A Study Evaluating the Efficacy and Safety of Multiple Immunotherapy-Based Treatment Combinations in Patients With Metastatic Colorectal Cancer (Morpheus-CRC)



Status:Recruiting
Conditions:Colorectal Cancer, Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:18 - Any
Updated:3/30/2019
Start Date:September 27, 2018
End Date:January 29, 2022
Contact:Reference Study ID Number: CO39612 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 Metastatic Colorectal Cancer (Morpheus-CRC)

A phase Ib/II, open-label, multicenter, randomized study designed to assess the safety,
tolerability, pharmacokinetics and preliminary anti-tumor activity of immunotherapy-based
treatment combinations in patients with metastatic colorectal cancer (mCRC) who experienced
disease progression during or following two lines of treatment.

Eligible patients will be assigned to one of several treatment arms.


Inclusion Criteria:

- Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1

- Life expectancy ≥ 3 months, as determined by the investigator

- Disease progression during or following two (but not more) separate lines of treatment
for metastatic colorectal cancer (mCRC) that consisted of fluoropyrimidine-,
oxaliplatin-, or irinotecan-containing chemotherapy in combination with a biologic
agent

- Measurable disease (at least one target lesion) according to RECIST v1.1

- Adequate hematologic and end-organ function obtained within 14 days prior to
initiation of study treatment

Exclusion Criteria:

- High microsatellite instability (MSI-H) tumor

- Mutation in the BRAF oncogene

- Prior treatment with any of the protocol-specified study treatments

- Prior treatment with T-cell co-stimulating or immune checkpoint blockade therapies
including anti-CTLA-4, anti-PD-1, and anti-PD-L1 therapeutic antibodies

- Biologic treatment within 2 weeks prior to initiation of study treatment, or other
systemic treatment for CRC within 2 weeks or 5 half-lives of the drug (whichever is
shorter) prior to initiation of study treatment

- Treatment with investigational therapy within 28 days prior to initiation of study
treatment

- Eligibility only for the control arm

- Prior allogeneic stem cell or solid organ transplantation

- Treatment with systemic immunostimulatory agents within 4 weeks or 5 half-lives of the
drug (whichever is longer) prior to the initiation of study treatment

- Treatment with systemic immunosuppressive medication within 2 weeks prior to
initiation of study treatment, or anticipation of need for systemic immunosuppressant
medication during study treatment

- Treatment with a live, attenuated vaccine within 4 weeks prior to initiation of study
treatment, or anticipation of need for such a vaccine during atezolizumab treatment or
within 5 months after the last dose of atezolizumab

- Current treatment with anti-viral therapy for HBV

- Uncontrolled pleural effusion, pericardial effusion, ascites requiring recurrent
drainage procedures (once monthly or more frequently), or tumor related-pain,

- Uncontrolled or symptomatic hypercalcemia (ionized calcium >1.5 mmol/L, calcium >12
mg/dL, or corrected serum calcium >ULN)

- Symptomatic, untreated, or actively progressing CNS metastases

- 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

- History of malignancy other than CRC within 2 years prior to screening, with the
exception of malignancies with a negligible risk of metastasis or death

- Active tuberculosis

- Severe infection within 4 weeks prior to initiation of study treatment

- Significant cardiovascular disease

- Grade ≥3 hemorrhage or bleeding event within 28 days prior to initiation of study
treatment

- 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

- History of severe allergic reactions to chimeric or humanized antibodies or fusion
proteins
We found this trial at
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305 Grattan Street
Melbourne, Victoria 3000
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1500 E Duarte Rd
Duarte, California 91010
(626) 256-4673
City of Hope Comprehensive Cancer Center City of Hope is a leading research and treatment...
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450 Brookline Ave
Boston, Massachusetts 2215
617-632-3000
Dana-Farber Cancer Institute Since it’s founding in 1947, Dana-Farber has been committed to providing adults...
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Boston, MA
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New Haven, Connecticut 6520
(203) 432-4771
Yale University Yale's roots can be traced back to the 1640s, when colonial clergymen led...
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New Haven, CT
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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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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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New York, NY
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660 S Euclid Ave
Saint Louis, Missouri 63110
(314) 362-5000
Washington University School of Medicine Washington University Physicians is the clinical practice of the School...
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Saint Louis, MO
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