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

December 22, 2022 updated by: Centre Francois Baclesse

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

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)

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

67

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Besançon, France
        • CHU Besançon
      • Caen, France
        • Centre Francois Baclesse
      • Dijon, France
        • Centre Georges Francois Leclerc
      • Lille, France
        • CHRU Lille
      • Marseille, France
        • APHM Marseille
      • Montpellier, France
        • Institut Régional Cancer
      • Paris, France
        • Institut Mutualiste Montsouris
      • Paris, France
        • APHP St Louis
      • Poitiers, France
        • CHU Poitiers
      • Reims, France
        • CHU Robert Debré
      • Rennes, France
        • Centre Eugene Marquis
      • Saint-Herblain, France
        • ICO St Herblain
      • Saint-Malo, France
        • Ch St Malo

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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)
Drug: perioperative treatment
FLOT + Spartalizumab

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pathologic response after pre-operative treatment
Time Frame: At surgery, an average 3 months after treatment initiation
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
At surgery, an average 3 months after treatment initiation

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Evaluate the impact of perioperative treatment on disease-free survival
Time Frame: Through study completion, an average of 5 follow-up year
Disease-free survival (DFS) defined as time between inclusion and first disease progression
Through study completion, an average of 5 follow-up year
Evaluate the impact of perioperative treatment on overall survival
Time Frame: Up to death
Overall survival (OS) defined as the time between inclusion and death whatever cause;
Up to death
The correlation between pathologic Complete response and survival outcomes (disease-free and overall survival)
Time Frame: At surgery, an average 3 months after treatment initiation
Proportion of patients with margin-free resection (R0), defined as a microscopically margin-negative resection, in which no gross or microscopic tumor remains in the primary tumor bed
At surgery, an average 3 months after treatment initiation
Treatment-Related Adverse Events
Time Frame: Toxicities occurring up to 1 month after the end of treatment
Type, grade and number of Adverse Events as Assessed by CTCAE v5.0
Toxicities occurring up to 1 month after the end of treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Centre Francois Baclesse

Collaborators

National Cancer Institute, France

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 28, 2021

Primary Completion (Anticipated)

March 1, 2024

Study Completion (Anticipated)

March 1, 2027

Study Registration Dates

First Submitted

January 26, 2021

First Submitted That Met QC Criteria

January 29, 2021

First Posted (Actual)

February 3, 2021

Study Record Updates

Last Update Posted (Actual)

December 23, 2022

Last Update Submitted That Met QC Criteria

December 22, 2022

Last Verified

December 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2020-004497-21

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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