deltatrials
Terminated PHASE1 INTERVENTIONAL NCT01598792

Safety Study of Recombinant Listeria Monocytogenes(Lm)Based Vaccine Virus Vaccine to Treat Oropharyngeal Cancer (REALISTIC:)

REALISTIC: A Phase I, Dose Escalation Trial Of Recombinant Listeria Monocytogenes (Lm)-Based Vaccine Encoding Human Papilloma Virus Genotype 16 Target Antigens (ADXS11-001) In Patients With HPV-16 +ve Oropharyngeal Carcinoma

Sponsor: Advaxis, Inc.

Interventions ADXS11-001
Updated 10 times since 2017 Last updated: May 17, 2016 Started: Feb 29, 2012 Primary completion: Nov 30, 2014 Completion: Nov 30, 2014
This information is for research purposes only and is not medical advice. Consult a healthcare provider before making any medical decision.

Terminated

Patient 2 suffered DLT post-vaccination. The vaccine manufacturers withdrew support for the study on commercial grounds.

Listed as NCT01598792, this PHASE1 trial focuses on HPV-16 +ve Oropharyngeal Carcinoma and remains terminated or withdrawn. Sponsored by Advaxis, Inc., it has been updated 10 times since 2012, reflecting substantial change activity. This study contributes to the evolving evidence base for cancer treatment protocols.

Status Flow

~Jan 2017 – ~Aug 2017 · 7 months · monthly snapshotTerminated~Aug 2017 – ~May 2018 · 9 months · monthly snapshotTerminated~May 2018 – ~Jun 2018 · 31 days · monthly snapshotTerminated~Jun 2018 – ~Feb 2020 · 20 months · monthly snapshotTerminated~Feb 2020 – ~Nov 2020 · 9 months · monthly snapshotTerminated~Nov 2020 – ~Jan 2021 · 2 months · monthly snapshotTerminated~Jan 2021 – ~Dec 2021 · 11 months · monthly snapshotTerminated~Dec 2021 – ~Jul 2024 · 31 months · monthly snapshotTerminated~Jul 2024 – ~Sep 2024 · 2 months · monthly snapshotTerminated~Sep 2024 – present · 24 months · monthly snapshotTerminated

Change History

10 versions recorded
  1. Sep 2024 — Present [monthly]

    Terminated PHASE1

  2. Jul 2024 — Sep 2024 [monthly]

    Terminated PHASE1

  3. Dec 2021 — Jul 2024 [monthly]

    Terminated PHASE1

  4. Jan 2021 — Dec 2021 [monthly]

    Terminated PHASE1

  5. Nov 2020 — Jan 2021 [monthly]

    Terminated PHASE1

Show 5 earlier versions
  1. Feb 2020 — Nov 2020 [monthly]

    Terminated PHASE1

  2. Jun 2018 — Feb 2020 [monthly]

    Terminated PHASE1

  3. May 2018 — Jun 2018 [monthly]

    Terminated PHASE1

  4. Aug 2017 — May 2018 [monthly]

    Terminated PHASE1

  5. Jan 2017 — Aug 2017 [monthly]

    Terminated PHASE1

    First recorded

Feb 2012

Trial started

Per CT.gov start date — pre-dates our first snapshot

Eligibility Summary

No eligibility information available.

Contact Information

Sponsor contact:
  • Advaxis, Inc.
  • Cancer Research UK
  • Liverpool University Hospitals NHS Foundation Trust
  • Recipharm AB
  • University of Liverpool
Data source: University of Liverpool

For direct contact, visit the study record on ClinicalTrials.gov .