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Neoadjuvant Trial of Nivolumab in Combination With HF10 Oncolytic Viral Therapy in Resectable Stage IIIB, IIIC, IVM1a Melanoma | Clinical Trials | Clareo Health

TERMINATEDPHASE2

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

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

NCT03259425•University of Utah

View on ClinicalTrials.gov

Summary

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.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Participants must be \>18 years or older.
•Participants must have stage IIIB, IIIC, or IVM1a (equivalent staging at time of enrollment via American Joint Committee on Cancer (AJCC) 7th edition) 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-programmed death (PD)-1 inhibitors) are allowed provided three months have elapsed from last dose.
•Participants 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 AND
•Must have no known bleeding diathesis or coagulopathy that would make intratumoral injection unsafe.
•Participants 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.
•Participants have adequate organ function within 28 days prior to enrollment, as defined in the protocol
+3 more criteria

Exclusion Criteria

•Participants with active visceral, central nervous system, or any bone metastases melanoma (Stage IVM1b or IVM1c).
•Participants whose primary diagnosis was ocular melanoma.
•Participants receiving anti-herpes medication (i.e., acyclovir, famciclovir, or valacyclovir) within 1 week prior to initiating HF10 treatment. Participants may not require intermittent or chronic systemic (intravenous or oral) treatment with an antiherpetic drug other than intermittent topical use.
•Participants who have an active herpetic skin lesion(s) or prior complications of herpes simplex virus (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.
•Participants 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.

Locations (1)

Huntsman Cancer Institute

Salt Lake City, Utah, United States

Key Dates

Start Date

January 3, 2018

Primary Completion Date

September 21, 2018

Completion Date

September 25, 2020

Last Updated

June 13, 2022

Enrollment

ACTUAL participants

Conditions

Melanoma

Interventions

Nivolumab

DRUG

HF10

DRUG

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: June 13, 2022Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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

Inclusion Criteria

Exclusion Criteria

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