Phase 1
Completed N=41
A Study of Olaratumab (LY3012207) Plus Pembrolizumab in Participants With Advanced or Metastatic Soft Tissue Sarcoma
Source: ClinicalTrials.gov NCT03126591 ↗Enrolled (actual)
41
Serious AEs
41.5%
Results posted
Oct 2024
Primary outcomePrimary: Number of Participants With Olaratumab Dose Limiting Toxicities (DLTs) — 0; 0; 0 participants
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Olaratumab Dose Limiting Toxicities (DLTs) |
0; 0; 0 | — |
| SECONDARY Pharmacokinetics (PK): Maximum Serum Concentration (Cmax) of Olaratumab |
385; 548; 529; NA; 682; 693 | — |
| SECONDARY PK: Minimum Serum Concentration (Cmin) of Olaratumab |
129; 141; 135; 132; 144; 134 | — |
| SECONDARY PK: Elimination Half-Life (t½) of Olaratumab |
5.20; 4.47; 4.12; NA; 7.82; 7.53 | — |
| SECONDARY Number of Participants With Anti-Olaratumab Antibodies (ADA) When Administered in Combination With Pembrolizumab |
1; 1; 2 | — |
| SECONDARY Objective Response Rate (ORR): Percentage of Participants With a Complete Response (CR) or Partial Response (PR) |
0; 0; 21.4 | — |
| SECONDARY Disease Control Rate (DCR): Percentage of Participants With a Best Response of CR, PR or Stable Disease (SD) |
14.3; 66.7; 53.6 | — |
| SECONDARY Duration of Response (DoR) |
16.16 | — |
| SECONDARY Progression Free Survival (PFS) |
1.38; 2.71; 2.69 | — |
| SECONDARY Overall Survival (OS) |
11.37; 16.39; 14.78 | — |
Eligibility 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.
Data sourced from ClinicalTrials.gov (NCT03126591). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.