Clinical Trials Directory

Trials / Completed

CompletedNCT02897765

A Personal Cancer Vaccine (NEO-PV-01) w/ Nivolumab for Patients With Melanoma, Lung Cancer or Bladder Cancer

An Open-label, Phase IB Study of NEO-PV-01 + Adjuvant With Nivolumab in Patients With Melanoma, Non-Small Cell Lung Carcinoma or Transitional Cell Carcinoma of the Bladder

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

Summary

The purpose of this study is to evaluate if the treatment with NEO-PV-01 + adjuvant in combination with nivolumab is safe and useful for patients with certain types of cancer. The study also will investigate if NEO-PV-01 + adjuvant with nivolumab may represent a substantial improvement over other available therapies such as nivolumab alone. All eligible patients will receive NEO-PV-01 + adjuvant and nivolumab while on this trial.

Detailed description

This clinical trial will enroll patients with metastatic or advanced melanoma, lung, or bladder cancer. The three 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 nivolumab (OPDIVO®) These agents are considered immunotherapy and work by stimulating the immune system to fight cancer. NEO-PV-01 is a truly personal vaccine therapy in that it is custom designed and manufactured to include targets for the immune system that are present uniquely on an individual's cancer. Poly-ICLC is an adjuvant that helps stimulate the immune system and make the vaccine, NEO-PV-01 more effective. Nivolumab helps T-cells, a certain type of immune cell, that recognize these targets to reach and attack the tumor. Nivolumab is in clinical development for treatment of bladder cancer and is approved by the FDA (the U.S. Food and Drug Administration) for the treatment of some lung, skin, kidney, and blood cancers. The purpose of this study is to find out if treatment with NEO-PV-01 + adjuvant in combination with nivolumab is safe and effective for patients with melanoma, lung, or bladder cancer. The study also will see if NEO-PV-01 vaccine + adjuvant with nivolumab can improve responses compared to available therapies such as nivolumab monotherapy The side effects of NEO-PV-01 + adjuvant and nivolumab will be monitored and additional research tests will be done to assess the immune response against each individual's cancer.

Conditions

Interventions

TypeNameDescription
BIOLOGICALNEO-PV-01Personal cancer vaccine
BIOLOGICALNivolumabmonoclonal antibody against PD1
OTHERAdjuvantimmune adjuvant

Timeline

Start date
2016-10-01
Primary completion
2019-02-01
Completion
2020-05-01
First posted
2016-09-13
Last updated
2021-02-25

Locations

9 sites across 1 country: United States

Source: ClinicalTrials.gov record NCT02897765. Inclusion in this directory is not an endorsement.