Study on Whether Immunotherapy Plus Chemotherapy is Better Than Chemotherapy Alone for Aggressive Sarcomas
Sponsor: National Cancer Institute (NCI)
ClinicalTrials ID:NCT06422806
This clinical trial is testing if adding an immunotherapy drug, pembrolizumab, to the standard chemotherapy drug, doxorubicin, can help patients with aggressive sarcomas that have spread or cannot be removed by surgery. The study aims to see if this combination can help patients live longer without the cancer getting worse.
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Program Overview
This study is comparing two treatments for patients with aggressive sarcomas that have spread or cannot be removed by surgery. One group will receive the standard chemotherapy drug, doxorubicin, while the other group will receive doxorubicin plus an immunotherapy drug called pembrolizumab. The goal is to see if the combination treatment can help patients live longer without the cancer progressing. Doxorubicin works by damaging the DNA of cancer cells, while pembrolizumab helps the immune system attack the cancer. The study will also look at the safety and effectiveness of these treatments.
Description
The main goal of this study is to find out if combining doxorubicin with pembrolizumab can help patients with aggressive sarcomas live longer without the cancer getting worse, compared to using doxorubicin alone.
Secondary goals include:
- Checking if starting pembrolizumab later, after doxorubicin alone, affects overall survival.
- Evaluating the safety and side effects of each treatment.
- Measuring how well the cancer responds to each treatment.
Participants will be randomly assigned to one of two groups:
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Group A: Will receive doxorubicin and pembrolizumab together. Doxorubicin is given through an IV on the first day of each cycle, which repeats every 21 days for up to 6 cycles. Pembrolizumab is also given through an IV on the first day of each cycle, repeating every 21 days for up to 2 years.
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Group B: Will receive doxorubicin alone in the same way as Group A. If the cancer progresses, pembrolizumab may be added later.
Both groups will have heart scans and regular imaging tests to monitor the cancer. After treatment, participants will have follow-up visits every 3 months for 2 years, then every 6 months for up to 10 years.
Eligibility Criteria
Inclusion Criteria
- Must be 18 years or older.
- Must have a confirmed diagnosis of undifferentiated pleomorphic sarcoma (UPS) or a related poorly differentiated sarcoma.
- The cancer must be metastatic (spread to other parts of the body) or cannot be removed by surgery.
- Must not be pregnant or breastfeeding, and must agree to use effective contraception during the study and for a specified time after treatment.
- Must be able to understand and sign a consent form.
- Must have a heart function test showing a left ventricular ejection fraction (LVEF) greater than 50%.
- Must have certain blood counts and liver and kidney function within specified limits.
- HIV-positive patients must be on effective anti-retroviral therapy with an undetectable viral load.
- Patients with hepatitis B or C must have the virus under control.
- Patients with treated brain metastases are eligible if there is no progression.
- Must not have a history of interstitial lung disease.
- Must have measurable disease and provide imaging scans.
- Must have an ECOG performance status of 0-1.
- Must not have had prior treatment with an anthracycline or certain immunotherapy drugs.
- Must not have a significant immunodeficiency or autoimmune disorder requiring steroids.
- Must not have a known history of active tuberculosis.
- Must not have a known allergy to doxorubicin or pembrolizumab.
- Must have recovered from any prior treatments or surgeries.
- Must not have had prior radiation to the heart or chest area.
- Must not require daily corticosteroids over 10 mg of prednisone or equivalent.
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