Palbociclib and INCMGA00012 in People With Advanced Liposarcoma

  • STATUS
    Recruiting
  • participants needed
    30
  • sponsor
    Memorial Sloan Kettering Cancer Center
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Updated on 5 August 2020
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corticosteroids
absolute neutrophil count
measurable disease
metastasis
direct bilirubin
gilbert's syndrome
monoclonal antibodies
organ transplantation
palbociclib
primary tumor
systemic therapy
autoimmune disease
influenza
congestive heart failure
tumor progression
brain metastasis
attenuated vaccines

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.

Details
Condition liposarcoma, Sarcoma, Sarcoma
Age 18years - 100years
Treatment Palbociclib, INCMGA00012
Clinical Study IdentifierNCT04438824
SponsorMemorial Sloan Kettering Cancer Center
Last Modified on5 August 2020

Eligibility

 Yes No Not Sure

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
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)
Absolute neutrophil count 1.5 x 109/L
Hemoglobin 8.0 g/dL
WBC 3.0 x 109/L
Platelets 100 x 109/L
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)
AST (SGOT) /ALT (SGPT) 3 x institutional ULN
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
Patients with a CD4+ count of > 300 and an undetectable viral load who are currently on HAART are eligible for inclusion
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
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)
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