Cosibelimab for CSCC in Patients With Kidney Transplant or Hematologic Malignancy

Part of paid clinical trials in Boston, Massachusetts.

Sponsor
Dana-Farber Cancer Institute
Study ID
NCT07426484
Phase
PHASE4
Status
Not Yet Recruiting

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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Cosibelimab — DRUG
    Anti-PD-L1 antibody, single dose vials, via intravenous (into the vein) infusion per protocol
  • Prednisone — DRUG
    Corticosteroid, per standard of care
  • Sirolimus — DRUG
    mTOR Inhibitor, per standard of care
  • Everolimus — DRUG
    mTOR Inhibitor, per standard of care

Study Details

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)

Key Dates

Start date
Jul 31, 2026
Status verified
Feb 2026
Primary completion
Dec 15, 2030
Completion
Dec 15, 2032

Study Design

Enrollment
80 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Cohort A: Cosibelimab + Standard of Care Immunosuppressive Regimen
    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
  • Experimental: Cohort B: Cosibelimab
    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

Primary Outcome Measure

Best Overall Response Rate (BORR) [ Time Frame: Up to 102 weeks. ]

Central Contacts

Locations (2)

FacilityCityStateZIPSite coordinators
Brigham and Women's HospitalBostonMassachusetts02115
Ann Silk, MD
[email protected]
617-632-6836
Ann Silk, MD (PRINCIPAL_INVESTIGATOR)
Dana-Farber Cancer InstituteBostonMassachusetts02115
Ann Silk, MD
[email protected]
617-632-6836
Ann Silk, MD (PRINCIPAL_INVESTIGATOR)

Find similar trials in Boston, MA

By condition
Skin cancer
By specialty
OncologySkin cancerDermatology
By research site
Brigham and Women's Hospital· Boston, MADana-Farber Cancer Institute· Boston, MA

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