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| ID | Type | Description | Link |
|---|---|---|---|
| 2016-000112-15 | EudraCT Number |
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CC-122-HCC-002 is a Phase 1/2 dose escalation and expansion clinical study of CC-122 in combination with nivolumab in subjects with unresectable hepatocellular carcinoma (HCC) who have progressed after or were intolerant to no more than 2 previous systemic therapies for unresectable HCC, or are naïve to systemic therapy.
Study population included subjects who had progressed after or were intolerant to no more than 2 previous systemic therapies for unresectable HCC, or are naïve to systemic therapy.
The dose escalation part of the study was designed to explore three dose levels of CC-122 to identify the recommended phase 2 dose (RP2D) to be used in the expansion phase. Approximately 20 subjects were to be enrolled in the dose escalation part of the study. Subjects could be treated for up to 2 years, or until progression of disease, unacceptable toxicity, subject/physician decision, withdrawal of consent, death. Safety follow up until 28 days after CC122 treatment and 90 days after nivolumab treatment. RECIST 1.1 criteria was used to determine response. Survival follow up until death, withdrawal of consent, or the study closes. Subjects were permitted to continue treatment beyond progression (TBP) if they continue to meet protocol criteria, had stable performance status, had clinical benefit, other treatment options were discussed. A separate ICF was signed to continue TBP.
During the dose escalation phase, CC-122 was administered orally 5 consecutive days out of 7 (5 days on/2 days off weekly) on Days 1 to 5, 8 to 12, 15 to 19 and 22 to 26 of each 28-day cycle. Once the RP2D for dosing of CC-122 in combination with nivolumab was defined, expansion (Phase 2) would start. A modified 3+3 dose escalation design was used to identify the initial toxicity of the combination. Up to six subjects were concurrently enrolled into a dose level. Decisions as to which dose level to enroll a new subject were based on the number of subjects enrolled and evaluable, the number of subjects experiencing DLTs, and the number of subjects enrolled but who are not yet evaluable for toxicity in the current cohort at the time of new subject entry. A Safety Review Committee (SRC) comprised of investigators participating in the study made dose escalation decisions based on these criteria.
After completion of the Dose Escalation Phase, the Dose Expansion Phase of the study did not proceed due to the changing landscape in the treatment of HCC. There were no additional safety concerns or safety signals identified in the dose escalation phase of the study.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| CC-122 with Nivolumab | Experimental | CC-122 orally 5/7 days with nivolumab Intravenously (IV) 3mg/kg every 2 weeks. Cohorts of up to 6 subjects per dose level until Recommended Phase 2 dose (RP2D). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CC-122 | Drug |
| ||
| Nivolumab |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of Dose Limiting Toxicities (DLTs) | During dose escalation, the DLT assessment period is defined as Days 1 to 28 of Cycle 1 including the predose assessments specified for Day 1 of Cycle 2. A DLT is defined as any of the following toxicities occurring within the DLT assessment window unless the event can clearly be determined to be unrelated to the drug. | 28 days |
| Incidence and Severity of Treatment-Emergent Adverse Events (TEAEs) | During dose escalation, the TEAE phase 1 assessment period is defined as Days 1 to 28 of Cycle 1 including the predose assessments specified for Day 1 of Cycle 2. Number of participants who experienced a TEAE during the course of the study. | From first dose up to 28 days (CC-122) or 90 days (nivolumab) post-last dose (up to 2 years) |
| Objective Response Rate (ORR) by Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) | ORR is is defined as the number and percentage of participants with a best overall response (BOR) of confirmed complete response (CR) or partial response (PR). | up to 2 years |
| Measure | Description | Time Frame |
|---|---|---|
| Disease Control Rate (DCR) by RECIST 1.1 | DCR is is defined as the number and percentage of participants with a best overall response (BOR) of confirmed complete response (CR) or partial response (PR) or stable disease (SD). | up to 2 years |
