NANT Melanoma Vaccine: Combination Immunotherapy in Subjects With Melanoma Who Have Progressed on or After Chemotherapy and Anti-programmed Cell Death Protein 1 (PD-1)/Programmed Death Ligand 1 (PD-L1) Therapy

NCT03167177 Phase 1/Phase 2 WITHDRAWN

This is a phase 1b/2 study to evaluate the safety and efficacy of metronomic combination therapy in subjects with melanoma who have progressed on or after chemotherapy and anti-PD-1/PD-L1 therapy.

Details

Lead sponsor	ImmunityBio, Inc.
Phase	Phase 1/Phase 2
Status	WITHDRAWN
Start date	2017-12
Completion	2021-12-28

Conditions

• Melanoma

Interventions

• Avelumab
• Bevacizumab
• Capecitabine
• Cisplatin
• Cyclophosphamide
• 5-fluorouracil
• Leucovorin
• nab-paclitaxel
• Nivolumab
• omega-3-acid ethyl esters

Primary outcomes

• Incidence of treatment-emergent Adverse Events (AEs) and Serious Adverse Events (SAEs), graded using the NCI CTCAE Version 4.03. — 1 year
  Phase 1b primary endpoint
• Objective response rate by RECIST Version 1.1 — 1 year
  Phase 2 primary endpoint
• Objective response rate by irRC — 1 year
  Phase 2 primary endpoint