Cabozantinib Combined With Ipilimumab/Nivolumab and TACE in Patients With Hepatocellular Carcinoma
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|ClinicalTrials.gov Identifier: NCT04472767|
Recruitment Status : Recruiting
First Posted : July 15, 2020
Last Update Posted : February 26, 2021
|Condition or disease||Intervention/treatment||Phase|
|Hepatocellular Carcinoma HCC||Drug: Nivolumab Drug: Ipilimumab Drug: Cabozantinib Procedure: Transarterial Chemoembolization||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||35 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Phase 2 Study of Cabozantinib Combined With Ipilimumab/Nivolumab and Transarterial Chemoembolization (TACE) in Patients With Hepatocellular Carcinoma (HCC) Who Are Not Candidates for Curative Intent Treatment|
|Actual Study Start Date :||August 7, 2020|
|Estimated Primary Completion Date :||March 1, 2022|
|Estimated Study Completion Date :||September 1, 2024|
Experimental: Cabozantinib with Ipilimumab/Nivolumab and TACE
Subjects receive Cabozantinib 40 mg daily on days 1-28 of a 28 day cycle, this is to be started 7-14 days after the last TACE procedure.
Nivolumab 480 mg IV on day 1 of a 28 day cycle (cycle 2 and beyond), this is to be started 7-14 days after the last TACE procedure.
Nivolumab: 3mg/kg IV on day 1 of a 21 day cycle x 1 dose.
Ipilimumab: 1 mg/kg on day 1 of a 21 day cycle x 1 dose
TACE: Within 3-4 weeks of cycle 1 day 1; may be done up to 3 times (9-12 weeks total), the intervals between each TACE treatment can vary based on investigator's discretion
Other Name: OPDIVO®
Other Name: YERVOY®
Procedure: Transarterial Chemoembolization
TACE treatment will be administered using either the DEB-TACE or cTACE modality in a series of up to 3 individual procedures within the 9-12 weeks following Day 21 (= cycle 1 day 21) of a patient's first infusion of nivolumab/ipilimumab. The first TACE treatment should start no more than 7 working days after being cycle 1 day 21.
Other Name: TACE
- Percentage of Participants with Progression-free Survival at 6 Months [ Time Frame: 6 months ]This is defined as the percentage of subjects who are free of progression 6 months after study treatment start. Progression is defined death, radiographic progression or clinical deterioration attributed disease progression as judged by an investigator. Radiographic progression is defined using the modified Response Evaluation Criteria in Solid Tumors Criteria (mRECIST), as a 20% increase in the sum of diameters of of viable (enhancing) target lesions and/or appearance of one or new lesions and/or unequivocal progression of existing non-target lesions.
- Complete Response Rate [ Time Frame: From date of registration until first date of disease progression, toxicity, delay of treatment, or withdrawal of treatment, whichever came first, an average of 1 year. ]Complete Response (CR) is defined as the disappearance of all target lesions, determined by two separate observations conducted not less than 4 weeks apart. There can be no appearance of new lesions.
- Overall Survival of Patients who Received Cabozantinib with Ipilimumab/Nivolumab and TACE [ Time Frame: From date of registration for up to 18 months after last patient is enrolled or until death from any cause, whichever came first. ]To evaluate overall survival in patients with advanced gastric and gastroesophageal adenocarcinoma treated with this combination of cabozantinib and irinotecan.
- Percentage of Grade 3-5 Adverse Events [ Time Frame: From the start date of treatment until 4 weeks after removal of treatment due to disease progression, toxicity, delay of treatment, or withdrawal of treatment, whichever came first, an average of 1 year. ]To evaluate the tolerability of administering cabozantinib in combination with cabozantinib/nivolumab and TACE in patients with hepatocellular carcinoma from the start of treatment, duration of treatment and up to 4 weeks after completion of study treatment. Toxicity and adverse events are based on the CTCAE (NCI Common Terminology Criteria for Adverse Events) Version 5.0.
- Progression Free Survival [ Time Frame: From the start date of treatment until 4 weeks after removal of treatment due to disease progression, toxicity, delay of treatment, or withdrawal of treatment, whichever came first, an average of 1 year. ]Progression-free survival (PFS) is defined as the duration of time from start of treatment to time of progression or death, whichever occurs first.
- Conversion Rate to Resectable [ Time Frame: From the start date of treatment until 4 weeks after removal of treatment due to disease progression, toxicity, delay of treatment, or withdrawal of treatment, whichever came first, an average of 1 year. ]Rate of subjects suitable for liver transplant according to the Milan criteria. Milan criteria is defined as single tumors ≤5 cm in diameter or no more than three tumors ≤3 cm in diameter single tumors ≤5 cm in diameter or no more than three tumors ≤3 cm in diameter
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): NCT04472767
|Contact: Chao Family Comprehensive Cancer Center University of California, Irvineemail@example.com|
|Contact: University of California Irvine Medical|
|United States, California|
|Chao Family Comprehensive Cancer Center, University of California, Irvine||Recruiting|
|Orange, California, United States, 92868|
|Contact: Farshid Dayanni, MD, PhD 877-827-8839 firstname.lastname@example.org|
|Principal Investigator:||Farshid Dayyani, MD, PhD||Chao Family Comprehensive Cancer Center|