Clinical Trials /

Neoadjuvant Trial of Nivolumab in Combination With HF10 Oncolytic Viral Therapy in Resectable Stage IIIB, IIIC, IVM1a Melanoma

NCT03259425

Description:

This is a single-arm, open label, Phase II study evaluating the safety and efficacy of neoadjuvant Nivolumab and HF10 in resectable stage IIIB, IIIC, and IVM1a melanoma.

Related Conditions:
  • Melanoma
Recruiting Status:

Active, not recruiting

Phase:

Phase 2

Trial Eligibility

Document

Title

  • Brief Title: Neoadjuvant Trial of Nivolumab in Combination With HF10 Oncolytic Viral Therapy in Resectable Stage IIIB, IIIC, IVM1a Melanoma
  • Official Title: Phase II Neoadjuvant Trial of Nivolumab in Combination With HF10 Oncolytic Viral Therapy in Resectable Stage IIIB, IIIC, IVM1a Melanoma (Neo-NivoHF10)

Clinical Trial IDs

  • ORG STUDY ID: HCI102346
  • NCT ID: NCT03259425

Conditions

  • Melanoma

Interventions

DrugSynonymsArms
NivolumabOPDIVONivolumab and HF10, all patients
HF10Nivolumab and HF10, all patients

Purpose

This is a single-arm, open label, Phase II study evaluating the safety and efficacy of neoadjuvant Nivolumab and HF10 in resectable stage IIIB, IIIC, and IVM1a melanoma.

Trial Arms

NameTypeDescriptionInterventions
Nivolumab and HF10, all patientsExperimental
  • Nivolumab
  • HF10

Eligibility Criteria

        Inclusion Criteria:

          -  Patients must be >18 years or older.

          -  Patients must have stage IIIB, IIIC, or IVM1a (equivalent staging at time of
             enrollment) metastatic melanoma which is eligible for complete surgical resection.

          -  Prior systemic, regional and radiation anticancer therapies must have been completed
             at least three months prior to enrollment. Prior therapies (including anti-PD-1
             inhibitors) is allowed provided three months have elapsed from last dose.

          -  Patients must be a candidate for intralesional therapy.

          -  At least 1 injectable cutaneous, subcutaneous, or nodal melanoma lesion > 10 mm in
             longest diameter OR

          -  multiple injectable melanoma lesions which in aggregate have a longest diameter of >
             10 mm

          -  must have no known bleeding diathesis or coagulopathy that would make intratumoral
             injection unsafe.

          -  Patients must have an Eastern Cooperative Oncology Group (ECOG) performance status of
             0 or 1.

          -  Serum LDH level < 1.5 upper limit of normal (ULN) within 28 days prior to enrollment.

          -  Patients have adequate organ function within 28 days prior to enrollment, as defined
             in the protocol

          -  Men and women of childbearing potential must agree to use adequate contraception from
             the time of consent through 7 months after final nivolumab study treatment.

          -  Females of childbearing potential must have a negative urine or serum pregnancy test
             within 1 week prior to the start of treatment.

          -  Patients must be able to provide informed consent and willing to sign an approved
             consent form that conforms to federal and institutional guidelines.

        Exclusion Criteria:

          -  Patients with active visceral, central nervous system, or any bone metastases melanoma
             (Stage IVM1b or IVM1c).

          -  Patients whose primary diagnosis was ocular melanoma.

          -  Patients receiving anti-herpes medication (i.e., acyclovir, famciclovir, or
             valacyclovir) within 1 week prior to initiating HF10 treatment. Patients may not
             require intermittent or chronic systemic (intravenous or oral) treatment with an
             antiherpetic drug other than intermittent topical use.

          -  Patients who have an active herpetic skin lesion(s) or prior complications of HSV-1
             infection.

          -  Uncontrolled intercurrent illness including, but not limited to, ongoing or active
             infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac
             arrhythmia, or psychiatric illness/social situations that would limit compliance with
             study requirements, as determined by the investigator.

          -  Medical history of autoimmune disease (e.g. Crohn's disease, ulcerative colitis) or
             other disease requiring systemic glucocorticoid or immunosuppressive therapy. Subjects
             who receive daily steroid replacement therapy serve as an exception to this rule.
             Daily prednisone equivalent at doses up to 10 mg would qualify.

          -  Patients with clinically evident Human Immunodeficiency Virus (HIV), Hepatitis B Virus
             (HBV), Hepatitis C Virus (HCV), or Epstein-Barr Virus (EBV) infection are excluded.

          -  Pregnant or breast feeding women; women desiring to become pregnant within the
             timeframe of the study are also excluded.
      
Maximum Eligible Age:N/A
Minimum Eligible Age:18 Years
Eligible Gender:All
Healthy Volunteers:No

Primary Outcome Measures

Measure:Pathological Response after 12 weeks
Time Frame:12 weeks
Safety Issue:
Description:Assess pathologic response (including complete response) after completion of 12 weeks of neoadjuvant treatment with nivolumab and HF10.

Secondary Outcome Measures

Measure:Recurrence-free survival
Time Frame:1 year post surgery
Safety Issue:
Description:Recurrence after surgery will be assessed by radiologic scans scheduled per section 8 and confirmed by biopsy.
Measure:Overall Survival
Time Frame:2 years (1 year after stopping 1 year of Nivolumab)
Safety Issue:
Description:patients will be followed for survival for one year after completion of adjuvant nivolumab
Measure:Complete Surgical Resecetion
Time Frame:Within 28 days after Day 84
Safety Issue:
Description:patients will be assessed at surgery to determine if complete surgical resection was achievable after neo-adjuvant treatment with nivolumab and HF10.
Measure:Rate of adverse events for patients while taking nivolumab and HF10
Time Frame:Patient safety will be evaluated throughout the treatment period and follow up (Treatment with HF10 is expected to last for 84 days, treatment with nivolumab is expected to last 1 year for each patient after surgery and follow up for 1 year
Safety Issue:
Description:patients will be monitored for adverse events related to nivolumab and HF10 using CTCAE criteria

Details

Phase:Phase 2
Primary Purpose:Interventional
Overall Status:Active, not recruiting
Lead Sponsor:University of Utah

Trial Keywords

  • Resectable Stage IIIB, IIIC, and IVM1a

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