A Study of LY3022855 in Combination With Durvalumab or Tremelimumab in Participants With Advanced Solid Tumors
NCT ID: NCT02718911
Last Updated: 2023-10-16
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE1
72 participants
INTERVENTIONAL
2016-06-16
2018-12-14
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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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.
LY3022855
Administered IV
Durvalumab
Administered IV
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.
LY3022855
Administered IV
Tremelimumab
Administered IV
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.
LY3022855
Administered IV
Durvalumab
Administered IV
Interventions
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LY3022855
Administered IV
Durvalumab
Administered IV
Tremelimumab
Administered IV
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Part B: Must have a type of malignancy that is being studied.
* Part A and Part B (ovarian cancer cohort only): Must be willing to undergo pretreatment and on-treatment core needle or excisional tumor biopsies.
* Part A (all cohorts): Have the presence of measureable and /or nonmeasurable disease as defined by the Response Evaluation Criteria in Solid Tumors (RECIST) 1.1.
* Part B (all cohorts): Have the presence of measurable disease as defined by the RECIST 1.1.
* Have adequate normal organ and marrow function, including the following:
* Absolute neutrophil count ≥ 1.5 x 10⁹/Liters (L) (1500/cubic millimeters)
* Platelet count ≥ 100 x 10⁹/L (≥100,000/cubic millimeters)
* Hemoglobin ≥9 grams per deciliter or ≥5.6 millimoles per liter
* Serum Creatinine ≤1.5 × institutional upper limit of normal (ULN)
* Total bilirubin ≤1.5 × institutional ULN
* Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤2.5 × institutional ULN OR ≤5 × institutional ULN for participants with liver metastases
* International normalized ratio (INR) or prothrombin time (PT) INR ≤1.5 × institutional ULN or PT ≤5 seconds above institutional ULN
* PTT or activated partial thromboplastin time (aPTT) ≤5 seconds above institutional ULN
* Thyroid stimulating hormone (TSH) OR free thyroxine (T4) within the normal limits
* Have a performance status of 0 or 1 on the Eastern Cooperative Oncology Group (ECOG) scale.
Exclusion Criteria
* Have symptomatic central nervous system (CNS) malignancy or metastasis.
* Have had any prior Grade ≥3 immune-related adverse event (irAE) while receiving any previous immunotherapy agent, have any unresolved irAE Grade \>1, or any irAE that led to the permanent discontinuation of prior immunotherapy.
* Have experienced a Grade ≥3 AE or a neurologic or ocular AE of any grade while receiving prior immunotherapy.
18 Years
ALL
No
Sponsors
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AstraZeneca
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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Sarah Cannon Research Institute at HealthOne
Denver, Colorado, United States
Florida Cancer Specialists
Sarasota, Florida, United States
Winship Cancer Center Emory University
Atlanta, Georgia, United States
New York University Medical Center
New York, New York, United States
Columbia University College of Phys & Surgeons
New York, New York, United States
Sarah Cannon Cancer Center
Nashville, Tennessee, United States
Tennessee Oncology PLLC
Nashville, Tennessee, United States
Universitair Ziekenhuis Antwerpen
Edegem, , Belgium
Universitair Ziekenhuis Gent
Ghent, , Belgium
GZA St Augustinus
Wilrijk, , Belgium
Masarykuv Onkology Institute
Brno, Czech Republic, Czechia
Rambam Medical Center
Haifa, , Israel
Hadassah Medical Center
Jerusalem, , Israel
Sheba Medical Center
Ramat Gan, , Israel
Countries
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References
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Falchook GS, Peeters M, Rottey S, Dirix LY, Obermannova R, Cohen JE, Perets R, Frommer RS, Bauer TM, Wang JS, Carvajal RD, Sabari J, Chapman S, Zhang W, Calderon B, Peterson DA. A phase 1a/1b trial of CSF-1R inhibitor LY3022855 in combination with durvalumab or tremelimumab in patients with advanced solid tumors. Invest New Drugs. 2021 Oct;39(5):1284-1297. doi: 10.1007/s10637-021-01088-4. Epub 2021 Apr 14.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Related Links
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Click here for more information about this study: A Study of LY3022855 in Combination With Durvalumab or Tremelimumab in Participants With Advanced Solid Tumors
Other Identifiers
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I5F-MC-JSCC
Identifier Type: OTHER
Identifier Source: secondary_id
2016-000427-11
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
16348
Identifier Type: -
Identifier Source: org_study_id
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