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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02718911
Recruitment Status : Completed
First Posted : March 24, 2016
Last Update Posted : January 15, 2019
Sponsor:
Collaborator:
AstraZeneca
Information provided by (Responsible Party):
Eli Lilly and Company

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Solid Tumor Drug: LY3022855 Drug: Durvalumab Drug: Tremelimumab Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 178 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase 1a/1b Trial Investigating the CSF-1R Inhibitor LY3022855 in Combination With Durvalumab (MEDI4736) or Tremelimumab in Patients With Advanced Solid Tumors
Actual Study Start Date : June 16, 2016
Actual Primary Completion Date : December 14, 2018
Actual Study Completion Date : December 14, 2018

Resource links provided by the National Library of Medicine

Drug Information available for: Durvalumab

Arm Intervention/treatment
Experimental: LY3022855 + Durvalumab (Dose Escalation)
LY3022855 given intravenously (IV) in combination with durvalumab given IV. Treatment may continue until disease progression or discontinuation.
Drug: LY3022855
Administered IV

Drug: Durvalumab
Administered IV
Other Name: MEDI4736

Experimental: LY3022855 + Tremelimumab (Dose Escalation)
LY3022855 given IV in combination with tremelimumab given IV. Treatment may continue until disease progression or discontinuation.
Drug: LY3022855
Administered IV

Drug: Tremelimumab
Administered IV

Experimental: LY3022855 + Durvalumab (Expansion)
LY3022855 given IV in combination with durvalumab given IV. Treatment may continue until disease progression or discontinuation.
Drug: LY3022855
Administered IV

Drug: Durvalumab
Administered IV
Other Name: MEDI4736




Primary Outcome Measures :
  1. Maximum Tolerated Dose (MTD) of LY3022855 [ Time Frame: Cycle 1 (4 weeks) ]

Secondary Outcome Measures :
  1. Proportion of Participants Who Exhibit Complete Response (CR) or Partial Response (PR) [Overall Response Rate (ORR)] [ Time Frame: Baseline through Measured Progressive Disease or Death (estimated up to 24 months) ]
  2. Proportion of Participants who Exhibit Stable Disease (SD) or CR or PR [Disease Control Rate (DCR)] [ Time Frame: Baseline through Measured Progressive Disease (estimated up to 24 months) ]
  3. Number of Participants with Anti-LY3022855, Anti-Durvalumab or Anti-Tremelimumab Antibodies [ Time Frame: Baseline through Follow-up (estimated up to 12 months) ]
  4. Pharmacokinetics (PK): Maximum Concentration (Cmax) of LY3022855 in Combination with either Durvalumab or Tremelimumab, and the Single-Dose [ Time Frame: Baseline through Follow up (estimated up to 12 months) ]


Information from the National Library of Medicine

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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:

  • Must have histological or cytological evidence of a diagnosis of cancer that is not amenable to curative therapy.
  • Part B: Must have a type of malignancy that is being studied.
  • Part A and Part B: 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:

  • Are currently receiving or have had prior use of immunosuppressive medication within 28 days before the first dose of study drug, with the exceptions of intranasal and inhaled corticosteroids or systemic corticosteroids at physiological doses, which are not to exceed 10 milligrams/day of prednisone, or an equivalent corticosteroid.
  • 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.

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): NCT02718911


Locations
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United States, Colorado
Sarah Cannon Research Institute at HealthOne
Denver, Colorado, United States, 80218
United States, Florida
Florida Cancer Specialists
Sarasota, Florida, United States, 34232
United States, Georgia
Winship Cancer Center Emory University
Atlanta, Georgia, United States, 30322
United States, New York
New York University Medical Center
New York, New York, United States, 10016
Columbia University College of Phys & Surgeons
New York, New York, United States, 10032
United States, Tennessee
Sarah Cannon Cancer Center
Nashville, Tennessee, United States, 37203
Tennessee Oncology PLLC
Nashville, Tennessee, United States, 37203
Belgium
Universitair Ziekenhuis Antwerpen
Edegem, Belgium, 2650
Universitair Ziekenhuis Gent
Gent, Belgium, 9000
GZA St Augustinus
Wilrijk, Belgium, 2610
Czechia
Masarykuv Onkology Institute
Brno, Czech Republic, Czechia, 656 53
Israel
Rambam Medical Center
Haifa, Israel, 3109601
Hadassah Medical Center
Jerusalem, Israel, 9112001
Sheba Medical Center
Ramat Gan, Israel, 5262000
Sponsors and Collaborators
Eli Lilly and Company
AstraZeneca
Investigators
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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:
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Responsible Party: Eli Lilly and Company
ClinicalTrials.gov Identifier: NCT02718911     History of Changes
Other Study ID Numbers: 16348
I5F-MC-JSCC ( Other Identifier: Eli Lilly and Company )
2016-000427-11 ( EudraCT Number )
First Posted: March 24, 2016    Key Record Dates
Last Update Posted: January 15, 2019
Last Verified: January 2019
Additional relevant MeSH terms:
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Neoplasms
Durvalumab
Tremelimumab
Antibodies, Monoclonal
Antineoplastic Agents, Immunological
Antineoplastic Agents
Immunologic Factors
Physiological Effects of Drugs