Palbociclib + INCMGA00012 for Liposarcoma

Recruiting in Palo Alto (17 mi)

+6 other locations

Sandra P. D'Angelo, MD - MSK Sarcoma ...

Overseen bySandra D'Angelo, MD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Waitlist Available

Sponsor: Memorial Sloan Kettering Cancer Center

No Placebo Group

Prior Safety Data

Breakthrough Therapy

Trial Summary

What is the purpose of this trial?The researchers are doing this study to find out whether combining the study drugs palbociclib and INCMGA00012 is an effective and safe treatment for advanced liposarcoma. "Funding Source - FDA OOPD"

Eligibility Criteria

This trial is for adults with advanced liposarcoma that can't be removed by surgery or needs systemic therapy before an operation. Participants must have measurable disease, agree to use contraception, and have stable brain metastasis if present. They should not have had prior CDK4 inhibitor or anti-PD-1/PD-L1 treatment, uncontrolled illnesses, symptomatic heart failure, severe autoimmune disease in the past 2 years, certain infections like HIV or hepatitis B/C unless controlled.

Inclusion Criteria

I can swallow pills.

AST (SGOT) /ALT (SGPT) ≤ 3 x institutional ULN

Creatinine Clearance > 50 mL/min (calculated by Cockcroft-Gault method)

+14 more

Exclusion Criteria

I am on replacement therapy for a condition like hypothyroidism, diabetes, or adrenal insufficiency.

I have not had severe heart failure in the last 6 months.

You are currently taking any other experimental drugs or treatments.

+12 more

Participant Groups

The study is testing the combination of palbociclib and INCMGA00012 as a treatment for advanced liposarcoma. It aims to determine whether this drug duo is effective and safe for patients who meet specific health criteria.

1Treatment groups

Experimental Treatment

Group I: Palbociclib and INCMGA00012Experimental Treatment2 Interventions

Initial design (safety lead-in and expansion): One treatment cycle will consist of 28 days. Patients in both study phases will start palbociclib on Day 1 and INCMGA00012 on day 15 (+/- 7 days) of each cycle at the following dose schedule: INCMGA00012: 500 mg IV (flat dose) q28 days Palbociclib: 125 mg PO daily for 21 days, followed by 7 days off, q28 days Palbociclib will be taken on Day 1 of each cycle for 21 consecutive days followed by 7 days off (days 22-28 of each Cycle). INCMGA00012 will be administered on Day 15 of (+/- 7 days) each cycle and repeat every 28 days.(No longer using this) Amended design (Expansion only): One treatment cycle will consist of 28 days. Patients in both study phases will start palbociclib and INCMGA00012 on day 1 of each cycle: 500 mg IV (flat dose) of INCMGA00012 will be administered q28 days concurrently with palbociclib 125 mg PO daily for 21 days, followed by 7 days off, q28 days.

INCMGA00012 is already approved in United States, European Union for the following indications:

🇺🇸 Approved in United States as Zynyz for: