Study on Nivolumab With and Without Ipilimumab and Radiation Therapy for Treating Recurrent or Resectable Sarcoma Before Surgery

Sponsor: M.D. Anderson Cancer Center

Sponsor score: 0

ClinicalTrials ID:NCT03307616

This clinical trial is exploring how well the drugs nivolumab and ipilimumab, with or without radiation therapy, work in treating patients with certain types of sarcoma that can be surgically removed. The study aims to see if these treatments can help the immune system attack cancer cells and shrink tumors before surgery.

Patient Parameters

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Program Overview

This study is testing the effectiveness of using the immunotherapy drugs nivolumab and ipilimumab, with or without radiation therapy, before surgery in patients with undifferentiated pleomorphic sarcoma or dedifferentiated liposarcoma. These drugs may help the immune system target and destroy cancer cells, while radiation therapy uses high-energy rays to kill cancer cells and reduce tumor size. The goal is to see if this combination can improve treatment outcomes for patients with these types of sarcoma.

Description

The study has several goals:

To see how well the treatments work in reducing the amount of cancer cells in the tumor before surgery.
To evaluate changes in the tumor's immune environment and how the cancer responds to the treatment.
To measure the rate of tumor shrinkage using imaging tests.
To track the survival rates of patients 12 and 24 months after treatment.
To ensure the safety of the treatments and monitor any side effects.

Participants will be randomly assigned to one of four treatment groups:

Group A: Receives nivolumab alone before surgery.
Group B: Receives nivolumab and ipilimumab before surgery.
Group C: Receives nivolumab and radiation therapy before surgery.
Group D: Receives nivolumab, ipilimumab, and radiation therapy before surgery.

After completing the treatment, patients will have follow-up visits at 6 and 18 weeks, and then every 3 months for up to 2 years to monitor their health and the effectiveness of the treatment.

Eligibility Criteria

Inclusion Criteria

Adults with newly diagnosed or locally recurrent dedifferentiated liposarcoma or undifferentiated pleomorphic sarcoma that can be surgically removed.
Able to provide written informed consent and comply with study requirements.
Tumors must be considered removable by surgery without significant risk to major blood vessels, nerves, or bones.
Recent imaging tests showing measurable disease.
Willing to provide tumor samples for research purposes.
Medically fit for surgery and have a performance status score of 0-2, indicating good overall health.
Life expectancy of more than 6 months.
No prior treatment with immunotherapy.
Meet specific blood count and organ function criteria.
Women must not be pregnant or breastfeeding and must agree to use effective contraception if of childbearing potential.
Men must agree to use contraception if sexually active with women of childbearing potential.

Exclusion Criteria

Tumors that cannot be safely removed by surgery.
Recent major abdominal surgery.
Previous chemotherapy or radiation for the current sarcoma.
Active second cancer.
Previous or current treatment with certain immunotherapies.
Recent non-cancer vaccine therapy.
Pregnant or breastfeeding women.
Inability to follow study procedures.
Current use of blood thinners at therapeutic levels.
Serious medical conditions that could increase risk or interfere with the study.
Active autoimmune diseases requiring treatment.
Recent use of high-dose steroids or other immunosuppressive drugs.
Positive tests for hepatitis B or C, or HIV.
History of severe allergic reactions to monoclonal antibodies.
Individuals detained for psychiatric or infectious disease treatment.

Locations

FACILITY	ZIP	CITY	STATE
M D Anderson Cancer Center	77030	Houston	Texas

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