Safety Study of Enoblituzumab (MGA271) in Combination With Ipilimumab in Refractory Cancer
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|ClinicalTrials.gov Identifier: NCT02381314|
Recruitment Status : Active, not recruiting
First Posted : March 6, 2015
Last Update Posted : March 6, 2018
|Condition or disease||Intervention/treatment||Phase|
|Melanoma Non Small Cell Lung Cancer||Biological: enoblituzumab plus ipilimumab||Phase 1|
This study is a Phase 1 open-label, dose escalation, and cohort expansion study of enoblituzumab administered intravenously (IV) on a weekly schedule for up to 51 doses in combination with IV ipilimumab administered on an every-3-week schedule for 4 doses.
The dose escalation phase is designed to characterize the safety and tolerability of the combination of enoblituzumab and ipilimumab and to define the maximum tolerated or administered dose (MTD/MAD) in patients with B7-H3 expressing mesothelioma, urothelial cancer, NSCLC, SCCHN, Clear cell renal cell carcinoma (ccRCC), ovarian cancer, melanoma, thyroid cancer, Triple negative breast cancer (TNBC), pancreatic cancer, colon cancer, soft tissue sarcoma, or prostate cancer.
The cohort expansion phase, 2 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 and NSCLC.
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)|
|Estimated Enrollment :||59 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 Ipilimumab in Patients With Melanoma, Non-Small Cell Lung Cancer, and Other Cancers|
|Actual Study Start Date :||March 26, 2015|
|Actual Primary Completion Date :||November 9, 2017|
|Estimated Study Completion Date :||September 2018|
Experimental: enoblituzumab plus ipilimumab
Enoblituzumab: Fc-optimized, humanized monoclonal antibody. Ipilimumab: Yervoy; recombinant, fully humanized IgG-1 CTLA-4 blocking antibody approved by the US Food and Drug Administration and the European Medicines Agency for the treatment of unresectable or metastatic melanoma.
Biological: enoblituzumab plus ipilimumab
enoblituzumab is administered by IV infusion once per week. Ipilimumab is administered by IV infusion every 3 weeks for up to 4 doses.
Other Name: enoblituzumab (MGA271); ipilimumab (Yervoy)
- Number of participants with adverse events [ Time Frame: 1 year ]Adverse events, serious adverse events
- Peak plasma concentration [ Time Frame: 7 weeks ]PK of MGA271 in combination with ipilimumab
- Number of participants that develop anti-drug antibodies [ Time Frame: 7 weeks ]Proportion of patients who develop anti-MGA271 antibodies, immunogenicity
- Change in tumor volume [ Time Frame: Weeks 9, 18, 27, 39, and 51 ]Anti-tumor activity of MGA271 in combination with ipilimumab 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): NCT02381314
|United States, California|
|UCLA Hematology-Oncology Clinic|
|Los Angeles, California, United States, 90095|
|United States, Connecticut|
|New Haven, Connecticut, United States, 06520|
|United States, Florida|
|Mount Sinai Medical Center|
|Miami Beach, Florida, United States, 33140|
|United States, Illinois|
|University of Chicago|
|Chicago, Illinois, United States, 60637|
|United States, Indiana|
|Indiana University Simon Cancer Center|
|Indianapolis, Indiana, United States, 46202|
|United States, Missouri|
|Washington University School of Medicine in St. Louis|
|Saint Louis, Missouri, United States, 63110|
|United States, New York|
|Columbia University Medical Center|
|New York, New York, United States, 10032|
|United States, Oregon|
|Providence Portland Medical Center|
|Portland, Oregon, United States, 97213|
|United States, Texas|
|Center for Oncology and Blood Disorders|
|Houston, Texas, United States, 77030|
|United States, Wisconsin|
|University of Wisconsin|
|Madison, Wisconsin, United States, 53792|
|Study Director:||James Vasselli, M.D.||MacroGenics|