A Study of the Safety and Efficacy of Atezolizumab Administered in Combination With Bevacizumab and/or Other Treatments in Participants With Solid Tumors

Completed · Phase 1

Conditions studied: Solid Tumor

In brief

This study will evaluate the safety, efficacy, and pharmacokinetics of atezolizumab in combination with bevacizumab, bevacizumab + oxaliplatin, leucovorin and 5-fluorouracil (5-FU) (FOLFOX), vanucizumab, nab-paclitaxel + gemcitabine, FOLFOX, or 5-FU + cisplatin, in participants with solid tumors.

Key facts

Study ID

NCT02715531

Run by

Hoffmann-La Roche

People needed

243

Starts

2016-04-06

Expected to finish

2021-05-31

Last updated by the study team

2021-07-09

Who can join

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

You may qualify if…

• General Inclusion criteria
• Measurable disease per RECIST v1.1
• Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
• Adequate hematologic and end organ function
• Resolution of any acute, clinically significant treatment-related toxicity from prior therapy to Grade less than or equal to (</=) 1 prior to study entry, with the exception of alopecia
• Ready to use reliable contraceptive procedures
• Inclusion Criteria Specific to HCC (Arm A and Arm F):
• Participants with advanced or metastatic and/or unresectable HCC
• The participant has disease that is not amenable to a curative approach
• No prior line of systemic therapy (includes participants who are sorafenib-naïve)
• Willing to undergo fresh liver biopsy if provided archival tissue was taken greater than (>) 6 months from Cycle 1 Day 1
• Child-Pugh Score of up to B7
• Serum bilirubin </= 3 times upper limit of normal (x ULN)
• International normalized ratio (INR) and activated partial thromboplastin time (aPTT) </= 2 x ULN
• Albumin >2.8 grams per deciliter (g/dL)
• Documented virology status of hepatitis, as confirmed by screening hepatitis B surface antigen (HBsAg), antibody to hepatitis B core antigen (anti-HBc), and/or anti-hepatitis C virus (anti-HCV)
• Antiviral therapy per local standard-of-care if active hepatitis B virus (HBV)
• Inclusion Criteria Specific to Arm A (Patients must also meet all of the following specific inclusion criteria to be eligible for enrollment in Arm A:)
• Child-Pugh score of up to B7
• Willing to undergo biopsy if archival tissue is not available or if archival tissue was taken >6 months from Cycle 1, Day 1
• Anti-viral therapy per local standard-of-care if active hepatitis B virus (HBV).
• Inclusion Criteria Specific to Arm F (Patients must also meet all of the following specific inclusion criteria to be eligible for enrollment in Arm F:)
• LIfe expectancy >=3 months, as determined by the investigator
• Child-Pugh score A
• Platelet count ≥ 75x109/L (75,000/uL) without transfusion

You may not qualify if…

• General Exclusion Criteria
• Uncontrolled pleural effusion, pericardial effusion, or ascites
• Uncontrolled tumor-related pain
• Uncontrolled hypercalcemia or symptomatic hypercalcemia requiring continued use of bisphosphonate therapy
• Known clinically significant liver disease, including active viral, alcoholic, or other hepatitis, cirrhosis, fatty liver, and inherited liver disease (exception for participants in Arm A and Arm F)
• Known primary central nervous system (CNS) malignancy or untreated or active CNS metastases
• Known hypersensitivity to biopharmaceuticals produced in Chinese hamster ovary cells or other recombinant human antibodies
• Positive test for Human Immunodeficiency Virus (HIV)
• Active hepatitis B (chronic or acute), or hepatitis C (exception for participants in Arm A and Arm F)
• Active tuberculosis
• Severe infections within 4 weeks prior to Day 1
• Signs or symptoms of significant infection within 2 weeks prior to Day 1
• Received oral or IV antibiotics within 2 weeks prior to Cycle 1 Day 1
• Significant cardiovascular disease, such as New York Heart Association (NYHA) cardiac disease (Class II or greater), myocardial infarction within 3 months prior to Day 1, unstable arrhythmias, or unstable angina
• History of stroke, reversible ischemic neurological defect or transient ischemic attack within 6 months prior to Day 1
• Administration of a live, attenuated vaccine within 4 weeks before Cycle 1, Day 1 or anticipation that such a live attenuated vaccine will be required during the study
• Any serious medical condition or abnormality in clinical laboratory tests that, in the investigator's and/or Medical Monitor's judgment, precludes the participants safe participation in and completion of the study
• Malignancies other than pancreatic carcinoma within 2 years prior to study start, with the exception of those with a negligible risk of metastasis or death treated with expected curative outcome (such as adequately treated carcinoma in situ of the cervix, basal or squamous cell skin cancer, localized prostate cancer treated surgically with curative intent, ductal carcinoma in situ treated surgically with curative intent)
• Exclusion Criteria Related to Medications
• Prior treatment with anti-cytotoxic T-lymphocyte-associated protein 4 (anti-CTLA4), anti-programmed death-1 (anti-PD-1), or anti-programmed death ligand-1 (anti-PD-L1) therapeutic antibody
• Treatment with systemic immunostimulatory agents within 6 weeks or five half-lives of the drug, whichever is longer, prior to screening
• Treatment with systemic corticosteroids or other immunosuppressive medications within 2 weeks prior to Cycle 1, Day 1
• History of severe allergic, anaphylactic, or other hypersensitivity reactions to chimeric or humanized antibodies or fusion proteins
• Participants with prior allogeneic bone marrow transplantation or prior solid organ transplantation
• Known allergies to oxaliplatin (or other platinum agents), leucovorin, 5-FU, nab-paclitaxel (or other taxanes) or gemcitabine

Where it is running

• Stanford Cancer Institute; Hematology — Palo Alto, California, United States
• University of Colorado Hospital — Aurora, Colorado, United States
• Yale School of Medicine — New Haven, Connecticut, United States
• Georgetown University Medical Center — Washington D.C., District of Columbia, United States
• Massachusetts General Hospital — Boston, Massachusetts, United States
• Dana Farber Cancer Institute — Boston, Massachusetts, United States
• Mayo Clinic — Rochester, Minnesota, United States
• Columbia University Medical Center — New York, New York, United States
• UNC Lineberger Comprehensive Cancer Center — Chapel Hill, North Carolina, United States
• Duke Cancer Institute — Durham, North Carolina, United States
• Sarah Cannon Research Inst. — Nashville, Tennessee, United States
• Medical College of Wisconsin — Milwaukee, Wisconsin, United States
• Monash Medical Centre Clayton — Clayton, Victoria, Australia
• Austin Hospital — Heidelberg, Victoria, Australia
• The 81st Hospital of P.L.A. — Nanjing, China
• National Cancer Center Hospital East — Chiba, Japan
• Yokohama City University Medical Center — Kanagawa, Japan
• Kanagawa Cancer Center — Kanagawa, Japan
• The Cancer Institute Hospital of JFCR — Tokyo, Japan
• Auckland City Hospital — Auckland, New Zealand
• Seoul National University Bundang Hospital — Seongnam-si, South Korea
• Seoul National University Hospital — Seoul, South Korea
• Severance Hospital — Seoul, South Korea
• Asan Medical Center — Seoul, South Korea
• Samsung Medical Center — Seoul, South Korea

Full record on ClinicalTrials.gov

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