A Phase 1/2 interventional study of ADXS11-001 and MEDI4736 in Cervical Cancer, Cancer and Head and Neck Cancer, sponsored by Advaxis, Inc.. Terminated at 17 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-03-20.
Sponsored by Advaxis, Inc. · Phase 1/2, Interventional, and Treatment
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).
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.
2,366 studies on the registry are indexed under Uterine Cervical Neoplasms; 677 are open to participants now.
This study's enrollment of 75 is below the median of 100 across 1,738 interventional studies indexed under Uterine Cervical Neoplasms.
Browse Uterine Cervical Neoplasms studies →Advaxis, Inc. is the lead sponsor of 10 studies on the registry; none are open to participants now.
Of its 7 completed or terminated interventional studies of FDA-regulated products, 6 (86%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The standard rules for measuring tumours on CT or MRI scans, to tell whether a cancer is shrinking, stable or growing during treatment.
“Measurable disease per RECIST 1.1” usually means at least one tumour 10 mm or more at its longest on a CT scan, or a lymph node 15 mm or more across its short axis.
A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.
Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.
PD-1, PD-L1 and CTLA-4 are proteins that act as brakes on the immune system. Checkpoint inhibitors, such as pembrolizumab or nivolumab, block them so the immune system can attack a cancer.
PD-L1 can also be measured in a tumour sample. Some scores count stained tumour cells only (TPS); others also count certain immune cells (CPS). The study names the score and the minimum it uses.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
RECIST
The standard rules for measuring tumours on CT or MRI scans, to tell whether a cancer is shrinking, stable or growing during treatment.
“Measurable disease per RECIST 1.1” usually means at least one tumour 10 mm or more at its longest on a CT scan, or a lymph node 15 mm or more across its short axis.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ECOG performance status
A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.
Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
PD-1, PD-L1 and checkpoint inhibitors
PD-1, PD-L1 and CTLA-4 are proteins that act as brakes on the immune system. Checkpoint inhibitors, such as pembrolizumab or nivolumab, block them so the immune system can attack a cancer.
PD-L1 can also be measured in a tumour sample. Some scores count stained tumour cells only (TPS); others also count certain immune cells (CPS). The study names the score and the minimum it uses.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Immunosuppression
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Autoimmune disease
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Drug: ADXS11-001 · Drug: MEDI4736
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.
Drug: ADXS11-001 · Drug: MEDI4736
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.
Drug: ADXS11-001 · Drug: MEDI4736
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.
Drug: MEDI4736
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.
Drug: ADXS11-001 · Drug: MEDI4736
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.
Time frame: From first dose until 30 days after last dose (maximum duration: 98 weeks)
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.
Time frame: From randomization until objective tumor progression or death (maximum duration: 146 weeks)
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.
Time frame: From randomization until objective tumor progression or death (maximum duration: 146 weeks)
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.
Time frame: From randomization until objective tumor progression or death (maximum duration: 146 weeks)
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.
Time frame: From randomization until objective tumor progression or death (maximum duration: 146 weeks)
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.
Time frame: From randomization until objective tumor progression or death (maximum duration: 146 weeks)
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.
Time frame: From randomization until objective tumor progression or death (maximum duration: 146 weeks)
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.
Time frame: From randomization until objective tumor progression or death (maximum duration: 146 weeks)
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.
Time frame: From randomization until objective tumor progression or death (maximum duration: 146 weeks)
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.
Time frame: From randomization until objective tumor progression or death (maximum duration: 146 weeks)
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.
Time frame: From randomization until objective tumor progression or death (maximum duration: 146 weeks)
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.
Time frame: From first dose until death (maximum duration: 146 weeks)
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.
