Neoadjuvant PD-1 Blockade for Melanoma

Recruiting in Palo Alto (17 mi)

+2 other locations

Overseen byGiorgos Karakousis, MD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Waitlist Available

Sponsor: Abramson Cancer Center of the University of Pennsylvania

Stay on Your Current Meds

No Placebo Group

Prior Safety Data

Breakthrough Therapy

Trial Summary

What is the purpose of this trial?The main purpose of this study is to determine the rate of positive sentinel lymph nodes (i.e. the closest draining lymph node(s) to the primary melanoma site) and to test whether treatment with pembrolizumab before surgery to remove melanoma reduces the rate of positive sentinel lymph nodes in patients with Stage IIB/C melanoma. Subjects with stage II melanoma will receive one dose of pembrolizumab 200 mg, then undergo standard definitive surgery with wide excision and sentinel lymph node (SLN) biopsy approximately 3 weeks after the initial dose of pembrolizumab. Post-operatively, subjects will receive up to 1 year of adjuvant pembrolizumab 200 mg every 3 weeks.

Eligibility Criteria

This trial is for adults over 18 with Stage IIB/C melanoma that can be surgically removed. They must have good performance status, normal organ function, and agree to contraception rules. Excluded are those with non-resectable melanoma, recent treatments or surgeries, severe allergies to pembrolizumab, active infections including HIV/Hepatitis B/C/TB, certain heart diseases, live vaccines taken recently, immunodeficiencies or suppressive therapies within a week before the trial.

Inclusion Criteria

I am 18 years old or older.

My melanoma is at stage IIB or IIC and can be surgically removed. I do not have uveal or mucosal melanoma.

I am not pregnant and follow the required birth control guidelines.

+4 more

Exclusion Criteria

I have not received a live vaccine in the last 30 days.

My liver is not functioning well (Child-Pugh score >6).

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.

+21 more

Participant Groups

The study tests if pembrolizumab given before surgery reduces positive sentinel lymph nodes in patients with Stage IIB/C melanoma. Participants receive one dose of pembrolizumab followed by surgery after about three weeks and then up to one year of adjuvant therapy post-operation.

1Treatment groups

Experimental Treatment

Group I: Neoadjuvant PembrolizumabExperimental Treatment2 Interventions

Subjects will receive one dose of pembrolizumab 200 mg. Approximately 3 weeks after the initial dose of pembrolizumab, subjects will undergo wide excision and sentinel lymph node (SLN) biopsy. Post-operatively, subjects will receive up to 1 year of adjuvant pembrolizumab 200 mg every 3 weeks.