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

• Sponsor: Advaxis, Inc. (Industry)
• Overall Status: Unknown status
• CT.gov ID: NCT02291055
• Collaborator: MedImmune LLC (Industry)
• Enrollment: 66
• Locations: 17
• Arms: 2
• Duration (Months): 74
• Patients Per Site: 3.9
• Patients Per Site Per Month: 0.1

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Cervical Cancer; Cancer; Head and Neck Cancer	Drug: ADXS11-001; Drug: Medi4736	Phase 1/Phase 2

Study Design

• Study Type: Interventional
• Anticipated 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: Apr 1, 2015
• Actual Primary Completion Date: Aug 1, 2019
• Anticipated Study Completion Date: May 31, 2021

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Arm A ADXS11-001& Medi4736, IV Infusion	Drug: ADXS11-001; Drug: Medi4736
Experimental: Arm B Medi4736, IV Infusion vs. ADXS11-001 & Medi4736, IV Infusion	Drug: ADXS11-001; Drug: Medi4736

Outcome Measures

Primary Outcome Measures

1. Number of subjects with adverse events in each dose level (Part A) [2 years]

2. Progression Free Survival as measured by RECIST 1.1 an irRECIST (Part B) [2 years]

   Number of subjects with progression free survival

3. number of subject with adverse event in combination dose (Part B) [2 years]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Not Yet Recruiting	Los Angeles	California	United States
2	Not Yet Recruiting	New Haven	Connecticut	United States
3	Site	Jacksonville	Florida	United States
4	Recruiting	Miami	Florida	United States
5	Site	Tampa	Florida	United States
6	Site	Urbana	Illinois	United States
7	Site	Lexington	Kentucky	United States
8	Not Yet Recruiting	Baltimore	Maryland	United States
9	Site	Detroit	Michigan	United States
10	Site	Omaha	Nebraska	United States
11	Site	Brooklyn	New York	United States
12	Recruiting	New York	New York	United States
13	Recruiting	Canton	Ohio	United States
14	Site	Hilliard	Ohio	United States
15	Recruiting	Oklahoma City	Oklahoma	United States
16	Site	Chattanooga	Tennessee	United States
17	Site	Milwaukee	Wisconsin	United States

Sponsors and Collaborators

• Advaxis, Inc.
• MedImmune LLC

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Advaxis, Inc.
• ClinicalTrials.gov Identifier: NCT02291055
• Other Study ID Numbers: ADXS001-04
• First Posted: Nov 14, 2014
• Last Update Posted: Feb 19, 2020
• Last Verified: Feb 1, 2020

• Additional relevant MeSH terms: Head and Neck Neoplasms; Durvalumab

Study Results

No Results Posted as of Feb 19, 2020