Time frame: From first dose until death (maximum duration: 146 weeks)
Participants were enrolled at study centers in the United States.
| Milestone | 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 |
|---|---|---|---|---|---|
| Started | 5 | 5 | 11 | 27 | 27 |
| Completed | 0 | 0 | 3 | 0 | 0 |
| Not completed | 5 | 5 | 8 | 27 | 27 |
| Withdrew: Death | 2 | 2 | 5 | 8 | 12 |
| Withdrew: Lost to follow-up | 0 | 0 | 0 | 1 | 2 |
| Withdrew: Withdrawal by subject | 3 | 1 | 1 | 5 | 10 |
| Withdrew: Progressive disease | 0 | 0 | 1 | 4 | 2 |
| Withdrew: Study terminated by sponsor | 0 | 0 | 0 | 5 | 1 |
| Withdrew: Other | 0 | 2 | 1 | 4 | 0 |
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.
| participants | 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 |
|---|---|---|---|---|---|
| TEAEs | 5 | 5 | 11 | 25 | 27 |
| TESAEs | 2 | 3 | 4 | 13 | 15 |
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.
| months | Part A (Cervical): 1×10^9 CFU ADXS11-001/ 3 mg/kg MEDI4736 | Part A + Part B (Cervical): 1×10^9 CFU ADXS11-001/ 10 mg/kg MEDI4736 | Part B Expansion (Cervical): 10 mg/kg MEDI4736 |
|---|---|---|---|
| Progression Free Survival (Part A and Part B): Cervical Cancer Population | 3.7 (1.8 to 22.1) | 2.1 (1.7 to 3.8) | 5.0 (1.8 to 6.9) |
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.
| months | Part A Escalation and Expansion (Head and Neck): 1×10^9 CFU ADXS11-001/ 10 mg/kg MEDI4736 |
|---|---|
| Progression Free Survival (Part A): Human Papillomavirus (HPV)+ Head and Neck Cancer Population | 3.5 (1.6 to 5.3) |
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 | Part A (Cervical): 1×10^9 CFU ADXS11-001/ 3 mg/kg MEDI4736 | Part A + Part B (Cervical): 1×10^9 CFU ADXS11-001/ 10 mg/kg MEDI4736 | Part B Expansion (Cervical): 10 mg/kg MEDI4736 |
|---|---|---|---|
| Percentage of Participants With Objective Response as Per RECIST Criteria (Part A and Part B): Cervical Cancer Population | 25.0 (0.6 to 80.6) | 8.7 (1.1 to 28.0) | 10.0 (1.2 to 31.7) |
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 | Part A Escalation and Expansion (Head and Neck): 1×10^9 CFU ADXS11-001/ 10 mg/kg MEDI4736 |
|---|---|
| Percentage of Participants With Objective Response as Per RECIST Criteria (Part A): HPV+ Head and Neck Cancer Population | 0.00 (0.0 to 0.0) |
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 | Part A (Cervical): 1×10^9 CFU ADXS11-001/ 3 mg/kg MEDI4736 | Part A + Part B (Cervical): 1×10^9 CFU ADXS11-001/ 10 mg/kg MEDI4736 | Part B Expansion (Cervical): 10 mg/kg MEDI4736 |
|---|---|---|---|
| Percentage of Participants With Objective Response as Per irRECIST Criteria (Part A and Part B): Cervical Cancer Population | 25.0 (0.6 to 80.6) | 8.7 (1.1 to 28.0) | 10.0 (1.2 to 31.7) |
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 | Part A Escalation and Expansion (Head and Neck): 1×10^9 CFU ADXS11-001/ 10 mg/kg MEDI4736 |
|---|---|
| Percentage of Participants With Objective Response as Per irRECIST Criteria (Part A): HPV+ Head and Neck Cancer Population | 0.00 (0.0 to 0.0) |
