Study on Palbociclib and INCMGA00012 for Treating Advanced Liposarcoma

Sponsor: Memorial Sloan Kettering Cancer Center

Sponsor score: 60

ClinicalTrials ID:NCT04438824

This clinical trial is exploring whether a combination of the drugs palbociclib and INCMGA00012 is a safe and effective treatment for people with advanced liposarcoma, a type of cancer that affects fat cells.

Patient Parameters

Program Overview

The purpose of this study is to determine if using the drugs palbociclib and INCMGA00012 together can safely and effectively treat advanced liposarcoma, a cancer that occurs in fat cells and has either spread to other parts of the body or cannot be surgically removed.

Eligibility Criteria

Inclusion Criteria

  • Have a diagnosis of advanced liposarcoma that has spread or cannot be surgically removed. The cancer must include a specific type called dedifferentiated liposarcoma.
  • Have measurable cancer that can be tracked using standard criteria.
  • Be 18 years or older.
  • Be in good overall health with an ECOG performance status of 0 or 1, meaning fully active or restricted in physically strenuous activity but ambulatory.
  • Have adequate organ and bone marrow function as shown by specific blood tests.
  • Women and men must agree to use effective birth control during the study and for at least 120 days after the last dose of treatment.
  • Be able to understand and sign a consent form.
  • Be able to swallow tablets or capsules.
  • If there are brain metastases, they must have been treated and stable for at least 3 months.

Exclusion Criteria

  • Have not recovered from significant side effects of previous treatments, except for hair loss and stable nerve damage.
  • Are taking other experimental drugs.
  • Have previously been treated with drugs similar to palbociclib or INCMGA00012.
  • Have uncontrolled illnesses, such as active infections, heart failure, or psychiatric conditions that could interfere with the study.
  • Have a history of severe autoimmune diseases in the past 2 years, except for replacement therapies like insulin for diabetes.
  • Have a prolonged QT interval on an ECG (QTcF greater than 450 ms for men and 470 ms for women).
  • Have received a live vaccine within 30 days before starting the study.
  • Have had radiation therapy within 2 weeks before starting the study.
  • Have had an organ transplant, including stem-cell transplants.
  • Have severe allergies to the study drugs or similar medications.
  • Need to take medications that strongly affect liver enzymes involved in drug metabolism.

Locations

FACILITYZIPCITYSTATE
Memorial Sloan Kettering at Basking Ridge (Limited Protocol Activities)07920Basking RidgeNew Jersey
Memorial Sloan Kettering Monmouth (Limited Protocol Activities)07748MiddletownNew Jersey
Memorial Sloan Kettering Bergen (Limited Protocol Activities)07645MontvaleNew Jersey
Memorial Sloan Kettering Suffolk - Commack (Limited Protocol Activities)11725CommackNew York
Memorial Sloan Kettering Westchester (Limited Protocol Activities)10604HarrisonNew York
Memorial Sloan Kettering Cancer Center10065New YorkNew York
Memorial Sloan Kettering Nassau (Limited protocol activities)11553Rockville CentreNew York

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