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

• Status: Active, not recruiting
• Trial end date: 2022-04-28
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Eli Lilly and Company
• Collaborator: Merck Sharp & Dohme Corp.
• Treatments: Olaratumab; Pembrolizumab

Criteria

Inclusion Criteria:

• Histologically confirmed diagnosis of advanced unresectable or metastatic STS, not amenable to curative treatment and after available standard therapies have failed to provide clinical benefit. Note: 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.

• Presence of measurable or nonmeasurable but evaluable disease as defined by the Response Evaluation Criteria in Solid Tumors (RECIST 1.1).

• Performance status 0-1 on the Eastern Cooperative Oncology Group (ECOG) scale.

• Must be able to provide tumor tissue obtained within 6 months of study enrollment. If such tissue is not available, a newly obtained core or excisional biopsy of a tumor lesion must be performed.

• Have an anticipated life expectancy of ≥3 months.

Exclusion Criteria:

• Have received any previous systemic therapy (including investigational agents) targeting PD-1/programmed cell death ligand 1 (PDL-1) or PD-1/PDL-2 signaling pathways (including previous participation in Merck MK-3475 trials). Prior treatment with olaratumab is allowed. Prior therapy with other immune checkpoint inhibitors, including but not limited to, anti-CD137 antibody or anti-cytotoxic T-lymphocyte-associated antigen-4 (CTLA-4) antibody, is not permitted.

• Have 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.

• Have active autoimmune disease or other syndrome that requires systemic steroids or autoimmune agents in the past 2 years.

• History of interstitial lung disease or non-infectious pneumonia.

• Have received a live-virus vaccine within 30 days prior to planned treatment start.

• Have histologically or cytologically confirmed Kaposi's sarcoma or gastrointestinal stromal tumor (GIST).

• Have inflammatory bowel disease for which the participant has used immunosuppressive agents within the last 2 years.