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



Status:Recruiting
Conditions:Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:18 - Any
Updated:4/5/2019
Start Date:July 3, 2017
End Date:October 9, 2020
Contact:There may be multiple sites in this clinical trial. 1-877-CTLILLY (1-877-285-4559) or
Email:ClinicalTrials.gov@lilly.com
Phone:1-317-615-4559

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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

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.


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.
We found this trial at
4
sites
1275 York Ave
New York, New York 10021
(212) 639-2000
Principal Investigator: William Tap
Phone: 646-888-4545
Memorial Sloan Kettering Cancer Center Memorial Sloan Kettering Cancer Center — the world's oldest and...
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450 Brookline Ave
Boston, Massachusetts 2215
617-632-3000
Principal Investigator: Andrew Wagner
Phone: 617-632-5204
Dana-Farber Cancer Institute Since it’s founding in 1947, Dana-Farber has been committed to providing adults...
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Leuven, 3001
Principal Investigator: Patrick Schöffski
Phone: 3216343821
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200 Lothrop St
Pittsburgh, Pennsylvania 15213
Principal Investigator: Melissa Burgess
Phone: 412-623-7277
University of Pittsburgh Medical Center UPMC is one of the leading nonprofit health systems in...
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