Safety Study of Enoblituzumab (MGA271) in Combination With Pembrolizumab in Refractory Cancer
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|ClinicalTrials.gov Identifier: NCT02475213|
Recruitment Status : Active, not recruiting
First Posted : June 18, 2015
Last Update Posted : March 26, 2019
|Condition or disease||Intervention/treatment||Phase|
|Melanoma Head and Neck Cancer Non Small Cell Lung Cancer Urethelial Carcinoma||Biological: Enoblituzumab Biological: Pembrolizumab||Phase 1|
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.
During the Cohort Expansion Phase, additional cohorts of patients with B7-H3 expressing unresectable, locally-advanced or metastatic melanoma (up to n=16), 2 cohorts of NSCLC (n= up to 20 in each cohort), 2 cohorts of SCCHN (up to n=20 in each cohort) or urothelial cancer (up to n=16) will be enrolled to receive MGA271 in combination with pembrolizumab at the MTD (or MAD) established from the Dose Escalation Phase of the study.
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).
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||134 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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 B7-H3-Expressing Cancers|
|Study Start Date :||July 2015|
|Estimated Primary Completion Date :||September 2019|
|Estimated Study Completion Date :||August 2020|
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: MGA271
Pembrolizumab is administered by IV infusion every 3 weeks for up to 17 doses.
Other Name: Keytruda
- 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02475213
Show 21 Study Locations
|Study Director:||Stacie Goldberg, M.D.||MacroGenics|