Trial Outcomes & Findings for Abemaciclib and Nivolumab for Subjects With Hepatocellular Carcinoma (NCT NCT03781960)
NCT ID: NCT03781960
Last Updated: 2022-12-14
Results Overview
The objective response rate is determined by the percentage of participants on study attaining a partial or complete response as noted per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.
Recruitment status
TERMINATED
Study phase
PHASE2
Target enrollment
7 participants
Primary outcome timeframe
up to 2 years
Results posted on
2022-12-14
Participant Flow
7 met inclusion criteria and began treatment.
Participant milestones
| Measure |
Abemaciclib & Nivolumab
Subjects will receive abemaciclib monotherapy 150mg twice daily for seven days then will initiate nivolumab 480mg IV every 28 days while continuing twice daily abemaciclib.
Abemaciclib: Abemaciclib will be given at a dose of 150mg by mouth twice daily continuously for the duration of trial therapy.
Nivolumab: Nivolumab will be administered at a dose of 480mg IV every 28 days. Treatment with nivolumab will begin after an initial 7-day treatment period with abemaciclib monotherapy.
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|---|---|
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Overall Study
STARTED
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7
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Overall Study
COMPLETED
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7
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Overall Study
NOT COMPLETED
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0
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Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Abemaciclib and Nivolumab for Subjects With Hepatocellular Carcinoma
Baseline characteristics by cohort
| Measure |
Abemaciclib & Nivolumab
n=7 Participants
Subjects will receive abemaciclib monotherapy 150mg twice daily for seven days then will initiate nivolumab 480mg IV every 28 days while continuing twice daily abemaciclib.
Abemaciclib: Abemaciclib will be given at a dose of 150mg by mouth twice daily continuously for the duration of trial therapy.
Nivolumab: Nivolumab will be administered at a dose of 480mg IV every 28 days. Treatment with nivolumab will begin after an initial 7-day treatment period with abemaciclib monotherapy.
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|---|---|
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Age, Categorical
<=18 years
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0 Participants
n=5 Participants
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Age, Categorical
Between 18 and 65 years
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3 Participants
n=5 Participants
|
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Age, Categorical
>=65 years
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4 Participants
n=5 Participants
|
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Sex: Female, Male
Female
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1 Participants
n=5 Participants
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Sex: Female, Male
Male
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6 Participants
n=5 Participants
|
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Ethnicity (NIH/OMB)
Hispanic or Latino
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0 Participants
n=5 Participants
|
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Ethnicity (NIH/OMB)
Not Hispanic or Latino
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7 Participants
n=5 Participants
|
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Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
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0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
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2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
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0 Participants
n=5 Participants
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Race (NIH/OMB)
Black or African American
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1 Participants
n=5 Participants
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Race (NIH/OMB)
White
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3 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
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0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
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Region of Enrollment
United States
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7 participants
n=5 Participants
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PRIMARY outcome
Timeframe: up to 2 yearsThe objective response rate is determined by the percentage of participants on study attaining a partial or complete response as noted per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.
Outcome measures
| Measure |
Abemaciclib & Nivolumab
n=7 Participants
Subjects will receive abemaciclib monotherapy 150mg twice daily for seven days then will initiate nivolumab 480mg IV every 28 days while continuing twice daily abemaciclib.
Abemaciclib: Abemaciclib will be given at a dose of 150mg by mouth twice daily continuously for the duration of trial therapy.
Nivolumab: Nivolumab will be administered at a dose of 480mg IV every 28 days. Treatment with nivolumab will begin after an initial 7-day treatment period with abemaciclib monotherapy.
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|---|---|
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Objective Response Rate
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1 Participants
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SECONDARY outcome
Timeframe: From the start of study treatment until disease progression, death, whichever came first up to 2 yearsPopulation: All subjects who received study therapy
Progression-Free survival is determined from the start of study treatment until the time of documented disease progression or death per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) and iRECIST criteria (guidelines for response criteria for use in trials testing immunotherapies)
Outcome measures
| Measure |
Abemaciclib & Nivolumab
n=7 Participants
Subjects will receive abemaciclib monotherapy 150mg twice daily for seven days then will initiate nivolumab 480mg IV every 28 days while continuing twice daily abemaciclib.
Abemaciclib: Abemaciclib will be given at a dose of 150mg by mouth twice daily continuously for the duration of trial therapy.
