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)

  • STATUS
    Recruiting
  • End date
    Feb 8, 2025
  • participants needed
    410
  • sponsor
    Hoffmann-La Roche
Updated on 21 July 2022

Summary

A Phase Ib/II, open label, multi-center, randomized study designed to assess the safety, tolerability, pharmacokinetics and preliminary anti-tumor activity of immunotherapy-based treatment combinations in patients with locally advanced unresectable or metastatic G/GEJ cancer (hereafter referred to as gastric cancer) and esophageal cancer. Two cohorts of patients with gastric cancer have been enrolled in parallel in this study: the second-line (2L) Gastric Cancer Cohort consists of patients with gastric cancer who have progressed after receiving a platinum-containing or fluoropyrimide-containing chemotherapy regimen in the first-line setting, and the first-line (1L) Gastric Cancer Cohort consists of patients with gastric cancer who have not received prior chemotherapy in this setting. In each cohort, eligible patients will be assigned to one of several treatment arms. Additionally, a cohort of patients with esophageal cancer who have not received prior systemic treatment for their disease will be enrolled in this study. Eligible patients will be randomized to chemotherapy or the combination of chemotherapy with checkpoint inhibitor immunotherapy.

Details
Condition Gastric Adenocarcinoma or Gastroesophageal Junction Adenocarcinoma or Esophageal Carcinoma
Treatment cisplatin, Paclitaxel, Oxaliplatin, Leucovorin, 5-Fluorouracil (5-FU), Cobimetinib, Ramucirumab, Atezolizumab, BL-8040, Linagliptin, PEGylated recombinant human hyaluronidase (PEGPH20), Tiragolumab
Clinical Study IdentifierNCT03281369
SponsorHoffmann-La Roche
Last Modified on21 July 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

Gastric Cancer Cohorts Inclusion Criteria
Age >/= 18 years
Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1
Life expectancy >/= 3 months, as determined by the investigator
Histologically or cytologically confirmed locally advanced unresectable or metastatic adenocarcinoma of gastric or gastroesophageal junction; (for the 1L Gastric Cancer Cohort: no prior systemic therapy for the locally advanced or metastatic disease; for the 2L Gastric Cancer Cohort: disease progression during or following a first-line platinum-containing or fluoropyrimidine-containing chemotherapy regimen)
Availability of a representative tumor specimen that is suitable for determination of PD-L1 and TIGIT levels by IHC and/or additional biomarker status by means of retrospective central testing
Only for the 1L Gastric Cancer Cohort: human epidermal growth factor receptor 2 (HER2)-negative tumors
Measurable disease (at least one target lesion) according to Response Evaluation Criteria in Solid Tumors, Version 1.1 (RECIST v1.1)
Adequate hematologic and end organ function based on laboratory results obtained within 14 days prior to initiation of study treatment
For women of childbearing potential: agreement to remain abstinent (refrain from heterosexual intercourse) or use contraceptive measures as outlined for each specific treatment arm
For men: agreement to remain abstinent (refrain from heterosexual intercourse) or use contraceptive measures, and agreement to refrain from donating sperm, as outlined for each specific treatment arm
Esophageal Cancer Cohort Inclusion Criteria
Histologically or cytologically confirmed diagnosis of squamous cell carcinoma or adenocarcinoma of the esophagus in locally advanced or metastatic disease
No prior systemic treatment for esophageal cancer, with the following exception
For patients treated with chemotherapy in the locally advanced setting: occurrence of
metastasis after 6 months from the last dose of chemotherapy
For patients with adenocarcinoma: absence of HER2 expression
Life expectancy >/=3 months as determined by the investigator
Measurable disease per RECIST v1.1
Adequate hematologic and end-organ function
For women of childbearing potential: agreement to remain abstinent (refrain from
heterosexual intercourse) or use contraceptive measures, and agreement to refrain from
ECOG Performance Status of 0, 1, or 2
donating eggs
For men: agreement to remain abstinent (refrain from heterosexual intercourse) or use
contraceptive measures, and agreement to refrain from donating sperm

Exclusion Criteria

Exclusion criteria for the 2L Gastric Cancer Cohort
Urinary protein is > 1 + on dipstick and the required following 24-hour urine
collection shows urinary protein > 2000 mg
Serious or non-healing wound, peptic ulcer, or bone fracture within 28 days prior to
Gastric Cancer Exclusion Criteria
initiation of study treatment
History of gastrointestinal perforation and/or fistulae within 6 months prior to
initiation of study treatment
History of leptomeningeal disease
Presence of a bowel obstruction, history or presence of inflammatory enteropathy, or
Active or history of autoimmune disease or immune deficiency
extensive intestinal resection, Crohn disease, ulcerative colitis, or chronic
diarrhea
Positive test for human immunodeficiency virus (HIV) at screening
Uncontrolled arterial hypertension >/= 150/ >/= 90 millimeter of mercury (mmHg)
Active hepatitis B virus (HBV) or hepatitis C (HCV) infection
despite standard medical management
Severe infection within 4 weeks prior to initiation of study treatment
Chronic therapy with non-steroidal anti-inflammatory agents or other anti-platelet
Significant cardiovascular disease
agents
Significant bleeding disorder
Prior allogeneic stem cell or solid organ transplantation
Uncontrolled hypercalcemia or symptomatic hypercalcemia requiring continued use of
bisphosphonate therapy
Symptomatic, untreated, or actively progressing central nervous system (CNS)
metastases
Known allergy or hypersensitivity to any of the study drugs or their excipients
Esophageal Cancer Cohort Exclusion Criteria
High risk for developing esophageal fistula by clinical assessment or imaging
History of idiopathic pulmonary fibrosis, organizing pneumonia (e.g., bronchiolitis
obliterans), drug-induced pneumonitis, or idiopathic pneumonitis, or evidence of
Positive EBV viral capsid antigen IgM test at screening
active pneumonitis on screening chest computed tomography (CT) scan
History of leptomeningeal disease
Active or history of autoimmune disease or immune deficiency
Active tuberculosis
Major surgical procedure, other than for diagnosis, within 4 weeks prior to initiation
of study treatment, or anticipation of need for a major surgical procedure during the
study
Treatment with anticoagulation with warfarin, low-molecular-weight heparin, or similar
agents for therapeutic purposes
History of malignancy other than gastric or gastroesophageal junction carcinoma within
years prior to screening, with the exception of those with a negligible risk of
metastasis or death
Symptomatic, untreated, or actively progressing central nervous system (CNS)
Metastases
History of idiopathic pulmonary fibrosis, organizing pneumonia, drug-induced
pneumonitis, or idiopathic pneumonitis, or evidence of active pneumonitis on screening
chest computed tomography (CT) scan
Significant cardiovascular disease within 3 months prior to initiation of study
treatment, unstable arrhythmia, or unstable angina
History of malignancy other than esophageal cancer within 2 years prior to screening
with the exception of malignancies with a negligible risk of metastasis or death
Pregnancy or breastfeeding, or intention of becoming pregnant during study treatment
or within 5 months after the final dose of atezolizumab or within 90 days after the
final dose of tiragolumab
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