Neoplasms

All Conditions

Skin and Connective Tissue Diseases

Respiratory Tract (Lung and Bronchial) Diseases

Rare Diseases

Carcinoma

Melanoma

Carcinoma, Non-Small-Cell Lung

Carcinoma, Squamous Cell

Head and Neck Neoplasms

Lung Neoplasms

Respiratory Tract Neoplasms

Thoracic Neoplasms

Lung Diseases

Respiratory Tract Diseases

Carcinoma, Bronchogenic

Bronchial Neoplasms

Neuroendocrine Tumors

Neuroectodermal Tumors

Neuroectodermal Tumors, Primitive

Neoplasms, Germ Cell and Embryonal

Neoplasms by Histologic Type

Neoplasms, Nerve Tissue

Nevus, Pigmented

Nevus

Nevi and Melanomas

Skin Neoplasms

Skin Diseases

Neuroendocrine Tumor

Neuroepithelioma

Antineoplastic Agents

All Drugs and Chemicals

Pembrolizumab

Antibodies

Antibodies, Monoclonal

Immunoglobulins

Mitoguazone

Antineoplastic Agents, Immunological

Immune Checkpoint Inhibitors

enoblituzumab 3 mg/kg IV weekly plus pembrolizumab 2 mg/kg IV every 3 weeks

enoblituzumab 10 mg/kg IV weekly plus pembrolizumab 2 mg/kg IV every 3 weeks

enoblituzumab 15 mg/kg IV weekly plus pembrolizumab 2 mg/kg IV every 3 weeks

enoblituzumab 15 mg/kg IV weekly plus MGA012 375 mg

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

Enoblituzumab

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

MGA012

Chet Bohac, PharmD MD MSc

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.

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

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

PK of MGA271 in combination with pembrolizumab

Proportion of patients who develop anti-MGA271 antibodies, immunogenicity

Anti-tumor activity of MGA271 in combination with pembrolizumab and in combination with MGA012 using both conventional RECIST 1.1.

Anti-tumor activity of MGA271 in combination with pembrolizumab and in combination with MGA012 using immune-related RECIST criteria.

MacroGenics

Symptoms and General Pathology

Recurrence

Squamous Cell Carcinoma of Head and Neck

Neoplasms, Glandular and Epithelial

Neoplasms, Squamous Cell

Laryngeal Cancer

Immunomodulating Agents

enoblituzumab

MGD013

This is an open-label study designed to evaluate safety and efficacy of enoblituzumab in combination with MGA012 or MGD013 in first-line treatment of patients with recurrent or metastatic squamous cell carcinoma of the head and neck (SCCHN).

The study will initially be conducted in 2 modules, Module X (enoblituzumab plus MGA012) and Module Y (enoblituzumab plus MGD013). Enrollment into Modules X and Y, with approximately 30 patients each, will occur independently in a non-randomized fashion. Data from these modules will determine if further evaluation will occur in randomized Module A (Phase 2) and randomized Module B (Phase 3).

Parallel study model refers to concurrent enrollment of non-randomized Modules X and Y.

Enoblituzumab Plus MGA012 or MGD013 in Squamous Cell Carcinoma of the Head and Neck

A Phase 2/3 Open-Label Trial to Evaluate Enoblituzumab in Combination With MGA012 or MGD013 in the First-Line Treatment of Patients With Recurrent or Metastatic Squamous Cell Carcinoma of the Head and Neck

Proportion of patients with best overall response of complete response (CR) plus partial response (PR) per RECIST 1.1

Evaluation of adverse events and serious adverse events

Time from start of study treatment to the first documented disease progression per RECIST v1.1 or death due to any cause, whichever occurs first.

Percentage of patients who experienced response of CR, PR or stable disease for at least 3 months from start of study treatment

Time from the date of initial response to the date of first documented progression or death from any cause, whichever occurs first

Percentage of patients developing anti-drug antibodies to enoblituzumab and/or MGA012

Percentage of patients developing anti-drug antibodies to enoblituzumab and/or MGD013

Maximum serum concentration of enoblituzumab and MGA012

Trough serum concentration of enoblituzumab and MGA012

Maximum serum concentration of enoblituzumab and MGD013

Trough serum concentration of enoblituzumab and MGD013

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Safety Study of Enoblituzumab (MGA271) in Combination With Pembrolizumab or MGA012 in Refractory Cancer	NCT02475213	Melanoma Head and Neck C... Non Small Cell ... Urethelial Carc...	Enoblituzumab Pembrolizumab MGA012	18 Years -	MacroGenics
Enoblituzumab Plus MGA012 or MGD013 in Squamous Cell Carcinoma of the Head and Neck	NCT04129320	Head and Neck C... Squamous Cell C...	enoblituzumab MGA012 MGD013	18 Years -	MacroGenics

Spots Global Cancer Trial Database for mga012

Every month we try and update this database with for mga012 cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Spots Global Cancer Trial Database for mga012

Every month we try and update this database with for mga012 cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for mga012 cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.