A Study of Multiple Immunotherapy-Based Treatment Combinations in Patients With Locally Advanced Unresectable or Metastatic Gastric or Gastroesophageal Junction Cancer (G/GEJ) or Esophageal Cancer (Morpheus-Gastric and Esophageal Cancer)

PHASE1/PHASE2Active, not recruitingINTERVENTIONAL
Enrollment

410

Participants

Timeline

Start Date

October 13, 2017

Primary Completion Date

November 30, 2025

Study Completion Date

November 30, 2025

Conditions
Gastric Adenocarcinoma or Gastroesophageal Junction Adenocarcinoma or Esophageal Carcinoma
Interventions
DRUG

5-Fluorouracil (5-FU)

5-FU 2400 milligrams per square meter (mg/m\^2) by continuous intravenous (IV) infusion over 46 hours on Days 1 and 2 and Days 15 and 16 of every 28-day cycle.

DRUG

Leucovorin

Leucovorin: 100 mg/m\^2 IV over 2 hours on Days 1 and 15 of every 28-day cycle.

DRUG

Oxaliplatin

Oxaliplatin: 100 mg/m\^2 administered by IV infusion over 2 hours on Days 1 and 15 of every 28-day cycle.

DRUG

Atezolizumab

Atezolizumab: 840 mg by IV infusion on Days 1 and 15 of every 28-day cycle.

DRUG

Cobimetinib

Cobimetinib: 60 mg by mouth once a day on Days 1-21 of every 28-day cycle

BIOLOGICAL

Ramucirumab

Ramucirumab: 8 mg/kg administered by IV infusion over 60 minutes on Days 1 and 15 of every 28-day cycle.

DRUG

Paclitaxel

Paclitaxel: 80 mg/m\^2 administered by IV infusion on Days 1, 8, and 15 of every 28-day cycle.

BIOLOGICAL

PEGylated recombinant human hyaluronidase (PEGPH20)

PEGPH20: 3 micrograms per kilogram (mcg/kg) administered by IV infusion on Days 1, 8, and 15 of every 21-day cycle.

DRUG

BL-8040

BL-8040: 1.25 mg/kg administered by subcutaneous (SC) injection on Days 1-5 during the 5-day priming period prior to Cycle 1; 1.25 mg/kg administered by SC injection three times a week (Days 1, 3, 5, 8, 10, 12, 15, 17, and 19 of every 21-day cycle).

DRUG

Linagliptin

Linagliptin: 5 mg orally once a day of every 21-day cycle.

DRUG

Atezolizumab

Atezolizumab: 1200 mg administered by IV infusion on Day 1 of every 21-day cycle

DRUG

Cobimetinib

Cobimetinib: 40 or 60 mg (depending on the recommended dose determined during the safety run-in phase) by mouth once a day on Days 1-21 of every 28-day cycle.

DRUG

Cisplatin

Cisplatin: 80 mg/m\^2 administered by IV infusion on Day 1 of each 21 day cycle. Treatment will be capped after 6 doses.

DRUG

Tiragolumab

Tiragolumab: 600 mg administered by IV infusion on Day 1 of every 21 day cycle.

DRUG

5-Fluorouracil (5-FU)

5-FU 800 mg/m\^2 administerd by IV infusion on Days 1-5 of each 21 day cycle.

Trial Locations (27)

0

Barts and The London School of Medicine and Dentistry - Barts Cancer Institute (BCI)-CECM, London

2148

Blacktown Hospital, Blacktown

3000

Peter MacCallum Cancer Centre, Melbourne

3168

Monash Medical Centre-Moorabbin Campus, Clayton

10032

Columbia University Medical Center, New York

11217

Taipei Veterans General Hospital, Taipei

13620

Seoul National University Bundang Hospital, Gyeonggi-do

31008

Universidad de Navarra - Clinica Universitaria de Navarra (CUN), Pamplona

37203

Tennessee Oncology - Nashville, Nashville

64239

Sourasky Medical Centre, Tel Aviv

70457

National Cheng Kung University Hospital, Tainan City

85259

Mayo Clinic Cancer Center, Scottsdale

90033

Uni of Southern California, Los Angeles

90404

UCLA Jonsson Comprehensive Cancer Center, Santa Monica

3109601

Rambam Health Care Campus, Haifa

77030-4000

The University of Texas MD Anderson Cancer Center, Houston

02841

Korea University Anam Hospital, Seoul

03080

Seoul National University Hospital (SNUH) - Medical Oncology Center, Seoul

135-710

Samsung Medical Center, Seoul

Unknown

Yonsei University College of Medicine (YUCM)-Yonsei Cancer Center, Seoul

05505

University of Ulsan College of Medicine - Asan Medical Center (AMC) - Asan Cancer Center (ACC), Songpa-gu

442-723

The Catholic University of Korea St. Vincent's Hospital, Suwon

08035

Hospital Universitari Vall dHebron, Barcelona

G12 0YN

Beatson West of Scotland Cancer Centre, Glasgow

SW7 3RP

The Royal Marsden, London

M20 4BX

The Christie NHS Foundation Trust, Manchester

SM2 5PT

The Royal Marsden NHS Foundation Trust - Royal Marsden Hospital (RMH) - Sutton, Sutton

Sponsors
All Listed Sponsors
collaborator

Halozyme Therapeutics

INDUSTRY

collaborator

BioLineRx, Ltd.

INDUSTRY

lead

Hoffmann-La Roche

INDUSTRY

NCT03281369 - A Study of Multiple Immunotherapy-Based Treatment Combinations in Patients With Locally Advanced Unresectable or Metastatic Gastric or Gastroesophageal Junction Cancer (G/GEJ) or Esophageal Cancer (Morpheus-Gastric and Esophageal Cancer) | Biotech Hunter | Biotech Hunter