Safety and Efficacy of Tag-7 Gene-modified Vaccine in Locally Advanced or Metastatic Malignant Melanoma or Kidney Cancer

NCT04180774 | Completed Phase 1

• 1 other identifier: 07-Ген-М
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief Summary

This study was designed to assess the safety and efficacy of inactivated tumor cells genetically modified with the TAG-7 gene as immunotherapy for cancer. Patients with melanoma or kidney cancer were included since they have immune-dependent tumors. Treatment was done in the adjuvant setting after complete cytoreduction of locally advanced or metastatic disease or in the therapeutic setting in patients where complete cytoreduction was impossible.

Conditions

Melanoma; Kidney Cancer

Keywords

gene modified vaccine; tag-7; immunotherapy; tumor cells-based vaccine

Outcome Measures

Primary Outcomes (1)

• Adverse events rate

  CTC AE v.3 was used for safety assesment

  From the fist injection to 3 month after the last injection

Secondary Outcomes (23)

• Response rate

  every 8 weeks until disease progression or therapy completion, then every 3 month for 2 years, every 6 month for the next 2 years and annually thereafter

• Concentration of MICA in patient's cultures supernatants

  Samples obtained before therapy start

• Concentration of TGF-β1 in patient's cultures supernatants

  Samples obtained before therapy start

• Concentration of IL-10 in patient's cultures supernatants

  Samples obtained before therapy start

• Concentration of VEGF in patient's cultures supernatants

  Samples obtained before therapy start

Study Arms (4)

Melanoma Adjuvant

EXPERIMENTAL

Patients with completely resected stage III or IV melanoma receiving GMV in the adjuvant setting

Biological: Tag-7 gene modified inactivated tumor cells

Melanoma Therapeutic

EXPERIMENTAL

Patients with incompletely resected stage III or IV melanoma receiving GMV in the therapeutic setting

Biological: Tag-7 gene modified inactivated tumor cells

Renal Cell Adjuvant

EXPERIMENTAL

Patients with completely resected stage III or IV kidney cancer receiving GMV in the adjuvant setting

Biological: Tag-7 gene modified inactivated tumor cells

Renal Cell Therapeutic

EXPERIMENTAL

Patients with incompletely resected stage III or IV kidney cancer receiving GMV in the therapeutic setting

Biological: Tag-7 gene modified inactivated tumor cells

Interventions

Tag-7 gene modified inactivated tumor cells BIOLOGICAL

Patients received GMV once in three weeks subcutaneously in three points in the paravertebral region. One dose consisted of 10 million transfected and inactivated tumor cells. No dose reduction was allowed.

Melanoma Adjuvant; Melanoma Therapeutic; Renal Cell Adjuvant; Renal Cell Therapeutic

Eligibility Criteria

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

You may qualify if:

• Signed inform consent form.
• Patients age ≥ 18 years of age at the time of informed consent.
• Ability to provide and understand written informed consent prior to any study procedures.
• Histologically confirmed locally advanced or metastatic MM or RCC.
• No evaluable therapy with a proved survival advantage in the current patient setting.
• The life expectancy of \> 3 months as estimated by the investigator
• Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 -2 at Screening.

You may not qualify if:

• Patient with any out-of-range laboratory values defined as:
• Serum creatinine \> 1.5 × upper limit of normal (ULN) and/or creatinine clearance (calculated using Cockcroft-Gault formula, or measured) \< 50 mL/minute
• Total bilirubin \> 2.5 × ULN, except for patients with Gilbert's syndrome who are excluded if total bilirubin \> 3.0 × ULN or direct bilirubin \> 1.5 × ULN
• Alanine aminotransferase \> 2.5 × ULN
• Aspartate aminotransferase \> 2.5 × ULN
• Absolute neutrophil count \< 1.5 × 109/L
• Platelet count \< 100 × 109/L
• Hemoglobin \< 80 g/L (blood transfusions permitted)
• History of severe hypersensitivity reactions (eg, anaphylaxis) to other biologic drugs or monoclonal antibodies
• Any clinically significant unstable disease
• Presence of symptomatic or untreated central nervous system (CNS) metastases
• Active infection requiring systemic antibiotic therapy. Patients requiring systemic antibiotics for infection must have completed therapy at least 1 week prior to the first dose of study drug
• Known history of human immunodeficiency virus infection (HIV). Testing for HIV status is not necessary unless clinically indicated
• Active hepatitis B virus (HBV) or hepatitis C virus (HCV) infection per institutional protocol. Testing for HBV or HCV status is not necessary unless clinically indicated or the patient has a history of HBV or HCV infection
• Malignant disease, other than that being treated in this study

Sponsors & Collaborators

• N.N. Petrov National Medical Research Center of Oncology: lead
• Institute of Gene Biology Russian Academy of Sciences: collaborator

Study Sites (1)

N.N. Petrov Research Institute of Oncology Chemotherapy and Innovative Technologies Department

Saint Petersburg, 197758, Russia

Location

MeSH Terms

Conditions

Melanoma; Kidney Neoplasms

Condition Hierarchy (Ancestors)

Neuroendocrine Tumors; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Nerve Tissue; Nevi and Melanomas; Skin Neoplasms; Neoplasms by Site; Skin Diseases; Skin and Connective Tissue Diseases; Urologic Neoplasms; Urogenital Neoplasms; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Kidney Diseases; Urologic Diseases; Male Urogenital Diseases

Study Officials

• Georgy P Georgiev

  Institute of Gene Biology of the Russian Academy of Sciences

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Studied therapy - tag-7 gene-modified vaccine (GMV) is administered intradermally at three spots (3 cm from each other) in the paravertebral area 4-6 weeks after surgery in an adjuvant or metastatic setting in patients with melanoma or kidney cancer (4 cohorts in parallel). Treatment with GMV will be administered as described until the patient experiences either unacceptable toxicity or unequivocal disease progression (PD). Biomarkers were assessed at the end of the study.

Study Record Dates

• First Submitted: November 22, 2019
• First Posted: November 29, 2019
• Study Start: January 31, 2001
• Primary Completion: December 31, 2018
• Study Completion: December 31, 2018
• Last Updated: December 6, 2019

Record last verified: 2019-11

Data Sharing

• IPD Sharing: Will not share

Locations

RU (1)