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

Perioperative Treatment in Resectable Gastric Cancer With Spartalizumab (PDR001) in Combination With Fluorouracil, Leucovorin, Oxaliplatin, and Docetaxel (FLOT): A Phase II Study (GASPAR)

Sponsors

Lead Sponsor: Centre Francois Baclesse

Collaborator: National Cancer Institute, France

Source Centre Francois Baclesse
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 fluorouracil, leucovorin, oxaliplatin, and docetaxel (FLOT)

Overall Status Not yet recruiting
Start Date 2021-03-01
Completion Date 2027-03-01
Primary Completion Date 2024-03-01
Phase Phase 2
Study Type Interventional
Primary Outcome
Measure Time Frame
Pathologic response after pre-operative treatment At surgery, an average 3 months after treatment initiation
Secondary Outcome
Measure Time Frame
Evaluate the impact of perioperative treatment on disease-free survival Through study completion, an average of 5 follow-up year
Evaluate the impact of perioperative treatment on overall survival Up to death
The correlation between pathologic Complete response and survival outcomes (disease-free and overall survival) At surgery, an average 3 months after treatment initiation
Treatment-Related Adverse Events Toxicities occurring up to 1 month after the end of treatment
Enrollment 67
Condition
Intervention

Intervention Type: Drug

Intervention Name: perioperative treatment

Description: FLOT + Spartalizumab

Arm Group Label: FLOT regimen plus Spartalizumab

Eligibility

Criteria:

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/ 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 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

Gender:

All

Minimum Age:

18 Years

Maximum Age:

N/A

Healthy Volunteers:

No

Overall Contact

Last Name: Mélanie DOS SANTOS, MD

Phone: 33231455050

Email: [email protected]

Verification Date

2021-01-01

Responsible Party

Type: Sponsor

Keywords
Has Expanded Access No
Condition Browse
Number Of Arms 1
Arm Group

Label: FLOT regimen plus Spartalizumab

Type: Experimental

Description: 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)

Acronym GASPAR
Patient Data Undecided
Study Design Info

Allocation: N/A

Intervention Model: Single Group Assignment

Primary Purpose: Treatment

Masking: None (Open Label)

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