Study of E7386 and Pembrolizumab for Patients with Previously Treated Colorectal Cancer, Melanoma, or Hepatocellular Carcinoma

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What is this study about?

This clinical trial is focused on studying the effects of a new treatment combination for certain types of cancer. The diseases being studied include colorectal cancer, melanoma, and hepatocellular carcinoma, which is a type of liver cancer. The treatment involves a combination of medications: E7386, pembrolizumab (also known as Keytruda), and in some cases, lenvatinib (known as Lenvima). E7386 is a tablet taken by mouth, pembrolizumab is given as an infusion into a vein, and lenvatinib is available in capsule form.

The purpose of the study is to evaluate the safety and effectiveness of these medications when used together in patients who have already received other treatments for their cancer. The study is divided into two parts. In the first part, the focus is on understanding how safe and tolerable the combination of E7386 and pembrolizumab is for patients. In the second part, the study looks at how well the treatment works in shrinking tumors or stopping them from growing in patients with melanoma, colorectal cancer, and hepatocellular carcinoma. For some patients with hepatocellular carcinoma, the study also examines the effects of adding lenvatinib to the treatment.

Participants in the study will receive the medications and be monitored over time to see how their cancer responds to the treatment. The study aims to find the best dose of E7386 when used with pembrolizumab and to observe any side effects that may occur. The study will also measure how long the treatment can keep the cancer from getting worse. This research is important for developing new treatment options for patients with these types of cancer who have not had success with other therapies.

1 initial assessment

Upon joining the study, an initial assessment is conducted to confirm eligibility. This includes a review of medical history and current health status.

A biopsy may be required to obtain tissue samples for analysis. This is necessary to understand the specific characteristics of the tumor.

2 treatment phase 1b

The first phase of treatment involves the administration of E7386 in combination with pembrolizumab. The goal is to assess safety and determine the appropriate dosage.

E7386 is taken orally in tablet form, while pembrolizumab is administered through an intravenous infusion.

3 treatment phase 2

In the second phase, the treatment may include lenvatinib in addition to E7386 and pembrolizumab, especially for those with hepatocellular carcinoma.

Lenvatinib is available in capsule form and is taken orally. The combination aims to evaluate the response rate of the treatment.

4 monitoring and evaluation

Throughout the trial, regular monitoring is conducted to assess the treatment’s effectiveness and any side effects.

Imaging tests such as CT or MRI scans are used to measure tumor response according to specific criteria.

5 completion and follow-up

Upon completion of the treatment phases, a final evaluation is performed to determine the overall response and any long-term effects.

Follow-up visits may be scheduled to monitor health status and ensure any late-onset side effects are managed.

Who Can Join the Study?

Voluntary agreement to provide written informed consent and the willingness and ability to comply with all aspects of the study.
Have an Eastern Cooperative Oncology Group Performance Status (ECOG PS) of 0 to 1, which means being fully active or having some symptoms but still able to carry out light work.
Must have disease progression on current or since the last anticancer treatment.
Have at least one measurable lesion by CT or MRI based on RECIST 1.1, which is a way to measure how tumors respond to treatment.
Agree to provide a sample of tumor tissue for analysis, either from a previous biopsy or a new one.
Have adequate kidney function, which means the kidneys are working well enough to clear waste from the blood.
Have adequate bone marrow function, which means the body can produce enough blood cells.
Have adequate liver function, which means the liver is working well enough to process substances in the body.
All side effects from previous cancer treatments must have returned to mild levels, except for hair loss and mild nerve damage.
Agree to take Vitamin D supplements if their levels are low.
Have normal levels of certain minerals in the blood, like calcium, potassium, and magnesium.
Be male or female and at least 18 years old.
Have a life expectancy of at least 12 weeks.
Have a confirmed diagnosis of advanced solid tumors like melanoma, colorectal cancer, or hepatocellular carcinoma, where previous treatments have not worked.
For melanoma patients, must have advanced melanoma that cannot be removed by surgery and have tried certain treatments before.
For colorectal cancer patients, must have tried at least two different treatments before.
For hepatocellular carcinoma patients, must have a confirmed diagnosis and have tried one previous treatment.
For patients with hepatitis B, must have been on antiviral therapy for at least 3 months and have a low viral load.
For patients with hepatitis C, must have completed therapy at least 4 weeks before starting the study, or they can be untreated or uncured.
For those in the triplet treatment group, must have well-controlled blood pressure.

