CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 50 enrolled
Drug / intervention
ADXS31-142 +1 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02325557
NCT02325557Phase 2Completed
CompareCT.gov

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

Advaxis, Inc.·interventional·Posted Dec 25, 2014·Updated Apr 2, 2024

In Brief

A Phase 2 clinical trial evaluating ADXS31-142 and Pembrolizumab for Cancer and Prostate Cancer. Completed, enrolled 50 participants across 8 sites.

Detailed Summary

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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsCancer, Prostate Cancer
CountriesUnited States
CollaboratorsMerck Sharp & Dohme LLC

Timeline

Phase 2CompletedFinished
201520162017201820192020202120222023202420252026
First PostedDec 25, 2014
Enrollment StartJun 4, 2015
Primary CompletionAug 30, 2019
Study CompletionJan 22, 2020
TodayJul 2, 2026
Enrollment to primary: 4.2 yearsPosted 11.5 years ago

Interventions

ADXS31-142drug

ADXS31-142 IV infusion

Pembrolizumabdrug

Pembrolizumab IV infusion