Cemiplimab for Squamous Cell Carcinoma
(CONTRAC Trial)

Recruiting in Palo Alto (17 mi)

Overseen byGlenn J Hanna, MD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 1 & 2

Waitlist Available

Sponsor: Dana-Farber Cancer Institute

No Placebo Group

Breakthrough Therapy

Approved in 4 Jurisdictions

Trial Summary

What is the purpose of this trial?

In this research study, Cemiplimab is being evaluated as a treatment for advanced cutaneous squamous cell carcinoma in participants who have previously received an allogeneic hematopoietic stem cell transplant or kidney transplant. - This research study involves the following drug(s): * Cemiplimab * Everolimus or Sirolimus * Prednisone

Research Team

Glenn J Hanna, MD

Principal Investigator

Dana-Farber Cancer Institute

Eligibility Criteria

Adults with advanced skin cancer who've had a stem cell or kidney transplant can join. They need to be in decent health, have good organ function, and no severe immune conditions. Women must test negative for pregnancy and use contraception; men also need to use effective birth control.

Inclusion Criteria

I can care for myself but may not be able to do active work.

Willingness to provide blood and tissue from diagnostic biopsies

I have advanced skin cancer with a tumor larger than 1 cm.

See 5 more

Exclusion Criteria

I do not have any uncontrolled illnesses.

Participants receiving any other investigational agents

I have previously been treated with specific immunotherapies.

See 9 more

Treatment Details

Interventions

Cemiplimab (PD-1 Inhibitor)
Everolimus (mTOR Inhibitor)
Prednisone (Corticosteroid)
Sirolimus (mTOR Inhibitor)

Trial OverviewThe trial is testing Cemiplimab's effectiveness on advanced cutaneous squamous cell carcinoma in patients post-transplant. It includes drugs like Everolimus or Sirolimus and Prednisone as part of the treatment regimen.

Participant Groups

2Treatment groups

Experimental Treatment

Group I: Cohort 2 Cemiplimab + Everolimus/Sirolimus + PrednisoneExperimental Treatment4 Interventions

Participants who received a kidney transplant will receive * Cemiplimab via IV, flat predetermined dosage every 21 days * Everolimus or Sirolimus-least 7-10 days prior to receiving the first dose of cemiplimab (Cycle 1, Day 1) and then daily while receiving Cemiplimab * Prednisone 40 mg orally the day prior to the start of cemiplimab dosing (Cycle 1, Day 1) and then daily at tapering doses while receiving Cemiplimab

Group II: Cohort 1 CemiplimabExperimental Treatment1 Intervention

Participants who received allogeneic hematopoietic stem cell transplant -- Cemiplimab: via IV, flat predetermined dosage every 21 days

Cemiplimab is already approved in Canada, Brazil for the following indications: