Clinical Trials /

Phase 1-2 Study of ADXS11-001 or MEDI4736 Alone or Combo In Cervical or HPV+ Head & Neck Cancer

NCT02291055

Description:

Part A: (ADXS11-001 + MEDI4736 Combination Therapy) will determine the safety and tolerability of the combination and to identify a RP2D. Part B: 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.

Related Conditions:
  • Cervical Carcinoma
  • Head and Neck Squamous Cell Carcinoma
Recruiting Status:

Active, not recruiting

Phase:

Phase 1/Phase 2

Trial Eligibility

Document

Title

  • Brief Title: Phase 1-2 Study of ADXS11-001 or MEDI4736 Alone or Combo In Cervical or HPV+ Head & Neck Cancer
  • Official Title: Phase 1-2 Study of ADXS11-001 or MEDI4736 Alone or Combination In Previously Treated Locally Advanced or Metastatic Cervical or HPV+ Head & Neck Cancer

Clinical Trial IDs

  • ORG STUDY ID: ADXS001-04
  • NCT ID: NCT02291055

Conditions

  • Cervical Cancer
  • Cancer
  • Head and Neck Cancer

Interventions

DrugSynonymsArms
ADXS11-001Arm A
Medi4736Arm A

Purpose

Part A: (ADXS11-001 + MEDI4736 Combination Therapy) will determine the safety and tolerability of the combination and to identify a RP2D. Part B: 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.

Trial Arms

NameTypeDescriptionInterventions
Arm AExperimentalADXS11-001& Medi4736, IV Infusion
  • ADXS11-001
  • Medi4736
Arm BExperimentalMedi4736, IV Infusion vs. ADXS11-001 & Medi4736, IV Infusion
  • ADXS11-001
  • Medi4736

Eligibility Criteria

        Inclusion Criteria:

          1. Have histological diagnosis of squamous cell cancer of the head & neck with
             confirmation of HPV positivity or squamous, non-squamous, adenosquamous, carcinoma or
             adenocarcinoma of the cervix which HPV positivity is not required

          2. Have measurable and/or evaluable disease by RECIST 1.1

          3. Have ECOG performance status of 0 or 1

          4. Have adequate organ function defined by the protocol.:

        Exclusion Criteria:

          1. Has any prior Grade ≥3 immune-related adverse event (irAE) while receiving
             immunotherapy, including anti-CTLA-4 treatment, or any unresolved irAE >Grade 1.

          2. 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.

          3. Has any concurrent chemotherapy, immunotherapy, biologic or hormonal therapy for
             invasive malignancy within 2 years. Concurrent use of hormones for non-cancer-related
             conditions (eg, insulin for diabetes and hormone replacement therapy) is acceptable.

          4. 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.

          5. 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 subject who has any
             other device and/or implant
      
Maximum Eligible Age:N/A
Minimum Eligible Age:18 Years
Eligible Gender:All
Healthy Volunteers:No

Primary Outcome Measures

Measure:Number of subjects with adverse events in each dose level (Part A)
Time Frame:2 years
Safety Issue:
Description:Number of subjects with progression free survival

Details

Phase:Phase 1/Phase 2
Primary Purpose:Interventional
Overall Status:Active, not recruiting
Lead Sponsor:Advaxis, Inc.

Last Updated

February 19, 2020