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 | Part A (Cervical): 1×10^9 CFU ADXS11-001/ 3 mg/kg MEDI4736 | Part A + Part B (Cervical): 1×10^9 CFU ADXS11-001/ 10 mg/kg MEDI4736 | Part B Expansion (Cervical): 10 mg/kg MEDI4736 |
|---|---|---|---|
| Percentage of Participants With Disease Control as Per RECIST Criteria (Part A and Part B): Cervical Cancer Population | 50.0 (6.8 to 93.2) | 47.8 (26.8 to 69.4) | 65.0 (40.8 to 84.6) |
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 | Part A Escalation and Expansion (Head and Neck): 1×10^9 CFU ADXS11-001/ 10 mg/kg MEDI4736 |
|---|---|
| Percentage of Participants With Disease Control as Per RECIST Criteria (Part A): HPV+ Head and Neck Cancer Population | 58.3 (27.7 to 84.8) |
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 | Part A (Cervical): 1×10^9 CFU ADXS11-001/ 3 mg/kg MEDI4736 | Part A + Part B (Cervical): 1×10^9 CFU ADXS11-001/ 10 mg/kg MEDI4736 | Part B Expansion (Cervical): 10 mg/kg MEDI4736 |
|---|---|---|---|
| Percentage of Participants With Disease Control as Per irRECIST Criteria (Part A and Part B): Cervical Cancer Population | 75.0 (19.4 to 99.4) | 52.2 (30.6 to 73.2) | 65.0 (40.8 to 84.6) |
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 | Part A Escalation and Expansion (Head and Neck): 1×10^9 CFU ADXS11-001/ 10 mg/kg MEDI4736 |
|---|---|
| Percentage of Participants With Disease Control as Per irRECIST Criteria (Part A): HPV+ Head and Neck Cancer Population | 50.0 (21.1 to 78.9) |
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.
| months | Part A (Cervical): 1×10^9 CFU ADXS11-001/ 3 mg/kg MEDI4736 | Part A + Part B (Cervical): 1×10^9 CFU ADXS11-001/ 10 mg/kg MEDI4736 | Part B Expansion (Cervical): 10 mg/kg MEDI4736 |
|---|---|---|---|
| Overall Survival: Cervical Cancer Population | NA (2.8 to NA) | 9.3 (6.0 to NA) | 9.2 (6.9 to NA) |
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.
| months | Part A Escalation and Expansion (Head and Neck): 1×10^9 CFU ADXS11-001/ 10 mg/kg MEDI4736 |
|---|---|
| Overall Survival: HPV+ Head and Neck Cancer Population | 4.8 (3.6 to NA) |
Collected over All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks). Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Part A Escalation (Cervical): 1×10^9 CFU ADXS11-001/ 3 mg/kg MEDI4736 | 2/5 (40%) | 2/5 (40%) | 5/5 (100%) |
| Part A Escalation (Cervical and Head and Neck): 1×10^9 CFU ADXS11-001/ 10 mg/kg MEDI4736 | 2/5 (40%) | 3/5 (60%) | 5/5 (100%) |
| Part A Expansion (Head and Neck): 1×10^9 CFU ADXS11-001/ 10 mg/kg MEDI4736 | 7/11 (63.6%) | 4/11 (36.4%) | 11/11 (100%) |
| Part B Expansion (Cervical): 10 mg/kg MEDI4736 | 8/27 (29.6%) | 13/27 (48.1%) | 25/27 (92.6%) |
| Part B Expansion (Cervical): 1×10^9 CFU ADXS11-001/ 10 mg/kg MEDI4736 | 12/27 (44.4%) | 15/27 (55.6%) | 27/27 (100%) |
| Event | 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 |
|---|---|---|---|---|---|
| Cardiac arrestCardiac disorders | 0/5 | 1/5 | 0/11 | 0/27 | 0/27 |
| Colonic fistulaGastrointestinal disorders | 0/5 | 1/5 | 0/11 | 0/27 | 0/27 |
