ADXS31-142 Alone and in Combination With Pembrolizumab (MK-3475) in Patients With Prostate Cancer - KEYNOTE-046
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| ClinicalTrials.gov Identifier: NCT02325557 |
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Recruitment Status :
Active, not recruiting
First Posted : December 25, 2014
Last Update Posted : March 15, 2018
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Sponsor:
Advaxis, Inc.
Collaborator:
Merck Sharp & Dohme Corp.
Information provided by (Responsible Party):
Advaxis, Inc.
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Brief Summary:
A Phase 1/2 multicenter, dose determining, open-label study of ADXS31-142 monotherapy and a combination of ADXS31-142 with Pembrolizumab (MK-3475) in patients with metastatic castration-resistant prostate cancer. Part A will be dose-determining of ADXS31-142 monotherapy. Part B will be dose-determining of ADXS31-142 and Pembrolizumad (MK-3475) in combination. Part B expansion will treat additional patients with the recommended dose from Part B.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Cancer Prostate Cancer | Drug: ADXS31-142 Drug: ADXS31-142 + Pembrolizumab (MK-3475) | Phase 1 Phase 2 |
Part A of the study will be an open-label, Phase 1, multicenter, non-randomized, dose-determining trial of ADX31-142 monotherapy in subjects with metastatic castration-resistant prostate cancer (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 subjects 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 a RP2D for the combination.
Dose escalation/de-escalation for this study will be explored by applying the mTPI design.
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 51 participants |
| Allocation: | Non-Randomized |
| Intervention Model: | Single Group Assignment |
| Masking: | None (Open Label) |
| Primary Purpose: | Treatment |
| Official Title: | A Phase 1-2 Dose-Escalation and Safety Study of ADXS31-142 Alone and of ADXS31-142 in Combination With Pembrolizumab (MK-3475) in Patients With Previously Treated Metastatic Castration-Resistant Prostate Cancer |
| Study Start Date : | January 2015 |
| Estimated Primary Completion Date : | April 2019 |
| Estimated Study Completion Date : | December 2019 |
Resource links provided by the National Library of Medicine
Genetics Home Reference related topics:
Prostate cancer
MedlinePlus related topics:
Prostate Cancer
Drug Information available for:
Pembrolizumab
| Arm | Intervention/treatment |
|---|---|
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Experimental: Part A
Patients will receive ADXS31-142 monotherapy. Dosing will start at 1 x 10^9 cfu IV and escalate to 1 x 10^10 if appropriate.
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Drug: ADXS31-142
starting at 1x10^9 cfu IV |
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Experimental: Part B/Expansion
Patients will receive ADXS31-142 and pembrolizumab (MK-3475) in combination. Dosing of ADXS31-142 will start at one dose level less that appropriate in Part A in combination with 200 mg of pembrolizumab. Dosing of ADXS31-142 will be escalated if appropriate
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Drug: ADXS31-142 + Pembrolizumab (MK-3475)
starting at dose from Part A + 200mg of Pembrolizumab |
Primary Outcome Measures :
- Number of subjects with adverse events in each dose level [ Time Frame: 2 years ]Number of subjects with adverse events in each dose level
Secondary Outcome Measures :
- Progression Free Survival as measured by RECIST 1.1 or ir RECIST [ Time Frame: 2 years ]Progression Free Survival as measured by RECIST 1.1 or ir RECIST
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| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | Male |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Be willing and able to provide written informed consent for the trial.
- Be 18 years of age or older on day of signing informed consent.
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Have progressive metastatic castration resistant prostate cancer, on androgen deprivation therapy, based on as least one of the following criteria:
- PSA progression defined as 25% increase over baseline value with an increase in the absolute value of at least 2 ng/mL that is confirmed by another PSA level with a minimum of a 1 week interval with a minimum PSA of 2 ng/ml.
- Progression of bi-dimensionally measurable soft tissue (nodal metastasis) assessed within 1 month prior to registration by a CT scan or MRI of the abdomen and pelvis.
- Progression of bone disease (evaluable disease) (new bone lesion(s)) by bone scan.
- Has discontinued antiandrogens (bicalutamide, nilutamide) >6 weeks and enzalutamide >4 weeks prior to Day 1 of trial treatment
- Have a performance status of 0 or 1 on the ECOG Performance Scale.
Exclusion Criteria:
- Received more than 3 prior systemic treatment regimens with chemotherapy , hormonal, or immunotherapy in the metastatic setting or received more than 1 prior chemotherapeutic regimen in the metastatic setting
- 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. The use of physiologic doses of corticosteroids may be approved after consultation with the Sponsor.
- Has had a prior monoclonal antibody within 4 weeks prior to study Day 1 or who has not recovered (i.e., ≤Grade 1 or at baseline) from adverse events due to agents administered more than 4 weeks earlier.
- Has had prior chemotherapy, targeted small molecule therapy, or radiation therapy within 2 weeks prior to study Day 1 or who has not recovered (i.e., ≤Grade 1 or at baseline) from adverse events due to a previously administered agent.
- Has received prior therapy with an anti-PD-1, anti-PD-L1, or anti-PD-L2 agent or if the patient has previously participated in a Merck MK-3475 clinical trial.
- Has a contraindication to administration of ampicillin or trimethoprim/ sulfamethoxazole.
- 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.
Information from the National Library of Medicine
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02325557
Locations
| United States, California | |
| Recruiting | |
| San Francisco, California, United States | |
| United States, Colorado | |
| University of Colorado Health Sciences Center (UCHSC) | |
| Aurora, Colorado, United States | |
| United States, Maryland | |
| Recruiting | |
| Rockville, Maryland, United States | |
| Recruiting | |
| Towson, Maryland, United States | |
| United States, New Jersey | |
| New Brunswick, New Jersey, United States | |
| United States, Pennsylvania | |
| Recrutiing | |
| Philadelphia, Pennsylvania, United States | |
| Site | |
| Philadelphia, Pennsylvania, United States | |
| United States, Rhode Island | |
| Recruiting | |
| Providence, Rhode Island, United States | |
Sponsors and Collaborators
Advaxis, Inc.
Merck Sharp & Dohme Corp.
| Responsible Party: | Advaxis, Inc. |
| ClinicalTrials.gov Identifier: | NCT02325557 History of Changes |
| Other Study ID Numbers: |
ADXS142-03 |
| First Posted: | December 25, 2014 Key Record Dates |
| Last Update Posted: | March 15, 2018 |
| Last Verified: | March 2018 |
Additional relevant MeSH terms:
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Prostatic Neoplasms Genital Neoplasms, Male Urogenital Neoplasms Neoplasms by Site Neoplasms |
Genital Diseases, Male Prostatic Diseases Pembrolizumab Antineoplastic Agents |