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Phase II Trial of Efprezimod Alfa (CD24Fc, MK-7110) for the Prevention of Acute Graft-Versus-Host Disease (GVHD) Following Myeloablative Allogeneic Hematopoietic Stem Cell Transplantation (HSCT) (MK-7110-002)

NCT02663622 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 44

Last updated 2024-01-23

Study results available
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Summary

This is a multicenter prospective phase IIa dose escalation and phase IIa expansion cohort clinical trial designed to evaluate the safety and tolerability of efprezimod alfa for acute GVHD prophylaxis.

Conditions

Interventions

DRUG

Efprezimod alfa

Acute GVHD prophylaxis

DRUG

Methotrexate

Acute GVHD prophylaxis

DRUG

Tacrolimus

Acute GVHD prophylaxis

DRUG

Placebo

100 ml saline IV infusion.

Sponsors & Collaborators

  • Ohio State University

    collaborator OTHER

  • University of Michigan Rogel Cancer Center

    collaborator OTHER

  • Indiana University School of Medicine

    collaborator OTHER

  • Barbara Ann Karmanos Cancer Institute

    collaborator OTHER

  • National Cancer Institute (NCI)

    collaborator NIH

  • Oncoimmune, Inc., a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)

    lead INDUSTRY

Principal Investigators

  • Medical Director · Merck Sharp & Dohme LLC

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-09-19
Primary Completion
2020-06-08
Completion
2021-05-18
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02663622 on ClinicalTrials.gov