Cosibelimab for CSCC in Patients With Kidney Transplant or Hematologic Malignancy

NCT07426484 | Not Yet Recruiting Phase 4 DMC FDA Drug

• 1 other identifier: 25-743
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 2

Brief 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)

Conditions

Cutaneous Squamous Cell Carcinoma; Skin Cancer

Keywords

Advanced Cutaneous Squamous Cell Carcinoma; Cutaneous Squamous Cell Carcinoma; Skin Cancer; Kidney Transplant Recipient; Chronic lymphocytic leukemia (CLL); Myeloma; Waldenstrom macroglobulinemia; Solid Organ Transplant Recipient; Immunosuppressed; Lymphoma

Outcome Measures

Primary Outcomes (1)

• Best Overall Response Rate (BORR)

  BORR is defined as the proportion of participants whose best overall responses are complete metabolic response (CMR) and partial metabolic response (PMR). Per PERCIST 1.0 for target lesions, CMR is visual disappearance of all metabolically active tumor, and PMR is at least a 30% decrease in SUL peak (minimum 0.8-unit decrease) in the lesion with greatest uptake, not necessarily the same lesion.

  Up to 102 weeks.

Secondary Outcomes (8)

• Treatment-Emergent Adverse Events (TEAEs) Rate

  Treatment duration is up to 51 weeks, and adverse events will be collected through 30 days following the end of treatment.

• Immune-related Adverse Events (AE) Rate

  Treatment duration is up to 51 weeks, and adverse events will be collected through 30 days following the end of treatment.

• Allograft Rejection and Allograft Loss Rate in Cohort A

  Up to 51 weeks.

• Median Progression-Free Survival (PFS)

  Tumor assessments will be performed before Cycle 3, 5 Day 1 (28-day cycles) and every 4 cycles through Cycle 17. Follow-up assessments will occur on Cycle 18, 21, 29, and 33 Day 1.

• Duration of Response (DOR)

  2 years

Study Arms (2)

Cohort A: Cosibelimab + Standard of Care Immunosuppressive Regimen

EXPERIMENTAL

40 Kidney transplant recipients with advanced CSCC will be enrolled and will complete the following- * Baseline visit * Cycle 1 through Cycle 17 (21-day cycle) * Day 1: Predetermined dose Cosibelimab 1x daily. * Day 1 through 21: pre-determined dose of Prednisone 1X daily * Day 1 through 21: determined dose of sirolimus or everolimus 1X daily * Follow-up every three months * Long-term follow-up

Drug: Cosibelimab; Drug: Prednisone; Drug: Sirolimus; Drug: Everolimus

Cohort B: Cosibelimab

EXPERIMENTAL

40 Participants with co-diagnosis of hematologic malignancy/myeloproliferative disorder and advanced CSCC will be enrolled and will complete- * Baseline visit * Cycle 1 through Cycle 17 (21-day cycle) --Day 1: Predetermined dose Cosibelimab 1x daily. * Follow-up every three months * Long-term follow-up

Drug: Cosibelimab

Interventions

Cosibelimab DRUG

Anti-PD-L1 antibody, single dose vials, via intravenous (into the vein) infusion per protocol

Also known as: CK-301, Cosibelimab-ipdl, UNLOXCYT

Cohort A: Cosibelimab + Standard of Care Immunosuppressive Regimen; Cohort B: Cosibelimab

Prednisone DRUG

Corticosteroid, per standard of care

Cohort A: Cosibelimab + Standard of Care Immunosuppressive Regimen

Sirolimus DRUG

mTOR Inhibitor, per standard of care

Cohort A: Cosibelimab + Standard of Care Immunosuppressive Regimen

Everolimus DRUG

mTOR Inhibitor, per standard of care

Cohort A: Cosibelimab + Standard of Care Immunosuppressive Regimen

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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).
• Severe interstitial lung disease (ILD), or a history of pneumonitis that has required oral or IV steroids in the past 5 years.
• Participants who are receiving any other investigational agents for cancer within 2 weeks of study enrollment.
• Participants who have uncontrolled, symptomatic infections, or infections requiring systemic antibiotics (prophylactic antimicrobials are permitted).
• Participants who have uncontrolled or unstable brain metastases (or other CNS metastases) for whom systemic steroids are required. These patients are excluded because steroids may interfere with the effectiveness of immune checkpoint therapy.
• Uncontrolled or significant cardiovascular disease.
• Current need for dialysis (hemodialysis or peritoneal dialysis).
• History of stem cell transplant or bone marrow transplant
• Psychiatric illness or social situation that would preclude study compliance.
• Pregnant and breastfeeding women are excluded from this study because cosibelimab is classified as pregnancy class D agent with the potential for teratogenic or abortifacient effects. Because there is an unknown but potential risk for adverse events in nursing infants secondary to treatment of the mother with cosibelimab, breastfeeding should be discontinued if the mother is treated with cosibelimab.
• Participants with a prior or concurrent malignancy whose natural history or treatment has the potential to interfere with the safety or efficacy assessment of the study drug are excluded.
• COHORT A ONLY:

Sponsors & Collaborators

• Dana-Farber Cancer Institute: lead
• Checkpoint Therapeutics, Inc.: collaborator

Study Sites (2)

Brigham and Women's Hospital

Boston, Massachusetts, 02115, United States

Location

Dana-Farber Cancer Institute

Boston, Massachusetts, 02115, United States

Location

MeSH Terms

Conditions

Skin Neoplasms; Leukemia, Lymphocytic, Chronic, B-Cell; Neoplasms, Plasma Cell; Waldenstrom Macroglobulinemia; Lymphoma

Interventions

Prednisone; Sirolimus; Everolimus

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Skin Diseases; Skin and Connective Tissue Diseases; Leukemia, B-Cell; Leukemia, Lymphoid; Leukemia; Neoplasms by Histologic Type; Hematologic Diseases; Hemic and Lymphatic Diseases; Lymphoproliferative Disorders; Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Hemostatic Disorders; Vascular Diseases; Cardiovascular Diseases; Paraproteinemias; Blood Protein Disorders; Hemorrhagic Disorders

Intervention Hierarchy (Ancestors)

Pregnadienediols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Macrolides; Lactones; Organic Chemicals

Study Officials

• Ann Silk, MD

  Dana-Farber Cancer Institute

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ann Silk, MD

CONTACT

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

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Senior Physician/Medical Oncologist

Study Record Dates

• First Submitted: February 2, 2026
• First Posted: February 23, 2026
• Study Start (Estimated): July 1, 2026
• Primary Completion (Estimated): December 15, 2030
• Study Completion (Estimated): December 15, 2032
• Last Updated: February 23, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: Data can be shared no earlier than 1 year following the date of publication
• Access Criteria: Contact the Belfer Office for Dana-Farber Innovations (BODFI) at innovation@dfci.harvard.edu

Locations

US (2)