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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
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 belowSelect...
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:Select...
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
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
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
~3880
Find a Location
Who is running the clinical trial?
Incyte CorporationIndustry Sponsor
382 Previous Clinical Trials
57,010 Total Patients Enrolled
1 Trials studying Liposarcoma
27 Patients Enrolled for Liposarcoma
Memorial Sloan Kettering Cancer CenterLead Sponsor
1,956 Previous Clinical Trials
595,514 Total Patients Enrolled
5 Trials studying Liposarcoma
329 Patients Enrolled for Liposarcoma
Sandra D'Angelo, MDPrincipal InvestigatorMemorial Sloan Kettering Cancer Center
4 Previous Clinical Trials
175 Total Patients Enrolled
2 Trials studying Liposarcoma
57 Patients Enrolled for Liposarcoma
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I can swallow pills.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.I am currently pregnant or breastfeeding.I am not taking drugs that greatly affect liver enzyme CYP3A activity.I am 18 years old or older.I have a type of cancer called WD/DD liposarcoma that cannot be removed by surgery.I have had an organ or stem-cell transplant.My CD4+ count is over 300, my viral load is undetectable, and I am on HAART.My brain metastasis was treated and has been stable for 3 months.My target cancer lesions for this trial have not been previously treated with radiation, or if they have, they've shown growth since then.I have not received a live vaccine within the last 30 days, except for the flu shot.I have not had radiation therapy in the last 2 weeks.I have had symptoms of an autoimmune disease in the last 2 years.I have been treated with drugs targeting CDK4 or PD-1/PD-L1.I do not have any severe ongoing illnesses that could interfere with the study.You have had a very severe allergic reaction to the study drug or any of its ingredients in the past.My side effects from previous treatments are mild, except for hair loss or stable nerve issues.I am fully active or can carry out light work.I agree to use effective birth control or abstain from sex during and for 120 days after the trial.My organ and bone marrow functions are within normal ranges.
Research Study Groups:
This trial has the following groups:- Group 1: Palbociclib and INCMGA00012
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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