CLINICALTRIALS.GOV RECORD (excerpt) — NCT9999001
--- SYNTHETIC DEMONSTRATION DOCUMENT — NOT A REAL TRIAL ---

Study Title
A Phase 3 Randomized, Double-Blind, Placebo-Controlled Trial of ORT-451 (Meraltacept) as
First-Line Treatment for Adults With Unresectable or Metastatic Melanoma (MELIRA-3)

NCT Number: NCT9999001

Sponsor
Orion Therapeutics, Inc.
DUNS: 099001234

Collaborator (Contract Research Organization)
Bluewave Clinical Research, Ltd. — delegated activities: site management, monitoring,
data management, medical writing, pharmacovigilance

Principal Investigator
Elena Marquez, M.D., Ph.D. — Coordinating Principal Investigator
Massachusetts General Hospital, Boston, MA, United States

Medical Monitor
Robert Kingsley, M.D. — Bluewave Clinical Research (contract medical monitor)

Study Design
Phase: 3
Status: Recruiting
Estimated Enrollment: 640 participants (randomized 1:1)
Actual Study Start: March 1, 2024
Estimated Primary Completion: December 31, 2026

Intervention (Investigational Product)
Name: ORT-451
International Nonproprietary Name (INN): meraltacept
Sponsor Development Code: ORT-451
Modality: Humanized IgG1 monoclonal antibody
Molecular Target: PD-L1 (programmed death-ligand 1)
Approval Status: Investigational (Phase 3)

Condition (Indication)
Metastatic Melanoma (MeSH: D008545; ICD-10: C43)

Trial Sites (selected)
    Massachusetts General Hospital — Boston, MA, United States
    Mayo Clinic Rochester — Rochester, MN, United States
    UCSF Helen Diller Family Comprehensive Cancer Center — San Francisco, CA, United States
    Charité — Universitätsmedizin Berlin — Berlin, Germany
    National Cancer Center Hospital — Tokyo, Japan
    (36 additional sites globally)

Protocol
Protocol Version: 3.1
Effective Date: June 15, 2024
Governing Regulations: ICH E6 (R2) Good Clinical Practice; EU CTR 536/2014 (EU sites);
21 CFR Part 11 (electronic records)

Regulatory Submissions Referenced
Investigational New Drug (IND) 199-045 — U.S. FDA (Orion Therapeutics)
Clinical Trial Application EMEA/H/CTA/2023/091 — European Medicines Agency (Orion Therapeutics)
