Back to resultsA Study of ADXS11-001 or MEDI4736 Alone or Combination In Cervical or Human Papillomavirus (HPV)+ Head & Neck Cancer
Primary Purpose
Cervical Cancer, Cancer, Head and Neck Cancer
Status
Terminated
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
ADXS11-001
MEDI4736
Sponsored by
About this trial
This is an interventional treatment trial for Cervical Cancer
Eligibility Criteria
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
Sites / Locations
- Site
- Site
- Site
- Site
- Site
- Site
- Site
- Site
- Site
- Site
- Site
- Site
- Site
- Site
- Site
- Site
- Site
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm 5
Arm Type
Experimental
Experimental
Experimental
Experimental
Experimental
Arm Label
Part A Escalation (Cervical): 1×10^9 CFU ADXS11-001/ 3 mg/kg MEDI4736
Part A Escalation (Cervical and Head and Neck): 1×10^9 CFU ADXS11-001/ 10 mg/kg MEDI4736
Part A Expansion (Head and Neck): 1×10^9 CFU ADXS11-001/ 10 mg/kg MEDI4736
Part B Expansion (Cervical): 10 mg/kg MEDI4736
Part B Expansion (Cervical): 1×10^9 CFU ADXS11-001/ 10 mg/kg MEDI4736
Arm Description
Participants with cervical cancer received MEDI4736 3 milligrams per kilogram (mg/kg) intravenous (IV) infusion every 2 weeks (Q2W) at an infusion rate of approximately 60 minutes followed by ADXS11-001 1×10^9 CFU IV infusion every 4 weeks (Q4W) at an infusion rate of approximately 60 minutes. Treatment cycles were 8-week in duration and participants were to continue therapy for up to 1 year or until documented progression, unacceptable toxicity, withdrawal of consent, or other treatment discontinuation criteria were met.
Participants with cervical cancer and SCCHN received MEDI4736 10 mg/kg IV infusion Q2W at an infusion rate of approximately 60 minutes followed by ADXS11-001 1×10^9 CFU IV infusion Q4W at an infusion rate of approximately 60 minutes. Treatment cycles were 8-week in duration and participants were to continue therapy for up to 1 year or until documented progression, unacceptable toxicity, withdrawal of consent, or other treatment discontinuation criteria were met.
Participants with SCCHN received MEDI4736 10 mg/kg IV infusion Q2W at an infusion rate of approximately 60 minutes followed by ADXS11-001 1×10^9 CFU IV infusion Q4W at an infusion rate of approximately 60 minutes. Treatment cycles were 8-week in duration and participants were to continue therapy for up to 1 year or until documented progression, unacceptable toxicity, withdrawal of consent, or other treatment discontinuation criteria were met.
Participants with cervical cancer received MEDI4736 10 mg/kg IV infusion Q2W at an infusion rate of approximately 60 minutes. Treatment cycles were 8-week in duration and participants were to continue therapy for up to 1 year or until documented progression, unacceptable toxicity, withdrawal of consent, or other treatment discontinuation criteria were met.
Participants with cervical cancer received MEDI4736 10 mg/kg IV infusion Q2W at an infusion rate of approximately 60 minutes followed by ADXS11-001 1×10^9 CFU IV infusion Q4W at an infusion rate of approximately 60 minutes. Treatment cycles were 8-week in duration and participants were to continue therapy for up to 1 year or until documented progression, unacceptable toxicity, withdrawal of consent, or other treatment discontinuation criteria were met.
Outcomes
Primary Outcome Measures
Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Treatment Emergent Serious Adverse Events (TESAEs) in Part A and Part B
An adverse event (AE) was any untoward medical occurrence in a participant administered a pharmaceutical product and which did not necessarily have a causal relationship with this treatment. Any worsening (ie, any clinically significant adverse change in frequency and/or intensity) of a preexisting condition that was temporally associated with the use of the Sponsor's product, was also considered an AE. A serious adverse event (SAE) was any AE that: results in death; life threatening; resulted in or prolonged an existing inpatient hospitalization, persistent or significant disability/incapacity; congenital anomaly; a new cancer; associated with an overdose; another important medical event. Treatment emergent was defined as events with onset dates on or after the first dose of study medication and within 30 days following the last dose of study medication.
