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

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ClinicalTrials.gov Identifier: NCT03126591
Recruitment Status : Recruiting
First Posted : April 24, 2017
Last Update Posted : December 4, 2018
Sponsor:
Collaborator:
Merck Sharp & Dohme Corp.
Information provided by (Responsible Party):
Eli Lilly and Company

Brief 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.

Condition or disease Intervention/treatment Phase
Soft Tissue Sarcoma Drug: Olaratumab Drug: Pembrolizumab Phase 1

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 37 participants
Allocation: Non-Randomized
Intervention Model: Sequential Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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
Actual Study Start Date : July 3, 2017
Estimated Primary Completion Date : November 14, 2019
Estimated Study Completion Date : October 9, 2020


Arm Intervention/treatment
Experimental: Olaratumab Dose Level 1 + Pembrolizumab
Olaratumab given intravenously (IV) and pembrolizumab given IV.
Drug: Olaratumab
Administered IV
Other Name: LY3012207

Drug: Pembrolizumab
Administered IV
Other Name: MK3475

Experimental: Olaratumab Dose Level 2 + Pembrolizumab
Olaratumab given IV and pembrolizumab given IV.
Drug: Olaratumab
Administered IV
Other Name: LY3012207

Drug: Pembrolizumab
Administered IV
Other Name: MK3475

Experimental: Olaratumab + Pembrolizumab Expansion
Olaratumab given IV and pembrolizumab given IV.
Drug: Olaratumab
Administered IV
Other Name: LY3012207

Drug: Pembrolizumab
Administered IV
Other Name: MK3475




Primary Outcome Measures :
  1. Number of Participants with Olaratumab Dose Limiting Toxicities (DLTs) [ Time Frame: Cycle 1 (21 Days) ]
    DLT is defined as an adverse event (AE) during cycle 1 that is possibly related to the study drug and fulfills National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.0 criteria


Secondary Outcome Measures :
  1. Pharmacokinetics (PK): Maximum Serum Concentration (Cmax) of Olaratumab [ Time Frame: Post-dose on Days 1 and 8 of Cycles 1 and 3 (21 Day Cycles) ]
    PK: Cmax of olaratumab

  2. PK: Minimum Serum Concentration (Cmin) of Olaratumab [ Time Frame: Pre-dose on Day 1 of Cycles 2 and 4 (21 Day Cycles) ]
    PK: Cmin of olaratumab

  3. PK: Elimination Half-Life of Olaratumab [ Time Frame: Days 8 to 21 of Cycles 1 and 3 (21 Day Cycles) ]
    PK: Elimination half-life of olaratumab

  4. Number of Participants with Anti-Olaratumab Antibodies When Administered in Combination with Pembrolizumab [ Time Frame: Predose Cycle 1 Day 1 through Follow Up (Approximately 30 Months) ]
    Number of participants with anti-olaratumab antibodies

  5. Objective Response Rate (ORR): Percentage of Participants with a Complete Response (CR) or Partial Response (PR) [ Time Frame: Baseline to Measured Progressive Disease or Start of New Anti-Cancer Therapy (Approximately 18 Months) ]
    ORR is confirmed best overall tumor response of CR or PR

  6. Disease Control Rate (DCR): Percentage of Participants With a Best Overall Response of CR, PR, and Stable Disease (SD) [ Time Frame: Baseline to Measured Progressive Disease or Start of New Anti-Cancer Therapy (Approximately 18 Months) ]
    DCR defined as CR, PR or SD

  7. Duration of response (DoR) [ Time Frame: Date of CR or PR to Date of Objective Disease Progression or Death Due to Any Cause (Approximately 30 Months) ]
    DoR was defined as the time from the date of the first CR or PR to the first date of progressive disease (PD) or death from any cause

  8. Progression Free Survival (PFS) [ Time Frame: Baseline to Measured Progressive Disease or Death Due to Any Cause (Approximately 18 Months) ]
    PFS is defined as the time from randomization to the first date of objectively determined progressive disease or death from any cause, whichever is earlier

  9. Overall Survival (OS) [ Time Frame: Baseline to Death from Any Cause (Approximately 30 Months) ]
    OS defined as the time from the date of randomization to the date of death from any cause



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03126591


Contacts
Contact: There may be multiple sites in this clinical trial. 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 ClinicalTrials.gov@lilly.com

Locations
United States, Massachusetts
Dana Farber Cancer Institute Recruiting
Boston, Massachusetts, United States, 02115
Contact    617-632-5204      
Principal Investigator: Andrew Wagner         
United States, New York
Memorial Sloan Kettering Cancer Center Recruiting
New York, New York, United States, 10065
Contact    646-888-4545      
Principal Investigator: William Tap         
United States, Pennsylvania
University of Pittsburgh Medical Center Recruiting
Pittsburgh, Pennsylvania, United States, 15232
Contact    412-623-7277      
Principal Investigator: Melissa Burgess         
Belgium
Universitaire Ziekenhuizen Leuven - Campus Gasthuisberg Recruiting
Leuven, Belgium, 3000
Contact    3216343821      
Principal Investigator: Patrick Schöffski         
Denmark
Herlev Hospital Recruiting
Herlev, Denmark, 2730
Contact    4538682040      
Principal Investigator: Niels Junker         
France
Gustave Roussy Recruiting
Villejuif Cedex, France, 94805
Contact    33142114338      
Principal Investigator: Christophe Massard         
Sponsors and Collaborators
Eli Lilly and Company
Merck Sharp & Dohme Corp.
Investigators
Study Director: 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) Eli Lilly and Company

Additional Information:
Responsible Party: Eli Lilly and Company
ClinicalTrials.gov Identifier: NCT03126591     History of Changes
Other Study ID Numbers: 15847
I5B-MC-JGDQ ( Other Identifier: Eli Lilly and Company )
2016-001949-19 ( EudraCT Number )
KEYNOTE-505 ( Other Identifier: Merck )
First Posted: April 24, 2017    Key Record Dates
Last Update Posted: December 4, 2018
Last Verified: December 1, 2018

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Sarcoma
Neoplasms, Connective and Soft Tissue
Neoplasms by Histologic Type
Neoplasms
Pembrolizumab
Olaratumab
Antineoplastic Agents