| DiarrhoeaGastrointestinal disorders | 0/5 | 1/5 | 0/11 | 0/27 | 0/27 |
| Large intestine perforationGastrointestinal disorders | 0/5 | 1/5 | 0/11 | 0/27 | 0/27 |
| Chest painGeneral disorders | 0/5 | 1/5 | 0/11 | 0/27 | 1/27 |
| Disease progressionGeneral disorders | 0/5 | 1/5 | 0/11 | 3/27 | 4/27 |
| Performance status decreasedGeneral disorders | 0/5 | 1/5 | 0/11 | 0/27 | 0/27 |
| Abdominal abscessInfections and infestations | 0/5 | 1/5 | 0/11 | 0/27 | 0/27 |
| Compression fractureInjury, poisoning and procedural complications | 0/5 | 1/5 | 0/11 | 0/27 | 0/27 |
| Upper limb fractureInjury, poisoning and procedural complications | 1/5 | 0/5 | 0/11 | 0/27 | 0/27 |
| Event | 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 |
|---|---|---|---|---|---|
| ChillsGeneral disorders | 4/5 | 5/5 | 1/11 | 1/27 | 18/27 |
| NauseaGastrointestinal disorders | 1/5 | 3/5 | 3/11 | 4/27 | 12/27 |
| PyrexiaGeneral disorders | 3/5 | 3/5 | 3/11 | 3/27 | 13/27 |
| FatigueGeneral disorders | 1/5 | 1/5 | 5/11 | 8/27 | 12/27 |
| Cytokine release syndromeImmune system disorders | 0/5 | 1/5 | 5/11 | 0/27 | 7/27 |
| HypotensionVascular disorders | 1/5 | 2/5 | 5/11 | 1/27 | 12/27 |
| ConstipationGastrointestinal disorders | 0/5 | 1/5 | 3/11 | 5/27 | 12/27 |
| VomitingGastrointestinal disorders | 1/5 | 0/5 | 3/11 | 5/27 | 11/27 |
| TachycardiaCardiac disorders | 0/5 | 2/5 | 3/11 | 1/27 | 8/27 |
| Abdominal painGastrointestinal disorders | 2/5 | 1/5 | 0/11 | 3/27 | 5/27 |
All Treated Population included participants who received at least 1 dose of study drug.
| Age, Categorical(Participants) | 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 | Total |
|---|---|---|---|---|---|---|
| <=18 years | 0 | 0 | 0 | 0 | 0 | 0 |
| Between 18 and 65 years | 5 | 4 | 9 | 23 | 27 | 68 |
| >=65 years | 0 | 1 | 2 | 4 | 0 | 7 |
| Sex: Female, Male(Participants) | 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 | Total |
|---|---|---|---|---|---|---|
| Female | 5 | 4 | 0 | 27 | 27 | 63 |
| Male | 0 | 1 | 11 | 0 | 0 | 12 |
| Ethnicity (NIH/OMB)(Participants) | 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 | Total |
|---|---|---|---|---|---|---|
| Hispanic or Latino | 0 | 1 | 2 | 3 | 6 | 12 |
| Not Hispanic or Latino | 5 | 4 | 9 | 24 | 21 | 63 |
| Unknown or Not Reported | 0 | 0 | 0 | 0 | 0 | 0 |
| Race/Ethnicity, Customized(Participants) | 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 | Total |
|---|---|---|---|---|---|---|
| Race — Asian | 1 | 0 | 0 | 0 | 1 | 2 |
| Race — Black or African American | 1 | 0 | 1 | 5 | 3 | 10 |
| Race — White | 3 | 4 | 10 | 19 | 21 | 57 |
| Race — Other | 0 | 1 | 0 | 3 | 2 | 6 |
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: No
Ran from Apr 2015 to primary completion in Jul 2019, 51 months.
Results were first posted in Mar 2023, 3 years 8 months after primary completion.
How these figures are worked out, and which studies are left out of them.
This study is terminated, as verified in Feb 2023. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Studies of the drug tested here: Durvalumab
Advaxis, Inc.