Methods

KEYNOTE-087 (NCT02453594) is a multicenter, nonrandomized, multicohort Phase II study comprising patients with cHL who have failed to achieve a response or progressed after auto-SCT and BV (cohort 1); patients who are not eligible for auto-SCT and have failed to achieve a response or progressed after BV (cohort 2); and patients who have failed to achieve a response or progressed after auto-SCT and have not received BV after auto-SCT (cohort 3). Key eligibility criteria include age ≥18 years, measurable disease, ECOG performance status 0/1, and adequate organ function. Exclusion criteria include immunosuppression, allogeneic stem cell transplantation within 5 years, active pneumonitis, and prior anti-PD-1/PD-L1 therapy. Treatment with pembrolizumab IV 200 mg Q3W will continue for ≤24 months or until confirmed disease progression, intolerable toxicity, or physician decision. AEs are collected throughout the study and for 30 days thereafter (90 days for serious AEs). Response is centrally assessed every 12 weeks per 2007 IWG criteria. Patients who achieve a complete response can discontinue treatment and then be retreated at the time of relapse. Primary efficacy end point is objective response rate (ORR) using IWG criteria per central review secondary end points are ORR per investigator review, ORR per central review using Lugano 5-point classification, complete remission rate, duration of response, progression-free survival, and overall survival. Exploratory end points include assessments of PK profile, relationship between candidate efficacy biomarkers and antitumor activity of pembrolizumab, and efficacy in patients who continue pembrolizumab beyond documented progression. Planned enrollment is ~180 patients.