A Study of Olaratumab (LY3012207) Plus Pembrolizumab in Participants With Advanced or Metastatic Soft Tissue Sarcoma

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)

Population: All enrolled participants who received at least one dose of study drug.

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)

Population: All enrolled participants who received at least one dose of study drug.

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)

Population: All enrolled participants who received at least one dose of study drug and who had a PR or CR. Number of participants censored in 20 mg/kg Dose Expansion arm = 2.

Detection of ADA in the presence of Olaratumab

Time frame: Predose Cycle 1 Day 1 through Follow Up (up to 6 months)

Population: All enrolled participants who received at least one dose of study drug and had at least one anti-olaratumab antibody positive result.

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)

Population: All enrolled participants who received at least one dose of study drug.

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)

Population: All enrolled participants who received at least one dose of study drug. Number of participants censored per arm: 15 mg/kg Olaratumab - Dose Escalation = 1 participant; 20 mg/kg Olaratumab - Dose Escalation = 3 participants; 20 mg/kg Olaratumab - Dose Expansion = 12 participants.

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

Population: All enrolled participants who received at least 1 dose of study drug and have at least 1 post-baseline evaluable PK sample.

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

Population: All enrolled participants who received at least 1 dose of study drug and have at least 1 post-baseline evaluable PK sample.

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

Population: All enrolled participants who received at least 1 dose of study drug and have at least 1 post-baseline evaluable PK sample.

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)

Population: All enrolled participants who received at least one dose of study drug. Number of participants censored per arm: 15 mg/kg Olaratumab - Dose Escalation = 2 participants; 20 mg/kg Olaratumab - Dose Escalation = 0 participants; 20 mg/kg Olaratumab - Dose Expansion = 5 participants.