Study of Boserolimab, MK-0482, and Pembrolizumab for Patients with Advanced Non-Small Cell Lung Cancer Resistant to PD-(L)1 Therapy

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What is this study about?

This clinical trial is focused on studying treatments for Non-small Cell Lung Cancer (NSCLC), a type of lung cancer that is common and can be challenging to treat. The study is testing several investigational medications, including boserolimab (also known as MK-5890), rolistobart (MK-0482), MK-4830, and pembrolizumab (also known as Keytruda). These medications are given as a solution for infusion, which means they are administered directly into the bloodstream through a vein.

The purpose of the study is to explore how well these investigational agents work when used in combination with pembrolizumab in patients who have advanced NSCLC and have previously been treated with anti-PD-(L)1 therapy, a type of treatment that helps the immune system fight cancer. The study is designed to be flexible, allowing new treatments to be added as they become available. Participants will receive the study medications over a period of time, and their response to the treatment will be monitored by healthcare professionals.

Throughout the study, participants will be closely observed to assess the effectiveness of the treatment and to monitor for any side effects. The study aims to provide valuable information on the potential benefits of these investigational treatments for patients with advanced NSCLC, helping to improve future treatment options for this condition.

1 initial visit

Upon joining the study, you will attend an initial visit. During this visit, medical staff will review your medical history and confirm your diagnosis of non-small cell lung cancer (NSCLC). You will be asked to provide a tumor tissue sample if not already available.

You will undergo various screening procedures to ensure eligibility for the trial. These procedures must be completed within a 35-day window.

2 treatment plan discussion

Once eligibility is confirmed, the treatment plan will be discussed with you. The study involves investigational agents combined with pembrolizumab, administered through intravenous infusion.

The specific investigational agents you will receive may vary, and the medical team will provide detailed information about the medications, their dosages, and the frequency of administration.

3 treatment administration

You will begin receiving the study medications as per the treatment plan. The medications, including pembrolizumab, will be given through an intravenous infusion, which means they will be delivered directly into your bloodstream through a vein.

The frequency and duration of the treatment will be explained to you by the medical team, and you will be monitored closely for any side effects or adverse reactions.

4 regular follow-up visits

Throughout the trial, you will have regular follow-up visits. These visits are essential for monitoring your health and the effectiveness of the treatment.

During these visits, you may undergo various tests and assessments to evaluate your response to the treatment and to check for any side effects.

5 end of treatment evaluation

At the end of the treatment period, a comprehensive evaluation will be conducted. This evaluation will assess the overall response to the treatment and any changes in your condition.

The medical team will discuss the results with you and provide guidance on the next steps, which may include further treatment options or follow-up care.

Who Can Join the Study?

The patient must have a confirmed diagnosis of Stage IV Non-Small Cell Lung Cancer (NSCLC), which is a type of lung cancer.
If the patient has non-squamous NSCLC, they must not be eligible for an approved targeted therapy, which is a treatment that targets specific genes or proteins in cancer cells.
The patient must be able to provide a sample of their tumor tissue. This sample can be from a previous collection within the last 5 years, or a new sample taken within 90 days before starting the study, from a tumor that has not been treated with radiation.
The patient must have experienced disease progression after treatment with an anti-PD-(L)1 monoclonal antibody, which is a type of immune therapy, either alone or with other treatments.
The patient must have experienced disease progression during or after receiving platinum doublet chemotherapy, which is a common type of chemotherapy for lung cancer.
The patient must be able to complete all required screening procedures within a 35-day period before starting the study.
Male participants must agree to use contraception and not donate sperm during the study and for at least 120 days after the last dose of the study treatment.
Female participants must not be pregnant or breastfeeding. They must either not be of childbearing potential or agree to use contraception during the study and for at least 120 days after the last dose of the study treatment.
The patient must have adequate organ function, which will be checked within 10 days before starting the study treatment.

Who Cannot Join the Study?

Patients with a different type of cancer than Non-small Cell Lung Cancer cannot participate.
Patients who are not within the specified age range cannot participate.
Patients who are part of a vulnerable population cannot participate.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name	City	Country
Azienda Ospedaliero Universitaria Careggi	Florence	Italy
Fondazione Policlinico Universitario Agostino Gemelli IRCCS	Rome	Italy
Szpital Wojewodzki Im. Mikolaja Kopernika W Koszalinie	Koszalin	Poland
Koranyi National Institute For Pulmonology	Budapest	Hungary

Other Sites

Site Name	City	Country
Jasz-Nagykun-Szolnok Varmegyei Hetenyi Geza Korhaz-Rendelointezet	Szolnok	Hungary
Ospedale San Raffaele S.r.l.	Milan	Italy
Hospital Universitario Quironsalud Madrid	Pozuelo De Alarcon	Spain
Wielkopolskie Centrum Pulmonologii I Torakochirurgii Im. Eugenii I Janusza Zeylandow	Poznan	Poland
Iwhvlzxp Cmxrvz Dzurydrcfibqsxodc	L'hospitalet De Llobregat	Spain
Gygmpopgbwbasvwnn Vcrjvlbsh Poba Agncdh Ehlvcdbv Ofwobi Kdzhor	Gyor	Hungary
Ucnnvgrterjvlx Crtrzec Kghcztmva	Gdansk	Poland
Nkfhgipa Izpdmdio Oazlrylty Iyw Mfsfq Scgmzrxxwhsxzzqjsnuhcbzfpipk Ilucwfcv Bnadnfqn	Cracow	Poland

Trial status

Country	Status	Recruitment Start
Hungary	Not recruiting	03.11.2020
Italy	Not recruiting	03.11.2020
Poland	Not recruiting	03.11.2020
Spain	Not recruiting	03.11.2020

Trial locations

Investigated drugs:

Pembrolizumab is a type of cancer treatment known as immunotherapy. It works by helping your immune system recognize and attack cancer cells. Pembrolizumab is used in this trial to treat patients with advanced non-small cell lung cancer, either on its own or in combination with chemotherapy. It is designed to target and block a specific protein on the surface of cancer cells, which can help slow down or stop the growth of the cancer.

Non-small Cell Lung Cancer – Non-small Cell Lung Cancer (NSCLC) is a group of lung cancers that behave similarly and are the most common type of lung cancer. It typically begins in the epithelial cells lining the lungs and can spread to other parts of the body. The disease progresses through stages, starting with localized tumors and potentially advancing to involve nearby lymph nodes and distant organs. As it advances, symptoms may include persistent cough, chest pain, and difficulty breathing. The progression of NSCLC can vary significantly among individuals, with some experiencing slow growth and others more rapid advancement. Understanding the specific subtype and stage of NSCLC is crucial for determining its progression.

Trial ID:

2023-506934-56-00

Protocol code:

MK-3475-01C

Trial Phase:

Therapeutic exploratory (Phase II)

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Study of Boserolimab, MK-0482, and Pembrolizumab for Patients with Advanced Non-Small Cell Lung Cancer Resistant to PD-(L)1 Therapy

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?