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

Conditions

• Head and Neck Cancer
• Melanoma
• Non Small Cell Lung Cancer
• Urothelial Carcinoma

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Enoblituzumab Schedule 1 — BIOLOGICAL
  enoblituzumab is administered by IV infusion once per week for up to 51 doses.
• Pembrolizumab — BIOLOGICAL
  Pembrolizumab is administered by IV infusion every 3 weeks for up to 17 doses.
• Enoblituzumab Schedule 2 — BIOLOGICAL
  Enoblituzumab is administered by IV infusion every 3 weeks for up to 17 doses
• retifanlimab — BIOLOGICAL
  Retifanlimab is administered by IV infusion every 3 weeks for up to 17 doses

Study Details

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.

Key Dates

Start date

Jul 31, 2015

Status verified

Aug 2025

Primary completion

Aug 18, 2021

Completion

Aug 18, 2021

Study Design

Enrollment

146 participants (actual)

Allocation

NON_RANDOMIZED

Intervention model

SEQUENTIAL

Primary purpose

TREATMENT

Arms

• Experimental: Cohort 1
  Enoblituzumab 3 mg/kg IV weekly plus pembrolizumab 2 mg/kg IV every 3 weeks
• Experimental: Cohort 2
  Enoblituzumab 10 mg/kg IV weekly plus pembrolizumab 2 mg/kg IV every 3 weeks
• Experimental: Cohort 3
  Enoblituzumab 15 mg/kg IV weekly plus pembrolizumab 2 mg/kg IV every 3 weeks
• Experimental: Cohort 4
  Enoblituzumab 15 mg/kg IV plus retifanlimab 375 mg IV every 3 weeks
• Experimental: Melanoma Cohort
  Enoblituzumab 15 mg/kg IV weekly plus pembrolizumab 2 mg/kg IV every 3 weeks
• Experimental: Urothelial Cancer Cohort
  Enoblituzumab 15 mg/kg IV weekly plus pembrolizumab 2 mg/kg IV every 3 weeks
• Experimental: Non-small Cell Cancer (NSCLC) Cohort
  Enoblituzumab 15 mg/kg IV weekly plus pembrolizumab 2 mg/kg IV every 3 weeks
• Experimental: Squamous Cell Cancer of Head and Neck (SCCHN) Cohort
  Enoblituzumab 15 mg/kg IV weekly plus pembrolizumab 2 mg/kg IV every 3 weeks

Primary Outcome Measure

Number of Participants With Dose-limiting Toxicities (DLT) After Administration of Enoblituzumab and Pembrolizumab or Retifanlimab [ Time Frame: Study Day 1-42, for Cohorts 1-4. ]

Locations (20)

Related coverage on Hipa.ai

• Pembrolizumab/Enoblituzumab Combination Reports Low DLTs in Refractory Cancers
  Pembrolizumab · Aug 11, 2025 · ClinicalTrials.gov

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