Imvamune Vaccine for the Treatment of Non-melanoma Skin Cancer

NCT04410874 | Terminated Phase 1 DMC

• 1 other identifier: 2020-4599
• Study Type: interventional
• Target: 1
• Locations: 1 country
• Sites: 1

Brief Summary

This study examines the safety and efficacy of using the Imvamune smallpox vaccine in the treatment of non-melanoma skin cancers (basal cell carcinoma and squamous cell carcinoma).

Conditions

Non-melanoma Skin Cancer; Basal Cell Carcinoma; Squamous Cell Carcinoma

Keywords

Skin Cancer; Immunotherapy

Outcome Measures

Primary Outcomes (2)

• Maximum Tolerated Dose (MTD)

  The MTD will be defined as the dose at which 2 or more patients experience a grade 3 or 4 adverse event (as defined by NCI Common Terminology Criteria for Adverse Events version 5.0) that is at least "probably related" to the study drug (ex: dose limiting toxicity).

  25 days

• Objective Tumor Response Rate (ORR)

  Clinical and histological evaluation of the tumor to assess the development of immunity against BCC and/or SCC tumors or their protein markers.

  25 days

Secondary Outcomes (2)

• Viral load in NMSC tumours

  25 days

• Number of T cells/concentration of antigen specific antibodies

  25 days

Study Arms (1)

Imvamune

EXPERIMENTAL

Imvamune vaccine to be administered intratumorally at one of three doses on Days 0 and 4 of the study

Biological: Imvamune

Interventions

Imvamune BIOLOGICAL

Imvamune vaccine to be administered (via injection) intratumorally at one of three doses (1x10\^7, 1x10\^8, or 4x10\^8 PFU) twice, 4 days apart (first injection on Day 0 of the study and second injection on Day 4)

Also known as: MVA-BN Smallpox vaccine, Modified Vaccinia Ankara Smallpox Vaccine

Imvamune

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subjects must have histologically confirmed, BCC and/or SCC tumors located on the chest, back, thigh, or arm/forearm.
• Presence of clinically documented disease. Skin tumor should measure at least 10 mm in size and should be no larger than 5 cm in any axes. There should be no clinical suspicion of metastasis (i.e. no lymphadenopaties and no systemic symptoms).
• Age \> 18 years.
• Subjects must have a documented ECOG performance status of 0 or 1.
• Subjects could be treatment naive or could have had previous surgery or radiation
• Subjects may have had prior radiation therapy. A minimum of 28 days (4 weeks) must have elapsed between the last dose of radiation and date of registration (14 days for a single palliative fraction of radiation to a non-target lesion). Subjects must have recovered from any acute toxic effects from radiation prior to registration (unless grade 1, irreversible and considered not clinically significant).
• Previous surgery is permitted. A minimum of 28 days (4 weeks) must have elapsed between any major surgery and date of registration (7 days for minor surgery), provided that wound healing has occurred
• Each subject must sign a consent form prior to registration/at registration and prior to tests which are study specific.
• Subjects must be accessible for treatment and follow-up. Subjects registered on this trial must be treated and followed at the McGill University Health Centre (MUHC) or McGill Affiliated/other participating hospitals
• Laboratory requirements (must be done within 7 days prior to registration or at time of registration) as follows:
• White blood cell count ≥3.0x10\^9/L
• absolute neutrophils ≥1.5x10\^9/L
• hemoglobin ≥100g/L
• platelets ≥75x10\^9/L
• INR ≤1.2

You may not qualify if:

• Cancers located on cosmetically/functionally important areas (i.e. face, neck, genitalia, hands, feet, and lower legs).
• Tumor larger than 5 cm in size (any axes).
• Metastatic disease (or suspicion of metastasis).
• Tumors arising as part of a genetic syndrome (i.e., Bazex-Dupré-Christol, Basal Cell Nevus Syndrome, Rombo syndromes for BCC or Xeroderma Pigmentosa, Ferguson Smith, Grzybowski, Muir-Tore syndromes for SCC).
• Immunosuppressed individuals (e.g. organ transplant recipients, patient with inherited immunodeficiencies, HIV+ individuals or individuals receiving immunosuppressive medications for other reasons).
• Individuals that are not able or willing to sign an informed consent.
• Subjects with history of other active or current malignancies requiring active treatment.
• Patients undergoing concurrent treatments with other anti-cancer therapy or other investigational agents.
• Subjects with prior treatment with Imvamune
• Subjects with serious illness or medical condition that would not permit management
• Subjects with uncontrolled pre-existing cardiovascular conditions and/or symptomatic cardiac dysfunction.
• Pregnant or lactating women. Men or women of childbearing potential who do not agree to use adequate contraception while on trial and 6 weeks following the trial.
• Subjects using anti-viral medications, steroids, immunosuppressive agents, or immunization (including the flu shot) within 14 days prior to registration. Patients who are at high risk of influenza infection (65 years and older, people of any age with certain chronic medical conditions (such as asthma, diabetes, or heart disease), pregnant women and children younger than 5 years), and who have not received an influenza vaccination during the flu season (i.e., October to May).
• Subjects with a condition that could have resulted in splenic dysfunction (e.g. splenectomy, sickle cell anemia, radiation to the spleen ≥ 20Gy, congenital asplenism).

Sponsors & Collaborators

• Ivan Litvinov: lead

Study Sites (1)

McGill University Health Centre

Montreal, Quebec, Canada

Location

MeSH Terms

Conditions

Carcinoma, Basal Cell; Carcinoma, Squamous Cell; Skin Neoplasms

Interventions

smallpox and monkeypox vaccine modified vaccinia ankara-bavarian nordic

Condition Hierarchy (Ancestors)

Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Basal Cell; Neoplasms, Squamous Cell; Neoplasms by Site; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Ivan V Litvinov, M.D., Ph.D

  McGill University Health Centre/Research Institute of the McGill University Health Centre

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Scientist

Study Record Dates

• First Submitted: May 27, 2020
• First Posted: June 1, 2020
• Study Start: November 16, 2020
• Primary Completion: May 23, 2023
• Study Completion: May 23, 2023
• Last Updated: March 7, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)