Trials / Completed
CompletedNCT02475213
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
- Status
- Completed
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 146 (actual)
- Sponsor
- MacroGenics · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| BIOLOGICAL | Enoblituzumab Schedule 1 | enoblituzumab is administered by IV infusion once per week for up to 51 doses. |
| BIOLOGICAL | Pembrolizumab | Pembrolizumab is administered by IV infusion every 3 weeks for up to 17 doses. |
| BIOLOGICAL | Enoblituzumab Schedule 2 | Enoblituzumab is administered by IV infusion every 3 weeks for up to 17 doses |
| BIOLOGICAL | retifanlimab | Retifanlimab is administered by IV infusion every 3 weeks for up to 17 doses |
Timeline
- Start date
- 2015-07-01
- Primary completion
- 2021-08-18
- Completion
- 2021-08-18
- First posted
- 2015-06-18
- Last updated
- 2025-08-11
- Results posted
- 2025-08-11
Locations
20 sites across 1 country: United States
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT02475213. Inclusion in this directory is not an endorsement.