NCT04864379

Clinical Study of a Personalized Neoantigen Cancer Vaccine Combined With Anti-PD-1 and RFA in Patients With Solid Tumors

Safety, Tolerability and Immunogenicity of a Personalized Neoantigen Cancer Vaccine Combined With Anti-PD-1 and Radiofrequency Ablation in Patients With Advanced Solid Tumors

• Status: Unknown
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 30 (estimated)
• Sponsor: Sir Run Run Shaw Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

This research study is evaluating a new type of personalized neoantigen cancer vaccine（iNeo-Vac-P01）combined with anti-PD-1 antibody and radiofrequency ablation as a possible treatment for patients with advanced solid tumors. The primary objective of this trial is to evaluate safety, tolerability and immunogenicity of iNeo-Vac-P01 in combination with anti-PD-1 and radiofrequency ablation, so as to provide a new personalized therapeutic strategy for patients. It is known that cancer patients have mutations (changes in genetic material) that are specific to an individual patient and tumor. These mutations can cause the tumor cells to produce proteins that appear very different from the body's own cells. It is possible that these proteins used in a vaccine may induce strong immune responses, which may help the participant's body fight any tumor cells that could cause the cancer to come back in the future. The study will examine the safety of the vaccine when given at several different time points and will examine the participant's blood cells for signs that the vaccine induced an immune response.

Conditions

• Advanced Malignant Solid Tumor

Interventions

Type	Name	Description
BIOLOGICAL	iNeo-Vac-P01	iNeo-Vac-P01: 300 mcg per peptide
OTHER	GM-CSF	GM-CSF: 40 mcg
DRUG	PD-1	PD-1: 200mg administered by intravenous infusion every 2 weeks.
PROCEDURE	RFA	Radiofrequency ablation surgery

Timeline

• Start date: 2020-09-03
• Primary completion: 2025-08-03
• Completion: 2025-08-03
• First posted: 2021-04-28
• Last updated: 2021-04-28

Locations

1 site across 1 country: China