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).
Study sponsor and potential other locations can be found on ClinicalTrials.gov for NCT02291055.
Locations matching your search criteria
United States
Maryland
Baltimore
Johns Hopkins University/Sidney Kimmel Cancer CenterStatus: Active
Name Not Available
The study was conducted in 2 parts Part A (dose-escalation and expansion) and Part B
(expansion).
Part A:
Part A of the study was a Phase 1 dose escalation evaluation of the combination treatment
of ADXS11-001 at a fixed dose of 1×10^9 colony-forming units (CFU) administered
intravenously (IV) every 4 weeks (Q4W) and escalating doses of MEDI4736 (3 mg/kg and 10
mg/kg) administered IV every 2 weeks (Q2W) to determine the safety and tolerability of
the combination and to identify a recommended Phase 2 dose (RP2D). Part A also included
an expansion cohort of participants with metastatic SCCHN only. Once the RP2D was
identified, the expansion cohort of Part A of the study were to commence.
Part B:
Part B of the study was a Phase 2 design in which participants who had failed at least 1
prior systemic treatment for their recurrent, persistent or metastatic cervical cancer
were enrolled and randomized 1:1 to receive either MEDI4736 10 mg/kg alone or MEDI4736 10
mg/kg in combination with ADXS11-001 1×10^9 CFU.
Lead OrganizationAdvaxis, Inc.