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Palbociclib and INCMGA00012 in People With Advanced Liposarcoma

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04438824
Recruitment Status : Recruiting
First Posted : June 19, 2020
Last Update Posted : June 19, 2020
Sponsor:
Collaborator:
Incyte Corporation
Information provided by (Responsible Party):
Memorial Sloan Kettering Cancer Center

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Well Differentiated Liposarcoma Dedifferentiated Liposarcoma Drug: INCMGA00012 Drug: Palbociclib Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description: This is a phase II study of palbociclib plus INCMGA00012 in patients with advanced WD/DD liposarcoma.
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase II Study of CDK4/6 Inhibition (Palbociclib) Combined With PD-1 Blockade (INCMGA00012) in Patients With Advanced Well-differentiated and/or Dedifferentiated Liposarcoma
Actual Study Start Date : June 17, 2020
Estimated Primary Completion Date : June 2023
Estimated Study Completion Date : June 2023

Resource links provided by the National Library of Medicine

Drug Information available for: Palbociclib

Arm Intervention/treatment
Experimental: Palbociclib and INCMGA00012

One treatment cycle will consist of 28 days. Patients in both study phases will start palbociclib on Day 1 and INCMGA00012 on day 15 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 each cycle and repeat every 28 days.

Drug: INCMGA00012
INCMGA00012: 500 mg IV (flat dose) q28 days

Drug: Palbociclib
Palbociclib:125 mg PO daily for 21 days, followed by 7 days off, q28 days




Primary Outcome Measures :
  1. confirm the recommended phase two dose (RP2D [ Time Frame: within 6 weeks of treatment ]
    DLTs will be assess within the first 6 weeks of the treatment combination . DLT definitions are described in section 15.4, and will be defined using NCI CTCAE v 5.0. If ≤ 1 patient out of 6 has a dose-limiting toxicity, the dosing used in the safety lead-in phase will be declared the recommended phase 2 dose. If ≥ 2 of 6 patients in the safety lead-in experience a DLT, study treatment will be halted and no further patients will be enrolled. If the study is resumed with an alternative dosing schema, a new safety lead-in phase will be completed with the new dosing regimen


Secondary Outcome Measures :
  1. best overall response rate [ Time Frame: 48 weeks ]
    defined by RECIST v1.1



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • A diagnosis of metastatic or unresectable WD/DD liposarcoma. 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
  • Measurable disease by RECIST 1.1

    a. Target lesions must not be chosen from a previously irradiated field unless there has been radiographically and/or pathologically documented tumor progression in that lesion prior to enrollment

  • Age ≥ 18 years
  • ECOG performance status 0 or 1
  • Adequate organ and marrow function as defined below (ULN indicates institutional upper limit of normal):

    1. Absolute neutrophil count ≥ 1.5 x 109/L
    2. Hemoglobin ≥ 8.0 g/dL
    3. WBC ≥ 3.0 x 109/L
    4. Platelets ≥ 100 x 109/L
    5. ≤ 1.5 X ULN OR Direct bilirubin ≤ ULN for subjects with total bilirubin levels > 1.5 ULN. Except patients with Gilbert's disease (≤3x ULN)
    6. AST (SGOT) /ALT (SGPT) ≤ 3 x institutional ULN
    7. Creatinine Clearance > 50 mL/min (calculated by Cockcroft-Gault method)
  • Women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control or abstinence) during the trial period through at least 120 days after the last dose of study treatment.
  • Ability to understand and the willingness to sign a written informed consent document.
  • Ability to swallow tablets
  • Patients with brain metastasis that have been treated with definitive surgery or radiation, and have been clinically stable for 3 months are eligible

Exclusion Criteria:

  • Patients who have not recovered from clinically significant adverse events of prior therapy to ≤ NCI CTCAE v5 Grade 1, except alopecia and stable neuropathy, which must have resolved to Grade ≤ 2 or baseline.
  • Patients receiving any other investigational agents.
  • Patients who have received prior treatment with a selective CDK4 inhibitor or an anti-PD-1/PD-L1 agent
  • Uncontrolled intercurrent illness including, but not limited to, known ongoing or active infection, including uncontrolled HIV, active hepatitis B or C, symptomatic congestive heart failure, unstable angina pectoris, uncontrolled cardiac arrhythmias, psychiatric illness/social situations that would limit compliance with study requirements, clinically significant interstitial lung disease or active noninfectious pneumonitis, or active infection requiring systemic therapy

    1. Patients with a CD4+ count of > 300 and an undetectable viral load who are currently on HAART are eligible for inclusion
    2. Patients with NYHA class III or IV congestive heart failure within 6 months of study treatment will be excluded
  • Pregnant women and women who are breast-feeding.
  • History or evidence of symptomatic autoimmune disease in past 2 years prior to enrollment.

    a. Replacement therapy (e.g., thyroxine for hypothyroidism, insulin for diabetes or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency) is not considered a form of systemic treatment for autoimmune disease

  • Prolonged QTcF > 450 ms for men and > 470 ms for women at Screening.
  • Patients who have received a live vaccine within 30 days of the start date of the planned study therapy. Note: Seasonal influenza vaccines for injection are generally inactivated flu vaccines and are allowed; however intranasal influenza vaccines are live attenuated vaccines, and are not allowed
  • Radiation therapy within 2 weeks prior to study Day 1
  • Prior organ transplantation including allogenic stem-cell transplantation
  • Known prior severe hypersensitivity to investigational product or any component in its formulations, including known severe hypersensitivity reactions to monoclonal antibodies (NCI CTCAE v 5 Grade ≥ 3)
  • Patients who require concomitant use of medications that strongly induce or inhibit CYP3A (per section 15.0)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04438824


Contacts
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Contact: Sandra D'Angelo, MD 646-888-4159 dangelos@mskcc.org
Contact: William Tap, MD 646-888-4163

Locations
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United States, New York
Memorial Sloan Kettering Cancer Center Recruiting
New York, New York, United States, 10065
Contact: Sandra D'Angelo, MD    646-888-4159      
Contact: William Tap, MD    646-888-4163      
Sponsors and Collaborators
Memorial Sloan Kettering Cancer Center
Incyte Corporation
Investigators
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Principal Investigator: Sandra D'Angelo, MD Memorial Sloan Kettering Cancer Center
Additional Information:
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Responsible Party: Memorial Sloan Kettering Cancer Center
ClinicalTrials.gov Identifier: NCT04438824    
Other Study ID Numbers: 20-062
First Posted: June 19, 2020    Key Record Dates
Last Update Posted: June 19, 2020
Last Verified: June 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Memorial Sloan Kettering Cancer Center supports the international committee of medical journal editors (ICMJE) and the ethical obligation of responsible sharing of data from clinical trials. The protocol summary, a statistical summary, and informed consent form will be made available on clinicaltrials.gov when required as a condition of Federal awards, other agreements supporting the research and/or as otherwise required. Requests for deidentified individual participant data can be made beginning 12 months after publication and for up to 36 months post publication. Deidentified individual participant data reported in the manuscript will be shared under the terms of a Data Use Agreement and may only be used for approved proposals. Requests may be made to: crdatashare@mskcc.org.

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Memorial Sloan Kettering Cancer Center:
Palbociclib
INCMGA00012
20-062
Additional relevant MeSH terms:
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Liposarcoma
Neoplasms, Adipose Tissue
Neoplasms, Connective and Soft Tissue
Neoplasms by Histologic Type
Neoplasms
Sarcoma
Palbociclib
Antineoplastic Agents
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action