Phase 1-2 Study of ADXS11-001 or MEDI4736 Alone or Combo In Cervical or HPV+ Head & Neck Cancer
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ClinicalTrials.gov Identifier: NCT02291055 |
Recruitment Status : Unknown
Verified February 2020 by Advaxis, Inc..
Recruitment status was: Active, not recruiting
First Posted : November 14, 2014
Last Update Posted : February 19, 2020
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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.
Condition or disease | Intervention/treatment | Phase |
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Cervical Cancer Cancer Head and Neck Cancer | Drug: ADXS11-001 Drug: Medi4736 | Phase 1 Phase 2 |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 66 participants |
Allocation: | Randomized |
Intervention Model: | Single Group Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
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 |
Study Start Date : | April 2015 |
Actual Primary Completion Date : | August 2019 |
Estimated Study Completion Date : | May 31, 2021 |

Arm | Intervention/treatment |
---|---|
Experimental: Arm A
ADXS11-001& Medi4736, IV Infusion
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Drug: ADXS11-001 Drug: Medi4736 |
Experimental: Arm B
Medi4736, IV Infusion vs. ADXS11-001 & Medi4736, IV Infusion
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Drug: ADXS11-001 Drug: Medi4736 |
- 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 ]

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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- 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
- Have measurable and/or evaluable disease by RECIST 1.1
- Have ECOG performance status of 0 or 1
- Have adequate organ function defined by the protocol.:
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 (eg, 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 subject who has any other device and/or implant

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02291055
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Detroit, Michigan, United States | |
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Brooklyn, New York, United States | |
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Hilliard, Ohio, United States | |
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Oklahoma City, Oklahoma, United States | |
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Chattanooga, Tennessee, United States | |
United States, Wisconsin | |
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Milwaukee, Wisconsin, United States |
Responsible Party: | Advaxis, Inc. |
ClinicalTrials.gov Identifier: | NCT02291055 |
Other Study ID Numbers: |
ADXS001-04 |
First Posted: | November 14, 2014 Key Record Dates |
Last Update Posted: | February 19, 2020 |
Last Verified: | February 2020 |
Head and Neck Neoplasms Neoplasms by Site Neoplasms |
Durvalumab Antineoplastic Agents, Immunological Antineoplastic Agents |