ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 1 of 1 for:    Roche, IMprime PGG | colorectal cancer
Previous Study | Return to List | Next Study

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03555149
Recruitment Status : Recruiting
First Posted : June 13, 2018
Last Update Posted : November 5, 2018
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche

Brief Summary:

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.


Condition or disease Intervention/treatment Phase
Colorectal Cancer Drug: Regorafenib Drug: Atezolizumab Drug: Imprime PGG Drug: Bevacizumab Drug: Isatuximab Phase 1 Phase 2

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 120 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official 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 (Morpheus-CRC)
Actual Study Start Date : September 27, 2018
Estimated Primary Completion Date : May 23, 2021
Estimated Study Completion Date : November 19, 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Regorafenib (Control)
Participants will continue to receive treatment until unacceptable toxicity or disease progression per Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1. Participants who progressed on treatment may have the option of receiving Atezolizumab + Cobimetinib treatment, provided they meet the eligibility criteria
Drug: Regorafenib
Regorafenib will be administered orally on Days 1−21 of each 28-day cycle.

Experimental: Atezolizumab + Imprime PGG + Bevacizumab
Participants will continue to receive treatment until unacceptable toxicity or disease progression per RECIST V1.1. Participants who progressed on treatment may have the option of receiving Atezolizumab + Cobimetinib treatment, provided they meet the eligibility criteria.
Drug: Atezolizumab
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.

Drug: Imprime PGG
Imprime PGG will be administered by IV infusion weekly on Days 1, 8, and 15 of each 21-day cycle.

Drug: Bevacizumab
Bevacizumab will be administered IV infusion on Day 1 of each 21-day cycle.

Experimental: Atezolizumab + Isatuximab
Participants will continue to receive treatment until unacceptable toxicity or disease progression per RECIST V1.1. Participants who progress on treatment may have the option of receiving Atezolizumab + Cobimetinib treatment, provided they meet the eligibility criteria
Drug: Atezolizumab
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.

Drug: Isatuximab
Isatuximab will be administered by IV infusion. Cycles will be 21 days long.




Primary Outcome Measures :
  1. Percentage of Participants with Objective Response (ORR) as Determined by the Investigator According to Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 [ Time Frame: From randomization until disease progression or loss of clinical benefit (up to approximately 3-5 years) ]
  2. Percentage of Participants with Adverse Events (AEs) [ Time Frame: From first study treatment administration until 30 days after the last dose or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to approximately 3-5 years) ]

Secondary Outcome Measures :
  1. Progression Free Survival (PFS) as Determined by Investigator According to RECIST v1.1 [ Time Frame: From randomization up to the first occurrence of disease or death from any cause (up to approximately 3-5 years) ]
  2. Overall Survival (OS) After Randomization [ Time Frame: From randomization up to death from any cause (up to approximately 3-5 years) ]
  3. Percentage of Participants Who Are Alive at Month 6 [ Time Frame: Month 6 ]
  4. Duration of Response (DOR) as Deteremined by the Investigator Accordnig to RECIST v1.1 [ Time Frame: From the date of first occurrence of a documented objective response to disease progression or death from any cause, whichever occurs first (up to approximately 3-5 years) ]
  5. Percentage of Participants With Disease Control, as Determined by the Investigator per RECIST v1.1 [ Time Frame: From randomization until disease progression or loss of clinical benefit (up to approximately 3-5 years) ]
  6. Percentage of Participants with Anti-Drug Antibodies (ADAs) to Atezolizumab [ Time Frame: Pre-infusion (0 hr) on Day 1 of Cycles 1, 2, 3, 4, 8, 12, 16 (each cycle=21 days); 30 days after last dose (up to approximately 3-5 years ]
  7. Percentage of Participants with ADAs to Bevacizumab [ Time Frame: Predose (0 h) on Day 1 of Cycles 1, 3 (cycle = 21 days); 30 days after last dose (approximately 3-5 years) ]
  8. Percentage of Participants with ADAs to Isatuximab [ Time Frame: Predose (0 h) on Day 1 of Cycles 1, 2, 3 (expansion phase only), 4, 6, 8, 10, 12, 16 (cycle = 21 days); 30 days after last dose (approximately 3-5 years) ]
  9. Serum Concentration of Atezolizumab [ Time Frame: Pre-infusion (0 hour [hr]), Post infusion (30 minutes (min)) on Day 1 of Cycle 1; pre-infusion (0 hr) on Day 1 of Cycles 2, 4, 8, 12, 16 (each cycle=21 days); 30 days after last dose (up to approximately 3-5 years) ]
  10. Serum Concentration of Bevacizumab [ Time Frame: Pre-infusion (0 hour [hr]) on Day 1 of Cycle 1; pre-infusion (0 hr) on Day 1 of Cycles 3 (each cycle=21 days); 30 days after last dose (up to approximately 3-5 years) ]
  11. Serum Concentration of Imprime PGG [ Time Frame: Pre-infusion (0 hour [hr]), Post infusion (10 minutes (min)) on Day 1 and 15 of Cycle 1 (cycle=21 days) ]
  12. Plasma Concentration of Isatuximab [ Time Frame: Pre-infusion (0 hour [hr]), Post infusion (30 minutes (min)) on Day 1 of Cycle 1; pre-infusion (0 hr) on Day 1 of Cycles 2, 4, 8, 12, 16 (each cycle=21 days); 30 days after last dose (up to approximately 3-5 years) ]
  13. Plasma Concentration of Cobimetinib [ Time Frame: Pre-infusion (0 hour [hr]), Post infusion (2 to 4 hours) on Day 15 of Cycle 1 (cycle=21 days) ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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 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
  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03555149


