Houston, Texas 77030

  • Non Small Cell Lung Cancer

Purpose:

The purpose of this study is to evaluate the safety of enoblituzumab (MGA271) in combination with Yervoy (ipilimumab) 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 best dose of enoblituzumab to use when given with ipilimumab. 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 enoblituzumab in combination with ipilimumab.


Study summary:

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).


Criteria:

Inclusion Criteria - Cohort Expansion Phase: - Histologically-proven, unresectable, locally advanced or metastatic melanoma or NSCLC - Melanoma: Advanced or metastatic melanoma patients may be systemic therapy naïve or may have received systemic treatment for unresectable locally advanced or metastatic disease. A patient who previously received systemic therapy must have had progression on a checkpoint inhibitor (e.g., anti-PD-L1, anti-PD-1, anti-CTLA-4) as the most recent prior therapy. - NSCLC: NSCLC that has progressed during or following 1 or more prior systemic therapies for unresectable locally advanced or metastatic disease. Patients who are intolerant of, or have refused treatment with standard first line cancer therapy, will be allowed to enroll. Patients must not have had more than 5 prior systemic regimens (excluding experimental therapies) for unresectable locally advanced or metastatic disease. - B7-H3 expression is not required for eligibility in this study; however, tumor expression of B7-H3 will be evaluated for all patients. - Measurable disease per RECIST 1.1 criteria - ECOG performance status 0 or 1 - Acceptable laboratory parameters and adequate organ reserve. Exclusion Criteria - Cohort Expansion Phase: - Patients with a history of symptomatic central nervous system metastases, unless treated and asymptomatic - Patients with history of autoimmune disease with certain exceptions - History of allogeneic bone marrow, stem cell, or solid organ transplant - Treatment with systemic cancer therapy or investigational therapy within 4 weeks; radiation within 2 weeks; trauma or major surgery within 4 weeks - History of clinically-significant cardiovascular disease; gastrointestinal perforation; gastrointestinal bleeding, acute pancreatitis or diverticulitis within 4 weeks; - Active viral, bacterial, or systemic fungal infection requiring parenteral treatment within 7 days; positive for human immunodeficiency virus or AIDS, hepatitis B or C. - Known hypersensitivity to recombinant proteins, polysorbate 80, or any excipient contained in the drug or vehicle formulation for MGA271 or ipilimumab.


Study is Available At:


Original ID:

CP-MGA271-02


NCT ID:

NCT02381314


Secondary ID:


Study Acronym:


Brief Title:

Safety Study of Enoblituzumab (MGA271) in Combination With Ipilimumab in Refractory Cancer


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


Overall Status:

Completed


Study Phase:

Phase 1


Genders:

N/A


Minimum Age:

18 Years


Maximum Age:

N/A


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

MacroGenics


Oversight Authority:

United States: Food and Drug Administration


Reasons Why Stopped:


Study Type:

Interventional


Study Design:


Number of Arms:

1


Number of Groups:

0


Total Enrollment:

24


Enrollment Type:

Actual


Overall Contact Information

Official Name:Stacie Goldberg, M.D.
Study Director
MacroGenics

Study Dates

Start Date:March 26, 2015
Completion Date:September 26, 2018
Completion Type:Actual
Primary Completion Date:November 9, 2017
Primary Completion Type:Actual
Verification Date:March 2019
Last Changed Date:March 21, 2019
First Received Date:February 20, 2015

Study Outcomes

Outcome Type:Primary Outcome
Measure:Number of participants with adverse events
Time Frame:1 year
Safety Issues:False
Description:Adverse events, serious adverse events
Outcome Type:Secondary Outcome
Measure:Peak plasma concentration
Time Frame:7 weeks
Safety Issues:False
Description:PK of MGA271 in combination with ipilimumab
Outcome Type:Secondary Outcome
Measure:Number of participants that develop anti-drug antibodies
Time Frame:7 weeks
Safety Issues:False
Description:Proportion of patients who develop anti-MGA271 antibodies, immunogenicity
Outcome Type:Secondary Outcome
Measure:Change in tumor volume
Time Frame:Weeks 9, 18, 27, 39, and 51
Safety Issues:False
Description:Anti-tumor activity of MGA271 in combination with ipilimumab using both conventional RECIST 1.1 and immune-related RECIST criteria.

Study Interventions

Intervention Type:Biological
Name:enoblituzumab plus ipilimumab
Description:enoblituzumab is administered by IV infusion once per week. Ipilimumab is administered by IV infusion every 3 weeks for up to 4 doses.
Arm Name:enoblituzumab plus ipilimumab
Other Name:enoblituzumab (MGA271); ipilimumab (Yervoy)

Study Arms

Study Arm Type:Experimental
Arm Name:enoblituzumab plus ipilimumab
Description: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.

Study Agencies

Agency Class:Industry
Agency Type:Lead Sponsor
Agency Name:MacroGenics

Sample and Retention Information

There are no available Sample and Retention Information

Study References

There are no available Study References

Data Source: ClinicalTrials.gov

Date Processed: March 30, 2020

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