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



Status:Recruiting
Healthy:No
Age Range:18 - Any
Updated:3/23/2019
Start Date:October 13, 2017
End Date:November 13, 2021
Contact:Reference Study ID Number: YO39609 www.roche.com/about_roche/roche_worldwide.htm
Email:global-roche-genentech-trials@gene.com
Phone:888-662-6728 (U.S. and Canada)

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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 (Morpheus-Gastric Cancer)

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). Two cohorts will be enrolled in parallel in
this study: the second-line (2L) Cohort will consist 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) Cohort will consist 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.


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 Cohort: no prior
systemic therapy for the locally advanced or metastatic disease; for the 2L Cohort:
disease progression during or following a first-line platinum-containing or
fluoropyrimidine-containing chemotherapy regimen);

- Only for the 1L 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.

Exclusion Criteria:

Exclusion criteria for the 2L 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.

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.
We found this trial at
9
sites
1275 York Ave
New York, New York 10021
(212) 639-2000
Memorial Sloan Kettering Cancer Center Memorial Sloan Kettering Cancer Center — the world's oldest and...
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450 Brookline Avenue
Boston, Massachusetts 02111
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1515 Holcombe Blvd
Houston, Texas 77030
 713-792-2121
University of Texas M.D. Anderson Cancer Center The mission of The University of Texas MD...
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Houston, TX
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1441 Eastlake Avenue
Los Angeles, California 90033
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Los Angeles, CA
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Lyon, 69008
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Lyon,
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250 25th Ave N, Ste 100
Nashville, Tennessee 37023
615-320-5090
Tennessee Oncology, PLLC Since 1976 Tennessee Oncology has been providing quality cancer care. In 2013,...
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Nashville, TN
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630 W 168th St
New York, New York
212-305-2862
Columbia University Medical Center Situated on a 20-acre campus in Northern Manhattan and accounting for...
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New York, NY
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Rochester, MN
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Scottsdale, Arizona 85259
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Scottsdale, AZ
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