For mesothelioma patients and families who are interested in clinical trials, researching clinical trials and eligibility can be a time-consuming barrier to participation. The information about clinical trials is available on www.clinicaltrials.gov
Our goal is to feature one mesothelioma clinical trial monthly and break down to understandable terms, to decipher the eligibility requirements, and to possibly encourage participation in these trials.
CLINICAL TRIAL- NCT02718911
A Study of LY-33022855 in Combination With Durvalumab or Tremelimumab in Participants With Advanced Solid Tumors
Official Title- A Phase 1a/1b Trial Investigating the CSF-1R Inhibitor LY3022855 in Combination With Durvalumab (MED14736) or Tremelimumab in Patients With Advanced Solid Tumors
Listing on www.clinicaltrials.gov
Sponsor: Eli Lilly and Company – Collaborator Astra Zeneca
Location: Multiple locations throughout the world
Principal Investigator: Leena Gandhi M.D.at NYU – Study Director 1-877-285-4559 at Eli Lilly
Contact: NYU- 212 731 6199
Number of Participants: Estimated 178
Purpose: -The focus of this study is to evaluate the safety of the colony-stimulating factor 1 receptor (CSF-1R) inhibitor LY3022855 in combination with durvalumab or tremelimmab in patients with advanced solid tumors
Screening: – Must be willing to undergo pretreatment and on-treatment core needle or excisional tumor biopsies
Lab test that include:
- absolute neutrophil count> 1.5 x 10.9/Liters
- Platelet count. 100,000/ cubic millimeters
- Hemoglobin >9 gams per decliter
- Serum creatine, 1.5 x institutional upper limit of normal (ULN)
- Total billrubin <1.5 x institutional ULN
- Asparate aminotransferase (AST) and alanine aminotransferase (ALT), <2.5x institutional ULN or <5 x institutional ULN for participans with liver metastasis
- International normalized ratio (INR) or prothrombin time (PT) INR, 1.5 x institutional ULN or PT <% seconds above institutional ULN
Eligibility Criteria: Must have histological or cytological evidence of a diagnosis of cancer that is not amendable to curative therapy
Part B must have a type of malignancy that is being studied
Part A (all cohorts): Have the presence of measurable and/ or no measurable disease as defined by the Response Evaluation Criteria in Solid Tumors (RECIST)
Part B (all cohorts) Have the presence of measurable disease as defined by the RECIST
PTT or activated partial thromboplastin time (aPTT) < 5 seconda above institutional ULN
Thyroid stimulating hormone (TSH) or free thyroxine (T4) within the normal limits
Have a performance status 0 or 1 on the Eastern Cooperative Oncology Group (ECOG) scale
Exclusion Criteria: Are currently receiving or have used immunosuppressive medications within 28 days
Have symptomatic central nervous system (CNS) malignancy or metastasis
Have had any prior Grade>3 immune-related adverse event while receiving any previous immunotherapy agent
Have experienced a Grade>3 AE or a neurologic or ocular AE while receiving prior immunotherapy
How the Research Study Is Designed to Work: Trying to find the maximum dose tolerated by patients of drug LY3022855 when given in combination with Durvalumab- one group – another group LY3022855 and Tremelimumab. One group given escalating doses, the endpoint would be the maximum tolerated dose and measure the response through progression of disease, stable disease, complete response or death.
With any clinical trial, all participation is voluntary. Before enrollment a detailed consent form will be reviewed with the participant and signed. The participant can withdraw from a clinical trial at any point in time. Think about participating if able, the only way to progress to a cure for mesothelioma is through clinical trials.
Please do not hesitate to reach out with any questions.
Definition of Terms
Phase 1a/1b- initial phase of testing of an investigational drug in humans. Used to determine the side effects of the drug and how it works. Phase 1 is sometimes sub-divided into phases 1a and 1b with different doses being measured. New drug being combined with standard of care to find out what dose is best tolerated
Colony- stimulating factor 1 receptor (CSF-1R)- protein encoded by this gene is the receptor for colony stimulating factor 1- cytokine which controls the production, differentiation and function of macrophages. macrophages are important cells of the immune system that are formed in response to an infection. They are large specialized cells that recognize engulf and destroy target cells.
LY3022855- Human monoclonal antibody designed to target CSF1R, preventing ligands CSF1. Being investigated in phase 1 clinical trials, including a collaboration clinical trial with another immuno-oncology agent.
Durvalumab- another name is Imfinzi-ANTI pd-L1 antibody- blocks PD-l1 binding to PD-1 and CD 80- monoclonal antibody being used in treatment of some cancers
Tremelimumab- human immunoglobulin (Ig) G2 monoclonal antibody directed against the human T-cell receptor protein cytotoxic T-lymphocyte- associated protein 4 (CTLA4 with potential immune checkpoint inhibitory and antineoplastic activities.
Solid Tumor- is an abnormal mass of tissue that usually does not contain cysts or liquid area. Solid tumors may be benign (not cancer), or malignant (cancer). Different types of solid tumors are named for the type of cells that form them. Examples of solid tumors are sarcomas, carcinomas, and lymphomas. Leukemias (cancers of the blood) generally do not form solid tumors.