Safety Study of Enoblituzumab (MGA271) in Combination With Ipilimumab in Refractory Cancer

Part of paid clinical trials in Los Angeles, California.

Sponsor
MacroGenics
Study ID
NCT02381314
Phase
PHASE1
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • enoblituzumab plus ipilimumab — BIOLOGICAL
    enoblituzumab is administered by IV infusion once per week. Ipilimumab is administered by IV infusion every 3 weeks for up to 4 doses.

Study Details

The purpose of this study is to evaluate the safety of enoblituzumab (MGA271) in combination with Yervoy (ipilimumab) when given to patients with B7-H3-expressing melanoma, squamous cell carcinoma of the head and neck (SCCHN), non small cell lung cancer (NSCLC) and other B7-H3 expressing cancers. The study will also evaluate what is the best dose of enoblituzumab to use when given with ipilimumab. 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 enoblituzumab in combination with ipilimumab.

Key Dates

Start date
Mar 26, 2015
Status verified
Feb 2022
Primary completion
Nov 9, 2017
Completion
Sep 26, 2018

Study Design

Enrollment
24 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: enoblituzumab plus ipilimumab
    Enoblituzumab: Fc-optimized, humanized monoclonal antibody. Ipilimumab: Yervoy; recombinant, fully humanized IgG-1 CTLA-4 blocking antibody approved by the US Food and Drug Administration and the European Medicines Agency for the treatment of unresectable or metastatic melanoma.

Primary Outcome Measure

Number of participants with adverse events [ Time Frame: 1 year ]

Locations (10)

FacilityCityStateZIPSite coordinators
UCLA Hematology-Oncology ClinicLos AngelesCalifornia90095-
Yale UniversityNew HavenConnecticut06520-
Mount Sinai Medical CenterMiami BeachFlorida33140-
University of ChicagoChicagoIllinois60637-
Indiana University Simon Cancer CenterIndianapolisIndiana46202-
Washington University School of Medicine in St. LouisSt LouisMissouri63110-
Columbia University Medical CenterNew YorkNew York10032-
Providence Portland Medical CenterPortlandOregon97213-
Center for Oncology and Blood DisordersHoustonTexas77030-
University of WisconsinMadisonWisconsin53792-

Find similar trials in Los Angeles, CA

By condition
MelanomaLung cancer
By specialty
OncologySkin cancerDermatologyLung oncologyLung disease
By research site
UCLA Hematology-Oncology Clinic· Los Angeles, CAYale University· New Haven, CTMount Sinai Medical Center· Miami Beach, FLUniversity of Chicago· Chicago, ILIndiana University Simon Cancer Center· Indianapolis, INWashington University School of Medicine in St. Louis· St Louis, MO

Related Studies