Ignite Creation Date:
2024-05-06 @ 11:45 AM
Last Modification Date:
2024-10-26 @ 12:49 PM
Study NCT ID:
NCT03597282
Status:
TERMINATED
Last Update Posted:
2020-09-03
First Post:
2018-07-13
Brief Title:
A Personal Cancer Vaccine NEO-PV-01 and APX005M or Ipilimumab With Nivolumab in Patients With Advanced Melanoma
Sponsor:
BioNTech US Inc
Organization:
BioNTech SE
Study Overview
Official Title:
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
Status Verified Date:
2020-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Closed due to historically slow enrollment compounded by the COVID-19 pandemic
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None