NCT00264732

A Multi-Center, Double-Blind, Randomized, Placebo-Controlled Study of Amolimogene (ZYC101a) in the Treatment of High-Grade Cervical Intraepithelial Lesions (CIN 2/3) of the Uterine Cervix

Completed Phase 2/Phase 3 Last updated 21 May 2013

What this trial tests

Phase 2/Phase 3 trial testing Amolimogene in Uterine Cervical Dysplasia in 251 participants. Completed in 1 May 2009.

Timeline

1 July 2005

Primary endpoint
1 May 2009

1 May 2009

Quick facts

Lead sponsor	Eisai Inc.
Phase	Phase 2/Phase 3
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	triple
Primary purpose	treatment
Enrollment	251
Start date	1 July 2005
Primary completion	1 May 2009
Estimated completion	1 May 2009
Sites	26 locations across United States

Drugs / interventions tested

• Amolimogene — full drug profile →
• Amolimogene — full drug profile →
• Placebo

Conditions studied

• Uterine Cervical Dysplasia — all drugs for Uterine Cervical Dysplasia →

Sponsor

Eisai Inc. — full company profile →

Who can join

Adults 13 to 25, female only, with Uterine Cervical Dysplasia. 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.

• Cervical intraepithelial neoplasia (CIN) 2/3 resolution, defined as the histological evaluation of cervical tissue (presence or absence of CIN 2/3 as determined by pathology consensus diagnosis) at the End of Observation (EOO) period.
  Time frame: 24 weeks after enrollment.

Sponsor's own description

The purpose of this study is to evaluate the efficacy and safety of amolimogene, in the treatment of patients with high-grade cervical intraepithelial lesions of the uterine cervix.

Publications & conference data

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

1. Emerging human papillomavirus vaccines.
   Ma B, Maraj B, Tran NP, Knoff J, et al · · 2012 · cited 60× · PMID 23163511 · DOI 10.1517/14728214.2012.744393
2. Therapeutic vaccines against human papillomavirus and cervical cancer.
   Cid-Arregui A. · · 2009 · cited 16× · PMID 19915722 · DOI 10.2174/1874357900903010067
3. Molecular targets and strategies in the development of nucleic acid cancer vaccines: from shared to personalized antigens.
   Chi WY, Hu Y, Huang HC, Kuo HH, et al · · 2024 · cited 10× · PMID 39379923 · DOI 10.1186/s12929-024-01082-x
4. Cervical Cancer: Development of Targeted Therapies Beyond Molecular Pathogenesis.
   Knoff J, Yang B, Hung CF, Wu TC. · · 2014 · cited 10× · PMID 24533233 · DOI 10.1007/s13669-013-0068-1
5. Targeted immunotherapy of high-grade cervical intra-epithelial neoplasia: Expectations from clinical trials.
   Brun JL, Rajaonarison J, Nocart N, Hoarau L, et al · · 2018 · cited 6× · PMID 29435283 · DOI 10.3892/mco.2017.1531
6. The current landscape of therapeutic vaccination approaches for treatment of HPV-dependent malignancies.
   Audouze-Chaud J, Schlosser AK, Riemer AB. · · 2026 · PMID 41986361 · DOI 10.1038/s41541-026-01426-8
7. Personalizing DNA Cancer Vaccines.
   Wu AA, Peng K, Vukovich M, Zhu M, et al · · 2025 · PMID 41149836 · DOI 10.3390/jpm15100474