Not Yet RecruitingPhase 4

Cosibelimab for CSCC in Patients With Kidney Transplant or Hematologic Malignancy

United States80 participantsStarted 2026-07

Plain-language 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)

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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) * Lymphoplasmacytic lymphoma * Waldenström macroglobulinemia * Marginal zone lymphoma * Mantle cell lymphoma, indolent variety * Cutaneous T-cell lymphoma (mycosis fungoides and Sézary syndrome) * Examples of chronic myeloproliferative neoplasms (CMN), including but not limited to: * Chronic myelogenous leukemia (CML) * Polycythemia vera (PV) * Primary myelofibrosis * Essential thrombocythemia (ET) * Chronic neutrophilic leukemia * Chronic eosinophilic leukemia * Examples of myeloma, including but not limited to: * Multiple myeloma (MM) * Smoldering myeloma * Participants must have histologically or cytologically confirmed diagnosis of cutaneous squamous cell carcinoma (CSCC). * Note: Mixed histology is acceptable (e.g. basosquamous, squamous cell carcinoma with adnexal differentiation), and other histologic variants (sarcomatoid carcinoma, spindle cell carcinoma, poorly di…

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Best Overall Response Rate (BORR)

Timeframe: Up to 102 weeks.

Trial details

NCT IDNCT07426484

SponsorDana-Farber Cancer Institute

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2030-12-15

Contact for this trial

Ann Silk, MD

617-632-6836 Ann_Silk@dfci.harvard.edu

View on ClinicalTrials.gov More Cutaneous Squamous Cell Carcinoma trials

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.