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



Status:Completed
Conditions:Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:18 - Any
Updated:1/17/2019
Start Date:June 16, 2016
End Date:December 14, 2018

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A Phase 1a/1b Trial Investigating the CSF-1R Inhibitor LY3022855 in Combination With Durvalumab (MEDI4736) or Tremelimumab in Patients With Advanced Solid Tumors

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.


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.
We found this trial at
8
sites
Denver, Colorado 80218
Principal Investigator: Gerald Falchook
Phone: 720-754-2610
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Atlanta, Georgia 30322
Principal Investigator: Ragini Kudchadkar
Phone: 404-775-5849
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Atlanta, GA
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Edegem,
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230 25th Ave N
Nashville, Tennessee 37203
(615) 329-7274
Principal Investigator: SMO Sarah Cannon Research Inst.
Phone: 615-329-7274
Sarah Cannon Cancer Center People who live with cancer
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250 25th Ave N, Ste 100
Nashville, Tennessee 37023
615-320-5090
Principal Investigator: Todd Bauer
Phone: 615-524-4439
Tennessee Oncology, PLLC Since 1976 Tennessee Oncology has been providing quality cancer care. In 2013,...
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New York, New York 10021
Principal Investigator: Leena Gandhi
Phone: 212-731-6199
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New York, NY
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New York, New York 10032
Principal Investigator: Gulam Manji
Phone: 212-317-3141
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New York, NY
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Sarasota, Florida 34232
Principal Investigator: Judy Wang
Phone: 941-377-9993
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Sarasota, FL
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