Trials Sponsors Conditions Drugs Pricing

Conditions

Resectable Locally Advanced Oral Cavity Squamous Cell Carcinoma

Outcome Measures

Primary Outcomes (1)

Activity: rate of Major Pathological Response (MPR, i.e. less than 10% viable tumour cells identified on routine haematoxylin and eosin staining in pathological surgical specimen) in patients with locally advanced oral cavity squamous cell carcinoma treated with tislelizumab + carboplatin + paclitaxel in the neoadjuvant setting.

Secondary Outcomes (5)

Safety: Number of adverse events and percentages, stratified for grade, of the neoadjuvant treatment with tislelizumab + carboplatin + paclitaxel measured by Common Terminology Criteria for Adverse Events (CTCAE) v 5.0.
Survival a) 3-year overall survival (OS); b) 3-year disease free survival (DFS), defined as the time from treatment assignment to cancer recurrence, second cancer or death from any cause.
Exploratory endpoint: To evaluate longitudinal modification in circulating-DNA (ctDNA) and immune infiltrates in tumour samples and to correlate them with pathological response after neoadjuvant therapy;
Exploratory endpoint: Identification, quantification and correlation of specific biomarkers (e.g., protein expression patterns, immune cell phenotypes) associated with treatment response, measured via IMC in pre-treatment and post-treatment tissue samples
Exploratory endpoint: Overall survival (OS), progression-free survival (PFS) and longitudinal ctDNA levels evaluated in the subgroup of patients who lack bio-molecular eligibility but meet other clinical criteria.

Interventions

Paclitaxel 6 mg/ml Concentrate for Solution for InfusionType not reported

TislelizumabType not reported

Paclitaxel 6 mg/ml Concentrate for Solution for InfusionType not reported

Registry intervention entries

These entries preserve how the registry describes the intervention. Their treatment roles are shown separately from molecular identities.

Formulated product
Paclitaxel 6 mg/ml Concentrate for Solution for Infusion
The registry describes a specific formulation. Its exact chemical ingredients and approval status require separate evidence.
SOLUTION FOR INFUSION
View registry record
Formulated product
Tislelizumab
The registry describes a specific formulation. Its exact chemical ingredients and approval status require separate evidence.
CONCENTRATE FOR SOLUTION FOR INFUSION
View registry record
Formulated product
Paclitaxel 6 mg/ml Concentrate for Solution for Infusion
The registry describes a specific formulation. Its exact chemical ingredients and approval status require separate evidence.
SOLUTION FOR INFUSION
View registry record
Formulated product
Carboplatin 10 mg/ml concentrate for solution for infusion
The registry describes a specific formulation. Its exact chemical ingredients and approval status require separate evidence.
SOLUTION FOR INFUSION
View registry record
Formulated product

Ingredients named in source formulations

The registry names these ingredients. The formulation’s exact chemical form has not been confirmed.

Paclitaxel 6 mg/ml Concentrate for Solution for Infusion
Named ingredient: Paclitaxel
View registry record
Tislelizumab
Named ingredient: tislelizumab
View registry record
Paclitaxel 6 mg/ml Concentrate for Solution for Infusion
Named ingredient: Paclitaxel
View registry record
Carboplatin 10 mg/ml concentrate for solution for infusion
Named ingredient: Carboplatin
View registry record
Carboplatin 10 mg/ml concentrate for solution for infusion
Named ingredient: Carboplatin
View registry record
Paclitaxel 6 mg/mL concentrate for solution for infusion
Named ingredient: Paclitaxel
View registry record

Eligibility Criteria

Sexall

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

Patients of both genders, aged ≥18 years
Willing and able to sign written informed consent prior to study screening
Histologically confirmed, squamous cell carcinoma of the oral cavity

Sponsors & Collaborators

Fondazione GONO Plus
Type not reportedlead

Study Sites (8)

Azienda Socio Sanitaria Territoriale Papa Giovanni Xxiii

Bergamo, 24127, Italy

Cecilia Moro0000 cmoro@asst-pg23.it

Istituto Oncologico Veneto

Padova, 35128, Italy

Maria Grazia Ghi0 mariagrazia.ghi@iov.veneto.it

Istituto Europeo Di Oncologia S.r.l.

