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Intralesional Influenza Vaccine for the Treatment of Stage I-IV Melanoma

ConditionsClinical Stage I Cutaneous Melanoma AJCC v8Clinical Stage IA Cutaneous Melanoma AJCC v8Clinical Stage IB Cutaneous Melanoma AJCC v8Clinical Stage II Cutaneous Melanoma AJCC v8Clinical Stage IIA Cutaneous Melanoma AJCC v8Clinical Stage IIB Cutaneous Melanoma AJCC v8Clinical Stage IIC Cutaneous Melanoma AJCC v8Clinical Stage IV Cutaneous Melanoma AJCC v8Metastatic Melanoma
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18-99
SponsorCarlo Contreras

About this trial

This phase I trial investigates the effects of influenza vaccine in treating patients with stage I-IV melanoma. While intramuscular administration of influenza vaccine provides immunization against the influenza virus, giving influenza vaccine directly into the tumor (intralesional) may decrease the size of the injected melanoma tumor, or the extent of the melanoma within the body.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Males or females

18 to 99 years of age

Histologically confirmed cutaneous melanoma by historical pathology report review, clinical Stage I-III (Cohort #1), or Stage IV (Cohort #2) cutaneous melanoma

At least one, biopsy-proven, palpable melanoma tumor deposit suitable for intralesional injection measuring ≥ 1 cm by digital caliper (with digital photography documentation) or ultrasound (with ultrasound image documentation)

Disqualifiers

Known allergy or intolerance to influenza vaccination

Subjects with condition requiring systemic treatment with either corticosteroids (> 10 mg daily prednisone/equivalent) or other immunosuppressive medications within 14 days of study drug administration

Active, known or suspected autoimmune disease

Active brain metastasis or leptomeningeal metastasis

Trial design

Design model

Parallel

Treatments tested in this trial

  • Ipilimumab

    Biological/Vaccine

    immune checkpoint inhibitor

  • Nivolumab

    Biological/Vaccine

    immune checkpoint inhibitor

  • Pembrolizumab

    Biological/Vaccine

    immune checkpoint inhibitor

  • Quadrivalent Inactivated Influenza Vaccine

    Biological/Vaccine

    Given IM and intratumorally. For this protocol the U.S. F.D.A recently approved the use of recently expired influenza vaccine (only until new seasonal vaccine is available anticipated Sept 1). Use of expired vaccine will not exceed 4 months past June 30th expiry date (October 30th).

  • Resection

    Procedure/Surgery

    Undergo surgical resection

  • Nivolumab + Relatlimab

    Biological/Vaccine

    immune checkpoint inhibitor

Treatment groups

36 Participants
are divided into 2 treatment groups
Group A: Cohort I (resectable Stage I-III melanoma)Experimental treatment 2 interventions
Group B: Cohort II (unresectable Stage IV)Experimental treatment 5 interventions

Trial outcomes

Primary outcomes

1

Incidence of adverse events (AEs)

Frequency and severity of AEs and tolerability of the regimen will be collected and summarized by descriptive statistics. The maximum grade for each type of toxicity will be recorded for each patient, and frequency tables will be reviewed to determine toxicity patterns. All patients who have received at least one dose of the therapeutic agents will be evaluable for toxicity and tolerability.

Time frame
Up to 1 year after the last intra-tumoral dose
2

Maximum tolerated dose (MTD) in Cohorts #1 and #2

Will employ the Bayesian optimal interval design to find the MTD.

Time frame
Up to 98 days

Secondary outcomes

1

Tumor dimensions of injected (Cohorts #1)

Will be assessed by caliper or ultrasound measurement. Tumor dimensions will be summarized using descriptive statistics (i.e. mean with standard deviations, or median with range).

Time frame
Up to 1 year after the last intra-tumoral dose
2

Tumor dimensions of non-injected lesions (Cohort #2)

Will be assessed by caliper or ultrasound measurement. Tumor dimensions will be summarized using descriptive statistics (i.e. mean with standard deviations, or median with range).

Time frame
Up to 1 year after the last intra-tumoral dose
3

Time to disease progression (local or distant)

Time to disease progression will be analyzed using Kaplan-Meier method, resulting in median survival times with 95% confidence interval, assuming sufficient events have occurred.

Time frame
From the start of treatment until the documentation of local or distant disease progression, assessed up to 1 year
4

Biomarker analysis

Will analyze immunohistochemistry density, cells/mm\^2 of CD4, CD8, PD-L1, PD1, CD56, CD20, CD45RO, FOXP3. Summary statistics will be used.

Time frame
Up to 1 year after the last intra-tumoral dose

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Carlo Contreras

Lead sponsor

Ohio State University Comprehensive Cancer Center

Sponsor institution

Source ClinicalTrials.gov
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