Carcinoma, Hepatocellular
Conditions
Keywords
CC-122, Nivolumab, Hepatocellular Carcinoma, Phase 1/2, Safety
Brief summary
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.
Detailed description
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.
Interventions
DRUGCC-122
DRUGNivolumab
Sponsors
Celgene
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Subjects must satisfy the following criteria to be enrolled in the study: * Subject is ≥ 18 years of age at the time of signing the informed consent form (ICF) * Subject has a confirmed pathologic diagnosis of Hepatocellular carcinoma (HCC) according to the American Association for the Study of Liver Diseases (AASLD) Guidelines. * Subjects who have progressed after or were intolerant to no more than 2 previous systemic therapies for unresectable HCC, or are naïve to systemic therapy. * Subject has at least one measurable lesion according to RECIST 1.1. * Subject has a life expectancy of ≥ 12 weeks * Subject has an Eastern Cooperative Oncology Group Performance Status (ECOG PS) of 0 or 1 * Subject has adequate hematologic function and adequate hepatic function at screening
Exclusion criteria
* The presence of any of the following will exclude a subject from enrollment: * Subject has received more than 2 previous systemic therapies for Hepatocellular carcinoma (HCC). * Subject has received previous treatment with any anti-PD-1 (Programmed death 1) or anti-PD-L1 (PD-1 ligand receptor) antibody
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of Dose Limiting Toxicities (DLTs) | 28 days | 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. |
| Incidence and Severity of Treatment-Emergent Adverse Events (TEAEs) | From first dose up to 28 days (CC-122) or 90 days (nivolumab) post-last dose (up to 2 years) | 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. |
| Objective Response Rate (ORR) by Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) | up to 2 years | 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). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Overall Survival (OS) by RECIST 1.1 | up to 2 years | 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. |
| Time to Progression (TTP) by RECIST 1.1 | up to 2 years | 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. |
| Maximum Observed Concentration (Cmax) | 28 days | 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. |
| Disease Control Rate (DCR) by RECIST 1.1 | up to 2 years | 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). |
| Time to Maximum Concentration (Tmax) | 28 days | 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. |
| Terminal Half-life (T-HALF) | 28 days | 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. |
| Apparent Volume of Distribution (Vz/F) | 28 days | 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. |
| Area Under the Concentration Time Curve (AUC) | 28 days | 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. |
| Duration of Response (DoR) by RECIST 1.1 | up to 2 years | 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. |
| Progression-Free Survival (PFS) by RECIST 1.1 | up to 2 years | 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. |
Countries
France, Italy, Spain, United States
Participant flow
Pre-assignment details
21 participants treated
Participants by arm
| Arm | Count |
|---|---|
| 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. | 7 |
| 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. | 9 |
| 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 |
| Total | 21 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Overall Study | Death | 4 | 6 | 5 |
| Overall Study | Other reasons | 3 | 3 | 0 |
Baseline characteristics
| Characteristic | Total | CC-122 4mg + Nivolumab | CC-122 3mg + Nivolumab | CC-122 2mg + Nivolumab |
|---|---|---|---|---|
| Age, Continuous | 63.0 Years STANDARD_DEVIATION 10.65 | 66.4 Years STANDARD_DEVIATION 10.06 | 60.4 Years STANDARD_DEVIATION 11.75 | 63.9 Years STANDARD_DEVIATION 10.32 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 12 Participants | 5 Participants | 3 Participants | 4 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 9 Participants | 0 Participants | 6 Participants | 3 Participants |
| Race/Ethnicity, Customized Black or African American | 1 Participants | 0 Participants | 1 Participants | 0 Participants |
| Race/Ethnicity, Customized Not collected or reported | 9 Participants | 0 Participants | 6 Participants | 3 Participants |
| Race/Ethnicity, Customized White | 11 Participants | 5 Participants | 2 Participants | 4 Participants |
| Sex: Female, Male Female | 2 Participants | 1 Participants | 1 Participants | 0 Participants |
| Sex: Female, Male Male | 19 Participants | 4 Participants | 8 Participants | 7 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 4 / 7 | 6 / 9 | 5 / 5 |
| other Total, other adverse events | 7 / 7 | 9 / 9 | 5 / 5 |
| serious Total, serious adverse events | 6 / 7 | 5 / 9 | 4 / 5 |
Outcome results
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.
