Clinical Trial 18804

Cancer Type: Gynecological Tumor
Interventions:ADXS11-001; MEDI4736 (Durvalumab)

Study Type: Treatment
Phase of Study: Phase I/II
Investigators:

  • Hye Sook Chon

Overview

Study Title

Phase 1-2 Study Of Medi4736 Alone or in Combination With Adxs11-001 In Recurrent/Persistent or Metastatic Cervical or HPV + Head & Neck Cancer

Summary

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.

Objective

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.

Inclusion Criteria

  • Have histological diagnosis of squamous cell cancer of the head & neck with confirmation of human papilloma virus (HPV) positivity or squamous, non-squamous, adenosquamous, carcinoma or adenocarcinoma of the cervix which HPV positivity is not required.
  • Have measurable and/or evaluable disease by Response Evaluation Criteria in Solid Tumors (RECIST) 1.1.
  • Have Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
  • Have adequate organ function defined by the protocol.
  • Additional criteria may apply.

  • Exclusion Criteria

  • Has any prior Grade ≥3 immune-related adverse event (irAE) while receiving immunotherapy, including anti-CTLA-4 treatment, or any unresolved irAE >Grade 1.
  • Has a diagnosis of immunodeficiency or is receiving any systemic steroid therapy or any other form of immunosuppressive therapy within 7 days prior to Day 1 of trial treatment.
  • Has any concurrent chemotherapy, immunotherapy, biologic or hormonal therapy for invasive malignancy within 2 years. Concurrent use of hormones for non-cancer-related conditions (e.g., insulin for diabetes and hormone replacement therapy) is acceptable.
  • Has an active autoimmune disease requiring systemic treatment within the past 3 months or a documented history of clinically severe autoimmune disease, or a syndrome that requires systemic steroids or immunosuppressive agents.
  • Has implanted medical device(s) that pose a high risk for colonization and/or cannot be easily removed (e.g., prosthetic joints, artificial heart valves, pacemakers, orthopedic screw(s), metal plate(s), bone graft(s), or other exogenous implant(s)). NOTE: More common devices and prosthetics which include arterial and venous stents, dental and breast implants, and venous access devices (e.g., Port-a-Cath or Mediport) are permitted. Sponsor must be contacted prior to consenting any participant who has any other device and/or implant.
  • Additional criteria may apply.