A Phase Ib Study to Evaluate the Safety, Efficacy, and Pharmacokinetics of Cibisatamab in Combination With Atezolizumab After Pretreatment With Obinutuzumab in Participants With Previously Treated Metastatic Colorectal Adenocarcinoma



Status:Recruiting
Conditions:Colorectal Cancer, Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:18 - Any
Updated:3/13/2019
Start Date:April 17, 2019
End Date:February 22, 2022
Contact:Reference Study ID Number: CO40939 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, Multicenter, Open-Label Study to Evaluate the Safety, Efficacy, and Pharmacokinetics of Cibisatamab in Combination With Atezolizumab After Pretreatment With Obinutuzumab in Patients With Previously Treated Metastatic, Microsatellite-Stable Colorectal Adenocarcinoma With High CEACAM5 Expression

CO40939 is a Phase Ib, open-label, multicenter, single-arm study designed to evaluate the
safety, efficacy, pharmacokinetics, and immunogenicity of cibisatamab in combination with
atezolizumab administered after pretreatment with obinutuzumab in patients with Stage IV
microsatellite stable (MSS) metastatic colorectal cancer (mCRC) whose tumors have high
carcinoembryonic antigen-related cell adhesion molecule 5 (CEACAM5) expression and who have
progressed on two or more chemotherapy regimens. The study is composed of a safety run-in and
an exploratory part.


Inclusion criteria

- Histologically confirmed adenocarcinoma originating from the colon or rectum

- Metastatic disease not amenable to local treatment

- Tumors that are microsatellite stable or microsatellite instability low, as determined
by a local, certified laboratory

- Tumors that have high carcinoembryonic antigen-related cell adhesion molecule 5
(CEACAM5) expression as determined by quantitative reverse transcription polymerase
chain reaction in a fresh tumor biopsy (for the safety run-in, CEACAM5 expression can
be determined on the archival tumor tissue) and documented through central testing of
a representative tumor tissue specimen performed at baseline

- Experienced disease progression during or within 3 months following the last
administration of approved standard therapies

- Eastern Cooperative Oncology Group Performance Status of 0 or 1

- Life expectancy of >= 12 weeks

- Adequate hematologic and end-organ function

- Negative HIV test at screening

- Negative hepatitis B surface antigen test and total hepatitis B core antibody (HBcAb)
test at screening, or positive total HBcAb test followed by a negative hepatitis B
virus (HBV) DNA test at screening

- Negative hepatitis C virus (HCV) antibody test at screening, or positive HCV antibody
test followed by a negative HCV RNA test at screening

- Negative human T-cell lymphotropic virus type 1 test for participants from endemic
countries (Japan, countries in the Caribbean basin, South America, Central America,
sub-Saharan Africa, and Malaysia)

- For women of childbearing potential: agreement to remain abstinent or use
contraceptive methods, agreement to regular pregnancy testing, and agreement to
refrain from donating eggs, women must remain abstinent or use contraceptive methods
with a failure rate of < 1% per year during the treatment period and for 5 months
after the final dose of atezolizumab, for 4 months after the final dose of
cibisatamab, for 18 months after the final dose of obinutuzumab, and for 3 months
after the final dose of tocilizumab

- For men: agreement to remain abstinent or use a condom, and agreement to refrain from
donating sperm, with a female partner of childbearing potential or pregnant female
partner, men must remain abstinent or use a condom during the treatment period and for
3 months after the final dose of cibisatamab, for 3 months after the final dose of
obinutuzumab, and for 2 months after the final dose of tocilizumab to avoid exposing
the embryo

Additional Inclusion Criteria for patient enrollment into Part 2 of the study:

- No prior treatment with regorafenib or Trifluridine/Tipiracil (TAS-102)

Exclusion criteria

- Symptomatic, untreated, or actively progressing central nervous system metastases

- Non-irradiated tumor lesions > 2 cm at critical sites where tumor swelling induced by
cibisatamab is expected to lead to significant complications

- Dyspnea or peripheral capillary oxygen saturation < 92% at rest at baseline for
patients with bilateral lung lesions or metastases in the remaining lung following
lobectomy or pneumonectomy

- Spinal cord compression not definitively treated with surgery and/or radiation or
previously diagnosed and treated spinal cord compression without evidence that disease
has been clinically stable for >= 2 weeks prior to initiation of study treatment

- History of leptomeningeal disease and progressive multifocal leukoencephalopathy

- Uncontrolled tumor-related pain and pleural effusion or ascites requiring recurrent
drainage procedures

- Patients with pericardial effusion

- Uncontrolled or symptomatic hypercalcemia

- 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 scan

- Active tuberculosis that has required treatment within 3 years prior initiation of
study treatment or latent tuberculosis that has not been appropriately treated

- Uncontrolled hypertension, unstable angina, congestive heart failure of any New York
Heart Association Class II or greater, serious cardiac arrhythmia requiring treatment
and history of myocardial infarction within 6 months 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 malignancy other than CRC within 5 years prior to screening, with the
exception of malignancies with a negligible risk of metastasis or death, such as
adequately treated carcinoma in situ of the cervix, non-melanoma skin carcinoma,
localized prostate cancer, ductal carcinoma in situ, or Stage I uterine cancer

- Known active infection, or reactivation of a latent infection, whether bacterial,
viral, fungal, mycobacterial, or other pathogens, or any major episode of infection
requiring hospitalization or treatment with IV antibiotics

- Prior allogeneic stem cell or solid organ transplantation

- Any other disease, metabolic dysfunction, physical examination finding, or clinical
laboratory finding that contraindicates the use of an investigational drug, may affect
the interpretation of the results, or may render the patient at high risk from
treatment complications

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

- Current treatment with anti-viral therapy for HBV

- Treatment with any systemic anti-cancer therapy, including chemotherapy or hormonal
therapy, within 28 days prior to initiation of study treatment

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

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

- Prior treatment with T-cell bispecifics (TCBs), including CEACAM5-TCB, CD137 agonists
or immune checkpoint blockade therapies, including anti-CTLA-4, anti-PD-1, and
anti-PD-L1 therapeutic antibodies

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

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

- Adverse events from prior anti-cancer therapy that have not resolved to Grade 1 or
better with the exception of alopecia of any grade and Grade <= 2 peripheral
neuropathy

- History of severe allergic anaphylactic reactions to chimeric or humanized antibodies
or fusion proteins

- Known hypersensitivity to Chinese hamster ovary cell products

- Known allergy or hypersensitivity to any of the study drugs or any of their excipients

- Pregnancy or breastfeeding, or intention of becoming pregnant during study treatment
or within 5 months after the final dose of atezolizumab, within 4 months after the
final dose of cibisatamab, within 18 months after the final dose of obinutuzumab, and
within 3 months after the final dose of tocilizumab
We found this trial at
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Stanford, California 94305
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8700 Beverly Blvd # 8211
Los Angeles, California 90048
(1-800-233-2771)
Cedars Sinai Med Ctr Cedars-Sinai is known for providing the highest quality patient care. Our...
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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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Durham, North Carolina 27710
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Houston, Texas 77030
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3322 West End Avenue
Nashville, Tennessee 37203
(615)329-SCRI (7274)
Sarah Cannon Research Institute Sarah Cannon Research Institute (SCRI) is a global strategic research organization...
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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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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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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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Santa Monica, California
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