Cervical Adenocarcinoma Clinical Trial
Official title:
A Phase 1 Study Evaluating High Dose ADXS11-001 Treatment in Women With Carcinoma of the Cervix (ADXS001-07)
Verified date | December 2023 |
Source | Advaxis, Inc. |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
To evaluate the tolerability and safety of axalimogene filolisbac 1 x 10^10 colony forming units (cfu) administered with prophylactic premedication in repeating 3-dose study cycles in women with persistent, metastatic, or recurrent squamous and non-squamous carcinoma, adenosquamous, or adenocarcinoma of the cervix. To evaluate tumor response and progression-free survival (PFS) by Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 and immune-related Response Evaluation Criteria in Solid Tumors (irRECIST).
Status | Completed |
Enrollment | 12 |
Est. completion date | March 8, 2017 |
Est. primary completion date | March 8, 2017 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - Participants with histologically-confirmed, persistent, metastatic or recurrent squamous or non-squamous cell carcinoma, adenosquamous carcinoma, or adenocarcinoma of the cervix with documented disease progression (disease not amenable to surgery or standard radiotherapy). - Participants who have received no more than 1 prior cytotoxic treatment regimen. - Participant may have received =2 prior regimens for the treatment of their metastatic disease. - Participant is able to provide written informed consent. - Participant must have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1. Exclusion Criteria: - In the opinion of the investigator, participant has rapidly progressing disease, OR has life expectancy of less than 6 months, OR would be unable to receive at least one cycle of therapy. - Participant has received chemotherapy and/or radiation therapy (except palliative radiation therapy for disease-related pain) within =2 weeks of first axalimogene filolisbac infusion. - Participant has a known additional malignancy that is progressing or requires active treatment. Exceptions include basal cell carcinoma of the skin, squamous cell carcinoma of the skin, or in situ cervical cancer that has undergone potentially curative therapy. - Has a contraindication to administration of trimethoprim/sulfamethoxazole or ampicillin. - 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 participant who has any other device and/or implant. |
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
Advaxis, Inc. |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Number of Participants With Dose Limiting Toxicities (DLTs) | DLT was defined as occurrence of any of the following toxicities that are possibly, probably or definitely related to therapy.
Hematologic: Grade 4 hematologic toxicity. Febrile neutropenia, defined as absolute neutrophil count (ANC) < 1000/mm^3 with a single temperature of >38.3° C (101° F) or a sustained temperature of >38° C (100.4° F) for more than 1 hour. Grade 3 thrombocytopenia lasting >72 hours. Grade 4 thrombocytopenia. Non-Hematologic: =Grade 3 non-hematologic toxicity Grade 3 non hematologic laboratory values. Listeremia: positive blood cultures along with persistent (for 72 hours post dose) symptoms consistent with listeremia (e.g., fever and muscle aches, often preceded by diarrhea or other gastrointestinal symptoms). =Grade 3 flu-like symptoms or cytokine release symptoms that persist for >24 hours after study treatment administration despite symptomatic treatment. |
Up to 28 days in Cycle 1 (12 weeks cycle) | |
Primary | Listeria Monocytogenes Surveillance | Number of participants with delayed listeria infection was reported. | Up to 120 days post dose | |
Primary | Number of Participants With Adverse Events | Adverse event (AE): any untoward medical occurrence in a participant administered a study treatment & which did not necessarily have to have a causal relationship with the study treatment. An AE is, any unfavorable & unintended sign, symptom, or disease temporally associated with the use of a medicinal product or protocol-specified procedure, whether or not considered related to the medicinal product or protocol-specified procedure. Any worsening of a preexisting condition that was temporally associated with the use of study treatment. AE with onset on or after the date of first administration of the study treatment until the end of the Listeria Monocytogenes (Lm) surveillance period. | From first dose up to 2.3 years | |
Secondary | Objective Response Rate (ORR) as Per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 | ORR as per RECIST 1.1 was defined as the percentage of participants who achieved complete response (CR) or partial response (PR). CR was defined as disappearance of all lesions. PR was 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. | From first dose until end of treatment (Maximum duration: 1.5 years) | |
Secondary | Duration of Tumor Response as Per RECIST 1.1 | Duration of response as per RECIST 1.1 was defined as the time interval from CR or PR to disease progression or death. CR was defined as disappearance of all lesions. PR was 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. Progressive disease (PD) was 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 5mm. The appearance of one or more new lesions is also considered progression .Kaplan-Meier method was used to estimate median and 95% confidence interval (CI). | From first objective response to disease progression or death (Maximum duration: 1.5 years) | |
Secondary | Progression Free Survival (PFS) as Per RECIST 1.1 | PFS as per RECIST 1.1 was defined as the time interval from study enrollment to disease progression or death. Participants who were alive with no disease progression were censored at the date of the last tumor assessment. PD was 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 5mm. The appearance of one or more new lesions is also considered progression.The Kaplan-Meier method was used to estimate median and 95% CI. | From study enrollment to disease progression or death (Maximum duration: 1.5 years) | |
Secondary | ORR as Per Immune-related Response Evaluation Criteria in Solid Tumors (irRECIST) | ORR as per irRECIST was defined as the percent of participants who achieved immune response complete response (irCR) or immune response partial response (irPR). irCR was defined as disappearance of all lesions. irPR was defined as =30% decrease in tumor burden compared with baseline. | From first dose until end of treatment (Maximum duration was 1.5 years) | |
Secondary | Duration of Tumor Response as Per irRECIST | Duration of response as per irRECIST 1.1 was defined as the time interval from irCR or irPR to disease progression or death. irCR was defined as disappearance of all lesions. irPR was defined as =30% decrease in tumor burden compared with baseline. Immune response progressive disease (irPD) was defined as at least 20% increase in tumor burden compared with nadir (at any single time point). The Kaplan-Meier method was used to estimate median and 95% CI. | From first objective response to disease progression or death (Maximum duration: 1.5 years) | |
Secondary | PFS as Per irRECIST | PFS as per irRECIST 1.1 was defined as the time interval from study enrollment to disease progression or death. Participants who were alive with no disease progression were censored at the date of the last tumor assessment. irPD was defined as at least 20% increase in tumor burden compared with nadir (at any single time point). The Kaplan-Meier method was used to estimate median and 95% CI. | From study enrollment to disease progression or death (Maximum duration: 1.5 years) |
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