Perioperative Treatment in Resectable Gastric Cancer With Spartalizumab (PDR001) in Combination With Fluorouracil Leucovorin Oxaliplatin and Docetaxel (FLOT)

  • STATUS
    Recruiting
  • End date
    Mar 5, 2027
  • participants needed
    67
  • sponsor
    Centre Francois Baclesse
Updated on 5 July 2021

Summary

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)

Details
Condition Gastric Cancer by AJCC V8 Stage, Resectable Carcinoma
Treatment perioperative treatment
Clinical Study IdentifierNCT04736485
SponsorCentre Francois Baclesse
Last Modified on5 July 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

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
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/ mm
Neutrophils 1500/ mm
Platelets 100 000/ mm
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 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 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
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