Phase III, randomized, double-blind, placebo-controlled, multicenter study to evaluate the efficacy of pre-surgical HPV9-valente vaccination in women treated with loop electrosurgical excision (LEEP) for high-grade cervical intraepithelial neoplasia (CIN2+) up to cervical cancer initially invasive (FIGO IA1) - HOPE 9 STUDY

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Azienda Unita Sanitaria Locale Toscana Nord Ovest

Participant type

Patients

Age range

18-64 years, 65+ years

Gender

Female

Therapeutic area

Diseases [C] - Neoplasms [C04]

Trial duration

1 Oct 2021 → 15 Dec 2025

Decision date (initial)

2024-06-24

Transition trial

Yes

Low-intervention

No

Rare-disease indication

No

Vulnerable population

No

External identifiers

EU CT number

2024-513704-34-00

EudraCT number

2018-003507-19

ClinicalTrials.gov

NCT03848039

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Safety, Efficacy

To evaluate the impact of pre-surgical HPV 9-valent vaccination in patients subjected
to conization for the management of high-grade cervical intraepithelial neoplasia
(CIN2 +) and initially invasive cervical cancer in terms of possible reduction of
recurrent post-surgical disease.

Secondary objectives 2

1. Analysis of the possible impact of the 9-valent vaccine on the post-surgical natural history of HPV infection.
2. Evaluation of 9-valent HPV vaccination in patients treated for CIN2 + in terms of possible reduction of the follow-up scheme in the cervical screening program (investigation on the possible temporal reduction of post-surgical surveillance).

Conditions and MedDRA coding

cervical cancer

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 6

1. Patients >= 18 years old and ecog performance status <= 1
2. Patients diagnosed with high-grade cervical intraepithelial neoplasia or initially invasive cervical cancer (histological findings = CIN2 + and = Ia1 according to the FIGO staging of cervical cancer)
3. No fever at the time of vaccination
4. No previous HPV vaccination
5. Ability to understand and write in Italian
6. Signature of informed consent and consent to personal data

Exclusion criteria 8

1. Patients enrolled in other clinical trials
2. History of allergic reaction or serious adverse events to previous vaccinations
3. Assessment of the state of pregnancy at the time of vaccination
4. Patients on immunosuppressive therapy
5. Subjects who received immunoglobulins or blood products in the 3 months prior to vaccination.
6. Thrombocytopenia or any other coagulation disorder that may lead to bleeding following intramuscular administration
7. Clinical criteria contraindicating the surgical act of conization
8. ECOG performance status =2

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. evaluation of the reduction of disease recurrence (cervical intraepithelial neoplasia up to microinvasive cervical cancer) by comparing the number of recurrences in the two arms.

Secondary endpoints 2

1. Analysis of the impact of the vaccine on prevalent post-surgery infections by comparing the prevalence of persistent HPV infections (duration greater than 12 months after surgery) in the two arms.
2. Analysis of the impact of the vaccine in the post-surgical surveillance times, comparison of the viral wash-out times (negativity of the HPV test), times of negativization of the pap test and of the colposcopic exam in the post-operative period: comparison of the overexposed times of negativization in the two arms.

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 1

Placebo 1

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Azienda Unita Sanitaria Locale Toscana Nord Ovest

Sponsor organisation

Azienda Unita Sanitaria Locale Toscana Nord Ovest

Address

Via Enrico Mattei 21

City

Massa

Postcode

54100

Country

Italy

Scientific contact point

Organisation

Azienda Unita Sanitaria Locale Toscana Nord Ovest

Contact name

Cheti Puccetti

Public contact point

Organisation

Azienda Unita Sanitaria Locale Toscana Nord Ovest

Contact name

Cheti Puccetti

Locations

1 EU/EEA country · 9 investigational sites

By country

Investigational sites

Country notifications

Trial-start, recruitment-start, end and early-termination notifications submitted per Member State

Application history

1 submissions — initial application plus substantial / non-substantial modifications