A Phase 2, Single Arm Study of Cabozantinib in Patients With Hepatocellular Carcinoma Who Have Received Prior Atezolizumab and Bevacizumab
NCT ID: NCT06535737
Last Updated: 2024-08-02
Study Results
Results pending
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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Recruitment Status
NOT_YET_RECRUITING
Clinical Phase
PHASE2
Total Enrollment
40 participants
Study Classification
INTERVENTIONAL
Study Start Date
2024-08-31
Study Completion Date
2026-12-31
Brief Summary
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Hepatocellular carcinoma (HCC) is the most common liver cancer and a leading cancer death worldwide. Currently, atezolizumab and bevacizumab combination is the standard of care for patients with advanced HCC. There have not been proven therapy for patients with advanced HCC previously treated with atezolizumab and bevacizumab. Cabozantinib is a proven therapy for patients with advanced HCC previously treated with sorafenib. The study aims to demonstrate the efficacy and safety of cabozantinib in patients with advanced previously treated with atezolziumab and bevacizumab. It is a multi-center single-arm study which all participants will receive cabozantinib. Participants will continue cabozantinib until. disease progression or unacceptable toxicities.
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Detailed Description
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Currently, atezolizumab and bevacizumab combination is the standard of care for patients with advanced HCC. There have not been proven therapy for patients with advanced HCC previously treated with atezolizumab and bevacizumab. Cabozantinib is a proven therapy for patients with advanced HCC previously treated with sorafenib. The study aims to demonstrate the efficacy and safety of cabozantinib in patients with advanced previously treated with atezolziumab and bevacizumab.
This is a phase II, single-arm, multi-center trial which all participants will receive cabozantinib. Eligible patients will provide informed consent to participate the trial. The study will enroll 40 patients. All participants will receive cabozantinib until disease progression or unacceptable toxicities. Efficacy assessment will be performed with CT scan or MRI every 8 weeks. Clinical assessments and laboratory tests will be scheduled every 2-4 weeks for safety assessments.
This is a phase II, single-arm, multi-center trial which all participants will receive cabozantinib. Eligible patients will provide informed consent to participate the trial. The study will enroll 40 patients. All participants will receive cabozantinib until disease progression or unacceptable toxicities. Efficacy assessment will be performed with CT scan or MRI every 8 weeks. Clinical assessments and laboratory tests will be scheduled every 2-4 weeks for safety assessments.
Conditions
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Hepatocellular Carcinoma Non-resectable
Study Design
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Allocation Method
NA
Intervention Model
SINGLE_GROUP
Primary Study Purpose
TREATMENT
Blinding Strategy
NONE
Study Groups
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cabozantinib
Open-labelled
Group Type
EXPERIMENTAL
Cabozantinib
Intervention Type
DRUG
Cabozantinib (Cabometyx) 60, 40 and 20 mg
Interventions
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Cabozantinib
Cabozantinib (Cabometyx) 60, 40 and 20 mg
Intervention Type
DRUG
Eligibility Criteria
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Inclusion Criteria
* Radiological, histological or cytological diagnosis of HCC
* The subject has disease that is not amenable to a curative treatment approach (eg, transplant, surgery, radiofrequency ablation)
* Received prior atezolizumab and bevacizumab
* Progression following atezolizumab and bevacizumab treatment for advanced HCC
* Recovery to ≤ Grade 1 from toxicities related to any prior treatments, unless the adverse events are clinically nonsignificant and/or stable on supportive therapy
* Age ≥ 18 years old on the day of consent
* ECOG performance status of 0 or 1
* Adequate hematologic function, based upon meeting the following laboratory criteria within 7 days before enrollment:
* absolute neutrophil count (ANC) ≥ 1200/mm3 (≥ 1.2 x 109/L)
* platelets ≥ 60,000/mm3 (≥ 60 x 109/L)
* hemoglobin ≥ 8 g/dL (≥ 80 g/L)
* Adequate renal function, based upon meeting the following laboratory criteria within 7 days before enrollment:
