Immunotherapy for Skin Cancer

Recruiting in Palo Alto (17 mi)

Overseen byDiwaker Davar, MD, M.Sc

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Waitlist Available

Sponsor: Diwakar Davar

Stay on Your Current Meds

No Placebo Group

Prior Safety Data

Breakthrough Therapy

Approved in 3 Jurisdictions

Trial Summary

What is the purpose of this trial?This phase II single-arm two-stage neoadjuvant study of pembrolizumab in patients with PD-1 naïve high-risk resectable cutaneous squamous cell carcinoma (cSCC) will be conducted over a 52-week period. The study will include patients who have not undergone surgery to remove disease, to formally evaluate whether both biologically and clinically high-risk disease may benefit from neoadjuvant anti-PD-1 therapy. Response to neoadjuvant anti-PD-1 therapy will be evaluated for association with improved landmark Relapse-free Survival (RFS).

Eligibility Criteria

Adults with high-risk cutaneous squamous cell carcinoma (cSCC) that hasn't been surgically removed may join this trial. They must have measurable disease, be in good health otherwise, and women of childbearing age must agree to contraception. People can't join if they've had recent cancer treatments, immune system issues, certain other cancers within 3 years, or are pregnant.

Inclusion Criteria

My organs are functioning well.

The participant (or legally acceptable representative if applicable) provides written informed consent for the trial

I agree to use contraception and not donate sperm for 120 days after my last treatment dose.

+7 more

Exclusion Criteria

Is pregnant or breastfeeding or expecting to conceive or father children within the projected duration of the study, starting with the Screening visit through 120 days after the last dose of trial treatment

Has a history or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the study, interfere with the subject's participation for the full duration of the study, or is not in the best interest of the subject to participate, in the opinion of the treating investigator

You have mental health or drug problems that might make it difficult for you to follow the study's requirements.

+18 more

Participant Groups

The study is testing Pembrolizumab injections as a pre-surgery treatment for cSCC over a year. It aims to see if the drug helps prevent cancer from coming back after surgery in patients who haven't received PD-1 inhibitors before.

1Treatment groups

Experimental Treatment

Group I: PembrolizumabExperimental Treatment1 Intervention

Neoadjuvant Phase: 200 mg IV infusion, every 3 weeks (Day 1 of each 3-week cycle, 2 cycles) Adjuvant Phase: Day 1 of each 3-week cycle, 15 cycles