Clinical Trials Search
Clinical Trial 18804
Cancer Type: Gynecological Tumor
Interventions:ADXS11-001; MEDI4736 (Durvalumab)
Study Type: Treatment
Phase of Study: Phase I/II
- Hye Sook Chon
Phase 1-2 Study Of Medi4736 Alone or in Combination With Adxs11-001 In Recurrent/Persistent or Metastatic Cervical or HPV + Head & Neck Cancer
The main purpose of this study is to determine if the combination therapy of ADXS11-001 plus MEDI473 6 is safe and tolerable in participants with cervical or HPV + head and neck cancer. This study will also determine safe and tolerable dose of combination therapy and the effect of study drugs on their cancer.
The primary objective of Part A is to determine the safety and tolerability of the combination and to identify a RP2D. The primary objective of Part A Expansion is to evaluate the efficacy of the combination as determined by Response Evaluation Criteria in Solid Tumors (RECIST 1.1) and secondarily by irRECIST. Response and progression will be determined by the Investigator. Part B of the study will start once a RP2D has been identified from Part A. Part B will be a Phase 2 design which will randomize subjects 1:1 to either MEDI4736 alone or MEDI4736+ADXS11-001 in subjects who have failed at least 1 prior systemic treatment for their recurrent/persistent or metastatic cervical cancer.