Clinical trials are an important way to improve treatment for people with cancer. While most are continuing during the COVID-19 pandemic, the period of time that clinical trials are available and recruiting may change quickly. If you would like to get involved in a clinical trial, speak to your treatment team or the health service where the clinical trial is being undertaken, to confirm it is open and appropriate for you. For cancer information and support, call Cancer Council's experienced cancer nurses on 13 11 20 Monday to Friday from 9am-5pm.

NCT03281369 : 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)

Male or<br/>FemaleGender Male or
Female

RecruitingStatus Recruiting

Systemic<br/>Therapy TrialTypeSystemic
Therapy Trial

One/TwoPhase One/Two

18+Age Over 18

Stomach<br/>CancersCancer LocationStomach
Cancers

Systemic therapy | Stomach and upper gastrointestinal tractGastro-oesophageal junction ,Oesophagus,Stomach

Trial Overview Read MoreRead more

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 cancer.
 

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

This is a systemic therapy trial.

You may be able to join this trial if:

  • 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.

You may be excluded from this trial if:

  • You have a certain disease or psychological condition.
  • You have been diagnosed with a prior or secondary type of cancer.
  • You have had certain treatments, surgical procedures or drugs.

Clinical trials have complex eligibility criteria - talk to your doctor about your interest in this trial.

Clinical Summary Read MoreRead more

Trial Identifiers

Use the hyperlinks, where available to access additional clinical trial information.

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)

Commercial Sponsor

Hoffmann-La Roche

Summary

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

Recruiting Hospitals Read MoreRead more

Monash Health, Medical Oncology
Clayton
GI Research Study Coordinator
gi.oncresearch@monashhealth.org
0436386758

PCCTU (Parkville Cancer Clinical Trials Unit) *
Parkville
Enquiries Line Coordinator
clinicaltrials.enquiries@petermac.org
03 8559 7456 (9am-2pm, Mon-Fri)

Trial Overview: General information about a clinical trial. This section provides an overview of who might be able to join this trial and what type of treatment is involved.

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