The purpose of this study is to evaluate the safety of olaratumab plus pembrolizumab in participants with previously treated advanced or metastatic soft tissue sarcoma.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
41
Administered IV
Administered IV
Dana Farber Cancer Institute
Boston, Massachusetts, United States
Memorial Sloan Kettering Cancer Center
New York, New York, United States
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, United States
Universitaire Ziekenhuizen Leuven - Campus Gasthuisberg
Leuven, Belgium
Number of Participants With Olaratumab Dose Limiting Toxicities (DLTs)
A DLT was defined as an adverse event (AE) during Cycle 1 that is possibly related to the study drug and fulfills any 1 of the following criteria using the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.0: * Grade ≥3 nonhematologic toxicity, with exceptions * Grade 4 anemia * Grade 4 neutropenia or leukopenia of \>5 days duration * Febrile neutropenia * Grade 3 thrombocytopenia with clinically significant bleeding or Grade 4 thrombocytopenia * Any other significant toxicity deemed to be dose limiting
Time frame: Cycle 1 (21 Days)
Pharmacokinetics (PK): Maximum Serum Concentration (Cmax) of Olaratumab
Maximum observed serum concentration of Olaratumab
Time frame: Cycle 1 and Cycle 3 Day (D) 1: Predose, 1, 2, 5, 24, 96, 168 hours Postdose; Cycle 1 and Cycle 3 Day 8: Predose, 1, 2, 5, 48, 168, 336 hours Postdose
PK: Minimum Serum Concentration (Cmin) of Olaratumab
Cmin was the concentration of olaratumab in the sample taken just prior to the following dose.
Time frame: Cycle 1 and Cycle 3 Day 1: Predose, 1, 2, 5, 24, 96, 168 hours Postdose; Cycle 1 and Cycle 3 Day 8: Predose, 1, 2, 5, 48, 168, 336 hours Postdose
PK: Elimination Half-Life (t½) of Olaratumab
Terminal elimination half-life of Olaratumab
Time frame: Cycle 1 and Cycle 3 Day 1: Predose, 1, 2, 5, 24, 96, 168 hours Postdose; Cycle 1 and Cycle 3 Day 8: Predose, 1, 2, 5, 48, 168, 336 hours Postdose
Number of Participants With Anti-Olaratumab Antibodies (ADA) When Administered in Combination With Pembrolizumab
Detection of ADA in the presence of Olaratumab
Time frame: Predose Cycle 1 Day 1 through Follow Up (up to 6 months)
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Herlev and Gentofte Hospital
Herlev, Denmark
Gustave Roussy
Villejuif, France
Objective Response Rate (ORR): Percentage of Participants With a Complete Response (CR) or Partial Response (PR)
ORR was defined as the percentage of participants who achieved a CR or PR out of all participants treated, measured and recorded by Response Evaluation Criteria in Solid Tumors (RECIST v1.1). CR was defined as the disappearance of all target lesions; any pathological lymph nodes (whether target or non-target) must have had reduction in short axis to \<10 mm; tumor marker results must have normalized. PR was defined as at least a 30% decrease in the sum diameter of target lesions (taking as reference the baseline sum diameters). Long term follow up began the day after the safety follow up period was completed.
Time frame: Baseline to Measured Progressive Disease (PD) or Start of New Anti-Cancer Therapy (up to 28 months)
Disease Control Rate (DCR): Percentage of Participants With a Best Response of CR, PR or Stable Disease (SD)
DCR was defined according to RECIST v1.1 as the percentage of participants who have achieved CR, PR or stable disease (SD). SD was defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD. Long term follow up began the day after the safety follow up period was completed.
Time frame: Baseline to Measured Progressive Disease or Start of New Anti-Cancer Therapy (up to 28 months)
Duration of Response (DoR)
DoR was defined according to RECIST v1.1 as the time from the date of the first CR or PR to the first date of PD or death from any cause, whichever is earlier. For each participant who was not known to have died or to have had a progression of disease as of the data inclusion cut-off date, DOR was censored at the date of last objective response assessment prior to the date of any subsequent systemic anticancer therapy. Long term follow up began the day after the safety follow up period was completed.
Time frame: Date of CR or PR to Date of Objective Disease Progression or Death Due to Any Cause (up to 24 months)
Progression Free Survival (PFS)
Progression-free survival (PFS) time was defined as the time from the date of start of study treatment to the first date of PD (symptomatic or objective) or death due to any cause, whichever occurs first. For participants who were not known to have died or progressed as of the data-inclusion cut-off date, PFS time was censored at the date of the last objective progression-free disease assessment prior to the date of any subsequent systemic anticancer therapy. Long term follow up began the day after the safety follow up period was completed.
Time frame: Baseline to Measured Progressive Disease or Death Due to Any Cause (up to 28 months)
Overall Survival (OS)
OS was defined as the time from the date of randomization to the date of death from any cause. Data was censored for any participant who was not known to have died or was lost to follow up. Long term follow up began the day after the safety follow up period was completed.
Time frame: Baseline to Death from Any Cause (up to 35 months)