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Clinical Trial 21063

Cancer Type: Gastrointestinal Tumor
Study Type: Treatment
NCT#: NCT04541173

Phase: Phase II
Principal Investigator: Parikh, Nainesh

Call 813-745-6100
or 1-800-679-0775 Learn More

Overview

Study Title

A Randomized Phase II Study of Atezolizumab and Bevacizumab with Y-90 TARE in Patients with Unresectable Hepatocellular Carcinoma (HCC)

Summary

This is an open-label phase II study comparing the Y90 TARE followed by bevacizumab and atezolizumab treatment to the Y90 TARE treatment alone in unresectable intermediate stage HCC.

Objective

Primary Objective * Assess progression free survival (PFS) per RECIST 1.1 Secondary Objectives * Assess safety and tolerability of Y-90 TARE combined with atezolizumab and bevacizumab in patients with HCC. * Assess the progression free survival (PFS) per mRECIST * Assess Time to Progression (TTP) per RECIST 1.1 and mRECIST * Assess Overall response rate (ORR) per RECIST 1.1 and mRECIST * Assess Overall survival (OS) * Evaluate PROs of physical functioning, role functioning, social functioning, and global health status/quality of life experienced by patients receiving Y-90 TARE and bevacizumab plus atezolizumab treatment.

Treatments

Therapies

Immunotherapy; Radiotherapy

Medications

Atezolizumab (Tecentriq); Avastin (Bevacizumab); Bevacizumab (); Not Applicable (); Yttrium-90 ()

Inclusion Criteria

Written informed consent and HIPAA authorization for release of personal health information prior to registration. NOTE: HIPAA authorization may be included in the informed consent or obtained separately. Patients must be willing and able to provide written informed consent for this trial

Age > 18 years at the time of consent

ECOG Performance Status of 0-1 at screening

Histological or cytological evidence/confirmation per AJCC, 8th edition, of hepatocellular carcinoma (HCC)

Measurable disease by RECIST 1.1

Patients must have a Child-Pugh score of A

Patients must have at least Barcelona Clinic Liver Cancer (BCLC) stage B HCC and must be outside of downstaging criteria (downstaging criteria are defined as: one lesion > 5 cm and > Archival tissue obtained within 6 months of registration is required. If archival tissue is not available, subjects are not eligible

Patients must not be suitable for or amenable to transplant or resection

Patients may be treatment naive or have received any number of prior therapies except systemic therapy. No prior systemic therapy is permitted. NOTE: Patients who received prior local therapy (e.g., radiofrequency ablation, percutaneous ethanol or acetic acid injection, cryoablation, high-intensity focused ultrasound) are eligible provided the target lesion(s) have not been previously treated with local therapy or the target lesion(s) within the field of local therapy have subsequently progressed in accordance with RECIST 1.1. Prior TACE IS allowed if FLR is > 40%.

Patients must demonstrate adequate hepatic, bone marrow, and renal function as defined in protocol

International Normalized Ratio (INR) or Prothrombin Time (PT) or Activated Partial Thromboplastin Time (aPTT) > Negative HIV test at screening; NOTE: patients with a positive HIV test at screening are eligible provided they are stable on anti-retroviral therapy, have a CD4 count >/= 200/µL, and have an undetectable viral load.

Urine dipstick for proteinuria /= 2+ proteinuria on dipstick urinalysis at baseline should undergo a 24-hour urine collection and must demonstrate > Documented virology status of hepatitis, as confirmed by screening HBV and HCV serology test : For patients with active hepatitis B virus (HBV): HBV DNA > Co-infection of HBV and HCV is an exclusion. Patients with a history of HCV infection but who are negative for HCV RNA by PCR will be considered non-infected with HCV.

Prior cancer treatment must be completed at least six months prior to registration and the subject must have recovered from all reversible acute toxic effects of the regimen (other than alopecia) to Grade > Females of childbearing potential must have a negative serum pregnancy test within 14 days prior to registration.

Additional criteria may apply

Exclusion Criteria

Have signs of liver failure, e.g. clinically significant ascites, encephalopathy, or variceal bleeding within six months from enrollment

Prior bleeding event due to esophageal and/or gastric varices within 6 months prior to initiation of study treatment. NOTE: Patients must undergo an esophagogastroduodenoscopy (EGD), and all size of varices (small to large) must be assessed and treated per local standard of care prior to enrollment. Patients who have undergone an EGD within 6 months of prior to initiation of study treatment do not need to repeat the procedure

Untreated or incompletely treated esophageal and/or gastric varices with bleeding or high-risk for bleeding. Have evidence of excessive hepatopulmonary shunting (> 20% in 99mTc macro-aggregated albumin scan) or angiographically demonstrable and non-occludable gastrointestinal shunting, precluding from Y-90 treatment)

Prior history of TACE or transarterial treatment via hepatic artery

Subject not a TARE candidate, as defined by a lung dose threshold for Y-90 of 30Gy and an estimated (future liver remnants) FLR of > Inadequately controlled arterial hypertension

Prior history of hypertensive crisis or hypertensive encephalopathy

Significant cardiovascular disease

Known fibrolamellar HCC, sarcomatoid HCC, or mixed cholangiocarcinoma and HCC

Major surgery within 4 weeks prior to registration or anticipation of a major surgical procedure during study.

Have had prior transplant of any kind

Have active autoimmune disease that has required systemic treatment in the past 2 years (i.e. with use of disease modifying agents, corticosteroids, or immunosuppressive drugs). Replacement therapy (e.g., thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency, etc.) is not considered a form of systemic treatment. Have history of idiopathic pulmonary fibrosis (including bronchiolitis obliterans with organizing pneumonia) or evidence of active pneumonitis on screening chest CT scan

Have untreated central nervous system (CNS) metastatic disease (including spinal cord and leptomeningeal disease). NOTE: Subjects with previously treated CNS metastases that are radiographically and neurologically stable for at least 6 weeks and do not require corticosteroids (of any dose) for symptomatic management are permitted to enroll.

Have unresolved toxicities from prior anticancer therapy, defined as having not resolved to National Cancer Institute (NCI) CTCAE v5 grade 0 or 1 with the exception of alopecia and laboratory values listed per the inclusion criteria. NOTE: Subjects with irreversible toxicity that is not reasonably expected to be exacerbated by any of the investigational products may be included (e.g., hearing loss) after consultation with the sponsor-investigator

Diagnosed or treated for malignancy other than HCC, unless they meet one of the following exceptions: Malignancy treated with curative intent and with no known active disease present for > 2 years before registration and felt to be at low risk for recurrence by the treating physician; Adequately treated non-melanoma skin cancer or lentigo maligna without evidence of disease or Adequately treated cervical carcinoma in situ without evidence of disease

Have a known or suspected allergy to bevacizumab or atezolizumab or known hypersensitivity to Chinese hamster ovary cell products or to any component of of the atezolizumab or bevacizumab formulation

Additional criteria will apply

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