Cosibelimab for CSCC in Patients With Kidney Transplant or Hematologic Malignancy
Trial statusNot yet recruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age18+
SponsorDana-Farber Cancer Institute
About this trial
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)
Eligibility criteria
Qualifiers
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).
Chronic lymphocytic leukemia (CLL)
Small cell lymphocytic lymphoma (SLL)
Disqualifiers
Prior treatment within the past 12 months with any of the following classes of drugs: anti-PD-1 inhibitors, anti-PD-L1 inhibitors, or anti-CTLA-4 inhibitors.
Prior treatment within the past 6 months with CAR-T cell therapies, other cellular therapies, or multiagent cytotoxic chemotherapy regimens (e.g. R-CHOP). (Bispecific antibodies and EGFR- targeted therapies are permitted without a washout period.)
Participants who have adverse events due to prior anti-cancer therapy not recovered to Grade 1 or less, with the exception of alopecia, sensory neuropathy, and cytopenias.
Active autoimmune disease that is currently requiring systemic steroid treatment with prednisone >10mg daily (or equivalent), anti-CD20 antibodies, intravenous immunoglobulin (IVIG) or JAK inhibitors (ruxolitinib, tofacitinib, upadacitinib, etc).
Trial design
Treatments tested in this trial
- Cosibelimab
- Prednisone
- Sirolimus
- Everolimus
Treatment groups
80 Participants
are divided into 2 treatment groupsSponsors and collaborators
Dana-Farber Cancer Institute
Lead sponsor
Checkpoint Therapeutics, Inc.
Collaborator
Source ClinicalTrials.gov