A Phase 1/2 interventional study of ADXS31-142 and Pembrolizumab in Cancer and Prostate Cancer, sponsored by Advaxis, Inc.. Completed at 8 sites in United States. Open to male participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-04-02.
Sponsored by Advaxis, Inc. · Phase 1/2, Interventional, and Treatment
A Phase 1/2 multicenter, dose determining, open-label study of ADXS31-142 monotherapy and a combination of ADXS31-142 and pembrolizumab (MK-3475) in participants with metastatic castration-resistant prostate cancer. Part A will be dose-determining part of ADXS31-142 monotherapy. Part B will be dose-determining part of ADXS31-142 and pembrolizumab (MK-3475) in combination. Part B expansion will treat additional participants with the recommended dose from Part B.
Part A of the study will be an open-label, Phase 1, multicenter, non-randomized, dose-determining trial of ADXS31-142 monotherapy in participants with mCRPC. The dose determining phase is intended to select a recommended Phase 2 dose (RP2D) for Part B.
Part B of the study will be an open-label, Phase 1-2, multicenter, non-randomized dose-determining trial of ADXS31-142 in combination with pembrolizumab (MK-3475) in participants with mCRPC. Part B will consist of a dose-determination phase followed by an expansion cohort phase. The dose-determining phase is intended to select an RP2D for the combination.
Dose escalation/de-escalation for this study will be explored by applying the modified toxicity probability interval design.
7,046 studies on the registry are indexed under Prostatic Neoplasms; 1,580 are open to participants now.
This study's enrollment of 50 is below the median of 60 across 5,348 interventional studies indexed under Prostatic Neoplasms.
Browse Prostatic 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.
Compared within Prostatic Neoplasms, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is Neoplasms. The counts are of registry records indexed under each term, refreshed daily. How we classify →
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.
Have progressive mCRPC, on androgen deprivation therapy, based on at least one of the following criteria:
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.
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
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.
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.
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.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Metastases
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
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.
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.
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.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participants received ADXS31-142 1 × 10\^9 colony-forming units (CFU), 5 × 10\^9 CFU, or 1 × 10\^10 CFU intravenously (IV) every 3 weeks (Q3W) in a 12-week cycle for up to 24 months or until disease progression or discontinuation.
Drug: ADXS31-142
Participants received ADXS31-142 1 × 10\^9 CFU) IV Q3W (in a 12-week cycle) in combination with 200 mg pembrolizumab IV Q3W for three times, with a fourth pembrolizumab dose 3 weeks later (in 12 week-cycles) for up to 24 months or until disease progression or discontinuation.
Drug: ADXS31-142 · Drug: Pembrolizumab
ADXS31-142 IV infusion
Pembrolizumab IV infusion
Also known as: MK-3475
Number of Participants With Treatment-Emergent Adverse Events
An adverse event (AE) was defined as any untoward medical occurrence in a participant or clinical investigation participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), 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. Adverse events with onset dates on or after the first dose of study medication and within 30 days following the last dose of study medication were considered "treatment emergent".
Time frame: From first dose up to 30 days after last dose (maximum duration: 108 weeks)
Objective Response Rate (ORR)
The objective response rate (ORR) according to Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1 was defined as the number of participants with objective evidence of radiologic complete response (CR: disappearance of all target lesions) and partial response (PR: at least a 30% decrease in the sum of the longest diameters of target lesions compared with baseline, in absence of new lesions or unequivocal progression of non-target lesions) as determined from investigator response assessments. Disease Control Rates are based upon confirmed events only.
Time frame: From screening until progression or death (maximum duration: 104 weeks)
Objective Response Rate According to Immune-related Response Evaluation Criteria in Solid Tumors (irRECIST)
The ORR according to irRECIST was defined as the number of participants with objective evidence of radiologic immune-related CR (irCR: Disappearance of all target lesions) and immune-related PR (irPR: At least 30% decrease in tumor burden compared with baseline) as determined from investigator response assessments.