Milan, 20141, Italy

Maria Cossu Rocca+390257489460

Central Study Contacts

Paolo Bossi

0000000000 paolo.bossi@hunimed.eu

Study Design

Study Type: interventional
Phase: phase 2

Study Record Dates

First Submitted

June 27, 2025

Source record

Download the complete CTIS (EMA) record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.

Source: European Medicines Agency (EMA), Clinical Trials Information System (CTIS). Original record and public documents are available on CTIS.

JSON downloads include source attribution and retrieval details alongside the unchanged original record or the separately normalized values.

Registry identifier: 2024-517565-16-00
Data provider: European Medicines Agency (EMA)
Normalization version: ctis-v1

Open registry record

Source retrieved: 2026-10-31 05:43:48 UTC

Documents

K1_PERSEPHONE_Recruitment arrangements - Italy_v1_0_23Dec2024

You may not qualify if:

Patient has recurrent/metastatic disease
Patient with locally advanced disease not amenable of surgery with curative intent
Patient has received prior local or systemic treatment for HNSCC
Patient must not be simultaneously enrolled in an interventional clinical trial
Patient must not have had major surgery ≤3 weeks prior to initiating protocol therapy and patient must have recovered from any surgical effects
Participant must not have received investigational therapy ≤ 4 weeks, or within a time interval less than at least 5 half-lives of the investigational agent, whichever is longer, prior initiating protocol therapy
Participant has had radiation therapy encompassing >20% of the bone marrow within 2 weeks; or any radiation therapy within 1 week prior to Day 1 of protocol therapy
Participant must not have a known allergy to tislelizumab, paclitaxel or carboplatin components or excipients
Participant must not have received a transfusion (platelets or red blood cells) ≤ 4 weeks prior to initiating protocol therapy
Participant must not have a serious, uncontrolled medical disorder, non-malignant systemic disease, or active, uncontrolled infection. Examples include, but are not limited to, uncontrolled ventricular arrhythmia, recent (within 90 days) myocardial infarction, uncontrolled major seizure disorder, unstable spinal cord compression, superior vena cava syndrome, hypertension (defined as systolic blood pressure >140 mmHg or diastolic blood pressure > 90 mmHg) that has not been adequately controlled or treated; prior history of posterior reversible encephalopathy syndrome, or any psychiatric disorder that prohibits obtaining informed consent
Participant must not have known, symptomatic brain or leptomeningeal metastases
Participant has a diagnosis of immunodeficiency or has received systemic steroid therapy or any other form of immunosuppressive therapy within 7 days prior to initiating protocol therapy
Any concurrent chemotherapy, Investigational Product, biologic, or hormonal therapy for cancer treatment
Subjects with previous malignancies (except non-melanoma skin cancers, and the following in situ cancers: bladder, gastric, oesophageal, colon, endometrial, cervical/dysplasia, melanoma, or breast) unless a complete remission was achieved at least 2 years prior to study entry AND no additional therapy is required during the study period
Subjects with an active, known or suspected autoimmune disease. Subjects with type I diabetes mellitus, hypothyroidism only requiring hormone replacement, skin disorders (such as vitiligo, psoriasis, or alopecia) not requiring systemic treatment, or conditions not expected to recur in the absence of an external trigger are permitted to enrol
+8 more criteria

A Phase II, Open-Label, Single-Arm, Multicentre Study of Carboplatin, Paclitaxel, and Tislelizumab in Biomarker-Selected Patients with Resectable Locally Advanced Oral Cavity Squamous Cell Carcinoma - PERSEPHONE Trial

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

First Submitted

Conditions

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (5)

Interventions

Registry intervention entries

Ingredients named in source formulations

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (8)

Central Study Contacts

Study Design

Study Record Dates

Source record

Documents

You may not qualify if:

Locations

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

First Submitted

Conditions

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (5)

Interventions

Registry intervention entries

Ingredients named in source formulations

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (8)

Central Study Contacts

Study Design

Study Record Dates

Source record

Documents

You may not qualify if:

Locations