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Study of Futibatinib with Pembrolizumab and Chemotherapy for Patients with Solid Tumors

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What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial is focused on studying the effects of a new treatment combination for patients with solid tumors. Solid tumors are abnormal masses of tissue that usually do not contain cysts or liquid areas. The study will use a combination of medications, including Futibatinib, which is taken as a tablet, and a PD-1 antibody therapy, which is a type of treatment that helps the immune system fight cancer. The PD-1 antibody therapy is part of the standard care for treating solid tumors. The study will also involve other chemotherapy drugs, such as Cisplatin, Fluorouracil, Leucovorin, Irinotecan, Oxaliplatin, and Pembrolizumab, which are given through an intravenous infusion, meaning they are delivered directly into the bloodstream through a vein.

The purpose of this study is to evaluate how effective the combination of Futibatinib and PD-1 antibody therapy is in treating solid tumors. Participants in the study will receive these treatments over a period of time, and their response to the treatment will be monitored by healthcare professionals. The study will look at how well the tumors respond to the treatment, how long the response lasts, and the overall safety of the treatment combination. Participants will be closely monitored for any side effects or changes in their health during the study.

This study is designed to provide valuable information about the potential benefits and risks of using Futibatinib in combination with PD-1 antibody therapy and standard chemotherapy for treating solid tumors. The results of this study may help improve treatment options for patients with these types of cancers in the future.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Initial assessment
Upon joining the study, an initial assessment is conducted to confirm eligibility. This includes reviewing medical history and performing necessary tests to ensure adequate organ function and overall health status.
A negative pregnancy test is required for women of child-bearing potential. Consent forms are signed to confirm understanding and agreement to participate in the study.
Step 2
Treatment initiation
The treatment phase begins with the administration of futibatinib in combination with other medications. Futibatinib is taken orally in the form of film-coated tablets.
Additional medications include cisplatin, fluorouracil, folinic acid, irinotecan hydrochloride trihydrate, pembrolizumab, and oxaliplatin, all administered through intravenous infusion.
Step 3
Ongoing treatment and monitoring
Regular visits are scheduled to monitor the response to treatment and manage any side effects. This includes physical exams, blood tests, and imaging studies to assess the tumor's response.
The objective is to evaluate the antitumor efficacy of the treatment combination, focusing on the response rate and disease control.
Step 4
Safety and efficacy evaluation
Throughout the trial, safety is closely monitored by assessing adverse events, vital signs, and laboratory parameters.
The duration of response and progression-free survival are evaluated to determine the effectiveness of the treatment.
Step 5
Completion and follow-up
Upon completion of the treatment phase, a final assessment is conducted to evaluate the overall response and any long-term effects.
Follow-up visits may be scheduled to continue monitoring health status and any potential late effects of the treatment.

Who can join the trial?

12 criteria

Provide written informed consent before any study-specific procedures and agree to follow all study procedures.
Have adequate organ function as described in the study protocol.
Be able to take medications by mouth.
For Cohort B only: Have stored tumor tissue available for submission to the central laboratory.
Women who can have children must have a negative pregnancy test. Women are not considered able to have children if they are permanently unable to become pregnant (due to procedures like hysterectomy, removal of both fallopian tubes, or removal of both ovaries) or are post-menopausal (no menstrual periods for 12 months without another medical reason).
Be willing and able to attend scheduled visits and follow study procedures.
Be at least 18 years old at the time of giving informed consent (or meet the legal adult age as defined by the country).
Have a confirmed diagnosis of locally advanced, unresectable, or metastatic carcinoma. For Cohort A: This includes adenocarcinoma or squamous cell carcinoma of the esophagus or advanced/metastatic Siewert type 1 adenocarcinoma of the esophagogastric junction (EGJ). For Cohort B: This includes pancreatic ductal adenocarcinoma.
Have not received prior systemic treatment for locally advanced, unresectable, or metastatic esophageal carcinoma (EC) or pancreatic ductal adenocarcinoma (PDAC).
Have measurable disease as defined by the Response Evaluation Criteria in Solid Tumors (RECIST) guidelines. A lesion in a previously treated area can be considered measurable if it has shown progression and meets RECIST criteria.
Have documentation of PD-L1 CPS score (for Cohort A only).
Have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1, which indicates the level of daily functioning.

Who cannot join the trial?

10 criteria

Patients who have a different type of cancer than the one being studied, which is called solid tumors.
Patients who are not within the specified age range for the study.
Patients who are not part of the specific group being studied.
Patients who are not able to follow the study procedures or take the study medications.
Patients who have other medical conditions that might interfere with the study or make it unsafe for them to participate.
Patients who are pregnant or breastfeeding.
Patients who are participating in another clinical trial at the same time.
Patients who have had a recent major surgery or are recovering from a major illness.
Patients who have a history of severe allergic reactions to any of the study medications.
Patients who have a history of drug or alcohol abuse that might interfere with the study.

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Verified sites

All sites with verified contact details – recruitment status may not be available; ask directly

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Center For Pediatric And Adolescent Medicine Of The Johannes Gutenberg University Mainz
Mainz, Germany
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Centre Hospitalier Universitaire De Lille
Lille, France
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Centre Hospitalier Universitaire De Poitiers
Poitiers, France

Trial locations

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Investigated drugs

Futibatinib
is a medication being studied for its potential to treat solid tumors. It is being tested to see how well it works when used together with other cancer treatments. Futibatinib is thought to help stop cancer cells from growing and spreading.
PD-1 Antibody
is a type of therapy that helps the immune system recognize and attack cancer cells. It works by blocking a protein that prevents the immune system from attacking the cancer, allowing the body's natural defenses to fight the tumor more effectively.
Standard of Care Chemotherapy
refers to the usual treatment given to patients with solid tumors. This can include a variety of drugs that are commonly used to kill or slow the growth of cancer cells. The specific drugs used can vary depending on the type of cancer being treated.

What is already known about the treatment

Futibatinib – This medication is administered orally and is currently being studied in clinical trials for its effectiveness in treating solid tumors. It is not yet widely used in standard medical practice, as it is still under investigation. Futibatinib is primarily indicated for its potential to treat various types of solid tumors. At the molecular level, it works by inhibiting certain enzymes that are involved in the growth and survival of cancer cells. It is classified as a kinase inhibitor, which is a type of targeted cancer therapy.

Investigated diseases

Solid Tumors – Solid tumors are abnormal masses of tissue that usually do not contain cysts or liquid areas. They can occur in various parts of the body, including organs and bones. These tumors are characterized by the uncontrolled growth of cells that form a lump or mass. As they progress, they may invade nearby tissues and organs, potentially causing functional impairments. Solid tumors can vary greatly in their growth rate and potential to spread to other parts of the body. The progression of solid tumors depends on the type of cells involved and their location in the body.