Safety Study of Enoblituzumab (MGA271) in Combination With Pembrolizumab in Refractory Cancer
A Phase 1, Open-Label, Dose Escalation Study of MGA271 in Combination With Pembrolizumab in Patients With B7-H3-Expressing Melanoma, Squamous Cell Cancer of the Head and Neck, Non-Small Cell Lung Cancer and Other B7H3 Expressing Cancers
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),
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.
This study is a Phase 1 open-label, dose escalation, cohort expansion, and efficacy
follow-up study of enoblituzumab administered intravenously (IV) on a weekly schedule for up
to 51 doses in combination with IV pembrolizumab administered on an every-3-week schedule
for up to 17 doses.
The dose escalation phase is designed to characterize the safety and tolerability of the
combination of enoblituzumab and pembrolizumab and to define the maximum tolerated or
maximum administered dose (MTD/MAD). Patients with methothelioma, urethelial cancer, NSCLC,
SCCHN, clear cell renal cell carcinoma (ccRCC), ovarian cancer, melanoma, thyroid cancer,
triple negative breast cancer (TBNC), pancreatic cancer, colon cancer, soft tissue sarcoma,
or prostate cancer will be enrolled in this study phase.
In the cohort expansion phase, 3 cohorts of 16 patients each will be enrolled to further
evaluate the safety and potential efficacy of the combination administered at the MTD/MAD
dose in patients with melanoma, NSCLC, and SCCHN. Pre- and on-study biopsies are required
for melanoma patients in the cohort expansion phase.
The efficacy follow-up period consists of the 2-year period after the final dose of study
All tumor evaluations will be carried out by both Response Evaluation Criteria in Solid
Tumors (RECIST) and immune-related response criteria (irRC).
Melanoma, Head and Neck Cancer, Non Small Cell Lung Cancer, Mesothelioma, Urethelial Carcinoma, Clear Cell Renal Cell Carcinoma, Ovarian Cancer, Thyroid Cancer, Triple Negative Breast Cancer, Pancreatic Cancer, Colon Cancer, Soft Tissue Sarcoma, Prostate Cancer
Malanoma, Non small cell lung cancer, SCCHN, Other B7H3 expressing cancers