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
    • Adults at least 18 years of age
    • Eastern Cooperative Oncology Group (ECOG) performance status ≤ 1
    • Histopathologically or cytologically confirmed diagnosis of Melanoma, RCC or NSCLC, for whom the use of nivolumab is indicated
    • Must have at least one measurable target lesion as defined by Response Evaluation Criteria in Solid Tumors (RECIST) v.1.1
    • All prior chemotherapy, 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
    • Within 14 days prior to study drug administration must have adequate hematopoietic, electrolyte, hepatic, and renal laboratory findings as defined as
      • White Blood Cells (WBC) ≥ 3000/μL
      • Neutrophils ≥ 1500/μL
      • Platelets ≥ 100x103/μL
      • Hemoglobin ≥ 9.0 g/dL
      • Creatinine ≤ 1.5 mg/dL
      • Aspartate Aminotransferase (AST) and Alanine Aminotransferase (ALT) ≤ 3 x ULN
      • Alkaline phosphatase ≤ 2.5 x Upper Limit of Normal (ULN) unless bone metastases present
      • Bilirubin ≤ 1.5 x ULN (unless known Gilbert's disease where it must be ≤3xULN)
    • Life expectancy ≥ 12 weeks
    • A negative serum pregnancy test at screening for women of childbearing potential
    • Willing to either abstain from heterosexual activity or practice physical barrier contraception, from prior to time of study entry until 6 months after the last day of treatment
    • Has the ability to understand and the willingness to sign a written informed consent document

Exclusion Criteria

  • Patients who fulfill any of the following criteria at screening will not be eligible for admission into the study
    • Has received immune checkpoint inhibitors previously
      • Prior therapy with ipilimumab for melanoma is allowed
    • History of Grade 3 or above hypersensitivity reactions to other monoclonal antibodies
    • History of a cardiovascular illness including
      • Congestive heart failure (New York Heart Association grade III or IV)
      • Unstable angina or myocardial infarction within the previous 6 months
      • Symptomatic cardiac arrhythmia despite medical management
      • Uncontrolled hypertension, Systolic Blood Pressure (SBP)> 160 or Diastolic Blood Pressure (DBP)>100
    • Brain metastasis unless stable for 4 weeks or more and not requiring steroids
    • Presence of leptomeningeal disease
    • History of hemorrhagic diarrhea, inflammatory bowel disease or active uncontrolled peptic ulcer disease
    • 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)
    • Active uncontrolled bacterial, viral, or fungal infection requiring systemic therapy
    • Infection with human immunodeficiency virus (HIV) or active hepatitis A, B (serum hepatitis B surface antigen positive), or C (serum hepatitis C RNA positive), tested at screening
    • Concurrent medical condition requiring the use of immunosuppressive medications, or systemic steroids (prednisone dose is more than 10 mg/day or equivalent)
      • Topical corticosteroids are allowed
    • Use of other investigational drugs (drugs not marketed for any indication) within 28 days or at least 5 half-lives (whichever is longer) before study drug administration
    • Pregnant or breast-feeding women
    • Second malignancy unless in remission for 2 years
      • Non-melanomatous skin cancer or carcinoma in situ of the cervix treated with curative intent is not exclusionary
    • Underlying medical conditions that, in the Investigator's opinion, will make the administration of study drug hazardous or obscure the interpretation of toxicity determination or adverse events
    • Unwilling or unable to comply with procedures required in this protocol

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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