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

Stopped early · Phase 1/Phase 2

Conditions studied: Colorectal Cancer

In brief

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) that became refractory to first- and second-line standard therapies. Eligible patients will be assigned to one of several treatment arms.

Key facts

Study ID

NCT03555149

Run by

Hoffmann-La Roche

People needed

96

Starts

2018-09-27

Expected to finish

2022-09-26

Last updated by the study team

2023-11-07

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1
• Life expectancy ≥ 3 months, as determined by the investigator
• Histologically confirmed adenocarcinoma originating from the colon or rectum
• Metastatic disease not amenable to local treatment
• Disease progression during or following not more than two separate lines of treatment for metastatic colorectal cancer (mCRC) that consisted of fluoropyrimidine-, oxaliplatin-, and 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

You may not qualify if…

• High microsatellite instability (MSI-H) tumor
• Presence of BRAFV600E mutation
• 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

Where it is running

• City of Hope Comprehensive Cancer Center — Duarte, California, United States
• Yale University — New Haven, Connecticut, United States
• Dana Farber Cancer Institute — Boston, Massachusetts, United States
• Washington University School of Medicine — St Louis, Missouri, United States
• Columbia University Medical Center — New York, New York, United States
• Memorial Sloan-Kettering Cancer Center — New York, New York, United States
• Peter MacCallum Cancer Center — North Melbourne, Victoria, Australia
• Centre Georges François Leclerc; Pharmacie des Essais Cliniques — Dijon, France
• Centre Leon Berard — Lyon, France
• Institut Claudius Regaud; Departement Oncologie Medicale — Toulouse, France
• Institut Gustave Roussy — Villejuif, France
• Seoul National University Hospital — Seoul, South Korea
• Samsung Medical Center — Seoul, South Korea
• Asan Medical Center. — Seoul, South Korea
• CHUV; Departement d'Oncologie — Lausanne, Switzerland

Full record on ClinicalTrials.gov

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