A Personal Cancer Vaccine (NEO-PV-01) w/ Nivolumab for Patients With Melanoma, Lung Cancer or Bladder Cancer
NCT02897765 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 34
Last updated 2021-02-25
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.
Conditions
- Urinary Bladder Cancer
- Bladder Tumors
- Transitional Cell Carcinoma of the Bladder
- Malignant Melanoma
- Melanoma
- Skin Cancer
- Carcinoma, Non-Small-Cell Lung
- Lung Cancer
Interventions
- BIOLOGICAL
-
NEO-PV-01
Personal cancer vaccine
- BIOLOGICAL
-
monoclonal antibody against PD1
- OTHER
-
Adjuvant
immune adjuvant
Sponsors & Collaborators
- collaborator INDUSTRY
-
BioNTech US Inc.
lead INDUSTRY
Principal Investigators
-
Mark DeMario, MD · BioNTech US Inc.
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2016-10-31
- Primary Completion
- 2019-02-28
- Completion
- 2020-05-31
Countries
- United States
Study Locations
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