Study on the Safety and Effectiveness of MK-2870, Enfortumab Vedotin, and Pembrolizumab for Patients with Advanced Bladder Cancer

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What is this study about?

This clinical trial is focused on studying treatments for Advanced Urothelial Carcinoma, a type of cancer that affects the bladder and other parts of the urinary system. The study will explore the effectiveness and safety of a combination of medications, including MK-2870, Enfortumab Vedotin, and Pembrolizumab. MK-2870 is a new investigational drug, while Enfortumab Vedotin and Pembrolizumab are existing treatments used in cancer therapy. The purpose of the study is to evaluate how well these medications work together in treating this type of cancer.

Participants in the study will receive these medications in different combinations. The study will be conducted in two parts. In the first part, the focus will be on understanding the safety and tolerability of MK-2870 when used with Enfortumab Vedotin. In the second part, the study will assess the combination of MK-2870, Enfortumab Vedotin, and Pembrolizumab. The medications will be administered through intravenous infusion, which means they will be given directly into a vein. Some participants may receive a placebo, which is a substance with no active medication, to compare the effects of the actual drugs.

The study aims to gather information on how these treatments affect the cancer, including any side effects that may occur. Participants will be monitored closely by healthcare professionals throughout the study to ensure their safety and to collect data on the effectiveness of the treatment. This research is important for developing new and improved therapies for people with advanced urothelial carcinoma.

1 joining the study

Upon joining the study, eligibility is confirmed based on specific criteria related to advanced urothelial carcinoma. This includes a documented diagnosis and other health conditions that may affect participation.

2 initial assessment

An initial assessment is conducted to evaluate the current health status. This includes a review of medical history, current medications, and any previous treatments for urothelial carcinoma.

3 part 1 treatment

In Part 1, the treatment involves the administration of MK-2870 in combination with enfortumab vedotin. Both medications are given through an intravenous infusion. The focus is on evaluating safety and tolerability.

4 part 2 treatment

In Part 2, the treatment includes MK-2870, enfortumab vedotin, and pembrolizumab. These are administered through intravenous infusion. The aim is to assess safety, tolerability, and the overall response rate.

5 monitoring and follow-up

Throughout the study, regular monitoring is conducted to track health status and any side effects. This includes routine check-ups and assessments to ensure the safety and effectiveness of the treatment.

6 completion of study

Upon completion of the study, a final assessment is conducted. This includes a comprehensive review of the treatment’s impact on health and any long-term effects.

Who Can Join the Study?

The participant must have a type of cancer called urothelial carcinoma, which affects areas like the bladder, renal pelvis, ureter, or urethra. The cancer must be confirmed by a test called histology. If the cancer has mixed types, it must have a urothelial part and less than 10% of a type called sarcomatoid. If the cancer has any neuroendocrine part, the participant cannot join.
For Part 2 of the study, participants who have had platinum-based chemotherapy before are eligible.
For Part 2, participants who had treatments called anti-PD-1 or anti-PD-L1 for earlier stages of the disease and had a return of cancer more than 12 months after finishing treatment can join.
The participant can be of any sex or gender and must be at least 18 years old when they agree to join the study.
The participant must have a good level of daily functioning, known as an ECOG performance status of 0 to 1, checked within 7 days before starting the study.
Participants who have Hepatitis B can join if they have been on antiviral treatment for at least 4 weeks and have no detectable virus before starting the study. They must continue treatment during the study.
Participants with a history of Hepatitis C can join if they have no detectable virus at the start of the study.
Participants with HIV can join if their condition is well controlled with treatment.
Participants must have cancer that can be measured by the study team using specific guidelines called RECIST 1.1. If they had radiation therapy before, the cancer must be measurable outside the treated area or must have clearly grown since the radiation.
Participants must provide a sample of their tumor tissue, either from a previous test or a new biopsy, to check for specific markers. The sample should not be from an area that received radiation.
Participants who had side effects from previous cancer treatments must have recovered to a mild level or back to their normal state. If they have hormone-related side effects that are well managed with hormone replacement, they can join.
For Part 1, participants must have had platinum-based chemotherapy for their cancer. If they had this treatment for a type called MIUC within 12 months before joining, they are eligible and do not need to have had it for la/mUC.
For Part 1, participants who had anti-PD-L1 or anti-PD-1 therapy for MIUC or la/mUC can join. This includes therapy for a type called NMIBC, maintenance therapy after chemotherapy, or as a second-line treatment.
For Part 1, participants must not have had more than 2 lines of treatment for la/mUC. Having chemotherapy followed by a treatment called avelumab counts as 2 lines.
For Part 1, participants may have had a type of treatment called FGFR inhibitor, like erdafitinib.
For Part 2, participants must not have had any previous systemic therapy for la/mUC.

