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Closed (no longer recruiting)Last updated: 4 January 2024

MORPHEUS YO39609: This phase I/II trial is assessing how safe and tolerable a variety of immunotherapy-based treatment combinations are in people with locally advanced unresectable or metastatic gastric or gastroesophageal junction cancer, or esophageal cancerA Phase Ib/II, Open-Label, Multicenter, Randomized, Umbrella Study Evaluating the Efficacy and Safety of Multiple Immunotherapy-Based Treatment Combinations in Patients With Locally Advanced Unresectable or Metastatic Gastric or Gastroesophageal Junction Cancer or Esophageal Cancer (Morpheus-Gastric and Esophageal Cancer)

Clinical summary

Summary

This is a randomised trial with different cohorts and treatment arms.

Cohorts include:

  • 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.

Participants in the 1L-1: Atezo+Tiragolumab+Cisplatin+5FU(Esophageal Cancer Cohort) Experimental Arm will receive atezolizumab in combination with tiragolumab and chemotherapy (intravenously): Atezolizumab: 1200 mg administered by IV infusion on Day 1 of every 21-day cycle, Cisplatin: 80 mg/m^2 administered by IV infusion on Day 1 of each 21 day cycle. Treatment will be capped after 6 doses, Tiragolumab: 600 mg administered by IV infusion on Day 1 of every 21 day cycle, and 5-Fluorouracil (5-FU) 800 mg/m^2 administerd by IV infusion on Days 1-5 of each 21 day cycle.

Participants in the 1L-2: Atezo+Cisplatin+5-FU (Esophageal Cancer Cohort) Experimental Arm will receive atezolizumab in combination with chemotherapy (intravenously): Atezolizumab: 1200 mg administered by IV infusion on Day 1 of every 21-day cycle, Cisplatin: 80 mg/m^2 administered by IV infusion on Day 1 of each 21 day cycle. Treatment will be capped after 6 doses, and 5-Fluorouracil (5-FU) 800 mg/m^2 administerd by IV infusion on Days 1-5 of each 21 day cycle.

Participants in the 1L-Control: Cisplatin+5-FU (Esophageal Cancer Cohort) Active Comparator Arm will receive chemotherapy (intravenously): Cisplatin: 80 mg/m^2 administered by IV infusion on Day 1 of each 21 day cycle. Treatment will be capped after 6 doses and 5-Fluorouracil (5-FU) 800 mg/m^2 administerd by IV infusion on Days 1-5 of each 21 day cycle.

Participants in the 1L-3: Atezo+Tiragolumab (Esophageal Cancer Cohort) Experimental Arm will receive atezolizumab + tiragolumab treatment (intravenuosly): Atezolizumab: 1200 mg administered by IV infusion on Day 1 of every 21-day cycle and Tiragolumab: 600 mg administered by IV infusion on Day 1 of every 21 day cycle.

Participants from the cisplatin + 5-FU esophageal cancer cohort arm may be permitted to enroll in this arm if they progress after receiving chemotherapy.

The following arms are no longer enrolling participants (as at July 2021): 1L-Control: mFOLFOX6 (Gastric Cancer), 1L-A: mFOLFOX6 + Atezo + Cobi (Gastric Cancer),1L-A2: Atezo+mFOLFOX6 followed by Atezo+Cobi (Gastric Cancer), 1L-B: mFOLFOX6 + Atezo (Gastric Cancer), 2L-Control: Ramucirumab + Paclitaxel (Gastric Cancer), 2L-1: Atezo + Cobi (Gastric Cancer), 2L-2: Atezo + PEGPH20 (Gastric Cancer), 2L-3: Atezo + BL-8040 (Gastric Cancer), 2L-4: Atezo + Linagliptin (Gastric Cancer).

Conditions

This trial is treating patients with gastric, gastroesophageal junction, or oesophageal cancer

Cancer

Upper gastrointestinal tract Cancers Upper gastrointestinal tract

Age

People18+

Phase

I/II

Trial Acronym

MORPHEUS YO39609

More information

Trial Identifiers

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Trial sponsor

Hoffmann-La Roche

Scientific Title

A Phase Ib/II, Open-Label, Multicenter, Randomized, Umbrella Study Evaluating the Efficacy and Safety of Multiple Immunotherapy-Based Treatment Combinations in Patients With Locally Advanced Unresectable or Metastatic Gastric or Gastroesophageal Junction Cancer or Esophageal Cancer (Morpheus-Gastric and Esophageal Cancer)

Eligibility

Inclusion

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 donating eggs;
  • For men: agreement to remain abstinent (refrain from heterosexual intercourse) or use contraceptive measures, and agreement to refrain from donating sperm;
  • ECOG Performance Status of 0, 1, or 2.

Exclusion

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 initiation of study treatment;
  • History of gastrointestinal perforation and/or fistulae within 6 months prior to initiation of study treatment;
  • Presence of a bowel obstruction, history or presence of inflammatory enteropathy, or extensive intestinal resection, Crohn disease, ulcerative colitis, or chronic diarrhea;
  • Uncontrolled arterial hypertension >/= 150/ >/= 90 millimeter of mercury (mmHg) despite standard medical management;
  • Chronic therapy with non-steroidal anti-inflammatory agents or other anti-platelet agents.

Gastric Cancer Exclusion Criteria:

  • Uncontrolled hypercalcemia or symptomatic hypercalcemia requiring continued use of bisphosphonate therapy;
  • Symptomatic, untreated, or actively progressing central nervous system (CNS) metastases;
  • History of leptomeningeal disease;
  • Active or history of autoimmune disease or immune deficiency;
  • History of idiopathic pulmonary fibrosis, organizing pneumonia (e.g., bronchiolitis obliterans), drug-induced pneumonitis, or idiopathic pneumonitis, or evidence of active pneumonitis on screening chest computed tomography (CT) scan;
  • Positive test for human immunodeficiency virus (HIV) at screening;
  • Active hepatitis B virus (HBV) or hepatitis C (HCV) infection;
  • Severe infection within 4 weeks prior to initiation of study treatment;
  • Significant cardiovascular disease;
  • Significant bleeding disorder;
  • Prior allogeneic stem cell or solid organ transplantation;
  • 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 2 years prior to screening, with the exception of those with a negligible risk of metastasis or death;
  • 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;
  • Symptomatic, untreated, or actively progressing central nervous system (CNS) Metastases;
  • Positive EBV viral capsid antigen IgM test at screening;
  • History of leptomeningeal disease;
  • Active or history of autoimmune disease or immune deficiency;
  • 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;
  • Active tuberculosis;
  • 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.

Inclusion

  • You have been diagnosed with cancer, but have not received any treatment.
  • You have had treatment but your cancer has gotten worse or has not responded to the treatment you have been given.
  • You have had treatment, but your cancer has come back.
  • Your cancer has not spread to other parts of the body.
  • Your cancer has spread to other parts of the body.

Exclusion

  • You have been diagnosed with a prior or secondary type of cancer.
  • You have certain types of non-cancer medical conditions.
  • You have had certain treatments, surgical procedures or drugs.
Message

Clinical trials have complex eligibility criteria.

Ask your doctor if this trial could be right for you.

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