| Duration of Response (DoR) by RECIST 1.1 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Akshay Patel | Celgene Corporation | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UCLA Division of Hematology Oncology | Los Angeles | California | 90095-1752 | United States | ||
| University of Florida |
21 participants treated
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| ID | Title | Description |
|---|---|---|
| FG000 | CC-122 2mg + Nivolumab | CC-122 2.0 mg orally 5 consecutive days out of 7 (5 days on/2 days off weekly) on Days 1 to 5, 8 to 12, 15 to 19 and 22 to 26 of each 28-day cycle, and nivolumab 3.0 mg/kg intravenously (IV) every 2 weeks. |
| FG001 | CC-122 3mg + Nivolumab |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Aug 29, 2017 | Mar 17, 2021 |
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|
Duration of response is measured from the date the criterion is first met for CR/PR using RECIST 1.1 rules (whichever is first recorded) until the first date when progressive disease using RECIST 1.1 is documented or death occurred. |
| up to 2 years |
| Progression-Free Survival (PFS) by RECIST 1.1 | Progression-Free Survival (PFS) is defined as the time from the first dose date of study drug until tumor progression or death, whichever occurs first. A subject who has neither progressed nor died or who progresses or dies after an extended lost-to-follow up time (two or more missed assessments) is censored on the date of last adequate tumor assessment. Subjects without valid baseline or post-baseline tumor assessments are censored on their first dose date. Median and the 2-sided 95% confidence interval (CI) are based on Kaplan-Meier estimate of progression-free survival and time to progression using both observed and censored data. | up to 2 years |
| Overall Survival (OS) by RECIST 1.1 | Overall Survival (OS) is measured as the time from the first dose of study drug to death from any cause. Participants who have no death reported are censored at the last contact date the participant is known to be alive. Median and the 2-sided 95% confidence interval (CI) are based on Kaplan-Meier estimate of progression-free survival and time to progression using both observed and censored data. | up to 2 years |
| Time to Progression (TTP) by RECIST 1.1 | Time to Progression (TTP) is defined as the time from the first dose date of study drug until tumor progression; TTP does not include death. The censoring rules are the same as PFS except that deaths without progression are censored at last adequate tumor assessment. Median and the 2-sided 95% confidence interval (CI) are based on Kaplan-Meier estimate of progression-free survival and time to progression using both observed and censored data. | up to 2 years |
| Maximum Observed Concentration (Cmax) | Blood was collected according to intensive and sparse sampling strategies to estimate the population pharmacokinetic (PK) of CC-122 when administered in combination with nivolumab. | 28 days |
| Area Under the Concentration Time Curve (AUC) | Blood was collected according to intensive and sparse sampling strategies to estimate the population pharmacokinetic (PK) of CC-122 when administered in combination with nivolumab. | 28 days |
| Time to Maximum Concentration (Tmax) | Blood was collected according to intensive and sparse sampling strategies to estimate the population pharmacokinetic (PK) of CC-122 when administered in combination with nivolumab. | 28 days |
| Terminal Half-life (T-HALF) | Blood was collected according to intensive and sparse sampling strategies to estimate the population pharmacokinetic (PK) of CC-122 when administered in combination with nivolumab. | 28 days |
| Apparent Volume of Distribution (Vz/F) | Blood was collected according to intensive and sparse sampling strategies to estimate the population pharmacokinetic (PK) of CC-122 when administered in combination with nivolumab. | 28 days |
| Gainesville |
| Florida |
| 32610 |
| United States |
| NYU Langone Medical Center | New York | New York | 10016 | United States |
| Mary Crowley Cancer Research | Dallas | Texas | 75251 | United States |
| Institut Paoli Calmettes | Marseille | 13273 | France |
| Centre Eugene Marquis | Rennes | 35200 | France |
| Institut Universitaire du Cancer IUCT - Oncopole | Toulouse | 31059 | France |
| Institut Gustave Roussy Hematologie | Villejuif | 94805 | France |
| IRCCS - Istituo Clinico Humanitas - Humanitas Cancer Center | Milan | 20089 | Italy |
| Fondazione IRCCS Policlinico San Matteo | Pavia | 27100 | Italy |
| Istituto Nazionale Tumori Regina Elena | Roma | 144 | Italy |
| Hospital Universitario Vall D Hebron | Barcelona | 8035 | Spain |