* serum creatinine ≤ 1.5 × upper limit of normal or calculated creatinine clearance ≥ 40 mL/min (using the Cockroft-Gault equation: (140 - age) x weight (kg)/(serum creatinine × 72 \[mg/dL\]) for males. (For females multiply by 0.85.) AND
* urine protein/creatinine ratio (UPCR) ≤ 1 mg/mg (≤ 113.1 mg/mmol) or 24-hour urine protein \< 1g
* Child-Pugh Score of A or B7
* Total bilirubin ≤ 2 mg/dL (≤ 34.2 μmol/L) within 7 days before enrollment
* Serum albumin ≥ 2 g/dL (≥ 20 g/L) within 7 days before enrollment
* Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) \< 5.0 upper limit of normal (ULN) within 7 days before enrollment
* Hemoglobin A1c (HbA1c) ≤ 8% within 7 days before enrollment
* Antiviral therapy per local standard of care if active hepatitis B (HBV) infection
* Capable of understanding and complying with the protocol requirements and signed informed consent
* Sexually active fertile subjects and their partners must agree to use medically accepted methods of contraception (eg, barrier methods, including male condom, female condom, or diaphragm with spermicidal gel) during the course of the study and for 4 months after the last dose of study treatment
* Female subjects of childbearing potential must not be pregnant at screening. Females of childbearing potential are defined as premenopausal females capable of becoming pregnant (ie, females who have had any evidence of menses in the past 12 months, with the exception of those who had prior hysterectomy). However, women who have been amenorrheic for 12 or more months are still considered to be of childbearing potential if the amenorrhea is possibly due to prior chemotherapy, antiestrogens, ovarian suppression, low body weight, or other reasons.
* The subject has disease that is not amenable to a curative treatment approach (eg, transplant, surgery, radiofrequency ablation)
* Received prior atezolizumab and bevacizumab
* Progression following atezolizumab and bevacizumab treatment for advanced HCC
* Recovery to ≤ Grade 1 from toxicities related to any prior treatments, unless the adverse events are clinically nonsignificant and/or stable on supportive therapy
* Age ≥ 18 years old on the day of consent
* ECOG performance status of 0 or 1
* Adequate hematologic function, based upon meeting the following laboratory criteria within 7 days before enrollment:
* absolute neutrophil count (ANC) ≥ 1200/mm3 (≥ 1.2 x 109/L)
* platelets ≥ 60,000/mm3 (≥ 60 x 109/L)
* hemoglobin ≥ 8 g/dL (≥ 80 g/L)
* Adequate renal function, based upon meeting the following laboratory criteria within 7 days before enrollment:
* serum creatinine ≤ 1.5 × upper limit of normal or calculated creatinine clearance ≥ 40 mL/min (using the Cockroft-Gault equation: (140 - age) x weight (kg)/(serum creatinine × 72 \[mg/dL\]) for males. (For females multiply by 0.85.) AND
* urine protein/creatinine ratio (UPCR) ≤ 1 mg/mg (≤ 113.1 mg/mmol) or 24-hour urine protein \< 1g
* Child-Pugh Score of A or B7
* Total bilirubin ≤ 2 mg/dL (≤ 34.2 μmol/L) within 7 days before enrollment
* Serum albumin ≥ 2 g/dL (≥ 20 g/L) within 7 days before enrollment
* Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) \< 5.0 upper limit of normal (ULN) within 7 days before enrollment
* Hemoglobin A1c (HbA1c) ≤ 8% within 7 days before enrollment
* Antiviral therapy per local standard of care if active hepatitis B (HBV) infection
* Capable of understanding and complying with the protocol requirements and signed informed consent
* Sexually active fertile subjects and their partners must agree to use medically accepted methods of contraception (eg, barrier methods, including male condom, female condom, or diaphragm with spermicidal gel) during the course of the study and for 4 months after the last dose of study treatment
* Female subjects of childbearing potential must not be pregnant at screening. Females of childbearing potential are defined as premenopausal females capable of becoming pregnant (ie, females who have had any evidence of menses in the past 12 months, with the exception of those who had prior hysterectomy). However, women who have been amenorrheic for 12 or more months are still considered to be of childbearing potential if the amenorrhea is possibly due to prior chemotherapy, antiestrogens, ovarian suppression, low body weight, or other reasons.
Exclusion Criteria
* • Fibrolamellar carcinoma or mixed hepatocellular cholangiocarcinoma
* Receipt of more than one prior systemic therapy for advanced HCC. Additional prior systemic therapies used as adjuvant or local therapy are allowed.