Time frame: From screening until progression or death (maximum duration: 104 weeks)
Progression-free Survival, Assessed by RECIST Version 1.1
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. 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 screening until progression or death (maximum duration: 104 weeks)
Overall Survival
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 screening until progression or death (maximum duration: 104 weeks)
| Milestone | Part A: ADXS31-142 1x10^9 CFU | Part A: ADXS31-142 5×10^9 CFU | Part A: ADXS31-142 1×10^10 CFU | Part B: ADXS31-142 1×10^9 CFU + Pembrolizumab |
|---|---|---|---|---|
| Started | 10 | 1 | 2 | 37 |
| Completed | 0 | 0 | 0 | 0 |
| Not completed | 10 | 1 | 2 | 37 |
| Withdrew: Progressive disease | 1 | 0 | 0 | 0 |
| Withdrew: Withdrawal by subject | 4 | 0 | 0 | 15 |
| Withdrew: Death | 5 | 1 | 1 | 16 |
| Withdrew: Lost to follow-up | 0 | 0 | 1 | 1 |
| Withdrew: Other | 0 | 0 | 0 | 5 |
An adverse event (AE) was defined as any untoward medical occurrence in a participant or clinical investigation participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), 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. Adverse events with onset dates on or after the first dose of study medication and within 30 days following the last dose of study medication were considered "treatment emergent".
| Participants | Part A: ADXS31-142 1×10^9 CFU | Part A: ADXS31-142 5×10^9 CFU | ADXS31-142 1×10^10 CFU | Part B: ADXS31-142 + Pembrolizumab |
|---|---|---|---|---|
| Number of Participants With Treatment-Emergent Adverse Events | 10 | 1 | 2 | 37 |
The objective response rate (ORR) according to Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1 was defined as the number of participants with objective evidence of radiologic complete response (CR: disappearance of all target lesions) and partial response (PR: at least a 30% decrease in the sum of the longest diameters of target lesions compared with baseline, in absence of new lesions or unequivocal progression of non-target lesions) as determined from investigator response assessments. Disease Control Rates are based upon confirmed events only.
| participants | Part A: ADXS31-142 1×10^9 CFU | Part A: ADXS31-142 5×10^9 CFU | Part A: ADXS31-142 1×10^10 CFU | Part B: ADXS31-142 + Pembrolizumab |
|---|---|---|---|---|
| Objective Response Rate (ORR) | 0 | 0 | — | 0 |
The ORR according to irRECIST was defined as the number of participants with objective evidence of radiologic immune-related CR (irCR: Disappearance of all target lesions) and immune-related PR (irPR: At least 30% decrease in tumor burden compared with baseline) as determined from investigator response assessments.
| participants | Part A: ADXS31-142 1×10^9 CFU | Part A: ADXS31-142 5×10^9 CFU | Part A: ADXS31-142 1×10^10 CFU | Part B: ADXS31-142 + Pembrolizumab |
|---|---|---|---|---|
| Objective Response Rate According to Immune-related Response Evaluation Criteria in Solid Tumors (irRECIST) | 0 | 0 | — | 0 |
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. 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: ADXS31-142 1×10^9 CFU | Part A: ADXS31-142 5×10^9 CFU | Part A: ADXS31-142 1×10^10 CFU | Part B: ADXS31-142 + Pembrolizumab |
|---|---|---|---|---|
| Progression-free Survival, Assessed by RECIST Version 1.1 | 2.2 (0.8 to NA) | NA (NA to NA) | NA (NA to NA) | 5.3 (2.1 to 7.9) |
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: ADXS31-142 1×10^9 CFU | Part A: ADXS31-142 5×10^9 CFU | Part A: ADXS31-142 1×10^10 CFU | Part B: ADXS31-142 + Pembrolizumab |
|---|---|---|---|---|
| Overall Survival | 7.8 (1.3 to NA) | 18.5 (NA to NA) | 7.8 (NA to NA) | 33.7 (15.4 to NA) |