| Hospital Ramon y Cajal | Madrid | 28034 | Spain |
| Hospital 12 de Octubre | Madrid | 28041 | Spain |
CC-122 3.0 mg orally 5 consecutive days out of 7 (5 days on/2 days off weekly) on Days 1 to 5, 8 to 12, 15 to 19 and 22 to 26 of each 28-day cycle, and nivolumab 3.0 mg/kg intravenously (IV) every 2 weeks. |
| FG002 | CC-122 4mg + Nivolumab | CC-122 4.0 mg orally 5 consecutive days out of 7 (5 days on/2 days off weekly) on Days 1 to 5, 8 to 12, 15 to 19 and 22 to 26 of each 28-day cycle, and nivolumab 3.0 mg/kg intravenously (IV) every 2 weeks. |
| COMPLETED | Completed = Did not discontinue study |
|
| NOT COMPLETED |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | CC-122 2mg + Nivolumab | CC-122 2.0 mg orally 5 consecutive days out of 7 (5 days on/2 days off weekly) on Days 1 to 5, 8 to 12, 15 to 19 and 22 to 26 of each 28-day cycle, and nivolumab 3.0 mg/kg intravenously (IV) every 2 weeks. |
| BG001 | CC-122 3mg + Nivolumab | CC-122 3.0 mg orally 5 consecutive days out of 7 (5 days on/2 days off weekly) on Days 1 to 5, 8 to 12, 15 to 19 and 22 to 26 of each 28-day cycle, and nivolumab 3.0 mg/kg intravenously (IV) every 2 weeks. |
| BG002 | CC-122 4mg + Nivolumab | CC-122 4.0 mg orally 5 consecutive days out of 7 (5 days on/2 days off weekly) on Days 1 to 5, 8 to 12, 15 to 19 and 22 to 26 of each 28-day cycle, and nivolumab 3.0 mg/kg intravenously (IV) every 2 weeks. |
| BG003 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | Years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Incidence of Dose Limiting Toxicities (DLTs) | During dose escalation, the DLT assessment period is defined as Days 1 to 28 of Cycle 1 including the predose assessments specified for Day 1 of Cycle 2. A DLT is defined as any of the following toxicities occurring within the DLT assessment window unless the event can clearly be determined to be unrelated to the drug. | All treated participants | Posted | Count of Participants | Participants | 28 days |
|
|
| ||||||||||||||||||||||||||||||||
| Primary | Incidence and Severity of Treatment-Emergent Adverse Events (TEAEs) | During dose escalation, the TEAE phase 1 assessment period is defined as Days 1 to 28 of Cycle 1 including the predose assessments specified for Day 1 of Cycle 2. Number of participants who experienced a TEAE during the course of the study. | All treated participants | Posted | Number | Number of participants | From first dose up to 28 days (CC-122) or 90 days (nivolumab) post-last dose (up to 2 years) |
| ||||||||||||||||||||||||||||||||||
| Primary | Objective Response Rate (ORR) by Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) | ORR is is defined as the number and percentage of participants with a best overall response (BOR) of confirmed complete response (CR) or partial response (PR). | All treated participants | Posted | Number | 95% Confidence Interval | Percentage of participants | up to 2 years |
| |||||||||||||||||||||||||||||||||
| Secondary | Disease Control Rate (DCR) by RECIST 1.1 | DCR is is defined as the number and percentage of participants with a best overall response (BOR) of confirmed complete response (CR) or partial response (PR) or stable disease (SD). | All treated participants | Posted | Number | 95% Confidence Interval | Percentage of participants | up to 2 years |
| |||||||||||||||||||||||||||||||||
| Secondary | Duration of Response (DoR) by RECIST 1.1 | Duration of response is measured from the date the criterion is first met for CR/PR using RECIST 1.1 rules (whichever is first recorded) until the first date when progressive disease using RECIST 1.1 is documented or death occurred. | All treated participants | Posted | Median | 95% Confidence Interval | Days | up to 2 years |
| |||||||||||||||||||||||||||||||||
| Secondary | Progression-Free Survival (PFS) by RECIST 1.1 | Progression-Free Survival (PFS) is defined as the time from the first dose date of study drug until tumor progression or death, whichever occurs first. A subject who has neither progressed nor died or who progresses or dies after an extended lost-to-follow up time (two or more missed assessments) is censored on the date of last adequate tumor assessment. Subjects without valid baseline or post-baseline tumor assessments are censored on their first dose date. Median and the 2-sided 95% confidence interval (CI) are based on Kaplan-Meier estimate of progression-free survival and time to progression using both observed and censored data. | All treated participants | Posted | Median | 95% Confidence Interval | Days | up to 2 years |
