Etude : GASPAR /



ATTENTION : pour chaque essai clinique, les éléments affichés ci-dessous ne sont pas exhaustifs, et le protocole fourni par le promoteur reste l’unique document à consulter pour mener à bien un essai clinique sur centre. Pour plus d'informations, contactez le référent du territoire concerné.


Acronyme / Nom
Situation thérapeutique
Traitement
Cadre réglementaire
MÀJ
Présentation de l'étude
Acronyme / Nom : GASPAR

Situation thérapeutique : Néoadjuvant / Adjuvant

Traitement : Chimiothérapie / Immunothérapie

Cadre réglementaire : RIPH1

Dernière MÀJ : 13/01/2022
Titre
Spécialité(s)
CIM10 - Localisation(s)
Informations principales
Titre : Traitement périopératoire dans le cancer gastrique résécable associant Spartalizumab (PDR001) avec fluorouracil, leucovorine, oxaliplatine, et docetaxel (FLOT) : étude de phase II

Spécialité : Organes digestifs
Localisation : C16 - Tumeur maligne de l'estomac
Schéma
Phase
Stade
Ligne(s)
Informations complémentaires
Schéma : Multicenter, open-label, non randomized, phase 2 trial in resectable gastric or gastroesophageal junction adenocarcinoma: Perioperative Treatment by Spartalizumab (PDR001) in Combination with fluorouracil, leucovorin, oxaliplatin, and docetaxel (FLOT)

STUDY ARM:
- Experimental: FLOT regimen plus Spartalizumab
Standard FLOT regimen:
*Docetaxel 50 mg/m² IV infusion on D1
*Oxaliplatine 85 mg/m² IV infusion on D1
*Leucovorin 200 mg/m² IV infusion on D1
*Fluorouracile 2600 mg/m² 24 h IV infusion on D1

with Spartalizumab PDR001 Patients will received the fixed dose of 400 mg per IV infusion on D1 every four weeks (q4w) for 2 pre-operative cycles (8 weeks) and 2 post-operative cycles (8 weeks)

MAIN OBJECTIVE:
To evaluate the pathologic response after pre-operative treatment

SECONDARY OBJECTIVES:
- To evaluate the impact of perioperative treatment on survival outcomes
- To evaluate the histological R0 resection margin
- To establish the association between pCR response and survival outcomes
- To determine the safety profile of the combination Spartalizumab + FLOT regimen
- To evaluate the post-operative morbidity and mortality
- To evaluate the ctDNA levels over time
- To determine potential biomarkers associated with clinical efficacy.
These biomarkers may include:
* PD-L1 expression measured as the CPS
* TMB, including MSI status
* EBV status
* To compare the characteristics of the initial tumor with the organoids cultures
* To evaluate treatment responses with tumor organoid cultures

Phase : II

Stade : Localisé

1
Informations libres de droit
Critères d'inclusion
Critères de non-inclusion
Informations libres de droit
Critères d'inclusion et de non-inclusion
Critères d'inclusion : - Age ≥ 18 years
- Untreated localized gastric or GEJ adenocarcinoma considered resectable (clinical stage ≥cT2 and/or cN+ and no metastasis)
- Histologically confirmed adenocarcinoma
- ECOG performance status score of 0 or 1
- All subjects must consent to allow the acquisition of blood samples and fresh tumor samples for performance of correlative studies.
- Screening laboratory values must meet the following criteria:
o WBC ≥ 2000/ mm³
o Neutrophils ≥ 1500/ mm³
o Platelets ≥ 100 000/ mm³
o Hemoglobin ≥ 9.0 g/dL
o Bilirubin ≤ 1.5 x ULN, AST and ALT ≤ 3 x ULN
o Serum creatinine ≤ 1.5 x ULN or measured or calculated creatinine ≥ 50 ml/min clearance (CrCl) (using the Cockcroft-Gault formula)
- Female subjects of childbearing potential must have a negative urine or serum pregnancy test within 72h before study start
- Subjects in reproductive age must be willing to use adequate contraception during the study and at least 6 months after the last dose of investigational drug
- Subjects affiliated to a social security regimen
- Patient has signed informed consents obtained before any trial related activities and according to local guidelines

Critères de non-inclusion : - Subject with any distant metastasis
- Subject with no recovering from the effects of major surgery or significant traumatic injury within 14 days before inclusion
- Documented significant cardiovascular disease within the past 6 months before the first dose of study treatment, including: history of congestive heart failure (defined as NYHA III or IV), myocardial infarction, unstable angina, coronary angioplasty, coronary stenting, coronary artery bypass graft, cerebrovascular accident or hypertensive crisis
- History of other malignancy within the previous 3 years (except for appropriately treated in-situ cervix carcinoma and non-melanoma skin carcinoma)
- Subject with active, known, or suspected autoimmune disease
- Subject with a condition requiring systemic treatment with either corticosteroids (> 10 mg daily prednisone equivalent) or other immunosuppressive medications within 14 days of start of study treatment
- Subject with symptomatic interstitial lung disease
- Known history of HIV or HBV infection
- Known active HCV infection
- Known history of active tuberculosis
- Vaccination with live vaccine within 30 days before the first dose of study treatment
- Prior treatment with an anti-PD-1, anti-PD-L1, anti-PD-L2 or any other antibody or drug specifically targeting T-cell co-stimulation or checkpoint pathways
- Prior anticancer therapy for the current malignancy
- Known hypersensitivity to any of the study drugs or their excipients
- Chronic inflammable gastro-intestinal disease
- Uracilemia ≥ 16 ng/ml
- QT/QTc > 450 msec for men and > 470 msec for women
- Peripheral neuropathy ≥ Grade II
- Uncontrolled diabetes
- Active infection requiring systemic therapy
- Participation in another therapeutic clinical study
- Patient deprived of liberty or placed under the authority of a tutor
- Patient assessed by the investigator to be unable or unwilling to comply with the requirements of the protocol
NCT
Promoteur
Coordonnateur
Informations relatives au promoteur
NCT :
NCT04736485
Promoteur :
Centre François BACLESSE
Type de sponsor : Institutionnel
14000 CAEN

Coordonnateur :
Docteur Mélanie DOS SANTOS
Centre investigateur
Investigateur
TEC / ARC / IDE
État
MÀJ
Informations relatives aux investigateurs
Centre investigateur :
Centre François BACLESSE - 3 avenue du Général Harris - 14000 CAEN
Apicrypt : essaitherapeutiquecfb@baclesse.unicancer.fr

Investigateur :
Mélanie DOS SANTOS

TEC / ARC / IDE :
Corentin LE GALLIC
c.legallic@
baclesse.unicancer.fr

Statut de l'essai : SUSPENDU

MAJ : 13/01/2022