participant or legally acceptable representative
- Measurable disease according to RECIST 1.1, including lesions previously irradiated if progression is shown
- Confirmed diagnosis by central pathology review
- Availability of archival tumor tissue or new biopsy from a non-irradiated tumor lesion, preferably formalin-fixed paraffin embedded tissue blocks
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1, evaluated within 7 days before first treatment dose
- Adequate organ function based on specified laboratory tests collected within 10 days before treatment start
- Hepatitis B positive participants eligible if on antiviral therapy for at least 4 weeks with undetectable viral load and continuing therapy during study
- Participants with history of hepatitis C eligible if viral load is undetectable at screening
- HIV-infected participants must have well-controlled infection on antiretroviral therapy with specific criteria including stable regimen and no recent opportunistic infections
You will not qualify if you...
- Prior therapy with anti-PD-1, anti-PD-L1, anti-PD-L2, or other immune checkpoint agents
- Anti-cancer systemic therapy or investigational agents within 2 weeks before treatment allocation
- Radiotherapy within 2 weeks before treatment or radiation-related toxicities requiring corticosteroids, except limited palliative radiotherapy
- Live vaccine within 30 days before first treatment dose; killed vaccines allowed
- Use of investigational agents or devices within 4 weeks before study intervention
- Immunodeficiency or chronic systemic steroid use exceeding 10 mg prednisone equivalent daily within 7 days before treatment
- Active or progressing additional malignancy needing treatment within past 2 years, excluding certain low-risk skin or prostate cancers
- Active central nervous system metastases or carcinomatous meningitis, unless stable and off steroids
- Severe hypersensitivity to pembrolizumab or its components
- Active autoimmune disease requiring systemic treatment in past 2 years, except replacement therapy
- History or current pneumonitis or interstitial lung disease requiring steroids
- Active infection needing systemic therapy
- Incomplete recovery from major surgery or ongoing surgical complications
- Conditions or circumstances that may interfere with study participation or confound results
- Known psychiatric or substance abuse disorders interfering with cooperation
- Pregnancy, breastfeeding, or intending to conceive or father children during the study and 120 days after last dose
- History of allogenic tissue or solid organ transplant
AI-Screening
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Trial Site Locations
Total: 1 location
1
Fondazione Irccs Istituto Dei Tumori Di Milano
Milan, Italy, 20133
Actively Recruiting
Research Team
G
Giuseppe Procopio, MD
CONTACT
M
Marco Stellato, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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