| |||||||||||||||||||||||||||||||||
| Secondary | Overall Survival (OS) by RECIST 1.1 | Overall Survival (OS) is measured as the time from the first dose of study drug to death from any cause. Participants who have no death reported are censored at the last contact date the participant is known to be alive. Median and the 2-sided 95% confidence interval (CI) are based on Kaplan-Meier estimate of progression-free survival and time to progression using both observed and censored data. | All treated participants | Posted | Median | 95% Confidence Interval | Days | up to 2 years |
| |||||||||||||||||||||||||||||||||
| Secondary | Time to Progression (TTP) by RECIST 1.1 | Time to Progression (TTP) is defined as the time from the first dose date of study drug until tumor progression; TTP does not include death. The censoring rules are the same as PFS except that deaths without progression are censored at last adequate tumor assessment. Median and the 2-sided 95% confidence interval (CI) are based on Kaplan-Meier estimate of progression-free survival and time to progression using both observed and censored data. | All treated participants | Posted | Median | 95% Confidence Interval | Days | up to 2 years |
| |||||||||||||||||||||||||||||||||
| Secondary | Maximum Observed Concentration (Cmax) | Blood was collected according to intensive and sparse sampling strategies to estimate the population pharmacokinetic (PK) of CC-122 when administered in combination with nivolumab. | Pharmacokinetic (PK) Evaluable Population -All participants who enrolled and received at least one dose of either investigational product (IP) and had at least one measurable concentration of CC-122 or nivolumab. Note: Nivolumab participants did not qualify for data analysis. | Posted | Geometric Mean | Geometric Coefficient of Variation | ng/mL | 28 days |
| |||||||||||||||||||||||||||||||||
| Secondary | Area Under the Concentration Time Curve (AUC) | Blood was collected according to intensive and sparse sampling strategies to estimate the population pharmacokinetic (PK) of CC-122 when administered in combination with nivolumab. | Pharmacokinetic (PK) Evaluable Population -All participants who enrolled and received at least one dose of either investigational product (IP) and had at least one measurable concentration of CC-122 or nivolumab. Note: Nivolumab participants did not qualify for data analysis. | Posted | Geometric Mean | Geometric Coefficient of Variation | h*ng/mL | 28 days |
| |||||||||||||||||||||||||||||||||
| Secondary | Time to Maximum Concentration (Tmax) | Blood was collected according to intensive and sparse sampling strategies to estimate the population pharmacokinetic (PK) of CC-122 when administered in combination with nivolumab. | Pharmacokinetic (PK) Evaluable Population -All participants who enrolled and received at least one dose of either investigational product (IP) and had at least one measurable concentration of CC-122 or nivolumab. Note: Nivolumab participants did not qualify for data analysis. | Posted | Median | Full Range | hour | 28 days |
| |||||||||||||||||||||||||||||||||
| Secondary | Terminal Half-life (T-HALF) | Blood was collected according to intensive and sparse sampling strategies to estimate the population pharmacokinetic (PK) of CC-122 when administered in combination with nivolumab. | Pharmacokinetic (PK) Evaluable Population -All participants who enrolled and received at least one dose of either investigational product (IP) and had at least one measurable concentration of CC-122 or nivolumab. Note: Nivolumab participants did not qualify for data analysis. | Posted | Geometric Mean | Geometric Coefficient of Variation | hour | 28 days |
| |||||||||||||||||||||||||||||||||
| Secondary | Apparent Volume of Distribution (Vz/F) | Blood was collected according to intensive and sparse sampling strategies to estimate the population pharmacokinetic (PK) of CC-122 when administered in combination with nivolumab. | Pharmacokinetic (PK) Evaluable Population -All participants who enrolled and received at least one dose of either investigational product (IP) and had at least one measurable concentration of CC-122 or nivolumab. Note: Nivolumab participants did not qualify for data analysis. | Posted | Geometric Mean | Geometric Coefficient of Variation | liter | 28 days |
|
From first dose up to 28 days (CC-122) or 90 days (nivolumab) post-last dose (up to 2 years) for all serious and non-serious adverse events. For all-cause mortality, the timeframe of reporting is over the entirety of the study (ca. 3.5 years).
