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Not yet recruitingRare disease

Study of Pembrolizumab and Enfortumab Vedotin for Patients with Collecting Duct and Renal Medullary Carcinoma

Verified siteRegistered drugNo placebo
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What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial is focused on studying two types of kidney cancer: Collecting Duct Carcinoma and Medullary Renal Cell Carcinoma. The study will use a combination of two treatments: Pembrolizumab, also known by its code name MK-3475, and Enfortumab Vedotin. Pembrolizumab is a type of medication called a humanized antibody, which helps the immune system fight cancer cells. Enfortumab Vedotin is an antibody-drug conjugate, which means it combines an antibody with a drug to target and kill cancer cells more effectively.

The purpose of this study is to evaluate how well the combination of Pembrolizumab and Enfortumab Vedotin works in treating these specific types of kidney cancer. Participants in the study will receive these medications through an infusion, which is a way of delivering the treatment directly into the bloodstream. The study will last for a period of up to 36 months, during which the effectiveness of the treatment will be monitored. Some participants may receive a placebo, which is a substance with no active medication, to compare the results.

The main goal of the study is to determine the Objective Response Rate (ORR), which measures how well the cancer responds to the treatment. Secondary goals include assessing progression-free survival (PFS), which is the length of time during and after treatment that the cancer does not get worse, and overall survival (OS), which is the length of time participants live after starting the treatment. The study will also look at how well participants tolerate the treatment. The trial is expected to continue until December 2029.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Initial assessment

    Upon joining the study, an initial assessment is conducted to confirm eligibility. This includes verifying a diagnosis of either collecting duct carcinoma or medullary renal cell carcinoma.

    A review of medical history and current health status is performed. This includes checking for any previous treatments and ensuring adequate organ function.

  2. Step 2

    Treatment initiation

    The treatment phase begins with the administration of two medications: pembrolizumab and enfortumab vedotin. Both are given as an infusion, which means they are delivered directly into the bloodstream through a vein.

    The specific dosage and frequency of these medications are determined by the study protocol and are administered under medical supervision.

  3. Step 3

    Ongoing monitoring

    Regular monitoring is conducted to assess the response to treatment. This includes imaging tests to measure the size of tumors and blood tests to evaluate overall health.

    Participants are observed for any side effects or adverse reactions to the medications. Adjustments to the treatment plan may be made based on these observations.

  4. Step 4

    Evaluation of response

    The primary goal is to evaluate the objective response rate (ORR), which measures the percentage of participants whose cancer shrinks or disappears after treatment.

    Secondary goals include assessing progression-free survival, overall survival, and the tolerability of the treatment.

  5. Step 5

    Completion of study

    The study is estimated to conclude by December 23, 2029. Participants will continue to be monitored until the end of the study period.

    Upon completion, a final assessment is conducted to determine the overall effectiveness and safety of the treatment.

Who can join the trial?

10 criteria

  • Participants must be **male or female** and at least **18 years old** on the day they sign the consent form.
  • Participants must have a confirmed diagnosis of **metastatic or advanced Collecting Duct Carcinoma** or **Medullary Renal Cell Carcinoma**. This means the cancer has spread or is in an advanced stage.
  • Participants who test positive for **Hepatitis B** (**HBsAg positive**) can join if they have been on anti-viral therapy for at least 4 weeks and have no detectable virus in their blood before starting the study treatment. They should continue the therapy during the study and follow local guidelines after the study.
  • Participants with a history of **Hepatitis C** can join if the virus is not detectable in their blood at the start of the study. They must have completed anti-viral therapy at least 4 weeks before starting the study treatment.
  • Participants with **HIV** must have their condition well-controlled with **antiretroviral therapy** (ART).
  • Participants must provide **written informed consent** to join the trial, which means they agree to participate after understanding the study details.
  • Participants must have **measurable disease** based on a specific guideline called **RECIST 1.1**. This means the cancer can be measured using medical imaging.
  • Participants must provide a **tumor tissue sample** from a biopsy. This sample should be from a tumor that has not been treated with radiation before.
  • Participants must have an **ECOG performance status** of 0 to 1. This is a scale that measures how well they can perform daily activities, with 0 being fully active and 1 being restricted in physically strenuous activity but able to carry out light work.
  • Participants must have **adequate organ function** as defined by specific medical tests. These tests should be done within 10 days before starting the study treatment.

