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

NCT04736485 | Active Not Recruiting Phase 2 Results DMC

• 1 other identifier: 2020-004497-21
• Study Type: interventional
• Target: 67
• Locations: 1 country
• Sites: 13

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)

Conditions

Gastric Cancer by AJCC V8 Stage; Resectable Carcinoma

Keywords

perioperative; spartalizumab; PDR001; Gastric Cancer

Outcome Measures

Primary Outcomes (1)

• Pathologic Response After Pre-operative Treatment

  Proportion of patients with pCR (pathologic complete response) in the primary tumour defined as: no tumour residue found in the tissue collected during the surgery evaluated by the pathologist. For the primary objective, the pathologic response after pre-operative treatment will be assessed by the local experienced pathologists. Tumour regression grade will be quantified using the Becker regression criteria, which are based on the estimation of the percentage of vital tumour cells in relation to the macroscopically identifiable tumour bed and include the following categories: * TRG1a (equivalent to pathological complete regression; no residual tumour cells); * TRG1b (subtotal regression; \<10% residual tumour cells); * TRG2 (partial regression; 10-50% residual tumour cells); and * TRG3 (minor or no regression; \>50% residual tumour cells).

  At surgery, an average 3 months after treatment initiation

Secondary Outcomes (4)

• Evaluate the Impact of Perioperative Treatment on Disease-free Survival

  24 months after study enrollment

• Evaluate the Impact of Perioperative Treatment on Overall Survival

  24 months after enrollment

• 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

Study Arms (1)

FLOT regimen plus Spartalizumab

EXPERIMENTAL

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)

Drug: perioperative treatment

Interventions

perioperative treatment DRUG

FLOT + Spartalizumab

FLOT regimen plus Spartalizumab

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Subject with any distant metastasis
• 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

Sponsors & Collaborators

• Centre Francois Baclesse: lead
• National Cancer Institute, France: collaborator

Study Sites (13)

CHU Besançon

Besançon, France

Location

Centre François Baclesse

Caen, France

Location

Centre Georges Francois Leclerc

Dijon, France

Location

Chru Lille

Lille, France

Location

APHM Marseille

Marseille, France

Location

Institut Régional Cancer

Montpellier, France

Location

APHP St Louis

Paris, France

Location

Institut Mutualiste Montsouris

Paris, France

Location

CHU Poitiers

Poitiers, France

Location

CHU Robert Debré

Reims, France

Location

Centre Eugène Marquis

Rennes, France

Location

ICO St Herblain

Saint-Herblain, France

Location

CH St Malo

St-Malo, France

Location

Related Publications (2)

• Dos Santos M, Lequesne J, Piessen G, Leconte A, Guimbaud R, Pernot S, Bouche O, Hiret S, Soularue E, Tougeron D, Dahan L, Le Sourd S, Borg C, Samalin E, Corbinais S, Parzy A, Guilloit JM, Varatharajah S, Brachet PE, Dorbeau M, Galais MP, Desgrippes R, Clarisse B. Perioperative treatment in resectable gastric cancer with spartalizumab in combination with fluorouracil, leucovorin, oxaliplatin and docetaxel (FLOT): Results from the GASPAR phase 2 study. Eur J Cancer. 2026 Mar 11;236:116258. doi: 10.1016/j.ejca.2026.116258. Epub 2026 Jan 30.

  PMID: 41653501 RESULT

• 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.

  PMID: 35549674 DERIVED

Related Links

• Trial protocol

MeSH Terms

Conditions

Stomach Neoplasms

Condition Hierarchy (Ancestors)

Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Stomach Diseases

Results Point of Contact

• Title: Justine Lequesne
• Organization: Centre François Baclesse

j.lequesne@baclesse.unicancer.fr

0231455002

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 26, 2021
• First Posted: February 3, 2021
• Study Start: June 28, 2021
• Primary Completion: March 1, 2024
• Study Completion (Estimated): March 1, 2027
• Last Updated: April 14, 2026
• Results First Posted: April 14, 2026

Record last verified: 2026-04

Locations

FR (13)