Progression Free Survival (Part A and Part B): Cervical Cancer Population
Progression-free survival (PFS) was defined as the time from randomization until objective tumor progression based on response evaluation criteria in solid tumors (RECIST) version 1.1 or death. The progressive disease is defined at least a 20% increase in the sum of the longest diameter of target lesions, taking as reference the smallest sum longest diameter recorded since the treatment started, the appearance of one or more new lesions, or unequivocal progression of existing non-target lesions. Participants who had not experienced disease progression or who were still alive at the time of evaluation were censored for the analysis. The PFS was estimated using Kaplan-Meier method.
Progression Free Survival (Part A): Human Papillomavirus (HPV)+ Head and Neck Cancer Population
PFS was defined as the time from randomization until objective tumor progression based on RECIST version 1.1 or death. The progressive disease is defined at least a 20% increase in the sum of the longest diameter of target lesions, taking as reference the smallest sum longest diameter recorded since the treatment started, the appearance of one or more new lesions, or unequivocal progression of existing non-target lesions. Participants who had not experienced disease progression or who were still alive at the time of evaluation were censored for the analysis. The PFS was estimated using Kaplan-Meier method.
Percentage of Participants With Objective Response as Per RECIST Criteria (Part A and Part B): Cervical Cancer Population
The objective response is defined as confirmed complete response (CR) or partial response (PR) based on RECIST v1.1 guidelines. The CR is defined as disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to <10 millimeter (mm). The PR is defined as >= 30% decrease in the sum of the longest diameter of all target lesions compared with baseline, in absence of new lesions or unequivocal progression of non-target lesions.
Percentage of Participants With Objective Response as Per RECIST Criteria (Part A): HPV+ Head and Neck Cancer Population
The objective response is defined as confirmed CR or PR based on RECIST v1.1 guidelines. The CR is defined as disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to <10 mm. The PR is defined as >= 30% decrease in the sum of the longest diameter of all target lesions compared with baseline, in absence of new lesions or unequivocal progression of non-target lesions.
Percentage of Participants With Objective Response as Per irRECIST Criteria (Part A and Part B): Cervical Cancer Population
The objective response is defined as confirmed CR or confirmed PR based on immune-related RECIST (irRECIST) v1.1 guidelines. The irCR is defined as disappearance of all target and non-target lesions, no new lesions, and normalization of tumor marker level. The irPR is defined as >= 30% decrease in tumor burden compared with baseline.
Percentage of Participants With Objective Response as Per irRECIST Criteria (Part A): HPV+ Head and Neck Cancer Population
The objective response is defined as confirmed CR or confirmed PR based on irRECIST v1.1 guidelines. The irCR is defined as disappearance of all target and non-target lesions, no new lesions, and normalization of tumor marker level. The irPR is defined as >= 30% decrease in tumor burden compared with baseline.
Percentage of Participants With Disease Control as Per RECIST Criteria (Part A and Part B): Cervical Cancer Population
The DCR is defined percentage of participants with CR, PR, or stable disease (SD) based on RECIST v1.1 guidelines. The CR is defined as disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to <10 mm. The PR is defined as >= 30% decrease in the sum of the longest diameter of all target lesions compared with baseline, in absence of new lesions or unequivocal progression of non-target lesions. The SD is defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum longest diameter since the study treatment started. The PD is defined as at least 20% increase in sum of diameters of target lesions, taking as reference the smallest sum on study. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. The appearance of one or more new lesions is also considered progression.
