Perioperative Treatment in Resectable Gastric Cancer With Spartalizumab (PDR001) in Combination With Fluorouracil, Leucovorin, Oxaliplatin, and Docetaxel (FLOT)
NCT ID: NCT04736485
Last Updated: 2022-12-23
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
PHASE2
67 participants
INTERVENTIONAL
2021-06-28
2027-03-31
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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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)
perioperative treatment
FLOT + Spartalizumab
Interventions
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perioperative treatment
FLOT + Spartalizumab
Eligibility Criteria
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Inclusion Criteria
* 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
* Tumor tissue must be provided for biomarker analyses (fresh or archival with an FFPE tissue block)
* All subjects must consent to allow the acquisition of blood samples for performance of correlative studies
* Screening laboratory values must meet the following criteria:
* WBC ≥ 2000/ mm³
* Neutrophils ≥ 1500/ mm³
* Platelets ≥ 100 000/ mm³
* Hemoglobin ≥ 9.0 g/dL
* Bilirubin ≤ 1.5 x ULN, AST and ALT ≤ 3 x ULN
* Measured or calculated creatinine ≥ 50 ml/min clearance (CrCl) (using the Cockcroft-Gault formula)
* Potassium ≥ LLN
* Magnesium ≥ LLN
* Calcium ≥ LLN
* Female subject of childbearing potential must have a negative urine or serum pregnancy test within 72h before study start
* Subject in reproductive age must be willing to use adequate contraception during the study and at least 9 months in men and 12 months in women after the last dose of investigational drug. In addition, given the toxicities observed on the male reproductive system, a conservation of gametes will be proposed for men, as usually in routine practice
* Subject affiliated to a social security regimen
* Patient has signed informed consents obtained before any trial related activities and according to local guidelines
Exclusion Criteria
* 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 anterior organ transplant, including stem cell allograft
* Pneumonitis or interstitial lung disease
* 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 GASPAR Protocol - EUDRACT number: 2020-004497-21 - version 1.3 / 2021-01-18 Page 8 sur 44
* 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
* Recent or concomitant treatment with brivudine (herpes virostatic)
* 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
18 Years
ALL
No
Sponsors
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National Cancer Institute, France
OTHER_GOV
Centre Francois Baclesse
OTHER
Responsible Party
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Locations
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CHU Besançon
Besançon, , France
Centre François Baclesse
Caen, , France
Centre Georges Francois Leclerc
Dijon, , France
Chru Lille
Lille, , France
APHM Marseille
Marseille, , France
Institut Régional Cancer
Montpellier, , France
APHP St Louis
Paris, , France
Institut Mutualiste Montsouris
Paris, , France
CHU Poitiers
Poitiers, , France
CHU Robert Debré
Reims, , France
Centre Eugène Marquis
Rennes, , France
ICO St Herblain
Saint-Herblain, , France
CH St Malo
St-Malo, , France
Countries
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References
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Dos Santos M, Lequesne J, Leconte A, Corbinais S, Parzy A, Guilloit JM, Varatharajah S, Brachet PE, Dorbeau M, Vaur D, Weiswald LB, Poulain L, Le Gallic C, Castera-Tellier M, Galais MP, Clarisse B. Perioperative treatment in resectable gastric cancer with spartalizumab in combination with fluorouracil, leucovorin, oxaliplatin and docetaxel (FLOT): a phase II study (GASPAR). BMC Cancer. 2022 May 12;22(1):537. doi: 10.1186/s12885-022-09623-z.
Other Identifiers
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2020-004497-21
Identifier Type: -
Identifier Source: org_study_id