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

Part of paid clinical trials in Duarte, California.

Sponsor
BioNTech US Inc.
Study ID
NCT02897765
Phase
PHASE1
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • NEO-PV-01 — BIOLOGICAL
    Personal cancer vaccine
  • Nivolumab — BIOLOGICAL
    monoclonal antibody against PD1
  • Adjuvant — OTHER
    immune adjuvant

Study Details

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.

Key Dates

Start date
Oct 31, 2016
Status verified
Feb 2021
Primary completion
Feb 28, 2019
Completion
May 31, 2020

Study Design

Enrollment
34 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Drug: NEO-PV-01 + Nivolumab + Adjuvant
    Nivolumab at a dose of 240 mg administered by intravenous (IV) infusion over 30 minutes every two weeks. At Week 12, all patients, regardless of their disease status, will receive NEO-PV-01 + adjuvant administered subcutaneously (one vial of pooled peptides per injection site) in up to four distinct sites (each extremity or flanks) while continuing therapy with nivolumab.

Primary Outcome Measure

Rate of adverse events including SAEs and AEs leading to treatment discontinuation [ Time Frame: Baseline through 100 days after last dose of nivolumab ]

Locations (9)

FacilityCityStateZIPSite coordinators
City of HopeDuarteCalifornia91010-
UCLA Medical CenterLos AngelesCalifornia90095-
University of California San FranciscoSan FranciscoCalifornia94143-
Dana Farber Cancer CenterBostonMassachusetts02115-
Massachusetts General HospitalBostonMassachusetts02114-
Washington University in St. LouisSt LouisMissouri63130-
Icahn School of Medicine at Mount SinaiNew YorkNew York10029-
Memorial Sloan Kettering Cancer CenterNew YorkNew York10065-
MD Anderson Cancer CenterHoustonTexas77030-

Find similar trials in Duarte, CA

By condition
Lung cancerMelanomaSkin cancer
By specialty
OncologyLung oncologyLung diseaseSkin cancerDermatology
By research site
City of Hope· Duarte, CAUCLA Medical Center· Los Angeles, CAUniversity of California San Francisco· San Francisco, CADana Farber Cancer Center· Boston, MAMassachusetts General Hospital· Boston, MAWashington University in St. Louis· St Louis, MO

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