Percentage of Participants With Disease Control as Per RECIST Criteria (Part A): HPV+ Head and Neck Cancer Population
The DCR is defined percentage of participants with CR, PR, or SD based on RECIST v1.1 guidelines. The CR is defined as disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to <10 mm. The PR is defined as >= 30% decrease in the sum of the longest diameter of all target lesions compared with baseline, in absence of new lesions or unequivocal progression of non-target lesions. The SD is defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum longest diameter since the study treatment started. The PD is defined as at least 20% increase in sum of diameters of target lesions, taking as reference the smallest sum on study. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. The appearance of one or more new lesions is also considered progression.
Percentage of Participants With Disease Control as Per irRECIST Criteria (Part A and Part B): Cervical Cancer Population
The DCR is defined percentage of participants with irCR, irPR, or irSD based on irRECIST v1.1 guidelines. The irCR is defined as disappearance of all target and non-target lesions, no new lesions, and normalization of tumor marker level. The irPR is defined as >= 30% decrease in tumor burden compared with baseline. The irSD is defined as neither a 30% decrease in tumor burden compared with baseline nor a 20% increase compared with nadir can be established.
Percentage of Participants With Disease Control as Per irRECIST Criteria (Part A): HPV+ Head and Neck Cancer Population
The DCR is defined percentage of participants with irCR, irPR, or irSD based on irRECIST v1.1 guidelines. The irCR is defined as disappearance of all target and non-target lesions, no new lesions, and normalization of tumor marker level. The irPR is defined as >= 30% decrease in tumor burden compared with baseline. The irSD is defined as neither a 30% decrease in tumor burden compared with baseline nor a 20% increase compared with nadir can be established.
Overall Survival: Cervical Cancer Population
Overall survival is defined as the time from the date of start of study treatment until death due to any cause. Any participant not died at the time of analysis was censored based on the last recorded date on which the participant was known to be alive. The OS was estimated using Kaplan-Meier method.
Overall Survival: HPV+ Head and Neck Cancer Population
Overall survival is defined as the time from the date of start of study treatment until death due to any cause. Any participant not died at the time of analysis was censored based on the last recorded date on which the participant was known to be alive. The OS was estimated using Kaplan-Meier method.
Secondary Outcome Measures
Full Information
NCT ID
NCT02291055
First Posted
November 6, 2014
Last Updated
February 20, 2023
Sponsor
Advaxis, Inc.
Collaborators
MedImmune LLC
1. Study Identification
Unique Protocol Identification Number
NCT02291055
Brief Title
A Study of ADXS11-001 or MEDI4736 Alone or Combination In Cervical or Human Papillomavirus (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
Study Type
Interventional
2. Study Status
Record Verification Date
February 2023
Overall Recruitment Status
Terminated
Study Start Date
April 2015 (Actual)
Primary Completion Date
July 9, 2019 (Actual)
Study Completion Date
November 20, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Advaxis, Inc.
Collaborators
MedImmune LLC
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
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).
Detailed Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cervical Cancer, Cancer, Head and Neck Cancer
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Sequential Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
75 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Part A Escalation (Cervical): 1×10^9 CFU ADXS11-001/ 3 mg/kg MEDI4736
Arm Type
Experimental
Arm Description
Participants with cervical cancer received MEDI4736 3 milligrams per kilogram (mg/kg) intravenous (IV) infusion every 2 weeks (Q2W) at an infusion rate of approximately 60 minutes followed by ADXS11-001 1×10^9 CFU IV infusion every 4 weeks (Q4W) at an infusion rate of approximately 60 minutes. Treatment cycles were 8-week in duration and participants were to continue therapy for up to 1 year or until documented progression, unacceptable toxicity, withdrawal of consent, or other treatment discontinuation criteria were met.
Arm Title
Part A Escalation (Cervical and Head and Neck): 1×10^9 CFU ADXS11-001/ 10 mg/kg MEDI4736
Arm Type
Experimental
Arm Description
Participants with cervical cancer and SCCHN received MEDI4736 10 mg/kg IV infusion Q2W at an infusion rate of approximately 60 minutes followed by ADXS11-001 1×10^9 CFU IV infusion Q4W at an infusion rate of approximately 60 minutes. Treatment cycles were 8-week in duration and participants were to continue therapy for up to 1 year or until documented progression, unacceptable toxicity, withdrawal of consent, or other treatment discontinuation criteria were met.
