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Trial Summary
| Protocol No. | CTO-MK-3475-937 | ||
|---|---|---|---|
| Status | OPEN TO ACCRUAL | ||
| Principal Investigator | Turk, Anita | ||
| Scope | National | ||
| Phase | Phase III | ||
| Age Group | Adult | ||
| Title | A Phase 3 Double-blinded, Two-arm Study to Evaluate the Safety and Efficacy of Pembrolizumab (MK-3475) versus Placebo as Adjuvant Therapy in Participants with Hepatocellular Carcinoma and Complete Radiological Response after Surgical Resection or Local Ablation (KEYNOTE-937) | ||
| Description | This study will evaluate the safety and efficacy of pembrolizumab (MK-3475) versus placebo as adjuvant therapy in participants with hepatocellular carcinoma (HCC) and complete radiological response after surgical resection or local ablation. The primary hypotheses of this study are that adjuvant pembrolizumab is superior to placebo with respect to: 1) recurrence-free survival (RFS) as assessed by blinded independent central review (BICR); and 2) overall survival (OS). | ||
| Key Eligibility | In order to be eligible to take part in this trial, patients must meet the following criteria:
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| Applicable Disease Sites | Liver | ||
| Participating Institutions | Indiana University (IU) | ||
| Treatment Type | Treatment | ||
| Contact | Phone: (317) 278-5632 Email: iutrials@iu.edu | ||