Study on Pembrolizumab and Pemetrexed for Treating Progressive Chordoma

Sponsor: Saint John's Cancer Institute

Sponsor score: 0

ClinicalTrials ID:NCT06794645

This clinical trial is testing a combination of two drugs, pembrolizumab and high-dose pemetrexed, to see if they can help control chordoma, a rare type of cancer that occurs along the spine. The study aims to evaluate the effectiveness and safety of this treatment in patients whose disease has progressed.

Patient Parameters

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Program Overview

The main goal of this study is to find out if the combination of pembrolizumab and high-dose pemetrexed can effectively treat chordoma, a rare cancer that affects the spine. Researchers will look at how well the treatment works in shrinking tumors and controlling the disease, as well as its safety and impact on patients' quality of life. The study will also explore how the treatment affects the cancer over time and its effects on the body.

Description

This study is testing a new treatment for chordoma, a rare cancer that can occur anywhere along the spine. The treatment combines two drugs: pembrolizumab, which is used for various cancers, and pemetrexed, which is typically used for certain lung cancers. In this study, a higher dose of pemetrexed is being tested to see if it can deliver more of the drug to the chordoma tumors. The study will monitor patients to see if the treatment can stop the cancer from growing and to check for any side effects. The study will last until the cancer progresses, the study is completed, or the patient withdraws, which is expected to be about two years. Currently, there are no approved drugs specifically for chordoma, so this study aims to find out if this combination can be effective and safe for patients with this type of cancer.

Eligibility Criteria

Inclusion Criteria

Must be able to understand and sign a consent form.
Willing to follow all study procedures and be available for the study duration.
Must have a confirmed diagnosis of chordoma.
The cancer must have shown signs of getting worse in the last six months.
Must have measurable disease based on specific criteria.
Must be 18 years or older.
Must be in good general health, able to perform daily activities with little or no assistance.
Must have adequate organ function based on blood tests.
Must be able to stop taking certain pain medications around the time of pemetrexed treatment.
Must be able to take folic acid, Vitamin B12, and dexamethasone as required.
Must have recovered from any previous treatment side effects.
If positive for Hepatitis B or C, must meet specific treatment and viral load criteria.
Men must agree to use effective birth control during and after treatment.
Women must either not be of childbearing potential or agree to use effective birth control during and after treatment.

Exclusion Criteria

Not enough time has passed since previous treatments, such as investigational drugs, surgery, or radiation.
Have received a live vaccine within 30 days before starting the study.
Have an immune deficiency or are on high-dose steroids or other immune-suppressing drugs.
Have an active autoimmune disease needing treatment in the past two years.
Have an active infection needing IV antibiotics or a known viral infection.
Have a history of lung inflammation or current lung issues.
Have a history of HIV or active Hepatitis B or C.
Have had a tissue or organ transplant.
Have fluid buildup that cannot be controlled by drainage.
Have severe or uncontrolled medical conditions that could interfere with the study.
Have a history of serious heart conditions.
Have another progressing cancer needing treatment in the past three years.
Are pregnant or breastfeeding.
Have a known severe allergy to pembrolizumab or its ingredients.

Locations

FACILITY	ZIP	CITY	STATE
Providence Saint John's Health Center	90404	Santa Monica	California

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