Cosibelimab for Skin Cancer

Not yet recruiting at 1 trial location

Overseen By Ann Silk, MD

Age: 18+

Sex: Any

Trial Phase: Phase 4

Sponsor: Dana-Farber Cancer Institute

Must not be taking: Anti-PD-1, Anti-PD-L1, Anti-CTLA-4, Steroids

Disqualifiers: Autoimmune disease, Severe ILD, Cardiovascular, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 2

Duration: 51 weeks

What You Need to Know Before You Apply

What is the purpose of 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)

Who Is on the Research Team?

Ann Silk, MD

Principal Investigator

Dana-Farber Cancer Institute

Are You a Good Fit for This Trial?

Inclusion Criteria

I had a kidney transplant at least 6 months ago.

I have an indolent (slow-growing) type of non-Hodgkin's lymphoma.

My skin cancer cannot be treated with surgery or radiation, or it has come back after such treatments.

Exclusion Criteria

COHORT B ONLY: History of solid organ transplant with specific exceptions.

Psychiatric illness or social situation affecting study compliance.

I do not have another cancer that could affect this study's results.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

1 visit (in-person)

Treatment

Participants receive cosibelimab with standard of care or alone for up to 17 cycles (21-day cycles)

51 weeks

Cycle 1 through Cycle 17 (in-person visits)

Follow-up

Participants are monitored for safety and effectiveness every three months after treatment

Up to 102 weeks

Follow-up every three months

Long-term follow-up

Participants are monitored for long-term outcomes and survival

Up to 147 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Cosibelimab

How Is the Trial Designed?

Group I: Cohort B: Cosibelimab Experimental Treatment 1 Intervention

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

Group II: Cohort A: Cosibelimab + Standard of Care Immunosuppressive Regimen Experimental Treatment 4 Interventions

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

Who Is Running the Clinical Trial?

Dana-Farber Cancer Institute

Lead Sponsor

Trials

1,128

Recruited

382,000+

Checkpoint Therapeutics, Inc.

Industry Sponsor

Trials

3

Recruited

430+