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

Brief Summary

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 B7H3 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.

Tracking Information
First Received DateFebruary 20, 2015
Last Changed DateAugust 10, 2016
Start DateMarch 2015
Anticipated Primary Completion DateMarch 2018
Primary Outcome Measures

Number of participants with adverse events [Time Frame: 1 year]

Secondary Outcome Measures

Peak plasma concentration [Time Frame: 7 weeks]

Number of participants that develop anti-drug antibodies [Time Frame: 7 weeks]

Change in tumor volume [Time Frame: Weeks 9, 18, 27, 39, and 51]

Descriptive Information
PhasePhase 1
Study TypeInterventional
Condition
  • Melanoma
  • Head and Neck Cancer
  • Non Small Cell Lung Cancer
  • Mesothelioma
  • Urothelial Carcinoma
  • Clear Cell Renal Cell Carcinoma
  • Ovarian Cancer
  • Thyroid Cancer
  • Triple Negative Breast Cancer
  • Pancreatic Cancer
  • Colon Cancer
  • Soft Tissue Sarcoma
  • Prostate Cancer
Intervention
  • Biological: enoblituzumab plus ipilimumab
Study Arms / Comparison Groups1 / 0
Detailed Description

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, 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.

All tumor evaluations will be carried out by both Response Evaluation Criteria in Solid Tumors (RECIST) and immune-related response criteria (irRC).

Recruitment Information
Recruitment StatusRecruiting
Anticipated Enrollment84
GenderAll
Ages18 Years - N/A
Accepts Healthy VolunteersNo
Contact Soyoung Yun
Email: yuns@macrogenics.com
Phone: 240 552-8058
Eligibility Criteria

Inclusion Criteria:

- Histologically-proven, unresectable, locally advanced or metastatic melanoma, SCCHN, or NSCLC that express B7-H3.

- Melanoma that has progressed within 90 days with progression on a checkpoint inhibitor (e.g., anti-PD-L1, anti-PD-1, anti-CTLA-4) as the most recent prior therapy

- SCHNN or NSCLC that has progressed during or following 1 - 5 prior systemic regimens

- Mesothelioma that has progressed during or following at least 1 and up to 3 prior systemic treatments for unresectable locally advanced or metastatic disease. The prior systemic chemotherapy must have included a pemetrexed (anti-folate)-based regimen in combination with platinum agent. For patients in whom pemetrexed was contraindicated or not tolerated or not an approved therapy (e.g., peritoneal mesothelioma), prior therapy with a first-line platinum-based regimen is required.

- Urothelial cancer arising in the bladder, renal pelvis, ureter or urethra that has progressed during or following at least 1 and up to 5 prior systemic treatments for unresectable locally advanced or metastatic disease (includes anti-PD-L1,anti-PD-1, but excludes other experimental therapies). Patients must have received at least one platinum-containing regimen (e.g., gemcitabine/cisplatin [GC], dose-dense methotrexate/vinblastine/doxorubicin/cisplatin [DDMVAC], or carboplatinum/gemcitabine). No more than 5 prior systemic regimens allowed.

- Thyroid cancer that has progressed during or following at least 1 and up to 5 prior chemotherapy regimen(s). Prior therapy excludes experimental therapies given in Phase 1 trials.

- Pancreatic cancer that has progressed during or following at least 1 and up to 3 prior chemotherapy regimens. Prior therapy excludes experimental therapies given in Phase 1 trials.

- Ovarian cancer that has progressed during or following at least 2 and up to 4 prior therapeutic regimens (e.g., 2 prior platinum containing regimens or if platinum resistant, a liposomal doxorubicin or topotecan containing regimen). Prior therapy excludes experimental therapies given in Phase 1 trials

- Colon cancer that has progressed during or following at least 2 and up to 4 prior therapeutic regimens (e.g., fluoropyrimidine and/or irinotecan and/or oxaliplatin and/or anti-EGFR antibody containing regimens). Prior therapy excludes experimental therapies given in Phase 1 trials.

- Prostate cancer that has progressed during or following at least 1 and up to 5 prior therapeutic regimens (e.g., abiraterone, enzalutamide, docetaxel). Prior therapy excludes experimental therapies given in Phase 1 trials.

- Soft tissue sarcoma that has progressed during or following at least 1 and up to 5 prior therapeutic regimens. Prior therapy excludes experimental therapies given in Phase 1 trials.

- TNBC that has progressed during or following at least 1 and up to 5 prior therapeutic regimens. Prior therapy excludes experimental therapies given in Phase 1 trials.

- ccRCC that has progressed during or following at least 1 and up to 5 prior therapeutic regimens. Prior therapy excludes experimental therapies given in Phase 1 trials.

- Measurable disease per RECIST 1.1 criteria

- ECOG performance status 0 or 1

- Acceptable laboratory parameters and adequate organ reserve.

Exclusion Criteria:

- 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.

Administrative Information
NCTIDNCT02381314
Responsible Party,
SponsorMacroGenics
Verification DateAugust 2016
Mesothelioma Doctors by State
  • Trust Funds Set Aside
  • VA Benefits Available
  • Delivered within 24 hrs

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