City of Hope Medical Center
This phase I trial tests the safety, side effects and best dose of lenalidomide in combination with cosibelimab for the treatment of patients with mycosis fungoides or Sézary syndrome that has come back after a period of improvement (relapsed) or that does not respond to treatment (refractory).Lenalidomide is in a class of medications called immunomodulatory agents. It works by helping the immune system kill cancer cells and by helping the bone marrow to produce normal blood cells. Immunotherapy with monoclonal antibodies, such as cosibelimab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Giving lenalidomide in combination with cosibelimab may be safe and tolerable in treating patients with relapsed or refractory mycosis fungoides or Sézary syndrome.
PRIMARY OBJECTIVE: I. Obtain a preliminary estimate of the safety and tolerability of the combination of cosibelimab with lenalidomide in patients with relapsed/refractory (R/R) mycosis fungoides (MF) or Sézary Syndrome (SS). SECONDARY OBJECTIVE: I. Obtain a preliminary estimate of the efficacy of the combination of cosibelimab with lenalidomide in patients with relapsed/refractory (R/R) mycosis fungoides (MF) or Sézary Syndrome (SS), as assessed by overall response rate (ORR), complete response (CR) rate, time to response, duration of response, sustained response (ORR4), progression-free s…
Inclusion Criteria: * Documented informed consent of the participant and/or legally authorized representative. * Assent, when appropriate, will be obtained per institutional guidelines * Agreement to allow the use of archival tissue from diagnostic tumor biopsies * If unavailable, exceptions may be granted with study principal investigator (PI) approval * Age: ≥ 18 years * Eastern Cooperative Oncology Group (ECOG) 0-2 * Ability to read and understand English for questionnaires * Female patients of childbearing potential must have a negative pregnancy test within 24 hours of dosing * His…
Undergo blood sample collection
Undergo CT scan
Given IV
Given PO
Undergo PET scan
Ancillary studies
Undergo skin biopsy