* Any type of anticancer agent (including investigational) within 2 weeks before enrollment
* Radiation therapy within 4 weeks (2 weeks for radiation for bone metastases) or radionuclide treatment (eg, I-131 or Y-90) within 6 weeks of enrollment. Subject is excluded if there are any clinically relevant ongoing complications from prior radiation therapy.
* Prior cabozantinib treatment
* Known brain metastases or cranial epidural disease unless adequately treated with radiotherapy and/or surgery (including radiosurgery) and stable for at least 3 months before enrollment. Eligible subjects must be without corticosteroid treatment at the time of enrollment.
* Concomitant anticoagulation, at therapeutic doses, with anticoagulants such as warfarin or warfarin-related agents, low molecular weight heparin (LMWH), thrombin or coagulation factor X (FXa) inhibitors, or antiplatelet agents (eg, clopidogrel). Low-dose aspirin for cardioprotection (per local applicable guidelines), low-dose warfarin (≤ 1 mg/day), and low-dose LMWH are permitted.
* The subject has uncontrolled, significant intercurrent or recent illness including, but not limited to, the following conditions:
* Cardiovascular disorders including
* Symptomatic congestive heart failure, unstable angina pectoris, or serious cardiac arrhythmias
* Uncontrolled hypertension defined as sustained BP \> 150 mm Hg systolic, or \> 100 mm Hg diastolic despite optimal antihypertensive treatment
* Stroke (including TIA), myocardial infarction, or other ischemic event within 6 months before enrollment
* Thromboembolic event within 3 months before enrollment. Subjects with thromboses of portal/hepatic vasculature attributed to underlying liver disease and/or liver tumor are eligible
o Gastrointestinal (GI) disorders including those associated with a high risk of perforation or fistula formation:
* Tumors invading the GI tract, active peptic ulcer disease, inflammatory bowel disease, diverticulitis, cholecystitis, symptomatic cholangitis or appendicitis, acute pancreatitis or acute obstruction of the pancreatic duct or common bile duct, or gastric outlet obstruction
* Abdominal fistula, GI perforation, bowel obstruction, intra-abdominal abscess within 6 months before enrollment, Note: Complete healing of an intra-abdominal abscess must be confirmed prior to enrollment
* Major surgery within 2 months before enrollment. Complete healing from major surgery must have occurred 1 month before enrollment. Complete healing from minor surgery (eg, simple excision, tooth extraction) must have occurred at least 7 days before enrollment. Subjects with clinically relevant complications from prior surgery are not eligible
* Cavitating pulmonary lesion(s) or endobronchial disease
* Lesion invading a major blood vessel (eg, pulmonary artery or aorta)
* Clinically significant bleeding risk including the following within 3 months of enrollment: hematuria, hematemesis, hemoptysis of \>0.5 teaspoon (\>2.5 mL) of red blood, or other signs indicative of pulmonary hemorrhage, or history of other significant bleeding if not due to reversible external factors
* Other clinically significant disorders such as:
* Active infection requiring systemic treatment, known infection with human immunodeficiency virus (HIV) or known acquired immunodeficiency syndrome (AIDS)-related illness
* Serious non-healing wound/ulcer/bone fracture
* Malabsorption syndrome
* Uncompensated/symptomatic hypothyroidism
* Requirement for hemodialysis or peritoneal dialysis
* History of solid organ transplantation
* 9\. Subjects with untreated or incompletely treated varices with bleeding or high risk for bleeding are excluded with the following clarification: subjects with history of prior variceal bleeding must have been treated with adequate endoscopic therapy without any evidence of recurrent bleeding for at least 6 months prior to study entry and must be stable on optimal medical management (e.g. non-selective beta blocker, proton pump inhibitor) at study entry.
* Moderate or severe ascites
* Corrected QT interval calculated by the Fridericia formula (QTcF) \> 500 ms within 7 days before enrollment
* Note: If the QTcF is \> 500 ms in first ECG, a total of 3 ECGs should be performed. If the average of these 3 consecutive results for QTcF is ≤ 500 ms, the subject meets eligibility in this regard.
