For more than 50 years, Lilly has been dedicated to delivering life-changing medicines and support to people living with cancer and those who care for them. Lilly is determined to build on this heritage and continue making life better for all those affected by cancer around the world. In 2019 Lilly created Loxo Oncology at Lilly, with the goal of rapidly delivering impactful new medicines for people with cancer. Our approach centers on creating new medicines that work in early clinical development and will matter to patients.
An Open-Label, Multicenter, Phase 1a/1b Study of Olaratumab (LY3012207) Plus Pembrolizumab (MK3475) in Patients With Unresectable Locally Advanced or Metastatic Soft Tissue Sarcoma (STS) Who Have Failed Standard Treatments*
Key Inclusion Criteria
- Advanced unresectable or metastatic STS not amenable to curative treatment and after available standard therapies have failed to provide clinical benefit. Participants with a diagnosis of grade 1 liposarcoma (atypical lipomatous neoplasms) are eligible if there is histological or radiographic evidence of evolution to more aggressive disease
- Measurable or nonmeasurable but evaluable disease as defined by Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
- Availability of tumor tissue obtained within 6 months of study enrollment, or a newly obtained core or excisional biopsy of a tumor lesion must be performed
- Life expectancy of ≥3 months
Key Exclusion Criteria
- Received any previous systemic therapy (including investigational agents) targeting PD-1/programmed cell death ligand 1 (PD-L1) or PD-1/PD-L2 signaling pathways (including previous participation in Merck MK-3475 trials)
- Prior therapy with other immune checkpoint inhibitors, including but not limited to anti-CD137 antibody or anticytotoxic T-lymphocyte-associated antigen-4 (CTLA4) antibody, is not permitted
- Known active central nervous system (CNS) metastasis and/or carcinomatous meningitis. Participants with treated CNS metastases are eligible for this study if they have not received corticosteroids and/or anticonvulsants within 7 days of study treatment, and their disease is asymptomatic and radiographically stable for at least 60 days
- Active autoimmune disease or other syndrome that requires systemic steroids or autoimmune agents in the past 2 years
- History of interstitial lung disease or noninfectious pneumonia
- Received a live-virus vaccine within 30 days prior to planned treatment start
- Kaposi’s sarcoma or gastrointestinal stromal tumor
- Inflammatory bowel disease for which the participant has used immunosuppressive agents within the last 2 years
Contact the Lilly Oncology Clinical Trial Navigation Service
Visit www.clinicaltrials.gov for more information on this trial.
The safety and efficacy of the agents under investigation have not been established. There is no guarantee that the agents will receive regulatory approval and become commercially available for the uses being investigated.