Safety Study of Enoblituzumab (MGA271) in Combination With Pembrolizumab in Refractory Cancer
Head and Neck Cancer
Non Small Cell Lung Cancer
Clear Cell Renal Cell Carcinoma
Triple Negative Breast Cancer
Soft Tissue Sarcoma
|Study Design:||Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||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|
- Number of participants with adverse events [ Time Frame: one year ]Adverse Events, Serious Adverse Events
- Peak plasma concentration [ Time Frame: 7 weeks ]PK of MGA271 in combination with pembrolizumab
- Number of participants that develop anti-drug antibodies [ Time Frame: One year ]Proportion of patients who develop anti-MGA271 antibodies, immunogenicity
- Change in tumor volume [ Time Frame: Weeks 6, 15, 24, 33, 42, 51 ]Anti-tumor activity of MGA271 in combination with pembrolizumab using both conventional RECIST 1.1 and immune-related RECIST criteria.
|Study Start Date:||July 2015|
|Estimated Study Completion Date:||August 2020|
|Estimated Primary Completion Date:||August 2018 (Final data collection date for primary outcome measure)|
Experimental: enoblituzumab plus pembrolizumab
Enoblituzumab: Fc-optimized, humanized monoclonal antibody. Pembrolizumab: Keytruda; human programmed death receptor-1 (PD-1)-blocking antibody approved by the US Food and Drug Administration for the treatment of patients with unresectable or metastatic melanoma and disease progression following ipilimumab and, if BRAF V600 mutation positive, a BRAF inhibitor, or with advanced (metastatic) non-small cell lung cancer (NSCLC) whose disease has progressed after other treatments and with tumors that express a protein called PD-L1. Keytruda is approved for use with a companion diagnostic, the PD-L1 IHC 22C3 pharmDx test, the first test designed to detect PD-L1 expression in non-small cell lung tumors.
enoblituzumab is administered by IV infusion once per week for up to 51 doses.
Other Name: MGA271Biological: Pembrolizumab
Pembrolizumab is administered by IV infusion every 3 weeks for up to 17 doses.
Other Name: Keytruda
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 drug.
All tumor evaluations will be carried out by both Response Evaluation Criteria in Solid Tumors (RECIST) and immune-related response criteria (irRC).
Please refer to this study by its ClinicalTrials.gov identifier: NCT02475213
|Contact: Soyoung Yun||240 email@example.com|
|United States, Florida|
|Moffitt Cancer Center||Active, not recruiting|
|Tampa, Florida, United States, 33612|
|United States, Maryland|
|University of Maryland Greenbaum Cancer Center||Recruiting|
|Baltimore, Maryland, United States, 21201|
|Contact: Shirley George firstname.lastname@example.org|
|Principal Investigator: Dan Zandberg, MD|
|United States, New York|
|Columbia University Medical Center||Recruiting|
|New York, New York, United States, 10032|
|Contact: Molly McGuinness 212-304-5552 email@example.com|
|Principal Investigator: Naiyer Rizvi, MD|
|United States, Pennsylvania|
|Hospital of the University of Pennsylvania/Abramson Cancer Center||Recruiting|
|Philadelphia, Pennsylvania, United States, 19104|
|Contact: Maryann Ghallagher, RN 215-662-7758 firstname.lastname@example.org|
|Contact: , RN|
|Principal Investigator: Charu Aggarwal, MD|
|University of Pittsburg||Recruiting|
|Pittsburg, Pennsylvania, United States|
|Contact: Shea McQuilkin, BSN, RN 412-623-6650 email@example.com|
|Principal Investigator: Robert Ferris, MD|
|United States, Texas|
|South Texas Accelerated Research Therapeutics, LLC||Recruiting|
|San Antonio, Texas, United States, 78229|
|Contact: Christina Duralde, RN, MSN 210-593-5242 firstname.lastname@example.org|
|Principal Investigator: Anthony Tolcher, M.D.|
|Study Director:||James Vasselli, M.D.||MacroGenics|