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | CC-122 2mg + Nivolumab | CC-122 2.0 mg orally 5 consecutive days out of 7 (5 days on/2 days off weekly) on Days 1 to 5, 8 to 12, 15 to 19 and 22 to 26 of each 28-day cycle, and nivolumab 3.0 mg/kg intravenously (IV) every 2 weeks. | 4 | 7 | 6 | 7 | 7 | 7 |
| EG001 | CC-122 3mg + Nivolumab | CC-122 3.0 mg orally 5 consecutive days out of 7 (5 days on/2 days off weekly) on Days 1 to 5, 8 to 12, 15 to 19 and 22 to 26 of each 28-day cycle, and nivolumab 3.0 mg/kg intravenously (IV) every 2 weeks. | 6 | 9 | 5 | 9 | 9 | 9 |
| EG002 | CC-122 4mg + Nivolumab | CC-122 4.0 mg orally 5 consecutive days out of 7 (5 days on/2 days off weekly) on Days 1 to 5, 8 to 12, 15 to 19 and 22 to 26 of each 28-day cycle, and nivolumab 3.0 mg/kg intravenously (IV) every 2 weeks. | 5 | 5 | 4 | 5 | 5 | 5 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Ascites | Gastrointestinal disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Rectal haemorrhage | Gastrointestinal disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Disease progression | General disorders | MedDRA 22.0 | Systematic Assessment |
| |
| General physical health deterioration | General disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Jaundice cholestatic | Hepatobiliary disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Abdominal wall abscess | Infections and infestations | MedDRA 22.0 | Systematic Assessment |
| |
| Herpes zoster | Infections and infestations | MedDRA 22.0 | Systematic Assessment |
| |
| Liver abscess | Infections and infestations | MedDRA 22.0 | Systematic Assessment |
| |
| Peritonitis bacterial | Infections and infestations | MedDRA 22.0 | Systematic Assessment |
| |
| Pulmonary sepsis | Infections and infestations | MedDRA 22.0 | Systematic Assessment |
| |
| Hyperglycaemia | Metabolism and nutrition disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Hyponatraemia | Metabolism and nutrition disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Musculoskeletal chest pain | Musculoskeletal and connective tissue disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Tumour pain | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 22.0 | Systematic Assessment |
| |
| Cerebrovascular accident | Nervous system disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Acute kidney injury | Renal and urinary disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Urinary retention | Renal and urinary disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Haemoptysis | Respiratory, thoracic and mediastinal disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Rash maculo-papular | Skin and subcutaneous tissue disorders | MedDRA 22.0 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Neutropenia | Blood and lymphatic system disorders | MedDRA 22.0 | Systematic Assessment |
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| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Cardiac failure congestive | Cardiac disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Sinus bradycardia | Cardiac disorders | MedDRA 22.0 | Systematic Assessment |
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| Tachycardia | Cardiac disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Vertigo | Ear and labyrinth disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Hyperthyroidism | Endocrine disorders | MedDRA 22.0 | Systematic Assessment |
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| Eye pain | Eye disorders | MedDRA 22.0 | Systematic Assessment |
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| Eyelid rash | Eye disorders | MedDRA 22.0 | Systematic Assessment |
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| Lacrimation increased | Eye disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Abdominal distension | Gastrointestinal disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Abdominal pain upper | Gastrointestinal disorders | MedDRA 22.0 | Systematic Assessment |
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| Ascites | Gastrointestinal disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Dry mouth | Gastrointestinal disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Haematochezia | Gastrointestinal disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Stomatitis | Gastrointestinal disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Asthenia | General disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Chills | General disorders | MedDRA 22.0 | Systematic Assessment |
