A randomized phase II study evaluating FOLFIRI + durvalumab vs FOLFIRI + durvalumab and tremelimumab in second-line treatment of patients with advanced gastric or gastro-oesophageal junction adenocarcinoma - DURIGAST

Fédération Francophone de Cancérologie Digestive0 sites94 target enrollmentOctober 3, 2018

ConditionsAdvanced gastric or gastro-oesophageal junction adenocarcinoma MedDRA version: 20.0 Level: LLT Classification code 10042080 Term: Stomach cancer System Organ Class: 100000004864 MedDRA version: 20.0 Level: LLT Classification code 10026476 Term: Malignant neoplasm of stomach System Organ Class: 100000004864 Therapeutic area: Diseases [C] - Cancer [C04]

Overview

Phase: Phase 1
Intervention: Not specified
Conditions: Advanced gastric or gastro-oesophageal junction adenocarcinoma
Sponsor: Fédération Francophone de Cancérologie Digestive
Enrollment: 94
Status: Active, not recruiting
Last Updated: 7 years ago

Overview Investigators Eligibility Criteria Outcomes Similar Trials

Overview

Brief Summary

No summary available.

Registry

who.int

Start Date

October 3, 2018

End Date

TBD

Last Updated

7 years ago

Study Type

Interventional clinical trial of medicinal product

Investigators

Sponsor

Fédération Francophone de Cancérologie Digestive

Eligibility Criteria

Inclusion Criteria

•\- Age \= 18 years.
•\- Body weight \> 30kg.
•\- Histologically proven advanced\-stage unresectable adenocarcinoma of the stomach or the GEJ (Siewert II or III).
•\- Known MSS/MSI status or tumor tissue available (frozen or paraffin\-embedded, primary tumors or metastases) in order to allow determination of MSS/MSI status. The investigator needs to ensure that tumor tissues will be sent after patient randomization.
•\- Failure to platinium\-based 1st line therapy or early recurrent disease after surgery with neo\-adjuvant and/or adjuvant platinium\-based chemotherapy or progression during neo\-adjuvant and/or adjuvant platinium\-based chemotherapy.
•\- Eligible for a second\-line treatment with irinotecan and 5\-FU.
•\- Measurable or non\-measurable lesion according to the Response Evaluation Criteria in Solid Tumors (RECIST 1\.1\).
•\- Eastern Cooperative Oncology Group (ECOG) performance status 0\-1\.
•\- Adequate organ function: ANC \= 1\.5 x 109/L, haemoglobin \= 9 g/dL, platelets \= 100 x 109/L, AST/ALT \= 3 x ULN (\= 5 x ULN in case of liver metastase(s)), GGT \= 3 x ULN (\= 5 x ULN in case of liver metastase(s)), bilirubin \= 1\.5 x ULN, creatinin clearance \> 40 mL/min (MDRD).
•\- Evidence of post\-menopausal status or negative urinary or serum pregnancy test for female pre\-menopausal patients.

Exclusion Criteria

•\-Concurrent enrolment in another clinical study – unless it is an observational study or during the follow\-up period of an interventional study.
•\-Receipt of the last dose of anticancer therapy \= 2 weeks prior to the first dose of study drug.
•\-Any unresolved significant toxicity NCI CTCAE v4\.0 \= grade 2 from previous anticancer therapy.
•\-Concurrent use of hormonal therapy for non–cancer\-related conditions is acceptable
•\-Major surgical procedure (e.g. exploratory laparoscopy is not considered as a major surgical procedure ) within 28 days prior to the first dose of treatment.
•\-Prior allogeneic bone marrow transplantation or prior solid organ transplantation.
•\-Active or prior documented autoimmune or inflammatory disorders (patients with alopecia, vitiligo, controlled hypo or hyperthyroidism, any chronic skin condition not requiring immunosuppressant therapy are eligible). Patients without active disease in the last 5 years may be included.
•\-Uncontrolled intercurrent illness, including but not limited to, ongoing or active infection, symptomatic congestive heart failure, uncontrolled hypertension, unstable angina pectoris, cardiac arrhythmia, interstitial lung disease, serious chronic gastrointestinal conditions associated with diarrhea, or psychiatric illness/social situations that would limit compliance with study requirement, substantially increase risk of incurring AEs or compromise the ability of the patient to give written informed consent.
•\-Severe cardiac disorders within 6 months.
•\-Severe liver dysfunction