Collected over From first dose up to 30 days after last dose (maximum duration: 108 weeks). Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Part A: ADXS31-142 1×10^9 CFU | 5/10 (50%) | 4/10 (40%) | 10/10 (100%) |
| Part A: ADXS31-142 5×10^9 CFU | 1/1 (100%) | 1/1 (100%) | 1/1 (100%) |
| Part A: ADXS31-142 1×10^10 CFU | 1/2 (50%) | 1/2 (50%) | 2/2 (100%) |
| Part B: ADXS31-142 + Pembrolizumab | 16/37 (43.2%) | 22/37 (59.5%) | 37/37 (100%) |
| Event | Part A: ADXS31-142 1×10^9 CFU | Part A: ADXS31-142 5×10^9 CFU | Part A: ADXS31-142 1×10^10 CFU | Part B: ADXS31-142 + Pembrolizumab |
|---|---|---|---|---|
| Disease progressionGeneral disorders | 3/10 | 1/1 | 1/2 | 0/37 |
| HypercalcaemiaMetabolism and nutrition disorders | 0/10 | 1/1 | 0/2 | 0/37 |
| Back PainMusculoskeletal and connective tissue disorders | 0/10 | 1/1 | 0/2 | 0/37 |
| Muscular WeaknessMusculoskeletal and connective tissue disorders | 0/10 | 1/1 | 0/2 | 0/37 |
| Iiird Nerve ParalysisNervous system disorders | 0/10 | 1/1 | 0/2 | 0/37 |
| Cytokine release syndromeImmune system disorders | 0/10 | 0/1 | 1/2 | 0/37 |
| DyspnoeaRespiratory, thoracic and mediastinal disorders | 0/10 | 0/1 | 1/2 | 1/37 |
| HypotensionVascular disorders | 0/10 | 0/1 | 0/2 | 4/37 |
| FatigueGeneral disorders | 1/10 | 0/1 | 0/2 | 1/37 |
| AstheniaGeneral disorders | 1/10 | 0/1 | 0/2 | 0/37 |
| Event | Part A: ADXS31-142 1×10^9 CFU | Part A: ADXS31-142 5×10^9 CFU | Part A: ADXS31-142 1×10^10 CFU | Part B: ADXS31-142 + Pembrolizumab |
|---|---|---|---|---|
| AnaemiaBlood and lymphatic system disorders | 2/10 | 1/1 | 1/2 | 9/37 |
| HypothyroidismEndocrine disorders | 0/10 | 1/1 | 0/2 | 9/37 |
| Vision blurredEye disorders | 0/10 | 1/1 | 0/2 | 2/37 |
| Abdominal painGastrointestinal disorders | 0/10 | 1/1 | 0/2 | 4/37 |
| ConstipationGastrointestinal disorders | 2/10 | 1/1 | 0/2 | 9/37 |
| DiarrhoeaGastrointestinal disorders | 0/10 | 1/1 | 0/2 | 5/37 |
| NauseaGastrointestinal disorders | 5/10 | 1/1 | 0/2 | 19/37 |
| VomitingGastrointestinal disorders | 3/10 | 1/1 | 0/2 | 9/37 |
| AstheniaGeneral disorders | 2/10 | 1/1 | 0/2 | 2/37 |
| Chest discomfortGeneral disorders | 0/10 | 1/1 | 0/2 | 1/37 |
The All Treated Population included all participants who received at least one dose of ADXS31-142 or pembrolizumab.
| Age, Categorical(Participants) | Part A: ADXS31-142 1×10^9 CFU | Part A: ADXS31-142 5×10^9 CFU | Part A: ADXS31-142 1×10^10 CFU | Part B: ADXS31-142 + Pembrolizumab | Total |
|---|---|---|---|---|---|
| <=18 years | 0 | 0 | 0 | 0 | 0 |
| Between 18 and 65 years | 3 | 0 | 0 | 11 | 14 |
| >=65 years | 7 | 1 | 2 | 26 | 36 |
| Sex: Female, Male(Participants) | Part A: ADXS31-142 1×10^9 CFU | Part A: ADXS31-142 5×10^9 CFU | Part A: ADXS31-142 1×10^10 CFU | Part B: ADXS31-142 + Pembrolizumab | Total |
|---|---|---|---|---|---|
| Female | 0 | 0 | 0 | 0 | 0 |
| Male | 10 | 1 | 2 | 37 | 50 |
| Ethnicity (NIH/OMB)(Participants) | Part A: ADXS31-142 1×10^9 CFU | Part A: ADXS31-142 5×10^9 CFU | Part A: ADXS31-142 1×10^10 CFU | Part B: ADXS31-142 + Pembrolizumab | Total |
|---|---|---|---|---|---|
| Hispanic or Latino | 0 | 0 | 0 | 1 | 1 |
| Not Hispanic or Latino | 10 | 1 | 2 | 36 | 49 |
| Unknown or Not Reported | 0 | 0 | 0 | 0 | 0 |
| Race (NIH/OMB)(Participants) | Part A: ADXS31-142 1×10^9 CFU | Part A: ADXS31-142 5×10^9 CFU | Part A: ADXS31-142 1×10^10 CFU | Part B: ADXS31-142 + Pembrolizumab | Total |
|---|---|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 | 0 | 0 |
| Asian | 1 | 0 | 0 | 0 | 1 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 | 0 | 0 |
| Black or African American | 0 | 0 | 0 | 7 | 7 |
| White | 9 | 1 | 2 | 30 | 42 |
| More than one race | 0 | 0 | 0 | 0 | 0 |
| Unknown or Not Reported | 0 | 0 | 0 | 0 | 0 |
PDFs hosted by the registry, ClinicalTrials.gov.
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Advaxis, Inc.