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

• ClinicalTrials.gov Identifier: NCT02291055
• Recruitment Status: Unknown
• First Posted: November 14, 2014
• Last Update Posted: February 19, 2020
• Sponsor: Advaxis, Inc.
• Collaborator: MedImmune LLC
• Information provided by (Responsible Party): Advaxis, Inc.

Tracking Information

• First Submitted Date: November 6, 2014
• First Posted Date: November 14, 2014
• Last Update Posted Date: February 19, 2020
• Study Start Date: April 2015
• Actual Primary Completion Date: August 2019 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: February 24, 2016)

• Number of subjects with adverse events in each dose level (Part A) [ Time Frame: 2 years ]
• Progression Free Survival as measured by RECIST 1.1 an irRECIST (Part B) [ Time Frame: 2 years ]
  Number of subjects with progression free survival
• number of subject with adverse event in combination dose (Part B) [ Time Frame: 2 years ]

Original Primary Outcome Measures (submitted: November 13, 2014)

• Number of subjects with adverse events in each dose level (Part A) [ Time Frame: 2 years ]
  Number of subjects with adverse events in each dose level
• Number of subjects with progression free survival (Part B) [ Time Frame: 2 years ]
  Number of subjects with progression free survival
• Number of subjects with adverse event in combination dose (Part B) [ Time Frame: 2 years ]
  Number of subjects with adverse event in combination dose

• Current Secondary Outcome Measures: Not Provided
• Original Secondary Outcome Measures: Not Provided
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• 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

Brief Summary

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.

• Detailed Description: Not Provided
• Study Type: Interventional
• Study Phase: Phase 1; Phase 2
• Study Design: Allocation: Randomized; Intervention Model: Single Group Assignment; Masking: None (Open Label); Primary Purpose: Treatment

Condition

• Cervical Cancer
• Cancer
• Head and Neck Cancer

Intervention

• Drug: ADXS11-001
• Drug: Medi4736

Study Arms

• Experimental: Arm A
  ADXS11-001& Medi4736, IV Infusion
  Interventions:

  • Drug: ADXS11-001
  • Drug: Medi4736
• Experimental: Arm B
  Medi4736, IV Infusion vs. ADXS11-001 & Medi4736, IV Infusion
  Interventions:

  • Drug: ADXS11-001
  • Drug: Medi4736

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Unknown status
• Estimated Enrollment (submitted: November 13, 2014): 66
• Original Estimated Enrollment: Same as current
• Estimated Study Completion Date: May 31, 2021
• Actual Primary Completion Date: August 2019 (Final data collection date for primary outcome measure)

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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT02291055
• Other Study ID Numbers: ADXS001-04
• Has Data Monitoring Committee: No
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Current Responsible Party: Advaxis, Inc.
• Original Responsible Party: Same as current
• Current Study Sponsor: Advaxis, Inc.
• Original Study Sponsor: Same as current
• Collaborators: MedImmune LLC
• Investigators: Not Provided
• PRS Account: Advaxis, Inc.
• Verification Date: February 2020