A Study of Olaratumab (LY3012207) Plus Pembrolizumab in Participants With Advanced or Metastatic Soft Tissue Sarcoma
NCT ID: NCT03126591
Last Updated: 2024-10-23
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE1
41 participants
INTERVENTIONAL
2017-07-03
2023-02-21
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
SEQUENTIAL
TREATMENT
NONE
Study Groups
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15 milligrams per kilogram (mg/kg) Olaratumab + 200 milligrams (mg) Pembrolizumab - Dose Escalation
Participants received15 mg/kg Olaratumab administered IV on Day 1 and Day 8 in addition to 200 mg Pembrolizumab administered IV on Day 1 of a 21-day cycle.
Olaratumab
Administered IV
Pembrolizumab (KEYTRUDA®)
Administered IV
20 mg/kg Olaratumab + 200 mg Pembrolizumab - Dose Escalation
Participants received 20 mg/kg Olaratumab administered IV on Day 1 and Day 8 in addition to 200 mg Pembrolizumab administered IV on Day 1 of a 21-day cycle.
Olaratumab
Administered IV
Pembrolizumab (KEYTRUDA®)
Administered IV
20 mg/kg Olaratumab + 200 mg Pembrolizumab - Dose Expansion
Participants received 20 mg/kg Olaratumab administered IV on Day 1 and Day 8 in addition to 200 mg Pembrolizumab administered IV on Day 1 of a 21-day cycle.
Olaratumab
Administered IV
Pembrolizumab (KEYTRUDA®)
Administered IV
Interventions
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Olaratumab
Administered IV
Pembrolizumab (KEYTRUDA®)
Administered IV
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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 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.
18 Years
ALL
No
Sponsors
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Merck Sharp & Dohme LLC
INDUSTRY
Eli Lilly and Company
INDUSTRY
Responsible Party
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Principal Investigators
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Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)
Role: STUDY_DIRECTOR
Eli Lilly and Company
Locations
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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
Herlev and Gentofte Hospital
Herlev, , Denmark
Gustave Roussy
Villejuif, , France
Countries
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Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Related Links
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A Study of Olaratumab (LY3012207) Plus Pembrolizumab in Participants With Advanced or Metastatic Soft Tissue Sarcoma
Other Identifiers
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I5B-MC-JGDQ
Identifier Type: OTHER
Identifier Source: secondary_id
2016-001949-19
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
KEYNOTE-505
Identifier Type: OTHER
Identifier Source: secondary_id
MK-3475-505
Identifier Type: OTHER
Identifier Source: secondary_id
15847
Identifier Type: -
Identifier Source: org_study_id
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