Trial purpose
Cancer treatment
Tumor type
Lower gastrointestinal tract
Age
18+
Trial acronym
Morpheus-CRC
Clinical summary
Summary
In this trial, eligible patients will be randomly assigned to one of three treatment arms. In the active comparator arm, participants will continue to receive treatment with Regorafenib, administered orally on Days 1-21 of each 28 day cycle, until unacceptable toxicity or disease progression occurs. In Experimental Arm 1, participants will receive Atezolizumab, Imprime PGG and Bevacizumab until unacceptable toxicity or disease progression occurs. In this Arm, Atezolizumab will be administered by intravenous (IV) infusion every 3 weeks (Q3W) on Day 1 of 21-day cycles or by IV infusion every 2 weeks (Q2W) on Days 1 and 15 of 28-day cycles; Imprime PGG will be administered by IV infusion weekly on Days 1, 8, and 15 of each 21-day cycle; and Bevacizumab will be administered IV infusion on Day 1 of each 21-day cycle. In Experimental Arm 2, participants will receive Atezolizumab and Isatuximab. In this Arm, Atezolizumab will be administered by intravenous (IV) infusion every 3 weeks (Q3W) on Day 1 of 21-day cycles or by IV infusion every 2 weeks (Q2W) on Days 1 and 15 of 28-day cycles; and Isatuximab will be administered by IV infusion. In all Arms, participants who progress on treatment may have the option of receiving Atezolizumab and Cobimetinib, provided they meet the eligibility criteria.
Conditions
This trial is treating people with colorectal cancer
Eligibility
Inclusion
- 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
Exclusion
- 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
- Inability to swallow medications
- Malabsorption condition that would alter the absorption of orally administered medications
- Evidence of inherited bleeding diathesis or significant coagulopathy at risk of bleeding
- Urine dipstick ≥ 2+ protein or ≥ 3.5 g of protein in a 24-hour urine collection
Inclusion
- Your cancer has spread to other parts of the body (metastatic) or has grown into nearby parts of the body (locally advanced).
- You have had treatment but your cancer has gotten worse or has not responded to the treatment you have been given.
Exclusion
- You are currently being treated on a clinical trial.
- 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.
Clinical trials have complex eligibility criteria, and other criteria may apply for this trial. Ask your doctor about whether this trial could be right for you.
More information
Trial Identifiers
Information on this page is partially produced from ClinicalTrials.gov *. View further details about this trial on the registry via the links below:
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 Metastatic Colorectal Cancer
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