Study of MK-1088 and Pembrolizumab for Patients with Advanced Solid Tumors

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What is this study about?

This clinical trial is focused on studying the treatment of advanced solid tumors, which are cancers that have spread beyond their original location and are difficult to treat. The study involves two treatments: MK-1088, a medication taken as a tablet, and pembrolizumab, also known by its brand name KEYTRUDA, which is given as an infusion through a vein. Pembrolizumab is a type of protein-based medication that helps the immune system fight cancer cells.

The purpose of the study is to evaluate the safety and tolerability of MK-1088 both on its own and in combination with pembrolizumab. Participants will receive either MK-1088 alone or together with pembrolizumab to determine the best dose that can be safely given. The study will monitor participants for any side effects and how well they tolerate the treatments. The trial will also look at how the body processes MK-1088 by measuring its levels in the blood over time.

Participants in the study will have a confirmed diagnosis of advanced solid tumors and may have already tried other treatments. The study will last for a period of time during which participants will receive the treatments and be closely monitored by the research team. The goal is to find a safe and effective dose of MK-1088, both alone and in combination with pembrolizumab, to help treat advanced solid tumors.

1 initial assessment

Upon joining the study, an initial assessment will be conducted to confirm eligibility. This includes reviewing your medical history and any previous treatments for advanced or metastatic solid tumors.

If applicable, additional criteria for specific conditions, such as metastatic castrate-resistant prostate cancer, will be evaluated.

2 treatment phase 1

In the first phase of treatment, you will receive MK-1088 as a monotherapy. This involves taking the medication orally in tablet form.

The dosage and frequency will be determined by the study team based on safety and tolerability assessments.

3 combination treatment

If you continue to the next stage, MK-1088 will be administered in combination with pembrolizumab.

Pembrolizumab is given as an intravenous infusion, which means it is delivered directly into your bloodstream through a vein.

The combination aims to evaluate the safety and determine the appropriate dosage for further study phases.

4 monitoring and follow-up

Throughout the trial, regular monitoring will occur to assess your response to the treatment and any side effects.

This includes blood tests, imaging studies, and other necessary evaluations to ensure your safety and the effectiveness of the treatment.

5 end of treatment

At the end of the treatment period, a final assessment will be conducted to evaluate the overall impact of the study medications on your condition.

You will be informed about the results and any potential next steps or recommendations for your ongoing care.

Who Can Join the Study?

The patient must have a diagnosis of advanced or metastatic solid tumors. This means the cancer has spread to other parts of the body.
The patient must have already received treatment that is known to help, or they must have been unable to tolerate or be ineligible for such treatment.
For patients with metastatic castrate-resistant prostate cancer (mCRPC):
- The patient must have previously received a chemotherapy drug called docetaxel.
- The patient may have had one other chemotherapy treatment and up to two treatments with newer hormone therapies.
- The patient’s prostate cancer must have worsened within 6 months before the start of the study, as determined by the study doctor.
If the patient is HIV positive, their HIV must be well-controlled with anti-retroviral therapy (ART), which is medication used to manage HIV.
The study is open to both male and female patients.
The study includes patients who may be considered part of a vulnerable population, meaning they might need extra protection or care.

Who Cannot Join the Study?

Patients who have not fully recovered from previous treatments or surgeries.
Patients with other active cancers that are not the focus of this study.
Patients with severe heart problems.
Patients with uncontrolled high blood pressure.
Patients with active infections that require treatment.
Patients who are pregnant or breastfeeding.
Patients with known allergies to the study drugs.
Patients who have received another investigational drug within a certain time frame before the study.
Patients with a history of certain autoimmune diseases, which are conditions where the immune system attacks the body.
Patients with a history of organ transplant.
Patients with certain mental health conditions that might interfere with the study.
Patients who are unable to follow the study procedures.

Where you can join this trial?

Verified and Recommended Sites

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Verified Sites

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Other Sites

Site Name	City	Country
Rigshospitalet	Copenhagen	Denmark
Odense University Hospital	Odense	Denmark
Hacnjf Homdhael	Herlev	Denmark

Trial status

Country	Status	Recruitment Start
Denmark	Not recruiting	29.06.2022

Trial locations

Investigated drugs:

MK-1088 is an experimental medication being tested to see if it is safe and well-tolerated when used alone or with another drug. It is being studied in people with advanced solid tumors, which are types of cancer that form in solid organs or tissues. The goal is to find out how much of this medication can be given safely and to see if it might help treat these types of cancers.

Pembrolizumab is a medication that helps the immune system fight cancer. It works by blocking a specific protein that prevents the immune system from attacking cancer cells. This medication is already used to treat several types of cancer, and in this study, it is being combined with MK-1088 to see if the combination is safe and if it might work better than using either medication alone. The study aims to understand how these two medications can work together to help treat advanced solid tumors.

Investigated diseases:

Neoplasm

Advanced/Metastatic Solid Tumors – Advanced or metastatic solid tumors refer to cancerous growths that have spread beyond their original site to other parts of the body. These tumors can originate in various organs, such as the lungs, breast, prostate, or colon, and are characterized by the uncontrolled growth of abnormal cells. As the disease progresses, these tumors invade surrounding tissues and can metastasize through the bloodstream or lymphatic system to distant organs. The progression of the disease often leads to the formation of new tumors in other parts of the body, complicating treatment and management. Symptoms vary depending on the location and size of the tumors, and they may include pain, fatigue, and organ dysfunction. The disease’s progression is influenced by factors such as the type of cancer, genetic mutations, and the body’s response to the tumor.

Trial ID:

2022-502288-40-00

Protocol code:

MK-1088-002

NCT ID:

NCT05394350

Trial Phase:

Therapeutic exploratory (Phase II)

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Study of MK-1088 and Pembrolizumab for Patients with Advanced Solid Tumors

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?