Arm Title
Part A Expansion (Head and Neck): 1×10^9 CFU ADXS11-001/ 10 mg/kg MEDI4736
Arm Type
Experimental
Arm Description
Participants with SCCHN received MEDI4736 10 mg/kg IV infusion Q2W at an infusion rate of approximately 60 minutes followed by ADXS11-001 1×10^9 CFU IV infusion Q4W at an infusion rate of approximately 60 minutes. Treatment cycles were 8-week in duration and participants were to continue therapy for up to 1 year or until documented progression, unacceptable toxicity, withdrawal of consent, or other treatment discontinuation criteria were met.
Arm Title
Part B Expansion (Cervical): 10 mg/kg MEDI4736
Arm Type
Experimental
Arm Description
Participants with cervical cancer received MEDI4736 10 mg/kg IV infusion Q2W at an infusion rate of approximately 60 minutes. Treatment cycles were 8-week in duration and participants were to continue therapy for up to 1 year or until documented progression, unacceptable toxicity, withdrawal of consent, or other treatment discontinuation criteria were met.
Arm Title
Part B Expansion (Cervical): 1×10^9 CFU ADXS11-001/ 10 mg/kg MEDI4736
Arm Type
Experimental
Arm Description
Participants with cervical cancer received MEDI4736 10 mg/kg IV infusion Q2W at an infusion rate of approximately 60 minutes followed by ADXS11-001 1×10^9 CFU IV infusion Q4W at an infusion rate of approximately 60 minutes. Treatment cycles were 8-week in duration and participants were to continue therapy for up to 1 year or until documented progression, unacceptable toxicity, withdrawal of consent, or other treatment discontinuation criteria were met.
Intervention Type
Drug
Intervention Name(s)
ADXS11-001
Intervention Type
Drug
Intervention Name(s)
MEDI4736
Primary Outcome Measure Information:
Title
Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Treatment Emergent Serious Adverse Events (TESAEs) in Part A and Part B
Description
An adverse event (AE) was any untoward medical occurrence in a participant administered a pharmaceutical product and which did not necessarily have a causal relationship with this treatment. Any worsening (ie, any clinically significant adverse change in frequency and/or intensity) of a preexisting condition that was temporally associated with the use of the Sponsor's product, was also considered an AE. A serious adverse event (SAE) was any AE that: results in death; life threatening; resulted in or prolonged an existing inpatient hospitalization, persistent or significant disability/incapacity; congenital anomaly; a new cancer; associated with an overdose; another important medical event. Treatment emergent was defined as events with onset dates on or after the first dose of study medication and within 30 days following the last dose of study medication.
Time Frame
From first dose until 30 days after last dose (maximum duration: 98 weeks)
Title
Progression Free Survival (Part A and Part B): Cervical Cancer Population
Description
Progression-free survival (PFS) was defined as the time from randomization until objective tumor progression based on response evaluation criteria in solid tumors (RECIST) version 1.1 or death. The progressive disease is defined at least a 20% increase in the sum of the longest diameter of target lesions, taking as reference the smallest sum longest diameter recorded since the treatment started, the appearance of one or more new lesions, or unequivocal progression of existing non-target lesions. Participants who had not experienced disease progression or who were still alive at the time of evaluation were censored for the analysis. The PFS was estimated using Kaplan-Meier method.
Time Frame
From randomization until objective tumor progression or death (maximum duration: 146 weeks)
Title
Progression Free Survival (Part A): Human Papillomavirus (HPV)+ Head and Neck Cancer Population
Description
PFS was defined as the time from randomization until objective tumor progression based on RECIST version 1.1 or death. The progressive disease is defined at least a 20% increase in the sum of the longest diameter of target lesions, taking as reference the smallest sum longest diameter recorded since the treatment started, the appearance of one or more new lesions, or unequivocal progression of existing non-target lesions. Participants who had not experienced disease progression or who were still alive at the time of evaluation were censored for the analysis. The PFS was estimated using Kaplan-Meier method.
