Status:
ACTIVE_NOT_RECRUITING
Perioperative Treatment in Resectable Gastric Cancer With Spartalizumab (PDR001) in Combination With Fluorouracil, Leucovorin, Oxaliplatin, and Docetaxel (FLOT)
Lead Sponsor:
Centre Francois Baclesse
Collaborating Sponsors:
National Cancer Institute, France
Conditions:
Gastric Cancer by AJCC V8 Stage
Resectable Carcinoma
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
Multicenter, open-label, non randomized, phase 2 trial in resectable gastric or gastroesophageal junction adenocarcinoma: Perioperative Treatment by Spartalizumab (PDR001) in Combination with fluorour...
Eligibility Criteria
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
- 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
- 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
Key Trial Info
Start Date :
June 28 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
March 1 2027
Estimated Enrollment :
67 Patients enrolled
Trial Details
Trial ID
NCT04736485
Start Date
June 28 2021
End Date
March 1 2027
Last Update
December 23 2022
Active Locations (13)
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1
CHU Besançon
Besançon, France
2
Centre François Baclesse
Caen, France
3
Centre Georges Francois Leclerc
Dijon, France
4
Chru Lille
Lille, France