NANT Non-small Cell Lung Cancer (NSCLC) Vaccine: Combination Immunotherapy in Subjects With NSCLC Who Have Progressed After Treatment With Programmed Cell Death Protein 1 (PD-1)/Programmed Death-ligand 1 (PD-L1) Inhibitors

NCT03169738 Phase 1/Phase 2 WITHDRAWN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 NSCLC who have progressed on or after treatment with PD-1/PD-L1 inhibitors.

Details

Lead sponsor	ImmunityBio, Inc.
Phase	Phase 1/Phase 2
Status	WITHDRAWN
Start date	2018-02
Completion	2021-12-28

Conditions

• Non-small Cell Lung Cancer

Interventions

• avelumab
• Bevacizumab
• Capecitabine
• Cisplatin
• cyclophosphamide
• 5-Fluorouracil (5-FU)
• fulvestrant
• leucovorin
• nab paclitaxel
• nivolumab

Primary outcomes

• Incidence of treatment-emergent adverse events (AEs) and serious AEs (SAEs), graded using the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) Version 4.03. — 1 year
  Phase 1b primary endpoint (safety)
• Objective response rate (ORR) by Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1 — 1 year
  Phase 2 primary endpoint (ORR by RECIST)
• ORR by Immune-related response criteria (irRC ) — 1 year
  Phase 2 primary endpoint (ORR by irRC)