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

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ClinicalTrials.gov Identifier: NCT04736485

Recruitment Status : Recruiting

First Posted : February 3, 2021

Last Update Posted : June 29, 2021

See Contacts and Locations

Sponsor:

Collaborator:

National Cancer Institute, France

Information provided by (Responsible Party):

Centre Francois Baclesse

Study Description

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)

Condition or disease	Intervention/treatment	Phase
Gastric Cancer by AJCC V8 Stage Resectable Carcinoma	Drug: perioperative treatment	Phase 2

Study Design

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Study Type :	Interventional (Clinical Trial)
Estimated Enrollment :	67 participants
Allocation:	N/A
Intervention Model:	Single Group Assignment
Masking:	None (Open Label)
Primary Purpose:	Treatment
Official Title:	Perioperative Treatment in Resectable Gastric Cancer With Spartalizumab (PDR001) in Combination With Fluorouracil, Leucovorin, Oxaliplatin, and Docetaxel (FLOT): A Phase II Study (GASPAR)
Actual Study Start Date :	June 28, 2021
Estimated Primary Completion Date :	March 2024
Estimated Study Completion Date :	March 2027

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Stomach Cancer

Drug Information available for: Leucovorin

Genetic and Rare Diseases Information Center resources: Stomach Cancer

U.S. FDA Resources

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures :

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

Secondary Outcome Measures :

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
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;
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
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

Eligibility Criteria

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Ages Eligible for Study:	18 Years and older (Adult, Older Adult)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04736485

Contacts

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Contact: Mélanie DOS SANTOS, MD	33231455050	m.dossantos@baclesse.unicancer.fr

Locations

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France
Centre François Baclesse	Recruiting
Caen, France
Contact: mélanie DOS SANTOS, MD m.dossantos@baclesse.unicancer.fr

Sponsors and Collaborators

Centre Francois Baclesse

National Cancer Institute, France

More Information

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Responsible Party:	Centre Francois Baclesse
ClinicalTrials.gov Identifier:	NCT04736485
Other Study ID Numbers:	2020-004497-21
First Posted:	February 3, 2021 Key Record Dates
Last Update Posted:	June 29, 2021
Last Verified:	June 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD:	Undecided

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Studies a U.S. FDA-regulated Drug Product:	No
Studies a U.S. FDA-regulated Device Product:	No

Keywords provided by Centre Francois Baclesse:


perioperative spartalizumab PDR001 Gastric Cancer

Additional relevant MeSH terms:

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

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