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
| Parameter | Options |
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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
| FACILITY | ZIP | CITY | STATE |
|---|---|---|---|
| Memorial Sloan Kettering at Basking Ridge (Limited Protocol Activities) | 07920 | Basking Ridge | New Jersey |
| Memorial Sloan Kettering Monmouth (Limited Protocol Activities) | 07748 | Middletown | New Jersey |
| Memorial Sloan Kettering Bergen (Limited Protocol Activities) | 07645 | Montvale | New Jersey |
| Memorial Sloan Kettering Suffolk - Commack (Limited Protocol Activities) | 11725 | Commack | New York |
| Memorial Sloan Kettering Westchester (Limited Protocol Activities) | 10604 | Harrison | New York |
| Memorial Sloan Kettering Cancer Center | 10065 | New York | New York |
| Memorial Sloan Kettering Nassau (Limited protocol activities) | 11553 | Rockville Centre | New York |
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