NCT03597282

A Personal Cancer Vaccine (NEO-PV-01) and APX005M or Ipilimumab With Nivolumab in Patients With Advanced Melanoma

An Open-label, Phase 1B Study of NEO-PV-01 + CD40 Agonist Antibody (APX005M) or Ipilimumab With Nivolumab in Patients With Advanced or Metastatic Melanoma

• Status: Terminated
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 22 (actual)
• Sponsor: BioNTech US Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The primary purpose of this study is to demonstrate that the NEO-PV-01 vaccine, either with APX005M or ipilimumab, and nivolumab is safe for the treatment of patients with advanced or metastatic melanoma. The study will also investigate an alternative schedule for the administration of the NEO-PV-01 vaccine. Study interventions will be assessed by both clinical and immune responses to treatment.

Detailed description

This clinical trial will enroll patients with advanced or metastatic melanoma not having received treatment for metastatic disease. The 5 agents being used in this study are: * A new, investigational, personal cancer vaccine called "NEO-PV-01". * Poly-ICLC (Hiltonol), an investigational adjuvant that is used to help stimulate the immune system. * A cancer drug called APX005M, a drug that stimulates specific types of immune cells that help the immune system to recognize specific targets. * A cancer drug called ipilimumab * A cancer drug called nivolumab NEO-PV-01, APX005M, ipilimumab, and nivolumab are considered immunotherapies and work using the immune system to fight cancer. NEO-PV-01 is a personal vaccine therapy in that it is manufactured specifically to include targets for the immune system that are present uniquely on your cancer. Poly-ICLC is an adjuvant that helps stimulate the immune system and make the vaccine, NEO-PV-01, more effective. The purpose of this study is to find out if treatment with NEO-PV-01 + Poly-ICLC (the NEO-PV-01 vaccine) in combination with either APX005M or ipilimumab, and nivolumab is safe and useful for patients with melanoma. The study also will assess if the NEO-PV-01 vaccine, when given at different intervals, can improve your response compared with the standard schedule. This study will also assess the effects of poly-ICLC in combination with nivolumab. The side effects of all study drugs will be monitored and additional research tests will be done to assess your immune response to your cancer. There is no guarantee that you will benefit from therapy with the study drugs. The FDA has not yet approved the NEO-PV-01 vaccine for use alone or in combination with other cancer drugs such as APX005M, ipilimumab, and nivolumab. Neither APX005M nor Poly-ICLC are approved for use in your type of cancer. Ipilimumab and nivolumab are both approved for use in your type of cancer.

Conditions

• Metastatic Melanoma

Interventions

Type	Name	Description
BIOLOGICAL	NEO-PV-01	Personal Cancer Vaccine
BIOLOGICAL	Nivolumab	monoclonal antibody against PD-1
OTHER	Adjuvant	immune adjuvant
BIOLOGICAL	APX005M	monoclonal agonist antibody against CD40
BIOLOGICAL	ipilimumab	monoclonal antibody against CTLA4

Timeline

• Start date: 2018-10-08
• Primary completion: 2020-05-05
• Completion: 2020-08-11
• First posted: 2018-07-24
• Last updated: 2020-09-03

Locations

8 sites across 1 country: United States

Regulatory

• FDA-regulated drug study