Time Frame
From randomization until objective tumor progression or death (maximum duration: 146 weeks)
Title
Percentage of Participants With Objective Response as Per RECIST Criteria (Part A and Part B): Cervical Cancer Population
Description
The objective response is defined as confirmed complete response (CR) or partial response (PR) based on RECIST v1.1 guidelines. The CR is defined as disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to <10 millimeter (mm). The PR is defined as >= 30% decrease in the sum of the longest diameter of all target lesions compared with baseline, in absence of new lesions or unequivocal progression of non-target lesions.
Time Frame
From randomization until objective tumor progression or death (maximum duration: 146 weeks)
Title
Percentage of Participants With Objective Response as Per RECIST Criteria (Part A): HPV+ Head and Neck Cancer Population
Description
The objective response is defined as confirmed CR or PR based on RECIST v1.1 guidelines. The CR is defined as disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to <10 mm. The PR is defined as >= 30% decrease in the sum of the longest diameter of all target lesions compared with baseline, in absence of new lesions or unequivocal progression of non-target lesions.
Time Frame
From randomization until objective tumor progression or death (maximum duration: 146 weeks)
Title
Percentage of Participants With Objective Response as Per irRECIST Criteria (Part A and Part B): Cervical Cancer Population
Description
The objective response is defined as confirmed CR or confirmed PR based on immune-related RECIST (irRECIST) v1.1 guidelines. The irCR is defined as disappearance of all target and non-target lesions, no new lesions, and normalization of tumor marker level. The irPR is defined as >= 30% decrease in tumor burden compared with baseline.
Time Frame
From randomization until objective tumor progression or death (maximum duration: 146 weeks)
Title
Percentage of Participants With Objective Response as Per irRECIST Criteria (Part A): HPV+ Head and Neck Cancer Population
Description
The objective response is defined as confirmed CR or confirmed PR based on irRECIST v1.1 guidelines. The irCR is defined as disappearance of all target and non-target lesions, no new lesions, and normalization of tumor marker level. The irPR is defined as >= 30% decrease in tumor burden compared with baseline.
Time Frame
From randomization until objective tumor progression or death (maximum duration: 146 weeks)
Title
Percentage of Participants With Disease Control as Per RECIST Criteria (Part A and Part B): Cervical Cancer Population
Description
The DCR is defined percentage of participants with CR, PR, or stable disease (SD) based on RECIST v1.1 guidelines. The CR is defined as disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to <10 mm. The PR is defined as >= 30% decrease in the sum of the longest diameter of all target lesions compared with baseline, in absence of new lesions or unequivocal progression of non-target lesions. The SD is defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum longest diameter since the study treatment started. The PD is defined as at least 20% increase in sum of diameters of target lesions, taking as reference the smallest sum on study. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. The appearance of one or more new lesions is also considered progression.
Time Frame
From randomization until objective tumor progression or death (maximum duration: 146 weeks)
Title
Percentage of Participants With Disease Control as Per RECIST Criteria (Part A): HPV+ Head and Neck Cancer Population
Description
The DCR is defined percentage of participants with CR, PR, or SD based on RECIST v1.1 guidelines. The CR is defined as disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to <10 mm. The PR is defined as >= 30% decrease in the sum of the longest diameter of all target lesions compared with baseline, in absence of new lesions or unequivocal progression of non-target lesions. The SD is defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum longest diameter since the study treatment started. The PD is defined as at least 20% increase in sum of diameters of target lesions, taking as reference the smallest sum on study. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. The appearance of one or more new lesions is also considered progression.
