A Study of LY3022855 in Combination With Durvalumab or Tremelimumab in Participants With Advanced Solid Tumors

Part of paid clinical trials in Denver, Colorado.

Sponsor
Eli Lilly and Company
Study ID
NCT02718911
Phase
PHASE1
Status
Completed

Conditions

  • Solid Tumor

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

Study Details

The main purpose of this study is to evaluate the safety of the colony-stimulating factor 1 receptor (CSF-1R) inhibitor LY3022855 in combination with durvalumab or tremelimumab in participants with advanced solid tumors.

Key Dates

Start date
Jun 16, 2016
Status verified
Oct 2023
Primary completion
Dec 14, 2018
Completion
Dec 14, 2018

Study Design

Enrollment
72 participants (actual)
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Experimental: LY3022855 + Durvalumab (Dose Escalation)
    Cohort D1A: LY3022855 (25 mg,QW)+Durvalumab (750mg,Q2W): 25 mg LY3022855 administered once weekly (QW) intravenously (IV) in combination with 750 mg durvalumab administered every 2 weeks (Q2W) IV. Treatment may continue until disease progression or discontinuation. Cohort D2A: LY3022855 (50 mg,QW)+Durvalumab (750mg,Q2W) 50 mg LY3022855 administered QW intravenously (IV) in combination with 750 mg durvalumab administered Q2W IV. Treatment may continue until disease progression or discontinuation. Cohort D3A: LY3022855 (75 mg,QW)+Durvalumab (750mg,Q2W) 75 mg LY3022855 administered QW intravenously (IV) in combination with 750 mg durvalumab administered Q2W IV. Treatment may continue until disease progression or discontinuation. Cohort D4A: LY3022855 (100 mg,QW)+Durvalumab (750mg,Q2W) 100 mg LY3022855 administered QW intravenously (IV) in combination with 750 mg durvalumab administered Q2W IV. Treatment may continue until disease progression or discontinuation.
  • Experimental: LY3022855 + Tremelimumab (Dose Escalation)
    Cohort T1A: LY3022855 (50 mg,QW) +Tremelimumab (75mg,Q4W): 50 mg LY3022855 administered QW intravenously (IV) in combination with 75 mg tremelimumab administered every 4 weeks (Q4W) IV. Treatment may continue until disease progression or discontinuation. Cohort T2A: LY3022855 (100 mg,QW) +Tremelimumab (75mg,Q4W) 100 mg LY3022855 administered QW intravenously (IV) in combination with 75 mg tremelimumab administered Q4W IV. Treatment may continue until disease progression or discontinuation. Cohort T3A: LY3022855 (100 mg,QW) +Tremelimumab (225 mg,Q4W) 100 mg LY3022855 administered QW intravenously (IV) in combination with 225 mg tremelimumab administered Q4W IV. Treatment may continue until disease progression or discontinuation. Cohort T4A: LY3022855 (100 mg,QW) +Tremelimumab (750 mg,Q4W) 100 mg LY3022855 administered QW intravenously (IV) in combination with 750 mg tremelimumab administered Q4W IV. Treatment may continue until disease progression or discontinuation.
  • Experimental: LY3022855 + Durvalumab (Expansion)
    Cohort B-1: NSCLC LY3022855+ Durvalumab: 100 mg LY3022855 administered QW intravenously (IV) in combination with 750 mg durvalumab administered Q2W IV. Treatment may continue until disease progression or discontinuation. Cohort B-1: OVARIAN LY3022855+ Durvalumab: 100 mg LY3022855 administered QW intravenously (IV) in combination with 750 mg durvalumab administered Q2W IV. Treatment may continue until disease progression or discontinuation.

Primary Outcome Measure

Recommended Phase 2 Dose of LY3022855 Combined With Durvalumab (Maximum Tolerated Dose [MTD]) [ Time Frame: Cycle 1 (4 weeks) ]

Locations (7)

FacilityCityStateZIPSite coordinators
Sarah Cannon Research Institute at HealthOneDenverColorado80218-
Florida Cancer SpecialistsSarasotaFlorida34232-
Winship Cancer Center Emory UniversityAtlantaGeorgia30322-
Columbia University College of Phys & SurgeonsNew YorkNew York10032-
New York University Medical CenterNew YorkNew York10016-
Sarah Cannon Cancer CenterNashvilleTennessee37203-
Tennessee Oncology PLLCNashvilleTennessee37203-

Find similar trials in Denver, CO

By research site
Sarah Cannon Research Institute at HealthOne· Denver, COFlorida Cancer Specialists· Sarasota, FLWinship Cancer Center Emory University· Atlanta, GAColumbia University College of Phys & Surgeons· New York, NYNew York University Medical Center· New York, NYSarah Cannon Cancer Center· Nashville, TN

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