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A Phase 2, Open-label, Randomized, Parallel Group, Controlled Study of Pemetrexed Maintenance With or Without ADXS11-001 Immunotherapy in Patients With Human Papillomavirus-Positive, Non-Squamous, Non-Small Cell Lung Carcinoma Following First-Line Induction Chemotherapy

NCT02531854 Phase 2 WITHDRAWN

* Open label * Enrollment in the order of confirmation of eligibility and HPV+ tumor status * Prospective stratification based on 3 factors, epidermal growth factor receptor (EGFR) mutation status, performance status and first-line induction chemotherapy outcome; * Randomization (2:1 ratio): (82 patients receiving the combination of pemetrexed plus ADXS11-001 vs. 42 patients receiving pemetrexed alone) * Treatment Arm: Pemetrexed plus ADXS11-001 immunotherapy * Control Arm: Pemetrexed only * Positive control: pemetrexed chemotherapy

Details

Lead sponsorAdvaxis, Inc.
PhasePhase 2
StatusWITHDRAWN
Start date2018-12
Completion2019-03

Conditions

Interventions

Primary outcomes