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

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What is this study about?

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.

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 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 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 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 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 Study?

  • 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 Study?

  • 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.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

No sites found in this category

Other Sites

Site Name City Country Status
Fondazione I.R.C.C.S. Istituto Neurologico Besta Milan Italy

Want to learn more about this study or check if you can participate? Contact us.

Trial status

Country Status Recruitment Start
Italy Italy
Not yet recruiting
23.12.2024

Trial locations

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.

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 ID:
2024-511587-93-00
Protocol code:
REPRINT
Trial Phase:
Therapeutic exploratory (Phase II)

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