Time Frame
From randomization until objective tumor progression or death (maximum duration: 146 weeks)
Title
Percentage of Participants With Disease Control as Per irRECIST Criteria (Part A and Part B): Cervical Cancer Population
Description
The DCR is defined percentage of participants with irCR, irPR, or irSD based on irRECIST v1.1 guidelines. The irCR is defined as disappearance of all target and non-target lesions, no new lesions, and normalization of tumor marker level. The irPR is defined as >= 30% decrease in tumor burden compared with baseline. The irSD is defined as neither a 30% decrease in tumor burden compared with baseline nor a 20% increase compared with nadir can be established.
Time Frame
From randomization until objective tumor progression or death (maximum duration: 146 weeks)
Title
Percentage of Participants With Disease Control as Per irRECIST Criteria (Part A): HPV+ Head and Neck Cancer Population
Description
The DCR is defined percentage of participants with irCR, irPR, or irSD based on irRECIST v1.1 guidelines. The irCR is defined as disappearance of all target and non-target lesions, no new lesions, and normalization of tumor marker level. The irPR is defined as >= 30% decrease in tumor burden compared with baseline. The irSD is defined as neither a 30% decrease in tumor burden compared with baseline nor a 20% increase compared with nadir can be established.
Time Frame
From randomization until objective tumor progression or death (maximum duration: 146 weeks)
Title
Overall Survival: Cervical Cancer Population
Description
Overall survival is defined as the time from the date of start of study treatment until death due to any cause. Any participant not died at the time of analysis was censored based on the last recorded date on which the participant was known to be alive. The OS was estimated using Kaplan-Meier method.
Time Frame
From first dose until death (maximum duration: 146 weeks)
Title
Overall Survival: HPV+ Head and Neck Cancer Population
Description
Overall survival is defined as the time from the date of start of study treatment until death due to any cause. Any participant not died at the time of analysis was censored based on the last recorded date on which the participant was known to be alive. The OS was estimated using Kaplan-Meier method.
Time Frame
From first dose until death (maximum duration: 146 weeks)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Have histological diagnosis of SCCHN 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 response evaluation criteria in solid tumors (RECIST) 1.1
Have Eastern Cooperative Oncology Group (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
Facility Information:
Facility Name
Site
City
Los Angeles
State/Province
California
Country
United States
Facility Name
Site
City
New Haven
State/Province
Connecticut
Country
United States
Facility Name
Site
City
Jacksonville
State/Province
Florida
Country
United States
Facility Name
Site
City
Miami
State/Province
Florida
Country
United States
Facility Name
Site
City
Tampa
State/Province
Florida
Country
United States
Facility Name
Site
City
Urbana
State/Province
Illinois
Country
United States
Facility Name
Site
City
Lexington
State/Province
Kentucky
Country
United States
Facility Name
Site
City
Baltimore
State/Province
Maryland
Country
United States
Facility Name
Site
City
Detroit
State/Province
Michigan
Country
United States
Facility Name
Site
City
Omaha
State/Province
Nebraska
Country
United States
Facility Name
Site
City
Brooklyn
State/Province
New York
Country
United States
Facility Name
Site
City
New York
State/Province
New York
Country
United States
Facility Name
Site
City
Canton
State/Province
Ohio
Country
United States
Facility Name
Site
City
Hilliard
State/Province
Ohio
Country
United States
Facility Name
Site
City
Oklahoma City
State/Province
Oklahoma
Country
United States
Facility Name
Site
City
Chattanooga
State/Province
Tennessee
Country
United States
Facility Name
Site
City
Milwaukee
State/Province
Wisconsin
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
Citation
Slomovitz BM, Moore K, Vangala S, Parsi M, Sheerie S, John Heyburn J ,Posner M. Phase II study of durvalumab alone or in combination with ADXS11-001 (AXAL) in recurrent/persistent or metastatic cervical cancer. Annual Meeting on Women's Cancer. March 28-31, 2020. Toronto Canada.
Results Reference
result
Learn more about this trial
A Study of ADXS11-001 or MEDI4736 Alone or Combination In Cervical or Human Papillomavirus (HPV)+ Head & Neck Cancer
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