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Safety Study of Enoblituzumab (MGA271) in Combination With Pembrolizumab or MGA012 in Refractory Cancer

NCT02475213 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 146

Last updated 2025-08-11

Study results available
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Summary

The purpose of this study is to evaluate the safety of enoblituzumab (MGA271) in combination with Keytruda (pembrolizumab) when given to patients with B7-H3-expressing melanoma, squamous cell carcinoma of the head and neck (SCCHN), non small cell lung cancer (NSCLC), Urothelial Cancer and other B7-H3 expressing cancers. The study will also evaluate what is the highest dose of enoblituzumab that can be given safely when given with pembrolizumab. Assessments will also be done to see how the drug acts in the body (pharmacokinetics (PK), pharmacodynamics) and to evaluate potential anti-tumor activity of MGA271 in combination with pembrolizumab. Safety and efficacy of enoblituzumab in combination with MGA012 (anti-PD-1 monoclonal antibody; also known as INCMGA00012) will also be evaluated.

Conditions

Interventions

BIOLOGICAL

Enoblituzumab Schedule 1

enoblituzumab is administered by IV infusion once per week for up to 51 doses.

BIOLOGICAL

Pembrolizumab

Pembrolizumab is administered by IV infusion every 3 weeks for up to 17 doses.

BIOLOGICAL

Enoblituzumab Schedule 2

Enoblituzumab is administered by IV infusion every 3 weeks for up to 17 doses

BIOLOGICAL

retifanlimab

Retifanlimab is administered by IV infusion every 3 weeks for up to 17 doses

Sponsors & Collaborators

Principal Investigators

  • Ashley Ward, MD · MacroGenics

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-07-31
Primary Completion
2021-08-18
Completion
2021-08-18
FDA Drug
Yes

Countries

  • United States

Study Locations

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Entities

Drugs
Diseases
Companies

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 NCT02475213 on ClinicalTrials.gov