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| Fatigue | General disorders | MedDRA 22.0 | Systematic Assessment |
| |
| General physical health deterioration | General disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Oedema peripheral | General disorders | MedDRA 22.0 | Systematic Assessment |
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| Pyrexia | General disorders | MedDRA 22.0 | Systematic Assessment |
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| Swelling | General disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Hepatic failure | Hepatobiliary disorders | MedDRA 22.0 | Systematic Assessment |
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| Hyperbilirubinaemia | Hepatobiliary disorders | MedDRA 22.0 | Systematic Assessment |
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| Jaundice | Hepatobiliary disorders | MedDRA 22.0 | Systematic Assessment |
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| Jaundice cholestatic | Hepatobiliary disorders | MedDRA 22.0 | Systematic Assessment |
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| Bronchitis | Infections and infestations | MedDRA 22.0 | Systematic Assessment |
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| Cellulitis | Infections and infestations | MedDRA 22.0 | Systematic Assessment |
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| Conjunctivitis | Infections and infestations | MedDRA 22.0 | Systematic Assessment |
| |
| Escherichia urinary tract infection | Infections and infestations | MedDRA 22.0 | Systematic Assessment |
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| Gastroenteritis | Infections and infestations | MedDRA 22.0 | Systematic Assessment |
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| Nasopharyngitis | Infections and infestations | MedDRA 22.0 | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA 22.0 | Systematic Assessment |
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| Rash pustular | Infections and infestations | MedDRA 22.0 | Systematic Assessment |
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| Respiratory tract infection | Infections and infestations | MedDRA 22.0 | Systematic Assessment |
| |
| Tinea versicolour | Infections and infestations | MedDRA 22.0 | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA 22.0 | Systematic Assessment |
| |
| Infusion related reaction | Injury, poisoning and procedural complications | MedDRA 22.0 | Systematic Assessment |
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| Alanine aminotransferase increased | Investigations | MedDRA 22.0 | Systematic Assessment |
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| Amylase increased | Investigations | MedDRA 22.0 | Systematic Assessment |
| |
| Aspartate aminotransferase increased | Investigations | MedDRA 22.0 | Systematic Assessment |
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| Blood alkaline phosphatase increased | Investigations | MedDRA 22.0 | Systematic Assessment |
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| Blood bilirubin increased | Investigations | MedDRA 22.0 | Systematic Assessment |
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| Blood creatine increased | Investigations | MedDRA 22.0 | Systematic Assessment |
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| Blood creatine phosphokinase increased | Investigations | MedDRA 22.0 | Systematic Assessment |
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| Blood phosphorus decreased | Investigations | MedDRA 22.0 | Systematic Assessment |
| |
| Electrocardiogram QT prolonged | Investigations | MedDRA 22.0 | Systematic Assessment |
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| Gamma-glutamyltransferase increased | Investigations | MedDRA 22.0 | Systematic Assessment |
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| Lipase increased | Investigations | MedDRA 22.0 | Systematic Assessment |
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| Neutrophil count decreased | Investigations | MedDRA 22.0 | Systematic Assessment |
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| Troponin I increased | Investigations | MedDRA 22.0 | Systematic Assessment |
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| Weight decreased | Investigations | MedDRA 22.0 | Systematic Assessment |
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| Decreased appetite | Metabolism and nutrition disorders | MedDRA 22.0 | Systematic Assessment |
