Clinical trial NCT03597282: A Personal Cancer Vaccine (NEO-PV-01) and APX005M or Ipilimumab With Nivolumab in Patients With Advanced Melanoma
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
Conditions: Metastatic Melanoma
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.
Interventions:
description: Personal Cancer Vaccine
name: NEO-PV-01
type: Biological
description: monoclonal antibody against PD-1
name: Nivolumab
other_name: Opdivo
type: Biological
description: immune adjuvant
name: Adjuvant
other_name: Hiltonol
Poly-ICLC
type: Other
description: monoclonal agonist antibody against CD40
name: APX005M
type: Biological
description: monoclonal antibody against CTLA4
name: ipilimumab
other_name: Yervoy
type: Biological
Study arms:
design_group_description: 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.
design_group_title: NEO-PV-01 + adjuvant + nivolumab
design_group_type: Experimental
design_group_description: 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.
design_group_title: Nivolumab + adjuvant
design_group_type: Experimental
design_group_description: 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.
design_group_title: NEO-PV-01 + adjuvant + nivolumab on alternate schedule
design_group_type: Experimental
design_group_description: 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.
design_group_title: NEO-PV-01 + adjuvant + nivolumab + APX005M
design_group_type: Experimental
design_group_description: 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.
design_group_title: Nivolumab + APX005M
design_group_type: Experimental
design_group_description: 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.
design_group_title: NEO-PV-01 + adjuvant + nivolumab + ipilimumab
design_group_type: Experimental
design_group_description: 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.
design_group_title: Nivolumab + ipilimumab
design_group_type: Experimental
Sponsor: BioNTech US, Inc.
Collaborators: Apexigen America, Inc.
Drug name mappings:
name: 伊匹木单抗
lang: CN
name: Ipilimumab
lang: EN
name: イピリムマブ（遺伝子組換え）
lang: JP
name: 纳武利尤单抗
lang: CN
name: Nivolumab
lang: EN
name: ニボルマブ（遺伝子組換え）
lang: JP
name: Sotigalimab
lang: EN
name: NEO-PV-01
lang: EN