A Study of the Safety and Effectiveness of HBI-8000 with Nivolumab to Treat Melanoma, Renal Cell Carcinoma and Non-Small Cell Lung Cancer

Overview

  • Study type

    Interventional
  • Study phase

    I/II
  • Study IDs

  • Describes the nature of a clinical study. Types include:

    • Observational study — observes people and measures outcomes without affecting results.
    • Interventional study (clinical trial) — studies new tests, treatments, drugs, surgical procedures or devices.
    • Medical records research — uses historical information collected from medical records of large groups of people to study how diseases progress and which treatments and surgeries work best.
  • During the early phases (phases 1 and 2), researchers assess safety, side effects, optimal dosages and risks/benefits. In the later phase (phase 3), researchers study whether the treatment works better than the current standard therapy. They also compare the safety of the new treatment with that of current treatments. Phase 3 trials include large numbers of people to make sure that the result is valid. There are also less common very early (phase 0) and later (phase 4) phases. Phase 0 trials are small trials that help researchers decide if a new agent should be tested in a phase 1 trial. Phase 4 trials look at long-term safety and effectiveness, after a new treatment has been approved and is on the market.

  • Site IRB
    • Scottsdale/Phoenix, Arizona: 16-004675
    NCT ID: NCT02718066
    Sponsor Protocol Number: HBI-8000-302

About this study

The purpose of this study is to evaluate the safety, tolerability and effectiveness of HBI-8000 when combined with a standard dose and regimen of nivolumab.

 

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. If you need assistance understanding the eligibility criteria, please contact the study team.

See eligibility criteria

Inclusion Criteria

  • Patients may be entered in the study only if they meet all of the following criteria
    1. Adults at least 18 years of age
    2. Eastern Cooperative Oncology Group (ECOG) performance status ≤ 1
      1. Subjects with histopathologically or cytologically confirmed diagnosis of non-uveal Melanoma, RCC or NSCLC, for whom the use of nivolumab is indicated. NSCLC subjects with EGFR or ALK genomic aberrations in tumor should have disease progression on FDA-approved therapy for these aberrations prior to receiving nivolumab. (Phase 1b)
      2. Subjects with histopathologically or cytologically confirmed diagnosis of non-uveal Melanoma, or NSCLC, for whom the use of nivolumab is indicated. NCSLC subjects with EGFR or ALK genomic aberrations in tumor should have disease progression on FDA-approved therapy for these aberrations prior to receiving nivolumab. (Phase 2 expansion)
      3. Non-uveal melanoma and NSCLC patients whose disease has progressed after achieving SD, PR or CR on previous treatment with antagonists to PD1-PD-L1 axis, or patients whose disease remains stable on previous treatment with antagonists to PD1-PD-L1 axis and modification to treatment is being considered. NSCLC patients with EGFR or ALK genomic aberrations in tumor should have disease progression on FDA-approved therapy for these aberrations prior to receiving nivolumab. (Phase 2 expansion)
    3. Subject must have at least one measurable target lesion as defined by Response Evaluation Criteria in Solid Tumors (RECIST) v.1.1.
    4. Evaluation Criteria in Solid Tumors (RECIST) v.1.1.
    5. All prior systemic therapy (chemotherapy, mutation targeting therapy, immune checkpoint therapy), surgical or radiation treatment must have been completed at least 4 weeks before study drug administration (2 weeks for palliative radiotherapy, 1 week for minor surgery) pending full recovery from therapy.
    6. The following laboratory results within 7 days prior to study drug administration: Adequate hematopoietic, electrolyte, hepatic, and renal laboratory findings as defined below:
      1. WBC ≥ 3000/μL 
      2. Neutrophils ≥ 1500/μL 
      3. Platelets ≥ 100x103/μL 
      4. Hemoglobin ≥ 9.0 g/dL independent of transfusion 
      5. Creatinine ≤ 1.5 mg/dL 
      6. AST and ALT ≤ 3 x ULN 
      7. Alkaline phosphatase ≤ 2.5 x ULN unless bone metastases present 
      8. Bilirubin ≤ 1.5 x ULN (unless known Gilbert’s disease where it must be ≤3xULN)
      9. Serum albumin ≥3.0 g/dL
    7. Life expectancy ≥ 12 weeks.
    8. A negative serum pregnancy test at baseline for women of childbearing potential.
    9. Are willing to abstain from heterosexual activity or practice physical barrier contraception prior to time of study entry to at least 5 months after the last day of treatment.
    10. Have the ability to understand and the willingness to sign a written informed consent document.

Exclusion Criteria

  • Subjects who fulfill any of the following criteria at screening will not be eligible for admission into the study:History of Grade 3 or above hypersensitivity reactions to other monoclonal antibodies.
  1. Subjects with a history of a cardiovascular illness including:
    1. QTcF > 450 ms in male, and > 470 ms in female, congenital long QT syndrome, congestive heart failure (New York Heart Association Grade III or IV); unstable angina or myocardial infarction within the previous 6 months; or symptomatic cardiac arrhythmia despite medical management.
  2. Uncontrolled hypertension, SBP> 160 or DBP>100.
  3. Subjects with untreated, or treated brain metastasis, unless stable for 4 weeks or more and not requiring steroids.
  4. Presence of leptomeningeal disease.
  5. History of hemorrhagic diarrhea, inflammatory bowel disease, active uncontrolled peptic ulcer disease or recurrent pleural effusion requiring repetitive palliative thoracentesis within 3 months prior to study entry, except for subjects with a pleurex port. and immune-mediated toxicity leading to treatment discontinuation
  6. Active, known, or suspected autoimmune disease, except for type I diabetes mellitus, hypothyroidism only requiring hormone replacement, skin disorders (such as vitiligo, psoriasis, or alopecia).
  7. Active uncontrolled bacterial, viral, or fungal infection requiring systemic therapy.
  8. Known history of testing positive for human immunodeficiency virus (HIV), known acquired immunodeficiency syndrome (AIDS).
  9. Active hepatitis B (serum hepatitis B surface antigen [HBV sAg] positive), or hepatitis C (HCV antibody test or serum hepatitis C RNA positive) indicating acute or chronic infection.
  10. Subjects with a condition requiring systemic treatment with either corticosteroids (> 10 mg daily prednisone equivalents) or other immunosuppressive medications within 14 days of study drug administration. Inhaled or topical steroids are permitted.
  11. Use of other investigational agent (drug not marketed for any indication) within 28 days or at least 5 half-lives (whichever is longer) before study drug administration.
  12. Pregnant or breast-feeding women.
  13. Second malignancy unless in remission for 2 years, except for non-melanomatous skin cancer, carcinoma in situ of the cervix treated with curative intent.

 

Participating Mayo Clinic locations

Study statuses change often. Please contact us for help.

Mayo Clinic Location Status Contact

Scottsdale/Phoenix, Ariz.

Mayo Clinic principal investigator

Thai Ho, M.D., Ph.D.

Open for enrollment

Contact information:

Cancer Center Clinical Trials Referral Office

855-776-0015

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CLS-20233410

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