NCT04180774

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

Completed Phase 1, PHASE2 Last updated 6 December 2019

What this trial tests

Phase 1, PHASE2 trial testing Tag-7 gene modified inactivated tumor cells in Melanoma in 80 participants. Completed in 31 December 2018.

Timeline

31 January 2001

Primary endpoint
31 December 2018

31 December 2018

Quick facts

Lead sponsor	N.N. Petrov National Medical Research Center of Oncology
Phase	Phase 1, PHASE2
Status	Completed
Study type	INTERVENTIONAL
Allocation	non randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	80
Start date	31 January 2001
Primary completion	31 December 2018
Estimated completion	31 December 2018
Sites	1 location across Russia

Drugs / interventions tested

• Tag-7 gene modified inactivated tumor cells — full drug profile →

Conditions studied

• Melanoma — all drugs for Melanoma →
• Kidney Cancer — all drugs for Kidney Cancer →

Sponsor

N.N. Petrov National Medical Research Center of Oncology — full company profile →

Who can join

18 and older, any sex, with Melanoma or Kidney Cancer. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

1. Engineered tumor cell-derived vaccines against cancer: The art of combating poison with poison.
   Zhang X, Cui H, Zhang W, Li Z, et al · · 2023 · cited 54× · PMID 36330160 · DOI 10.1016/j.bioactmat.2022.10.016
2. An Open-Label Study of the Safety and Efficacy of Tag-7 Gene-Modified Tumor Cells-Based Vaccine in Patients with Locally Advanced or Metastatic Malignant Melanoma or Renal Cell Cancer.
   Novik AV, Danilova AB, Sluzhev MI, Nehaeva TL, et al · · 2020 · cited 1× · PMID 32240562 · DOI 10.1634/theoncologist.2020-0160