Who Cannot Join the Study?

Patients who have not previously been treated for their cancer.
Patients with medical conditions other than colorectal cancer, melanoma, or hepatocellular carcinoma.
Patients who are not within the specified age range for the study.
Patients who are not able to safely tolerate the study medications.
Patients who are part of a vulnerable population that cannot safely participate in the study.
Patients who are not able to follow the study procedures or attend required visits.
Patients who are pregnant or breastfeeding.
Patients who have another serious illness that could interfere with the study.
Patients who are taking other medications that could interfere with the study treatment.
Patients who have had a recent surgery or medical procedure that could affect their participation.

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
Hospital General Universitario De Valencia	Valencia	Spain
Fundacio De Recerca Clinic Barcelona-Institut D’Investigacions Biomediques August Pi I Sunyer	Barcelona	Spain
Hospital General Universitario Gregorio Maranon	Madrid	Spain
Fhxltqplc Psbn Lu Izvkqvrcalbnr Brdmeecdh Dag Hkzfwibe Udblxefepasig Ly Pau	Madrid	Spain
Hswlzjyu Vcok dhrnkgez	Barcelona	Spain

Trial status

Country	Status	Recruitment Start
Spain	Not recruiting	22.07.2022

Trial locations

Investigated drugs:

E7386 is an investigational medication being studied for its potential to treat certain types of solid tumors. It is being tested in combination with other treatments to see if it can help improve outcomes for patients who have already received other therapies.

Pembrolizumab is a type of immunotherapy that helps the body’s immune system fight cancer. It works by blocking a specific protein on cancer cells, allowing the immune system to better recognize and attack these cells. In this trial, pembrolizumab is used in combination with E7386 to evaluate their combined effect on solid tumors.

Lenvatinib is a medication that targets specific proteins involved in the growth of cancer cells and blood vessels that supply tumors. It is used in combination with E7386 and pembrolizumab in this trial to assess its effectiveness in treating hepatocellular carcinoma, a type of liver cancer.

Investigated diseases:

Colorectal Cancer – This is a type of cancer that starts in the colon or rectum, parts of the large intestine. It often begins as small, noncancerous clumps of cells called polyps that form on the inside of the colon. Over time, some of these polyps can become cancerous. As the cancer progresses, it can invade and destroy normal tissue nearby and may spread to other parts of the body. Symptoms can include changes in bowel habits, blood in the stool, and abdominal discomfort. The progression can vary, with some cases remaining localized while others spread to distant organs.

Melanoma – Melanoma is a serious form of skin cancer that develops in the cells that produce melanin, the pigment that gives skin its color. It can also form in the eyes and, rarely, in internal organs. Melanoma is more likely than other skin cancers to spread to other parts of the body if not caught early. It often appears as a new spot on the skin or a change in an existing mole. The progression of melanoma can be rapid, and it may spread to lymph nodes and other organs. Early detection is crucial for managing its spread.

Hepatocellular Carcinoma – This is the most common type of primary liver cancer, originating in the liver cells called hepatocytes. It often occurs in the context of chronic liver disease, such as cirrhosis caused by hepatitis or alcohol use. The cancer can grow and spread to other parts of the liver and nearby organs. Symptoms may include weight loss, upper abdominal pain, and jaundice. As the disease progresses, it can lead to liver failure and other complications. The rate of progression can vary depending on the underlying liver condition and other factors.

Trial ID:

2023-505425-14-00

Protocol code:

E7386-G000-201

NCT ID:

NCT05091346

Trial Phase:

Human Pharmacology (Phase I) – Other

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Study of E7386 and Pembrolizumab for Patients with Previously Treated Colorectal Cancer, Melanoma, or Hepatocellular Carcinoma

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?