* Inability to swallow tablets
* Previously identified allergy or hypersensitivity to components of the study treatment formulations
* Pregnant or lactating females
* Diagnosis of another malignancy within 2 years before enrollment, except for superficial skin cancers, or localized, low-grade tumors deemed cured and not treated with systemic therapy
* Receipt of more than one prior systemic therapy for advanced HCC. Additional prior systemic therapies used as adjuvant or local therapy are allowed.
* Any type of anticancer agent (including investigational) within 2 weeks before enrollment
* Radiation therapy within 4 weeks (2 weeks for radiation for bone metastases) or radionuclide treatment (eg, I-131 or Y-90) within 6 weeks of enrollment. Subject is excluded if there are any clinically relevant ongoing complications from prior radiation therapy.
* Prior cabozantinib treatment
* Known brain metastases or cranial epidural disease unless adequately treated with radiotherapy and/or surgery (including radiosurgery) and stable for at least 3 months before enrollment. Eligible subjects must be without corticosteroid treatment at the time of enrollment.
* Concomitant anticoagulation, at therapeutic doses, with anticoagulants such as warfarin or warfarin-related agents, low molecular weight heparin (LMWH), thrombin or coagulation factor X (FXa) inhibitors, or antiplatelet agents (eg, clopidogrel). Low-dose aspirin for cardioprotection (per local applicable guidelines), low-dose warfarin (≤ 1 mg/day), and low-dose LMWH are permitted.
* The subject has uncontrolled, significant intercurrent or recent illness including, but not limited to, the following conditions:
* Cardiovascular disorders including
* Symptomatic congestive heart failure, unstable angina pectoris, or serious cardiac arrhythmias
* Uncontrolled hypertension defined as sustained BP \> 150 mm Hg systolic, or \> 100 mm Hg diastolic despite optimal antihypertensive treatment
* Stroke (including TIA), myocardial infarction, or other ischemic event within 6 months before enrollment
* Thromboembolic event within 3 months before enrollment. Subjects with thromboses of portal/hepatic vasculature attributed to underlying liver disease and/or liver tumor are eligible
o Gastrointestinal (GI) disorders including those associated with a high risk of perforation or fistula formation:
* Tumors invading the GI tract, active peptic ulcer disease, inflammatory bowel disease, diverticulitis, cholecystitis, symptomatic cholangitis or appendicitis, acute pancreatitis or acute obstruction of the pancreatic duct or common bile duct, or gastric outlet obstruction
* Abdominal fistula, GI perforation, bowel obstruction, intra-abdominal abscess within 6 months before enrollment, Note: Complete healing of an intra-abdominal abscess must be confirmed prior to enrollment
* Major surgery within 2 months before enrollment. Complete healing from major surgery must have occurred 1 month before enrollment. Complete healing from minor surgery (eg, simple excision, tooth extraction) must have occurred at least 7 days before enrollment. Subjects with clinically relevant complications from prior surgery are not eligible
* Cavitating pulmonary lesion(s) or endobronchial disease
* Lesion invading a major blood vessel (eg, pulmonary artery or aorta)
* Clinically significant bleeding risk including the following within 3 months of enrollment: hematuria, hematemesis, hemoptysis of \>0.5 teaspoon (\>2.5 mL) of red blood, or other signs indicative of pulmonary hemorrhage, or history of other significant bleeding if not due to reversible external factors
* Other clinically significant disorders such as:
* Active infection requiring systemic treatment, known infection with human immunodeficiency virus (HIV) or known acquired immunodeficiency syndrome (AIDS)-related illness
* Serious non-healing wound/ulcer/bone fracture
* Malabsorption syndrome
* Uncompensated/symptomatic hypothyroidism
* Requirement for hemodialysis or peritoneal dialysis
* History of solid organ transplantation
* 9\. Subjects with untreated or incompletely treated varices with bleeding or high risk for bleeding are excluded with the following clarification: subjects with history of prior variceal bleeding must have been treated with adequate endoscopic therapy without any evidence of recurrent bleeding for at least 6 months prior to study entry and must be stable on optimal medical management (e.g. non-selective beta blocker, proton pump inhibitor) at study entry.