Nivolumab: Nivolumab will be administered at a dose of 480mg IV every 28 days. Treatment with nivolumab will begin after an initial 7-day treatment period with abemaciclib monotherapy.
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|---|---|
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Progression-Free Survival
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2.1 months
Interval 1.6 to 5.6
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SECONDARY outcome
Timeframe: up to 2 yearsPopulation: Subjects with objective response
Time from the first recorded partial response or complete response (whichever comes first) defined Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; until disease progression or death
Outcome measures
| Measure |
Abemaciclib & Nivolumab
n=1 Participants
Subjects will receive abemaciclib monotherapy 150mg twice daily for seven days then will initiate nivolumab 480mg IV every 28 days while continuing twice daily abemaciclib.
Abemaciclib: Abemaciclib will be given at a dose of 150mg by mouth twice daily continuously for the duration of trial therapy.
Nivolumab: Nivolumab will be administered at a dose of 480mg IV every 28 days. Treatment with nivolumab will begin after an initial 7-day treatment period with abemaciclib monotherapy.
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|---|---|
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Duration of Response
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10.2 months
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SECONDARY outcome
Timeframe: From the start of treatment to death, due to any cause or last patient contact alive, assessed up to 2 yearsPopulation: All subjects who received study therapy
Outcome measures
| Measure |
Abemaciclib & Nivolumab
n=7 Participants
Subjects will receive abemaciclib monotherapy 150mg twice daily for seven days then will initiate nivolumab 480mg IV every 28 days while continuing twice daily abemaciclib.
Abemaciclib: Abemaciclib will be given at a dose of 150mg by mouth twice daily continuously for the duration of trial therapy.
Nivolumab: Nivolumab will be administered at a dose of 480mg IV every 28 days. Treatment with nivolumab will begin after an initial 7-day treatment period with abemaciclib monotherapy.
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|---|---|
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Overall Survival
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7.9 months
Interval 2.6 to 22.7
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Adverse Events
Abemaciclib & Nivolumab
Serious events: 3 serious events
Other events: 7 other events
Deaths: 2 deaths
Serious adverse events
| Measure |
Abemaciclib & Nivolumab
n=7 participants at risk
Subjects will receive abemaciclib monotherapy 150mg twice daily for seven days then will initiate nivolumab 480mg IV every 28 days while continuing twice daily abemaciclib.
Abemaciclib: Abemaciclib will be given at a dose of 150mg by mouth twice daily continuously for the duration of trial therapy.
Nivolumab: Nivolumab will be administered at a dose of 480mg IV every 28 days. Treatment with nivolumab will begin after an initial 7-day treatment period with abemaciclib monotherapy.
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|---|---|
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Gastrointestinal disorders
Abdominal Pain
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14.3%
1/7 • Number of events 1 • From the initiation of any study procedures until 30 days following the last administration of study treatment, up to 2 years.
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Infections and infestations
Sepsis
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14.3%
1/7 • Number of events 1 • From the initiation of any study procedures until 30 days following the last administration of study treatment, up to 2 years.
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Respiratory, thoracic and mediastinal disorders
Dyspnea
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14.3%
1/7 • Number of events 1 • From the initiation of any study procedures until 30 days following the last administration of study treatment, up to 2 years.
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Other adverse events
| Measure |
Abemaciclib & Nivolumab
n=7 participants at risk
Subjects will receive abemaciclib monotherapy 150mg twice daily for seven days then will initiate nivolumab 480mg IV every 28 days while continuing twice daily abemaciclib.
Abemaciclib: Abemaciclib will be given at a dose of 150mg by mouth twice daily continuously for the duration of trial therapy.
Nivolumab: Nivolumab will be administered at a dose of 480mg IV every 28 days. Treatment with nivolumab will begin after an initial 7-day treatment period with abemaciclib monotherapy.
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|---|---|
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Gastrointestinal disorders
Diarrhea
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85.7%
6/7 • Number of events 6 • From the initiation of any study procedures until 30 days following the last administration of study treatment, up to 2 years.
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Gastrointestinal disorders
Nausea
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42.9%
3/7 • Number of events 3 • From the initiation of any study procedures until 30 days following the last administration of study treatment, up to 2 years.
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Gastrointestinal disorders
constipation
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42.9%
3/7 • Number of events 3 • From the initiation of any study procedures until 30 days following the last administration of study treatment, up to 2 years.
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Gastrointestinal disorders
Abdominal Pain
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28.6%
2/7 • Number of events 2 • From the initiation of any study procedures until 30 days following the last administration of study treatment, up to 2 years.
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Gastrointestinal disorders
Ascites
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14.3%
1/7 • Number of events 1 • From the initiation of any study procedures until 30 days following the last administration of study treatment, up to 2 years.
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Gastrointestinal disorders
gastritis
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14.3%
1/7 • Number of events 1 • From the initiation of any study procedures until 30 days following the last administration of study treatment, up to 2 years.
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Gastrointestinal disorders
Abdominal Distension
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14.3%
1/7 • Number of events 1 • From the initiation of any study procedures until 30 days following the last administration of study treatment, up to 2 years.
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Gastrointestinal disorders
Vomiting
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14.3%
1/7 • Number of events 1 • From the initiation of any study procedures until 30 days following the last administration of study treatment, up to 2 years.
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Gastrointestinal disorders
bloating
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14.3%
1/7 • Number of events 1 • From the initiation of any study procedures until 30 days following the last administration of study treatment, up to 2 years.
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Psychiatric disorders
Depression
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14.3%
1/7 • Number of events 1 • From the initiation of any study procedures until 30 days following the last administration of study treatment, up to 2 years.
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Metabolism and nutrition disorders
Anorexia
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28.6%
2/7 • Number of events 2 • From the initiation of any study procedures until 30 days following the last administration of study treatment, up to 2 years.
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Metabolism and nutrition disorders
Hypokalemia
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14.3%
1/7 • Number of events 1 • From the initiation of any study procedures until 30 days following the last administration of study treatment, up to 2 years.
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Metabolism and nutrition disorders
Hyponatremia
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28.6%
2/7 • Number of events 2 • From the initiation of any study procedures until 30 days following the last administration of study treatment, up to 2 years.
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Gastrointestinal disorders
Edema Limbs
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28.6%
2/7 • Number of events 2 • From the initiation of any study procedures until 30 days following the last administration of study treatment, up to 2 years.
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General disorders
Fatigue
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71.4%
5/7 • Number of events 5 • From the initiation of any study procedures until 30 days following the last administration of study treatment, up to 2 years.
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General disorders
Fever
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14.3%
1/7 • Number of events 1 • From the initiation of any study procedures until 30 days following the last administration of study treatment, up to 2 years.
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General disorders
Chills
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14.3%
1/7 • Number of events 1 • From the initiation of any study procedures until 30 days following the last administration of study treatment, up to 2 years.
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General disorders
Non-cardiac chest pain
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14.3%
1/7 • Number of events 1 • From the initiation of any study procedures until 30 days following the last administration of study treatment, up to 2 years.
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Musculoskeletal and connective tissue disorders
Chest Wall Pain
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14.3%
1/7 • Number of events 1 • From the initiation of any study procedures until 30 days following the last administration of study treatment, up to 2 years.
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Musculoskeletal and connective tissue disorders
Flank Pain
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14.3%
1/7 • Number of events 1 • From the initiation of any study procedures until 30 days following the last administration of study treatment, up to 2 years.
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Musculoskeletal and connective tissue disorders
Back Pain
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14.3%
1/7 • Number of events 1 • From the initiation of any study procedures until 30 days following the last administration of study treatment, up to 2 years.
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Musculoskeletal and connective tissue disorders
Bone Pain
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14.3%
1/7 • Number of events 1 • From the initiation of any study procedures until 30 days following the last administration of study treatment, up to 2 years.
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Musculoskeletal and connective tissue disorders
Arthralgia
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14.3%
1/7 • Number of events 1 • From the initiation of any study procedures until 30 days following the last administration of study treatment, up to 2 years.
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Blood and lymphatic system disorders
Anemia
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57.1%
4/7 • Number of events 4 • From the initiation of any study procedures until 30 days following the last administration of study treatment, up to 2 years.
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Skin and subcutaneous tissue disorders
Dry Skin
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28.6%
2/7 • Number of events 2 • From the initiation of any study procedures until 30 days following the last administration of study treatment, up to 2 years.
