Study on Oleclumab and Durvalumab for Treating Sarcoma That Has Returned, Not Responded, or Spread

Sponsor: M.D. Anderson Cancer Center

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT04668300

Provider View

This clinical trial is exploring how well the combination of two immunotherapy drugs, oleclumab and durvalumab, works in treating sarcoma that has come back, not responded to treatment, or spread to other parts of the body. These drugs may help the immune system attack cancer cells and stop them from growing and spreading.

Patient Parameters

Program Overview

This study is testing the effectiveness of two immunotherapy drugs, oleclumab and durvalumab, in patients with sarcoma that has returned, not responded to previous treatments, or spread to other areas. Immunotherapy uses the body's immune system to fight cancer, and these drugs may help stop the cancer from growing and spreading.

Description

The main goals of this study are to see how well the treatment works in shrinking tumors and to measure how long patients live without the cancer getting worse. Researchers will also look at the safety of the treatment and how well patients tolerate it.

Patients will receive oleclumab through an IV every two weeks for the first five doses, then every four weeks. Durvalumab will be given through an IV every four weeks. Each treatment cycle lasts 28 days, and patients will continue treatment as long as it is effective and side effects are manageable.

After finishing the treatment, patients will have follow-up visits 30 days later and then every three months for up to five years to monitor their health and any changes in their cancer.

Eligibility Criteria

Inclusion Criteria

  • Age 18 or older for most patients, but 12 or older for some specific cases.
  • Have a confirmed diagnosis of certain types of sarcoma, such as angiosarcoma, dedifferentiated liposarcoma, or osteosarcoma.
  • The cancer must have returned, not responded to standard treatments, or spread to other parts of the body.
  • Must have at least one tumor that can be measured by scans.
  • Must agree to provide a sample of the tumor for research purposes.
  • Be in good overall health with a performance status score of 0 or 1, meaning fully active or restricted in physically strenuous activity but ambulatory.
  • Have adequate blood cell counts and organ function as determined by specific blood tests.
  • Women of childbearing potential must use effective contraception during the study and for 90 days after the last dose.
  • Men must use condoms and spermicide during the study and for 90 days after the last dose.
  • Have a life expectancy of at least six months.
  • Be able to understand the study and agree to sign informed consent.
  • Weigh at least 35 kg (about 77 pounds).

Exclusion Criteria

  • Have previously received treatment with similar immunotherapy drugs.
  • Have an active or recent history of autoimmune diseases, except for certain conditions that do not require treatment.
  • Have untreated cancer that has spread to the brain or spinal cord.
  • Be participating in another clinical trial, unless it is non-interventional.
  • Have received any cancer treatment within 21 days before starting the study.
  • Have unresolved side effects from previous cancer treatments.
  • Be using immunosuppressive medications within 14 days before starting the study, with some exceptions.
  • Have a history of certain infections or conditions like HIV, hepatitis B or C, or tuberculosis.
  • Have had major surgery within four weeks before starting the study.
  • Have other active cancers within the past two years, except for certain non-invasive cancers.
  • Have uncontrolled health conditions that could interfere with the study or increase risks.
  • Have a history of lung inflammation or blood clots within the past few months.
  • Have had a heart attack or stroke in the last three months.

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