CI

At a glance

ClinicalIndex Comparison Record
Phase 1Completed· 146 enrolled
Drug / intervention
Enoblituzumab Schedule 1 +3 morebiological
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02475213
NCT02475213Phase 1Completed
CompareCT.gov

A Phase 1, Open-Label, Dose Escalation Study of MGA271 in Combination With Pembrolizumab and in Combination With MGA012 in Patients With Melanoma, Squamous Cell Cancer of the Head and Neck, Non-Small Cell Lung Cancer, Urothelial Cancer, and Other Cancers

MacroGenics·interventional·Posted Jun 18, 2015·Updated Aug 11, 2025

In Brief

A Phase 1 clinical trial evaluating Enoblituzumab Schedule 1, Pembrolizumab, and 2 other interventions for Melanoma and 3 related conditions. Completed, enrolled 146 participants across 20 sites.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsMelanoma, Head and Neck Cancer, Non Small Cell Lung Cancer, Urothelial Carcinoma
CountriesUnited States
Collaborators--

Timeline

Phase 1CompletedFinished
20162017201820192020202120222023202420252026
First PostedJun 18, 2015
Enrollment StartJul 1, 2015
Primary CompletionAug 18, 2021
TodayJul 2, 2026
Enrollment to primary: 6.1 yearsPosted 11.0 years ago

Interventions

Enoblituzumab Schedule 1biological

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

Pembrolizumabbiological

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

Enoblituzumab Schedule 2biological

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

retifanlimabbiological

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