Who Cannot Join the Study?

Patients who have a different type of cancer other than Advanced Urothelial Carcinoma cannot participate. Urothelial carcinoma is a type of cancer that affects the bladder and other parts of the urinary system.
Patients who are not within the specified age range for the study cannot participate. The study is open to certain age groups only.
Patients who are part of a vulnerable population, such as those who cannot give consent or have certain disabilities, are not eligible.
Patients who are not able to safely take the study medications due to other health conditions or medications they are currently taking cannot participate.
Patients who have had a recent major surgery or are recovering from a major illness may not be eligible.
Patients who are pregnant or breastfeeding are not allowed to participate in the study.
Patients who have participated in another clinical trial recently may not be eligible.
Patients who have a history of severe allergic reactions to any of the study medications cannot participate.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name	City	Country	Status
Hospital Clinico San Carlos	Madrid	Spain

Other Sites

Site Name	City	Country
IRCCS Istituto Nazionale Tumori Fondazione Pascale	Naples	Italy
Ospedale San Raffaele S.r.l.	Milan	Italy
Rigshospitalet	Copenhagen	Denmark
Netherlands Cancer Institute	Amsterdam	The Netherlands
Centre Hospitalier Lyon Sud	Pierre Benite	France
Fondazione I.R.C.C.S. Istituto Neurologico Besta	Milan	Italy
Hxxiiiwg Vdpz dlnfjbvi	Barcelona	Spain

Trial status

Country	Status	Recruitment Start
Denmark	Not recruiting	01.08.2024
France	Not recruiting	01.08.2024
Italy	Not recruiting	01.08.2024
Spain	Not recruiting	01.08.2024
The Netherlands	Not recruiting	01.08.2024

Trial locations

Investigated drugs:

MK-2870 is an investigational medication being studied for its potential to treat advanced urothelial carcinoma. It is being tested in combination with other treatments to evaluate its safety and effectiveness.

Enfortumab Vedotin (EV) is a medication used in cancer treatment. It works by targeting and delivering a toxic substance directly to cancer cells, which may help to kill them. In this trial, it is combined with other therapies to assess its role in treating advanced urothelial carcinoma.

Pembrolizumab is an immunotherapy drug that helps the immune system recognize and attack cancer cells. It is used in this study to determine its effectiveness when combined with other treatments for advanced urothelial carcinoma.

Advanced Urothelial Carcinoma – This is a type of cancer that occurs in the urothelial cells lining the bladder and other parts of the urinary tract. It is considered advanced when it has spread beyond the bladder to nearby tissues or distant organs. The disease often begins with symptoms such as blood in the urine, frequent urination, or pain during urination. As it progresses, it may cause more severe symptoms like pelvic pain or swelling in the legs. The progression of the disease can vary, with some cases advancing more rapidly than others. Understanding the specific behavior of the cancer is crucial for managing its impact on the body.

Trial ID:

2023-506387-14-00

Protocol code:

MK-3475-04C

NCT ID:

NCT06483334

Trial Phase:

Phase I and Phase II (Integrated) – First administration to humans

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Study on the Safety and Effectiveness of MK-2870, Enfortumab Vedotin, and Pembrolizumab for Patients with Advanced Bladder Cancer

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?