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NCT02880345

RADVAX™: A Pilot Trial of Combined Pembrolizumab and Hypofractionated Radiation in Patients With Advanced Urothelial Cancer Who Have Progressed on Anti-PD-1/PD-L1 Monotherapy

Withdrawn Phase 1 Last updated 22 April 2019
What this trial tests

Phase 1 trial testing PEMBROLIZUMAB in Urothelial Cancer. Withdrawn.

Timeline
1 August 2016
Primary endpoint
1 August 2017
1 December 2018

Quick facts

Lead sponsorAbramson Cancer Center at Penn Medicine
PhasePhase 1
StatusWithdrawn
Study typeINTERVENTIONAL
Allocationnon randomized
Designsequential
Maskingnone
Primary purposetreatment
Start date1 August 2016
Primary completion1 August 2017
Estimated completion1 December 2018
Sites1 location across United States

Drugs / interventions tested

Conditions studied

Sponsor

Abramson Cancer Center at Penn Medicine — full company profile →

Who can join

18 and older, any sex, with Urothelial Cancer. Patients with the condition only — healthy volunteers not accepted.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

Sponsor's own description

This is a pilot study of a fixed dose of Pembrolizumab in combination with two different regimens of hypofractionated radiation. It is designed to demonstrate the activity and safety of the combination treatment in advanced urothelial cancer patients with prior exposure to PD-1 inhibitors.

Publications & conference data

4 peer-reviewed publications reference this trial (live from Europe PMC):

  1. Immune checkpoint inhibitors in urothelial cancer: recent updates and future outlook.
    Gopalakrishnan D, Koshkin VS, Ornstein MC, Papatsoris A, et al · · 2018 · cited 52× · PMID 29892196 · DOI 10.2147/tcrm.s158753
  2. Combination therapy with PD-1/PD-L1 blockade: An overview of ongoing clinical trials.
    Johnson CB, Win SY. · · 2018 · cited 26× · PMID 29632719 · DOI 10.1080/2162402x.2017.1408744
  3. Radiotherapy and immune checkpoint blockades: a snapshot in 2016.
    Koo T, Kim IA. · · 2016 · cited 24× · PMID 28030901 · DOI 10.3857/roj.2016.02033
  4. Immunotherapy for Patients with Advanced Urothelial Cancer: Current Evidence and Future Perspectives.
    Zichi C, Tucci M, Leone G, Buttigliero C, et al · · 2017 · cited 10× · PMID 28680882 · DOI 10.1155/2017/5618174

Verify or expand the search:

Other recruiting trials for Urothelial Cancer

Currently open trials in the same condition.

Other Abramson Cancer Center at Penn Medicine trials

Trials by the same sponsor.

Verify against primary sources

Data sources for this page

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT02880345.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing