A Study of Nivolumab and Ipilimumab and Nivolumab Alone in Combination With Trans-arterial ChemoEmbolization (TACE) in Participants With Intermediate Stage Liver Cancer
- Conditions
- Cancer, Hepatocellular
- Interventions
- Registration Number
- NCT04340193
- Lead Sponsor
- Bristol-Myers Squibb
- Brief Summary
The purpose of this study is to evaluate the safety and tolerability of nivolumab with and without ipilimumab in combination with Trans-arterial ChemoEmbolization (TACE) to TACE alone in participants with intermediate liver cancer.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 26
- Participant has intermediate-stage hepatocellular carcinoma (HCC) whose tumor characteristics exceed the Beyond Milan and Up-to-7 (BMU7) criteria and is eligible for trans-arterial ChemoEmbolization (TACE)
- Participant has no extrahepatic spreading (EHS), no regional lymph node involvement, no main, left main, or right main portal vein thrombosis, and no macrovascular invasion (MVI)
- Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0 or 1
- Known fibrolamellar HCC, sarcomatoid HCC, or mixed cholangiocarcinoma and HCC
- Prior liver transplant or participants who are on the waiting list for liver transplantation
- Active, known, or suspected autoimmune disease
Other protocol defined inclusion/exclusion criteria apply
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Nivolumab + Ipilimumab + TACE TACE TACE (Trans-arterial ChemoEmbolization) Nivolumab + TACE TACE - TACE TACE - Nivolumab + Ipilimumab + TACE nivolumab TACE (Trans-arterial ChemoEmbolization) Nivolumab + Ipilimumab + TACE ipilimumab TACE (Trans-arterial ChemoEmbolization) Nivolumab + TACE nivolumab -
- Primary Outcome Measures
Name Time Method Number of Participants With Adverse Events From first dose and 30 days after last dose of study therapy (up to approximately 25 months) An Adverse Event (AE) is defined as any new untoward medical occurrence or worsening of a preexisting medical condition in a clinical investigation participant administered study treatment and that does not necessarily have a causal relationship with this treatment.
Number of Participants With Serious Adverse Events (SAEs) From first dose and 30 days after last dose of study therapy (up to approximately 25 months) Serious Adverse Event (SAE) is defined as any untoward medical occurrence that, at any dose that results in death, Is life-threatening (defined as an event in which the participant was at risk of death at the time of the event; it does not refer to an event which hypothetically might have caused death if it were more severe) or requires inpatient hospitalization or causes prolongation of existing hospitalization, or results in persistent or significant disability/incapacity or is a congenital anomaly/birth defect or is an important medical event.
Number of Participants Who Died From first dose and 100 days after last dose of study therapy (up to approximately 27 months) Number of participants who died due to any cause are summarized.
Number of Participants With Adverse Events Leading to Study Drug Discontinuation From first dose and 30 days after last dose of study therapy (up to approximately 25 months) An Adverse Event (AE) is defined as any new untoward medical occurrence or worsening of a preexisting medical condition in a clinical investigation participant administered study treatment and that does not necessarily have a causal relationship with this treatment.
Number of Participants With Worst Grade (Grade 3/4) Laboratory Results From first dose and 30 days after last dose of study therapy (up to approximately 25 months) Laboratory results were graded using the Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 (Grade 3 =Severe, Grade 4 = Life-threatening). Highest grade measured for hemoglobin and albumin was Grade 3.
Number of Participants With Laboratory Abnormalities in Specific Thyroid Tests From first dose and 30 days after last dose of study therapy (up to approximately 25 months) Blood samples were collected for specific thyroid test.
Number of Participants With Clinical Laboratory Abnormalities in Specific Liver Tests From first dose and 30 days after last dose of study therapy (up to approximately 25 months) Blood samples were collected for specific liver tests.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (89)
Local Institution - 0059
🇺🇸Louisville, Kentucky, United States
Local Institution - 0027
🇸🇬Singapore, Singapore
Local Institution - 0189
🇺🇸Coronado, California, United States
Local Institution
🇵🇱Warszawa, Poland
Local Institution - 0005
🇺🇸Louisville, Kentucky, United States
Local Institution - 0109
🇺🇸Dallas, Texas, United States
Local Institution - 0037
🇦🇺Birtinya, Queensland, Australia
Local Institution - 0010
🇦🇺Adelaide, South Australia, Australia
Local Institution - 0001
🇦🇺Melbourne, Victoria, Australia
Local Institution - 0139
🇦🇺Murdoch, Western Australia, Australia
Local Institution - 0026
🇦🇹Graz, Austria
Local Institution - 0013
🇦🇹St. Polten, Austria
Local Institution - 0078
🇦🇹West Springfield, Austria
Local Institution - 0048
🇦🇹Wiener Neustadt, Austria
Local Institution - 0020
🇧🇪Brussels, Belgium
Local Institution - 0053
🇧🇪Gent, Belgium
Local Institution - 0050
🇧🇪Plainfield, Belgium
Local Institution - 0039
🇨🇦Quebec, Canada
Local Institution - 0184
🇨🇳Beijing Shi, Beijing, China
Local Institution - 0196
🇨🇳Nanjing Shi, Jiangsu, China
Local Institution - 0176
🇨🇳Nanchang, Jiangxi, China
Local Institution - 0209
🇨🇳Xi'an, Shan3xi, China
Local Institution - 0151
🇨🇳Shanghai, Shanghai, China
Local Institution - 0055
🇨🇿Olomouc, Czechia
Local Institution - 0014
🇫🇷Lille, Mount, France
Local Institution - 0132
🇫🇷Caen, France
Local Institution - 0021
🇫🇷Clichy, France
Local Institution - 0064
🇫🇷Dijon, France
Local Institution - 0082
🇫🇷Englewood, France
Local Institution - 0052
🇫🇷La Tronche, France
Local Institution - 0061
🇫🇷Marseil, France
Local Institution - 0087
🇫🇷Nantes, France
Local Institution - 0012
🇫🇷Nice, France
Local Institution - 0093
🇫🇷Paris, France
Local Institution - 0046
🇫🇷Reims, France
Local Institution - 0094
🇫🇷Villejuif cedex, France
Local Institution - 0035
🇩🇪Goettingen, Germany
Local Institution - 0071
🇩🇪Leipzig, Germany
Local Institution - 0045
ðŸ‡ðŸ‡°Hong Kong, Hong Kong
Local Institution - 0004
ðŸ‡ðŸ‡°HongKong, Hong Kong
Local Institution - 0015
🇮🇹Orbassano, TO, Italy
Local Institution - 0025
🇮🇹Milano, Italy
Local Institution - 0076
🇮🇹Siena, Italy
Local Institution - 0070
🇮🇹Vicenza, Italy
Local Institution - 0108
🇯🇵Chiba-shi, Chiba, Japan
Local Institution - 0122
🇯🇵Matsuyama-shi, Ehime, Japan
Local Institution - 0148
🇯🇵Sapporo-shi, Hokkaido, Japan
Local Institution - 0118
🇯🇵Kanazawa, Ishikawa, Japan
Local Institution - 0120
🇯🇵Yokohama-shi, Kanagawa, Japan
Local Institution - 0113
🇯🇵Yokohama-Shi, Kanagawa, Japan
Local Institution - 0115
🇯🇵Kyoto-Shi, Kyoto, Japan
Local Institution - 0127
🇯🇵Abeno-ku, Osaka, Japan
Local Institution - 0125
🇯🇵Izunokuni-Shi, Shizuoka, Japan
Local Institution - 0116
🇯🇵Minato-ku, Tokyo, Japan
Local Institution - 0128
🇯🇵Minato-ku, Tokyo, Japan
Local Institution - 0121
🇯🇵Musashino-shi, Tokyo, Japan
Local Institution - 0119
🇯🇵Hiroshima, Japan
Local Institution - 0117
🇯🇵Osaka, Japan
Local Institution - 0123
🇯🇵Saitama, Japan
Local Institution - 0114
🇰🇷Busan, Korea, Republic of
Local Institution - 0135
🇰🇷Daegu, Korea, Republic of
Local Institution - 0047
🇰🇷Gyeongsangnam-do, Korea, Republic of
Local Institution - 0097
🇰🇷Hwasun-Gun, Korea, Republic of
Local Institution - 0161
🇰🇷Seoul, Korea, Republic of
Local Institution - 0186
🇰🇷Seoul, Korea, Republic of
Local Institution - 0160
🇰🇷Seoul, Korea, Republic of
Local Institution - 0164
🇰🇷Seoul, Korea, Republic of
Local Institution - 0049
🇵🇷San Juan, Puerto Rico
Local Institution - 0016
🇷🇺Barnaul, Russian Federation
Local Institution - 0077
🇷🇺Saint Petersburg, Russian Federation
Local Institution - 0009
🇷🇺Saint-Petersburg, Russian Federation
Local Institution - 0089
🇸🇬Singapore, Singapore
Local Institution - 0011
🇸🇬Singapore, Singapore
Local Institution - 0023
🇪🇸Alicante, Spain
Local Institution - 0092
🇪🇸Cordoba, Spain
Local Institution - 0101
🇪🇸Madrid, Spain
Local Institution - 0183
🇪🇸Madrid, Spain
Local Institution - 0084
🇪🇸Madrid, Spain
Local Institution - 0018
🇪🇸Madrid, Spain
Local Institution - 0099
🇪🇸Pamplona, Spain
Local Institution - 0131
🇪🇸Sabadell, Spain
Local Institution - 0102
🇪🇸Santiago de Compostela, Spain
Local Institution - 0141
🇨🇳Kaohsiung, Taiwan
Local Institution - 0136
🇨🇳Puzi City, Taiwan
Local Institution - 0030
🇨🇳Taichung City, Taiwan
Local Institution - 0057
🇨🇳Taichung, Taiwan
Local Institution - 0029
🇨🇳Tainan City, Taiwan
Local Institution - 0002
🇨🇳Taipei, Taiwan
Local Institution - 0044
🇨🇳Tapei, Taiwan