Who cannot join the trial?

8 criteria

  • Patients with other types of cancer that are not Collecting Duct Carcinoma or Medullary Renal Cell Carcinoma cannot participate.
  • Patients who are not within the specified age range for the study cannot participate. The age range is typically defined by the study, but it is not specified here.
  • Patients who are not able to provide informed consent, which means they cannot understand the study and agree to participate, cannot be included.
  • Patients who are pregnant or breastfeeding cannot participate in the study.
  • Patients with certain medical conditions that might interfere with the study treatment or outcomes cannot participate. These conditions are not specified here.
  • Patients who have participated in another clinical trial recently may not be eligible to join this study.
  • Patients who have allergies or adverse reactions to the study drugs, Enfortumab Vedotin or Pembrolizumab, cannot participate.
  • Patients with severe or uncontrolled medical conditions that could affect their safety or the study results cannot participate.
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Investigated drugs

  • Pembrolizumab

    is a type of immunotherapy that helps your immune system fight cancer. It works by blocking a specific protein on cancer cells, which allows your immune system to better recognize and attack these cells.

  • Enfortumab Vedotin

    is a targeted therapy that combines an antibody with a chemotherapy drug. The antibody part helps the medication find and attach to cancer cells, while the chemotherapy part helps kill the cancer cells. This combination aims to reduce the growth and spread of cancer.

What is already known about the treatment

  • Pembrolizumab

    Pembrolizumab is administered intravenously, typically as an infusion. It is currently well-established in medical literature as an immunotherapy used to treat various types of cancer. The main therapeutic indications include its use in treating certain types of kidney cancer, such as Collecting Duct Carcinoma and Medullary Renal Cell Carcinoma. At the molecular level, Pembrolizumab works by blocking the PD-1 pathway, which helps the immune system recognize and attack cancer cells. It is classified as a monoclonal antibody.

  • Enfortumab Vedotin

    Enfortumab Vedotin is also administered intravenously. It is an emerging treatment in the field of oncology, particularly for certain types of kidney cancer. The main therapeutic indications include its use in combination with Pembrolizumab for Collecting Duct Carcinoma and Medullary Renal Cell Carcinoma. Its mechanism of action involves delivering a cytotoxic agent directly to cancer cells by targeting a protein called Nectin-4, which is often overexpressed in these cells. Enfortumab Vedotin is classified as an antibody-drug conjugate.

Investigated diseases

  • Collecting Duct Carcinoma

    This is a rare type of kidney cancer that originates in the ducts of the kidney where urine is collected. It is known for its aggressive nature and tends to spread quickly to other parts of the body. The disease often presents with symptoms such as blood in the urine, pain in the side or back, and a palpable mass in the abdomen. As it progresses, patients may experience weight loss, fatigue, and swelling in the legs. It is typically diagnosed at an advanced stage due to its rapid progression and lack of early symptoms.

  • Medullary Renal Cell Carcinoma

    This is a rare and aggressive form of kidney cancer that primarily affects young adults, often those with sickle cell trait. It originates in the renal medulla, the innermost part of the kidney. The disease is characterized by rapid growth and early spread to other organs. Common symptoms include blood in the urine, flank pain, and a palpable abdominal mass. As the disease advances, individuals may experience systemic symptoms such as fever, weight loss, and fatigue. It is often diagnosed at a late stage due to its aggressive nature and non-specific early symptoms.

Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IITrial ID2024-511587-93-00Protocol codeREPRINTEstimated enrolment23 patientsSponsorFondazione IRCCS Istituto Nazionale Dei Tumori

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