A Study of LY3022855 in Combination With Durvalumab or Tremelimumab in Participants With Advanced Solid Tumors
Completed · Phase 1
Conditions studied: Solid Tumor
In brief
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 facts
- Study ID
- NCT02718911
- Run by
- Eli Lilly and Company
- People needed
- 72
- Starts
- 2016-06-16
- Expected to finish
- 2018-12-14
- Last updated by the study team
- 2023-10-16
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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 (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.
You may not qualify if…
- 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.
Where it is running
- 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
Full record on ClinicalTrials.gov
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