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Skin and subcutaneous tissue disorders
Nail Changes
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14.3%
1/7 • Number of events 1 • From the initiation of any study procedures until 30 days following the last administration of study treatment, up to 2 years.
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Skin and subcutaneous tissue disorders
Palmer-plantar erthrodysesthesia syndrome
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14.3%
1/7 • Number of events 1 • From the initiation of any study procedures until 30 days following the last administration of study treatment, up to 2 years.
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Skin and subcutaneous tissue disorders
Rash Maculopapular
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28.6%
2/7 • Number of events 2 • From the initiation of any study procedures until 30 days following the last administration of study treatment, up to 2 years.
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Respiratory, thoracic and mediastinal disorders
Cough
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28.6%
2/7 • Number of events 2 • From the initiation of any study procedures until 30 days following the last administration of study treatment, up to 2 years.
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Respiratory, thoracic and mediastinal disorders
nasal congestion
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14.3%
1/7 • Number of events 1 • From the initiation of any study procedures until 30 days following the last administration of study treatment, up to 2 years.
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Respiratory, thoracic and mediastinal disorders
rhinorrhea
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14.3%
1/7 • Number of events 1 • From the initiation of any study procedures until 30 days following the last administration of study treatment, up to 2 years.
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Respiratory, thoracic and mediastinal disorders
Dyspnea
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28.6%
2/7 • Number of events 2 • From the initiation of any study procedures until 30 days following the last administration of study treatment, up to 2 years.
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Nervous system disorders
Dysgeusia
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14.3%
1/7 • Number of events 1 • From the initiation of any study procedures until 30 days following the last administration of study treatment, up to 2 years.
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Nervous system disorders
Paresthesia
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14.3%
1/7 • Number of events 1 • From the initiation of any study procedures until 30 days following the last administration of study treatment, up to 2 years.
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Renal and urinary disorders
Acute Kidney Injury
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14.3%
1/7 • Number of events 1 • From the initiation of any study procedures until 30 days following the last administration of study treatment, up to 2 years.
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Infections and infestations
Sepsis
|
14.3%
1/7 • Number of events 1 • From the initiation of any study procedures until 30 days following the last administration of study treatment, up to 2 years.
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Hepatobiliary disorders
Hepatic Failure
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14.3%
1/7 • Number of events 1 • From the initiation of any study procedures until 30 days following the last administration of study treatment, up to 2 years.
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Eye disorders
Blurred Vision
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14.3%
1/7 • Number of events 1 • From the initiation of any study procedures until 30 days following the last administration of study treatment, up to 2 years.
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Investigations
AST Increased
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100.0%
7/7 • Number of events 7 • From the initiation of any study procedures until 30 days following the last administration of study treatment, up to 2 years.
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Investigations
ALT Increased
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71.4%
5/7 • Number of events 5 • From the initiation of any study procedures until 30 days following the last administration of study treatment, up to 2 years.
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Investigations
Blood bilirubin increased
|
100.0%
7/7 • Number of events 7 • From the initiation of any study procedures until 30 days following the last administration of study treatment, up to 2 years.
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|
Investigations
Alkaline Phosphate Increased
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85.7%
6/7 • Number of events 6 • From the initiation of any study procedures until 30 days following the last administration of study treatment, up to 2 years.
|
|
Investigations
Platelet Count Decreased
|
85.7%
6/7 • Number of events 6 • From the initiation of any study procedures until 30 days following the last administration of study treatment, up to 2 years.
|
|
Investigations
Creatinine increased
|
42.9%
3/7 • Number of events 3 • From the initiation of any study procedures until 30 days following the last administration of study treatment, up to 2 years.
|
|
Investigations
Neutrophil count decreased
|
100.0%
7/7 • Number of events 7 • From the initiation of any study procedures until 30 days following the last administration of study treatment, up to 2 years.
|
|
Investigations
Weight loss
|
14.3%
1/7 • Number of events 1 • From the initiation of any study procedures until 30 days following the last administration of study treatment, up to 2 years.
|
|
Investigations
CPK increased
|
14.3%
1/7 • Number of events 1 • From the initiation of any study procedures until 30 days following the last administration of study treatment, up to 2 years.
|
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Investigations
WBC Decreased
|
100.0%
7/7 • Number of events 7 • From the initiation of any study procedures until 30 days following the last administration of study treatment, up to 2 years.
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Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60