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Monoclonal Antibodies

Palbociclib + INCMGA00012 for Liposarcoma

Phase 2

Waitlist Available

Led By Sandra D'Angelo, MD

Research Sponsored by Memorial Sloan Kettering Cancer Center

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Age ≥ 18 years

A diagnosis of metastatic or unresectable WD/DD liposarcoma. DD liposarcoma must be present. Unresectable is defined as if the primary tumor a) cannot be safely removed surgically or b) would benefit from systemic therapy prior to a surgical approach

Must not have

Pregnant women and women who are breast-feeding

Patients who require concomitant use of medications that strongly induce or inhibit CYP3A (per section 15.0)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 2 years

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing a combination of drugs to see if they are effective and safe to treat advanced liposarcoma.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

Potential side effects may include immune system reactions due to INCMGA00012 (an immunotherapy), possible blood cell count changes from palbociclib (affects cell growth), fatigue, nausea, increased risk of infection and other symptoms related to organ inflammation.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am 18 years old or older.

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I have a type of cancer called WD/DD liposarcoma that cannot be removed by surgery.

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I am fully active or can carry out light work.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I am currently pregnant or breastfeeding.

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I am not taking drugs that greatly affect liver enzyme CYP3A activity.

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I have had an organ or stem-cell transplant.

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I have not received a live vaccine within the last 30 days, except for the flu shot.

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I have not had radiation therapy in the last 2 weeks.

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I have had symptoms of an autoimmune disease in the last 2 years.

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I have been treated with drugs targeting CDK4 or PD-1/PD-L1.

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I do not have any severe ongoing illnesses that could interfere with the study.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 2 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~2 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and 2 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

best overall response rate (Phase II)

confirm the recommended phase two dose (RP2D

Secondary study objectives

Safety

overall response rate

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

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.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

INCMGA00012

2021

Completed Phase 1

~60

Palbociclib

2017

Completed Phase 3

~3790