Pembrolizumab in locally advanced sinonasal carcinoma - NeoPeSino

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Istituti Clinici Scientifici Maugeri In Forma Abbreviata Istituti Clinici Scientifici Maugeri O Anche Ics Maugeri O Maugeri S.p.A. Sb

Participant type

Patients

Age range

18-64 years, 65+ years

Gender

Male and Female

Therapeutic area

Diseases [C] - Otorhinolaryngologic Diseases [C09]

Trial duration

5 Nov 2024 → ongoing

Decision date (initial)

2023-10-27

Transition trial

No

Low-intervention

No

Rare-disease indication

No

Vulnerable population

Yes

Funding sources

FRRB (Fondazione Regionale per la Ricerca Biomedica)

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Efficacy, Safety

Safety and activity of pembrolizumab plus chemotherapy as neoadjuvant treatment in locally advanced SNUC.

Conditions and MedDRA coding

Locally advanced sinonasal carcinoma

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 4

1. 1. Have centrally histologically-confirmed, treatment-naïve SNUC that is considered curable by local therapies. Resectability at diagnosis should be recorded on the electronic case report form (eCRF) but is not a required inclusion criteria. 2. Have locally advanced disease defined as stage III of IVa-b according to AJCC cancer staging system VIII edition. 3. Be willing and able to provide written informed consent for the trial. The subject may also provide consent for Future Biomedical Research. However, the subject may participate in the main trial without participating in Future Biomedical Research. 4. Be ≥ 18 years of age on day of signing informed consent. 5. Have measurable disease based on RECIST 1.1 as determined by the site. 6. Have a performance status of 0 or 1 on the ECOG Performance Scale. 7. Demonstrate adequate organ function as defined in Table 4, all screening labs should be performed within 15 days of treatment initiation. 8. A male participant must agree to use a contraception as detailed in Appendix 3 of this protocol during the treatment period and for at least 180 days, corresponding to time needed to eliminate any study treatments plus an additional 90 days (a spermatogenesis cycle) for study treatments with evidence of genotoxicity at any dose after the last dose of study treatment and refrain from donating sperm during this period. 9. A female participant is eligible to participate if she is not pregnant (see Appendix 3), not breastfeeding, and at least one of the following conditions applies: a. Not a woman of childbearing potential (WOCBP) as defined in Appendix 3 OR b. A WOCBP who agrees to follow the contraceptive guidance in Appendix 3 during the treatment period and for at least 180 days (corresponding to time needed to eliminate any study treatments plus 30 days (a menstruation cycle) for study treatments with risk of genotoxicity after the last dose of study treatment.. 10. Have provided tumor tissue sample or newly obtained core or excisional biopsy of a tumor lesion. Formalin-fixed, paraffin embedded (FFPE) tissue blocks are preferred to slides. Newly obtained biopsies are preferred.
2. 2. Have locally advanced disease defined as stage III of IVa-b according to AJCC cancer staging system VIII edition.
3. 5. Have measurable disease based on RECIST 1.1 as determined by the site.
4. 6. Have a performance status of 0 or 1 on the ECOG Performance Scale.

Exclusion criteria 4

1. 1. Has disease that is deemed not suitable for local therapy administered with curative intent (e.g. severe brain involvement).
2. 2. Have metastatic disease defined as stage IVc according to AJCC cancer staging system VIII edition.
3. 4. Has received prior therapy with an anti-PD-1, anti-PD-L1, or anti PD L2 agent or with an agent directed to another stimulatory or co-inhibitory T-cell receptor (eg, CTLA-4, OX 40, CD137).
4. 5. Has received prior systemic anti-cancer therapy including investigational agents prior to allocation.

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. Neoadjuvant therapy objective response rate (ORR, defined as the sum of complete remission (CRs) and partial responses (PRs) by RECIST v. 1.1 criteria will serve as the primary efficacy endpoint.

Investigational products

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

Test 1

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Istituti Clinici Scientifici Maugeri In Forma Abbreviata Istituti Clinici Scientifici Maugeri O Anche Ics Maugeri O Maugeri S.p.A. Sb

Sponsor organisation

Istituti Clinici Scientifici Maugeri In Forma Abbreviata Istituti Clinici Scientifici Maugeri O Anche Ics Maugeri O Maugeri S.p.A. Sb

Address

Via Salvatore Maugeri 4

City

Pavia

Postcode

27100

Country

Italy

Scientific contact point

Organisation

Istituti Clinici Scientifici Maugeri In Forma Abbreviata Istituti Clinici Scientifici Maugeri O Anche Ics Maugeri O Maugeri S.p.A. Sb

Contact name

Laura Deborah Locati

Public contact point

Organisation

Istituti Clinici Scientifici Maugeri In Forma Abbreviata Istituti Clinici Scientifici Maugeri O Anche Ics Maugeri O Maugeri S.p.A. Sb

Contact name

Laura Deborah Locati

Locations

1 EU/EEA country · 2 investigational sites

By country

Investigational sites

Country notifications

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

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 13 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Application history

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