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| Hyperkalaemia | Metabolism and nutrition disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Hypoalbuminaemia | Metabolism and nutrition disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Hypokalaemia | Metabolism and nutrition disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Hypomagnesaemia | Metabolism and nutrition disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Hyponatraemia | Metabolism and nutrition disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Muscle spasms | Musculoskeletal and connective tissue disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Musculoskeletal stiffness | Musculoskeletal and connective tissue disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Neck pain | Musculoskeletal and connective tissue disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Torticollis | Musculoskeletal and connective tissue disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Tumour pain | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 22.0 | Systematic Assessment |
| |
| Aphasia | Nervous system disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Encephalopathy | Nervous system disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Lacunar infarction | Nervous system disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Peripheral motor neuropathy | Nervous system disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Somnolence | Nervous system disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Anxiety disorder | Psychiatric disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Confusional state | Psychiatric disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Insomnia | Psychiatric disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Acute kidney injury | Renal and urinary disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Urinary incontinence | Renal and urinary disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Erectile dysfunction | Reproductive system and breast disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Epistaxis | Respiratory, thoracic and mediastinal disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Dry skin | Skin and subcutaneous tissue disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Erythema | Skin and subcutaneous tissue disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Exfoliative rash | Skin and subcutaneous tissue disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Hair colour changes | Skin and subcutaneous tissue disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Palmar-plantar erythrodysaesthesia syndrome | Skin and subcutaneous tissue disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Pruritus generalised | Skin and subcutaneous tissue disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Rash macular | Skin and subcutaneous tissue disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Rash maculo-papular | Skin and subcutaneous tissue disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Hypotension | Vascular disorders | MedDRA 22.0 | Systematic Assessment |
|
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Bristol-Myers Squibb Study Director | Bristol-Myers Squibb | Please email: | Clinical.Trials@bms.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Apr 30, 2020 | Mar 17, 2021 | SAP_001.pdf |
| ID | Term |
|---|---|
| D006528 | Carcinoma, Hepatocellular |
| ID | Term |
|---|---|
| D000230 | Adenocarcinoma |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D008113 | Liver Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D004066 | Digestive System Diseases |
| D008107 | Liver Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| C000602306 | 3-(5-amino-2-methyl-4-oxoquinazolin-3(4H)-yl)piperidine-2,6-dione |
| D000077594 | Nivolumab |
| ID | Term |
|---|---|
| D061067 | Antibodies, Monoclonal, Humanized |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
| D007162 | Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |
Not provided
Not provided
| Male |
|
| Not Hispanic or Latino |
|
| Unknown or Not Reported |
|
| White |
|
| Not collected or reported |
|
|
|
| Units | Counts |
|---|---|
| Participants |
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| Units | Counts |
|---|---|
| Participants |
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| Units | Counts |
|---|---|
| Participants |
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CC-122 4.0 mg orally 5 consecutive days out of 7 (5 days on/2 days off weekly) on Days 1 to 5, 8 to 12, 15 to 19 and 22 to 26 of each 28-day cycle, and nivolumab 3.0 mg/kg intravenously (IV) every 2 weeks. |
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