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

Part of paid clinical trials in Scottsdale, Arizona.

Sponsor
BioNTech US Inc.
Study ID
NCT03597282
Phase
PHASE1
Status
Terminated

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 PD-1
  • Adjuvant — OTHER
    immune adjuvant
  • APX005M — BIOLOGICAL
    monoclonal agonist antibody against CD40
  • ipilimumab — BIOLOGICAL
    monoclonal antibody against CTLA4

Study Details

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.

Key Dates

Start date
Oct 8, 2018
Status verified
Sep 2020
Primary completion
May 5, 2020
Completion
Aug 11, 2020

Study Design

Enrollment
22 participants (actual)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: NEO-PV-01 + adjuvant + nivolumab
    Nivolumab at a dose of 240 mg will be administered by intravenous infusion (IV) every 2 weeks throughout the study. At Week 12, all patients, regardless of their disease status, will receive NEO-PV-01 + adjuvant administered subcutaneously.
  • Experimental: Nivolumab + adjuvant
    Nivolumab at a dose of 240 mg will be administered by intravenous infusion (IV) every 2 weeks throughout the study. At Week 12, all patients, regardless of their disease status, will receive Poly-ICLC (adjuvant) administered subcutaneously.
  • Experimental: NEO-PV-01 + adjuvant + nivolumab on alternate schedule
    Nivolumab at a dose of 240 mg will be administered by intravenous infusion (IV) every 2 weeks throughout the study. At Week 12, all patients, regardless of their disease status, will receive NEO-PV-01 + adjuvant, administered on an alternative schedule, subcutaneously.
  • Experimental: NEO-PV-01 + adjuvant + nivolumab + APX005M
    Nivolumab at a dose of 240 mg will be administered by intravenous infusion (IV) every 2 weeks throughout the study. At Week 12, all patients, regardless of their disease status, will receive NEO-PV-01 + adjuvant administered subcutaneously. Patients on this arm will also receive APX005M at a dose of 0.1 mg/kg administered by IV infusion at Week 12, Week 15, and Week 19.
  • Experimental: Nivolumab + APX005M
    Nivolumab at a dose of 240 mg will be administered by intravenous infusion (IV) every 2 weeks throughout the study. At Week 12, Week 15, and Week 19, all patients, regardless of their disease status, will receive APX005M at a dose of 0.1 mg/kg administered by IV infusion.
  • Experimental: NEO-PV-01 + adjuvant + nivolumab + ipilimumab
    Nivolumab at a dose of 240 mg administered by intravenous infusion (IV) every 2 weeks throughout the study. At Week 12, all patients, regardless of their disease status, will receive NEO-PV-01 + adjuvant administered subcutaneously. Patients on this arm will also receive ipilimumab at a dose of 1.0 mg/kg administered by IV infusion at Week 12 and Week 19.
  • Experimental: Nivolumab + ipilimumab
    Nivolumab at a dose of 240 mg will be administered by intravenous infusion (IV) every 2 weeks throughout the study. At Week 12 and Week 19, all patients, regardless of their disease status, will receive ipilimumab at a dose of 1.0 mg/kg administered by IV infusion.

Primary Outcome Measure

The rate of adverse events and severe adverse events leading to treatment discontinuation [ Time Frame: Baseline through 90 days after the last dose of nivolumab ]

Locations (8)

FacilityCityStateZIPSite coordinators
HonorHealth Research InstituteScottsdaleArizona85258-
University of California, Los AngelesLos AngelesCalifornia90095-
University of Colorado DenverDenverColorado80045-
Dana Farber Cancer InstituteBostonMassachusetts02215-
Massachusetts General HospitalBostonMassachusetts02114-
University of OklahomaOklahoma CityOklahoma73104-
Sarah Cannon Research InstituteNashvilleTennessee37203-
University of Utah, Huntsman Cancer InstituteSalt Lake CityUtah84112-

Find similar trials in Scottsdale, AZ

By condition
Melanoma
By specialty
OncologySkin cancerDermatology
By research site
HonorHealth Research Institute· Scottsdale, AZUniversity of California, Los Angeles· Los Angeles, CAUniversity of Colorado Denver· Denver, CODana Farber Cancer Institute· Boston, MAMassachusetts General Hospital· Boston, MAUniversity of Oklahoma· Oklahoma City, OK

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