A Phase IV Master Protocol of Cosibelimab in Special Populations With Advanced Cutaneous Squamous Cell Carcinoma (CosiMaster)
Dana-Farber Cancer Institute
Summary
This is study is to evaluate the safety and efficacy of cosibelimab in special populations with advanced cutaneous squamous cell carcinoma (CSCC). The name of the drug involved in this research study is: -cosibelimab (a type of an anti-PD-L1 antibody)
Description
This is a Phase IV, multi-site, multi-cohort, open-label clinical trial investigating the safety and efficacy of cosibelimab in special populations with advanced cutaneous squamous cell carcinoma (CSCC). Checkpoint Therapeutics is supporting this research study by providing the study drug, cosibelimab. Participants will be enrolled into one of two study groups: Group A or Group B. Cosibelimab is FDA-approved for the treatment of advanced cutaneous squamous cell carcinoma The research study procedures include screening for eligibility, in-clinic visits, blood tests, urine tests, Computerized…
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: * COHORT A: Participant must have a history of kidney transplant (at least 6 months prior to enrollment). (A history of more than one kidney transplantation is permitted.) * COHORT B: Participant must have a diagnosis of a hematologic malignancy, including chronic myeloproliferative neoplasm (CMN) or an indolent non-Hodgkin's lymphoma (NHL), or multiple myeloma (MM). * Examples of indolent non-Hodgkin's lymphomas (NHL), including but not limited to: * Chronic lymphocytic leukemia (CLL) * Small cell lymphocytic lymphoma (SLL) * Follicular lymphoma (FL) * Lymphoplas…
Interventions
- DrugCosibelimab
Anti-PD-L1 antibody, single dose vials, via intravenous (into the vein) infusion per protocol
- DrugPrednisone
Corticosteroid, per standard of care
- DrugSirolimus
mTOR Inhibitor, per standard of care
- DrugEverolimus
mTOR Inhibitor, per standard of care
Locations (2)
- Brigham and Women's HospitalBoston, Massachusetts
- Dana-Farber Cancer InstituteBoston, Massachusetts