* Moderate or severe ascites
* Corrected QT interval calculated by the Fridericia formula (QTcF) \> 500 ms within 7 days before enrollment
* Note: If the QTcF is \> 500 ms in first ECG, a total of 3 ECGs should be performed. If the average of these 3 consecutive results for QTcF is ≤ 500 ms, the subject meets eligibility in this regard.
* Inability to swallow tablets
* Previously identified allergy or hypersensitivity to components of the study treatment formulations
* Pregnant or lactating females
* Diagnosis of another malignancy within 2 years before enrollment, except for superficial skin cancers, or localized, low-grade tumors deemed cured and not treated with systemic therapy
Minimum Eligible Age
18 Years
Eligible Sex
ALL
Accepts Healthy Volunteers
No
Sponsors
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Mahidol University
OTHER
Sponsor Role
collaborator
Chulalongkorn University
OTHER
Sponsor Role
lead
Responsible Party
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Responsibility Role
SPONSOR
Principal Investigators
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Suebpong Tanasanvimon, M.D.
Role: STUDY_CHAIR
Chulalongkorn University
Nuttapong Ngamphaiboon, M.D.
Role: PRINCIPAL_INVESTIGATOR
Marisol University
Krittaya Korphaisarn, M.D.
Role: PRINCIPAL_INVESTIGATOR
Mahidol University
Central Contacts
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References
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Llovet JM, Ricci S, Mazzaferro V, Hilgard P, Gane E, Blanc JF, de Oliveira AC, Santoro A, Raoul JL, Forner A, Schwartz M, Porta C, Zeuzem S, Bolondi L, Greten TF, Galle PR, Seitz JF, Borbath I, Haussinger D, Giannaris T, Shan M, Moscovici M, Voliotis D, Bruix J; SHARP Investigators Study Group. Sorafenib in advanced hepatocellular carcinoma. N Engl J Med. 2008 Jul 24;359(4):378-90. doi: 10.1056/NEJMoa0708857.
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Kudo M, Finn RS, Qin S, Han KH, Ikeda K, Piscaglia F, Baron A, Park JW, Han G, Jassem J, Blanc JF, Vogel A, Komov D, Evans TRJ, Lopez C, Dutcus C, Guo M, Saito K, Kraljevic S, Tamai T, Ren M, Cheng AL. Lenvatinib versus sorafenib in first-line treatment of patients with unresectable hepatocellular carcinoma: a randomised phase 3 non-inferiority trial. Lancet. 2018 Mar 24;391(10126):1163-1173. doi: 10.1016/S0140-6736(18)30207-1.
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Kelley RK, Rimassa L, Cheng AL, Kaseb A, Qin S, Zhu AX, Chan SL, Melkadze T, Sukeepaisarnjaroen W, Breder V, Verset G, Gane E, Borbath I, Rangel JDG, Ryoo BY, Makharadze T, Merle P, Benzaghou F, Banerjee K, Hazra S, Fawcett J, Yau T. Cabozantinib plus atezolizumab versus sorafenib for advanced hepatocellular carcinoma (COSMIC-312): a multicentre, open-label, randomised, phase 3 trial. Lancet Oncol. 2022 Aug;23(8):995-1008. doi: 10.1016/S1470-2045(22)00326-6. Epub 2022 Jul 4.
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Santoro A, Rimassa L, Borbath I, Daniele B, Salvagni S, Van Laethem JL, Van Vlierberghe H, Trojan J, Kolligs FT, Weiss A, Miles S, Gasbarrini A, Lencioni M, Cicalese L, Sherman M, Gridelli C, Buggisch P, Gerken G, Schmid RM, Boni C, Personeni N, Hassoun Z, Abbadessa G, Schwartz B, Von Roemeling R, Lamar ME, Chen Y, Porta C. Tivantinib for second-line treatment of advanced hepatocellular carcinoma: a randomised, placebo-controlled phase 2 study. Lancet Oncol. 2013 Jan;14(1):55-63. doi: 10.1016/S1470-2045(12)70490-4. Epub 2012 Nov 20.
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Reference Type
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Other Identifiers
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onco-059/67
Identifier Type: -
Identifier Source: org_study_id
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RECRUITING
PHASE2
Camrelizumab in Patients With Unresectable Hepatocellular Carcinoma
NCT04947956
UNKNOWN