Contacts
Contact: Reference Study ID Number: CO39612 www.roche.com/about_roche/roche_worldwide.htm 888-662-6728 (U.S. and Canada) global-roche-genentech-trials@gene.com

Locations
United States, California
City of Hope Comprehensive Cancer Center Recruiting
Duarte, California, United States, 91010
United States, Connecticut
Yale University Recruiting
New Haven, Connecticut, United States, 06511
United States, Massachusetts
Dana Farber Cancer Institute Not yet recruiting
Boston, Massachusetts, United States, 02215
United States, Missouri
Washington University School of Medicine Recruiting
Saint Louis, Missouri, United States, 63108
United States, New York
Columbia University Medical Center Recruiting
New York, New York, United States, 10032
Memorial Sloan-Kettering Cancer Center Not yet recruiting
New York, New York, United States, 10065
Australia, Victoria
Peter MacCallum Cancer Center Recruiting
Melbourne, Victoria, Australia, 3000
France
Centre Leon Berard Not yet recruiting
Lyon, France, 69008
Institut Claudius Regaud; Departement Oncologie Medicale Not yet recruiting
Toulouse, France, 31059
Institut Gustave Roussy Not yet recruiting
Villejuif, France, 94805
Korea, Republic of
Seoul National University Hospital Not yet recruiting
Seoul, Korea, Republic of, 03080
Asan Medical Center. Not yet recruiting
Seoul, Korea, Republic of, 138-736
Spain
Universidad de Navarra - Clinica Universitaria de Navarra (CUN) Not yet recruiting
Pamplona, Navarra, Spain, 31008
Hospital Universitario Vall d'Hebron Not yet recruiting
Barcelona, Spain, 08035
United Kingdom
Barts and The London School of Medicine and Dentistry - Barts Cancer Institute (BCI)-CECM Not yet recruiting
London, United Kingdom, 0
Royal Marsden Hospital - London Not yet recruiting
London, United Kingdom, SW3 6JJ
Royal Marsden Hospital; Dept of Medical Oncology Not yet recruiting
Sutton, United Kingdom, SM2 5PT
Sponsors and Collaborators
Hoffmann-La Roche
Investigators
Study Director: Clinical Trials Hoffmann-La Roche

Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT03555149     History of Changes
Other Study ID Numbers: CO39612
2017-004566-99 ( EudraCT Number )
First Posted: June 13, 2018    Key Record Dates
Last Update Posted: November 5, 2018
Last Verified: November 2018

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases
Bevacizumab
Atezolizumab
Antibodies, Monoclonal
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Physiological Effects of Drugs
Growth Inhibitors
Antineoplastic Agents
Immunologic Factors