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enoblituzumab plus ipilimumab

Phase 1

Melanoma | Monoclonal antibody | Oncology |MacroGenics, Inc.|Last Updated: Feb 8, 2022

Success Probability

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Market & Valuation

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Trial Design

UNCONTROLLED
Total Trials1
Total Enrollment24

FDA Designations

No designations recorded

Clinical trial landscape

enoblituzumab plus ipilimumab · 1 trial · 2 indications

Phase 1 1
NCT02381314Safety Study of Enoblituzumab (MGA271) in Combination With Ipilimumab in Refractory CancerMelanoma
COMPLETED24 Analytics
PHASE1COMPLETED
Safety Study of Enoblituzumab (MGA271) in Combination With Ipilimumab in Refractory Cancer
MelanomaUnlock trial analytics

Study Endpoints

Primary Endpoints

Number of participants with adverse events
1 year

Adverse events, serious adverse events

Secondary Endpoints

Peak plasma concentration
7 weeks
Number of participants that develop anti-drug antibodies
7 weeks
Change in tumor volume
Weeks 9, 18, 27, 39, and 51
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Study Design & Arms

AllocationNA
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
enoblituzumab plus ipilimumabEXPERIMENTALEnoblituzumab: 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.

Interventions

NameTypeDescription
enoblituzumab plus ipilimumabBIOLOGICALenoblituzumab is administered by IV infusion once per week. Ipilimumab is administered by IV infusion every 3 weeks for up to 4 doses.
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Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites10

Inclusion Criteria - Cohort Expansion Phase: * Histologically-proven, unresectable, locally advanced or metastatic melanoma or NSCLC * Melanoma: Advanced or metastatic melanoma patients may be systemic therapy naïve or may have received systemic treatment for unresectable locally advanced or met...

Countries:United States
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Frequently asked questions about enoblituzumab plus ipilimumab

What is Enoblituzumab used for?

Enoblituzumab is an investigational oncology drug being studied for the treatment of neuroblastoma and melanoma. It is also being evaluated in clinical trials for other B7-H3-expressing solid tumors, including non-small cell lung cancer, rhabdomyosarcoma, osteosarcoma, Ewing sarcoma, Wilms tumor, and desmoplastic small round cell tumor.

How does Enoblituzumab work?

Enoblituzumab targets B7-H3, a protein expressed on the surface of many solid tumors. By binding to B7-H3, the drug is designed to direct the immune system to attack and destroy cancer cells that express this protein.

Who makes Enoblituzumab?

Enoblituzumab is developed by MacroGenics, Inc., a biopharmaceutical company traded on the NASDAQ under the ticker symbol MGNX.

What phase is Enoblituzumab in?

Enoblituzumab is in Phase 1 clinical development. It is an investigational drug that has not been approved by the FDA and is still being studied in clinical trials.

What clinical trials is Enoblituzumab in?

Enoblituzumab has been studied in two completed Phase 1 clinical trials. NCT02381314 evaluated the drug in combination with ipilimumab in patients with refractory melanoma and non-small cell lung cancer. NCT02982941 evaluated Enoblituzumab as a single agent in children with B7-H3-expressing solid tumors, including neuroblastoma.

Is Enoblituzumab the same as MGA271?

Yes, Enoblituzumab is also known as MGA271. The clinical trial NCT02381314 refers to the drug as Enoblituzumab (MGA271), confirming that these names refer to the same investigational agent.