NCT01462838

Phase I/IIa Study of Immunization With a p16INK4a Peptide Combined With MONTANIDE ISA-51 VG in Patients With Advanced HPV-associated Cancers

Completed Phase 1/Phase 2 Last updated 22 June 2015

What this trial tests

Phase 1/Phase 2 trial testing P16_37-63 in HPV-induced Cancers in 26 participants. Completed in 1 May 2015.

Timeline

1 August 2011

Primary endpoint
1 January 2015

1 May 2015

Quick facts

Lead sponsor	Oryx GmbH & Co. KG
Phase	Phase 1/Phase 2
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	26
Start date	1 August 2011
Primary completion	1 January 2015
Estimated completion	1 May 2015
Sites	1 location across Germany

Drugs / interventions tested

• P16_37-63 — full drug profile →

Conditions studied

• HPV-induced Cancers — all drugs for HPV-induced Cancers →

Sponsor

Oryx GmbH & Co. KG — full company profile →

Who can join

18 and older, any sex, with HPV-induced Cancers. 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.

• Immune response
  Time frame: every 2 weeks
  Immune response against peptide P16\_37-63. A positive immune response is defined as positive DTH response against peptide P16\_37-63 or a humoral (ELISA for the detection of p16-specific IgG/IgM/IgA) and/or CD8 and/or CD4 cellular (IFN gamma ELISpot for the detection of p16INK4a-specific T cells) immune response exceeding the assay specific cut-off values for a positive response against peptide P

Sponsor's own description

Patients with advanced HPV- and p16INK4a-positive cancers will receive the peptide P16\_37-63 in combination with Montanide® ISA-51 VG so that an immune response directed against the tumor cells can be induced. The aim is to show that vaccination with P16\_37-63 is safe and can induce or enhance immune responses against p16INK4a.

Publications & conference data

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

1. Immunology and Immunotherapy of Head and Neck Cancer.
   Ferris RL. · · 2015 · cited 515× · PMID 26351330 · DOI 10.1200/jco.2015.61.1509
2. Tumor Immunity and Immunotherapy for HPV-Related Cancers.
   Shamseddine AA, Burman B, Lee NY, Zamarin D, et al · · 2021 · cited 140× · PMID 33990345 · DOI 10.1158/2159-8290.cd-20-1760
3. Trial Watch: Peptide-based anticancer vaccines.
   Pol J, Bloy N, Buqué A, Eggermont A, et al · · 2015 · cited 91× · PMID 26137405 · DOI 10.4161/2162402x.2014.974411
4. Therapeutic Vaccines for HPV-Associated Malignancies.
   Smalley Rumfield C, Roller N, Pellom ST, Schlom J, et al · · 2020 · cited 87× · PMID 33117742 · DOI 10.2147/itt.s273327
5. The emerging role of immunotherapy in head and neck squamous cell carcinoma (HNSCC): anti-tumor immunity and clinical applications.
   Economopoulou P, Perisanidis C, Giotakis EI, Psyrri A. · · 2016 · cited 78× · PMID 27275486 · DOI 10.21037/atm.2016.03.34
6. Trial watch: Peptide vaccines in cancer therapy.
   Vacchelli E, Martins I, Eggermont A, Fridman WH, et al · · 2012 · cited 74× · PMID 23264902 · DOI 10.4161/onci.22428
7. HNSCC: Tumour Antigens and Their Targeting by Immunotherapy.
   von Witzleben A, Wang C, Laban S, Savelyeva N, et al · · 2020 · cited 70× · PMID 32942747 · DOI 10.3390/cells9092103
8. Targeting the Immune Microenvironment in the Treatment of Head and Neck Squamous Cell Carcinoma.
   Wang HC, Chan LP, Cho SF. · · 2019 · cited 68× · PMID 31681613 · DOI 10.3389/fonc.2019.01084