A RANDOMIZED, MULTICENTER, OPEN-LABEL, PHASE 3 STUDY OF NIVOLUMAB PLUS IPILIMUMAB VERSUS OXALIPLATIN PLUS FLUOROPYRIMIDINE IN SUBJECTS WITH PREVIOUSLY UNTREATED ADVANCED OR METASTATIC GASTRIC OR GASTROESOPHAGEAL JUNCTION CANCER

• Register: RPEC
• Last refreshed on: 29 April 2024
• Main ID: PER-028-16
• Date of registration: 02/12/2016
• Prospective Registration: Yes
• Primary sponsor: BRISTOL MYERS SQUIBB COMPANY,
• Public title: A RANDOMIZED, MULTICENTER, OPEN-LABEL, PHASE 3 STUDY OF NIVOLUMAB PLUS IPILIMUMAB VERSUS OXALIPLATIN PLUS FLUOROPYRIMIDINE IN SUBJECTS WITH PREVIOUSLY UNTREATED ADVANCED OR METASTATIC GASTRIC OR GASTROESOPHAGEAL JUNCTION CANCER
• Scientific title: A RANDOMIZED, MULTICENTER, OPEN-LABEL, PHASE 3 STUDY OF NIVOLUMAB PLUS IPILIMUMAB VERSUS OXALIPLATIN PLUS FLUOROPYRIMIDINE IN SUBJECTS WITH PREVIOUSLY UNTREATED ADVANCED OR METASTATIC GASTRIC OR GASTROESOPHAGEAL JUNCTION CANCER
• Date of first enrolment: 05/01/2017
• Target sample size: 54
• Recruitment status: Pending
• URL: https://www.ins.gob.pe/ensayosclinicos/rpec/recuperarECPBNuevoEN.asp?numec=028-16
• Study type: Interventional
• Study design: This is a Phase 3, randomized, open-label, two-arm study of nivolumab plus ipilimumab versus oxaliplatin plus fluoropyrimidine in subjects with previously untreated advanced or metastatic GC or GEJ cancer.; Approximately 750 subjects will be randomized in an open-label fashion (1:1 ratio) to receive nivolumab plus ipilimumab and will be stratified by PD-L1 status (≥1% vs < 1% or indeterminate), region (Asia vs US vs Rest of World), and for the ECOG performance status (0 vs 1). During enrollment, the proportion of subjects with or without PD-L1 tumor expression will be monitored, and may be re-assessed in case it does not reflect study assumptions (ie, subjects with PD-L1 tumor expression ≥1% is approximately 40% of all comers).; The treatment will be given until PD (unless treatment beyond PD is permitted; see Section 4.5.1.6 of the protocol), unacceptable toxicity, or subject withdrawal of consent, whichever comes first.
• Phase: III

Countries of recruitment

Canada, Cape Verde, Chad, China, France, Greece, Hungary, Italy, Japan, Korea South, Peru, Poland, Portugal, Romania, Spain, Taiwan, United States

Contacts

• Name: Eddy Lazo Dumler
• Affiliation: BRISTOL MYERS SQUIBB PERU S.A.

• Name: Eddy Lazo Dumler
• Affiliation: BRISTOL MYERS SQUIBB PERU S.A.

Key inclusion & exclusion criteria

Inclusion criteria: 1) All subjects must have inoperable, advanced, locally advanced or metastatic GC or GEJ carcinoma and have histologically confirmed predominant adenocarcinoma. 2) Subject must be previously untreated with systemic treatment including HER 2 inhibitors given as primary therapy for advanced or metastatic disease. 3) Prior adjuvant or neoadjuvant chemotherapy, radiotherapy and/or chemoradiotherapy are permitted as long as the last administration of the prior regimen (whichever was given last) occurred at least 6 months prior to randomization. 4) Subject must have at least one measurable lesion or evaluable disease by CT or MRI per RECIST 1.1 criteria. 5) ECOG performance status score of 0 or 1. 6) Tumor tissue must be provided for PD-L1 biomarker analyses prior to randomization.
Exclusion criteria: 1) Known Her2 positive status. 2) Subjects with untreated CNS metastases. 3) Subjects with ascites which cannot be controlled with appropriate interventions. 4) Subjects with > Grade 1 peripheral neuropathy. 5) c) Subjects with a condition requiring systemic treatment with either corticosteroids (> 10 mg daily prednisone equivalents) or other immunosuppressive medications within 14 days of study drug administration. 6) d) Prior treatment with an anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CD137, or anti-CTLA-4 antibody, or any other antibody or drug specifically targeting T-cell co-stimulation or checkpoint pathways. 7) Known history of positive test for human immunodeficiency virus (HIV) or known acquired immunodeficiency syndrome (AIDS).

Age minimum:
Age maximum:
Gender: --

Health Condition(s) or Problem(s) studied

-C169 Stomach, unspecified -C160 Cardia
Cardia
Stomach, unspecified

C160

C169

Intervention(s)

Nivolumab-plus-Ipilimumab Arm.
Nivolumab (solution for inyection) 1mg/kg administered IV over 30 minutes followed by ipilimumab (Solution for inyection 5mg/mL) 3mg/kg administered IV over 30 minutes on Day 1 of each treatment cycle every 3 weeks for 4 doses (Cycles 1 to 4), followed by nivolumab (solution for inyection) 240 mg administered IV over 30 minutes on Day 1 of each treatment cycle every 2 weeks (Cycle 5 and beyond) until PD, unacceptable toxicity, withdrawal of consent, or the study ends, whichever occurs first.

Chemotherapy Arm: XELOX or FOLFOX.
Subjects assigned to XELOX will receive oxaliplatin (solution for infusion) 130 mg/m2 administered IV on Day 1 of each treatment cycle and capecitabine (tablets) 1000 mg/m2 administered orally twice daily on Days 1 to 14 of each treatment cycle, every 3 weeks.
Subjects assigned to FOLFOX will receive oxaliplatin (solution for infusion) 85 mg/m2, leucovorin (solution for injection) 400 mg/m2, and fluorouracil (solution for injection) 400 mg/m2 administered IV on Day 1 of each treatment cycle, and fluorouracil (solution for injection) 1200 mg/m2 IV continuous infusion over 24 hours daily or per local standard on Days 1 and 2 of each treatment cycle, every 2 weeks.

Secondary ID(s)

2016-001018-76

Source(s) of Monetary Support

Bristol Myers Squibb Company

Ethics review

Status: Approved
Approval date: 24/06/2016
Contact:

[e-mail]

Hospital Cayetano Heredia

97254626

[e-mail]

Status: Approved
Approval date: 23/02/2017
Contact:

[e-mail]

Comite Institucional de Etica en Investigacion de la Asociacion Benefica Prisma

616-5500 Anx. 246

[e-mail]

Status: Approved
Approval date: 23/03/2017
Contact:

[e-mail]

Instituto Nacional de Enfermedades Neoplasicas

7106099-3001

[e-mail]

Status: Approved
Approval date: 17/05/2017
Contact:

[e-mail]

Clinica Anglo Americana

6168900

[e-mail]

Results

• Results available: Yes
• Date Completed: 01/05/2021