Skip to main content

Summary

Eligibility
for males ages 18 years and up
Location
at San Francisco, California and other locations
Dates
study started
estimated completion:
Principal Investigator

Description

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.

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

Details

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.

Keywords

Cancer Prostate Cancer Pembrolizumab

Eligibility

You can join if…

Open to males ages 18 years and up

  1. Be willing and able to provide written informed consent for the trial.
  2. Be 18 years of age or older on day of signing informed consent.
  3. Have progressive metastatic castration resistant prostate cancer, on androgen deprivation therapy, based on as least one of the following criteria:
  4. 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.
  5. 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.
  6. Progression of bone disease (evaluable disease) (new bone lesion(s)) by bone scan.
  7. Has discontinued antiandrogens (bicalutamide, nilutamide)>6 weeks and enzalutamide>4 weeks prior to Day 1 of trial treatment
  8. Have a performance status of 0 or 1 on the ECOG Performance Scale.

You CAN'T join if...

  1. 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
  2. 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.
  3. 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.
  4. 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.
  5. 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.
  6. Has a contraindication to administration of ampicillin or trimethoprim/sulfamethoxazole.
  7. 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.

Locations

  • Recruiting accepting new patients
    San Francisco, California, United States
  • University of Colorado Health Sciences Center (UCHSC) accepting new patients
    Aurora, Colorado, United States
  • Recruiting accepting new patients
    Rockville, Maryland, United States
  • Recruiting accepting new patients
    Towson, Maryland, United States
  • Recrutiing accepting new patients
    Philadelphia, Pennsylvania, United States
  • Site accepting new patients
    Philadelphia, Pennsylvania, United States
  • New Brunswick, New Jersey, United States
  • Recruiting accepting new patients
    Providence, Rhode Island, United States

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Advaxis, Inc.
ID
NCT02325557
Phase
Phase 1/2
Lead Scientist
Lawrence Fong
Study Type
Interventional
Last Updated
January 1, 2017
I’m interested in this study!