drugset / Trial / NCT02291055

A Study of ADXS11-001 or MEDI4736 Alone or Combination In Cervical or Human Papillomavirus (HPV)+ Head & Neck Cancer

NCT02291055

Phase 1/2 Terminated 75 enrolled Advaxis, Inc. MedImmune LLC · collab
RandomizedSequentialOpen-labelTreatment

Summary

This was a multicenter, open-label, 2-part randomized study of MEDI4736 administered as monotherapy or in combination with ADXS11-001 to participants with recurrent/persistent or metastatic squamous or non-squamous carcinoma of the cervix or metastatic human papillomaviruses (HPV)+ squamous cell carcinoma of the head and neck (SCCHN).

Timeline

Start
2015-04
Primary completion
2019-07-09
Completion
2020-11-20

Publications

  • Results Slomovitz BM, Moore K, Vangala S, Parsi M, Sheerie S, John Heyburn J ,Posner M. Phase II study of durvalumab alone or in combination with ADXS11-001 (AXAL) in recurrent/persistent or metastatic cervical cancer. Annual Meeting on Women's Cancer. March 28-31, 2020. Toronto Canada.

Drugs

EvaluationDrugModalityDoseRoute
Subject ADXS11-001 Vaccine 1e+09 unknown Intravenous
Subject Durvalumab Monoclonal antibody 3 mg/kg Intravenous
Subject Durvalumab Monoclonal antibody 10 mg/kg Intravenous