Time frame: From first dose up to 28 days (CC-122) or 90 days (nivolumab) post-last dose (up to 2 years)
Population: All treated participants
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| CC-122 2mg + Nivolumab | Incidence and Severity of Treatment-Emergent Adverse Events (TEAEs) | Participants with Grade 3-4 TEAEs | 7 Number of participants |
| CC-122 2mg + Nivolumab | Incidence and Severity of Treatment-Emergent Adverse Events (TEAEs) | Participants with TEAE leading to discontinuation of CC-122 | 2 Number of participants |
| CC-122 2mg + Nivolumab | Incidence and Severity of Treatment-Emergent Adverse Events (TEAEs) | Participants with serious TEAEs | 6 Number of participants |
| CC-122 2mg + Nivolumab | Incidence and Severity of Treatment-Emergent Adverse Events (TEAEs) | TEAEs | 7 Number of participants |
| CC-122 2mg + Nivolumab | Incidence and Severity of Treatment-Emergent Adverse Events (TEAEs) | Participants with TEAE leading to discontinuation of both study drugs | 1 Number of participants |
| CC-122 2mg + Nivolumab | Incidence and Severity of Treatment-Emergent Adverse Events (TEAEs) | Participants with TEAE leading to discontinuation of nivolumab | 1 Number of participants |
| CC-122 2mg + Nivolumab | Incidence and Severity of Treatment-Emergent Adverse Events (TEAEs) | Participants with Grade 5 TEAEs | 2 Number of participants |
| CC-122 3mg + Nivolumab | Incidence and Severity of Treatment-Emergent Adverse Events (TEAEs) | Participants with serious TEAEs | 5 Number of participants |
| CC-122 3mg + Nivolumab | Incidence and Severity of Treatment-Emergent Adverse Events (TEAEs) | TEAEs | 9 Number of participants |
| CC-122 3mg + Nivolumab | Incidence and Severity of Treatment-Emergent Adverse Events (TEAEs) | Participants with Grade 3-4 TEAEs | 6 Number of participants |
| CC-122 3mg + Nivolumab | Incidence and Severity of Treatment-Emergent Adverse Events (TEAEs) | Participants with Grade 5 TEAEs | 0 Number of participants |
| CC-122 3mg + Nivolumab | Incidence and Severity of Treatment-Emergent Adverse Events (TEAEs) | Participants with TEAE leading to discontinuation of CC-122 | 1 Number of participants |
| CC-122 3mg + Nivolumab | Incidence and Severity of Treatment-Emergent Adverse Events (TEAEs) | Participants with TEAE leading to discontinuation of nivolumab | 1 Number of participants |
| CC-122 3mg + Nivolumab | Incidence and Severity of Treatment-Emergent Adverse Events (TEAEs) | Participants with TEAE leading to discontinuation of both study drugs | 1 Number of participants |
| CC-122 4mg + Nivolumab | Incidence and Severity of Treatment-Emergent Adverse Events (TEAEs) | Participants with TEAE leading to discontinuation of CC-122 | 3 Number of participants |
| CC-122 4mg + Nivolumab | Incidence and Severity of Treatment-Emergent Adverse Events (TEAEs) | Participants with Grade 3-4 TEAEs | 4 Number of participants |
| CC-122 4mg + Nivolumab | Incidence and Severity of Treatment-Emergent Adverse Events (TEAEs) | Participants with TEAE leading to discontinuation of both study drugs | 2 Number of participants |
| CC-122 4mg + Nivolumab | Incidence and Severity of Treatment-Emergent Adverse Events (TEAEs) | Participants with TEAE leading to discontinuation of nivolumab | 3 Number of participants |
| CC-122 4mg + Nivolumab | Incidence and Severity of Treatment-Emergent Adverse Events (TEAEs) | Participants with serious TEAEs | 4 Number of participants |
| CC-122 4mg + Nivolumab | Incidence and Severity of Treatment-Emergent Adverse Events (TEAEs) | Participants with Grade 5 TEAEs | 3 Number of participants |
| CC-122 4mg + Nivolumab | Incidence and Severity of Treatment-Emergent Adverse Events (TEAEs) | TEAEs | 5 Number of participants |
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.
Time frame: 28 days
Population: All treated participants
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| CC-122 2mg + Nivolumab | Incidence of Dose Limiting Toxicities (DLTs) | 1 Participants |
| CC-122 3mg + Nivolumab | Incidence of Dose Limiting Toxicities (DLTs) | 1 Participants |
| CC-122 4mg + Nivolumab | Incidence of Dose Limiting Toxicities (DLTs) | 2 Participants |
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).
Time frame: up to 2 years
Population: All treated participants
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| CC-122 2mg + Nivolumab | Objective Response Rate (ORR) by Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) | 42.9 Percentage of participants |
| CC-122 3mg + Nivolumab | Objective Response Rate (ORR) by Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) | 0 Percentage of participants |
| CC-122 4mg + Nivolumab | Objective Response Rate (ORR) by Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) | 0 Percentage of participants |
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.
Time frame: 28 days
Population: 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.
| Arm | Measure | Value (GEOMETRIC_MEAN) |
|---|---|---|
| CC-122 3mg + Nivolumab | Apparent Volume of Distribution (Vz/F) | 40.1 liter |
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.
Time frame: 28 days
Population: 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.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| CC-122 2mg + Nivolumab | Area Under the Concentration Time Curve (AUC) | 235.3 h*ng/mL | Geometric Coefficient of Variation 17.3 |
| CC-122 3mg + Nivolumab | Area Under the Concentration Time Curve (AUC) | 399.8 h*ng/mL | Geometric Coefficient of Variation 29.7 |
| CC-122 4mg + Nivolumab | Area Under the Concentration Time Curve (AUC) | 257.9 h*ng/mL | — |
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).
Time frame: up to 2 years
Population: All treated participants
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| CC-122 2mg + Nivolumab | Disease Control Rate (DCR) by RECIST 1.1 | 71.4 Percentage of participants |
| CC-122 3mg + Nivolumab | Disease Control Rate (DCR) by RECIST 1.1 | 44.4 Percentage of participants |
| CC-122 4mg + Nivolumab | Disease Control Rate (DCR) by RECIST 1.1 | 80.0 Percentage of participants |
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.
Time frame: up to 2 years
Population: All treated participants
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| CC-122 2mg + Nivolumab | Duration of Response (DoR) by RECIST 1.1 | NA Days |
| CC-122 3mg + Nivolumab | Duration of Response (DoR) by RECIST 1.1 | NA Days |
| CC-122 4mg + Nivolumab | Duration of Response (DoR) by RECIST 1.1 | NA Days |
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.
Time frame: 28 days
Population: 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.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| CC-122 2mg + Nivolumab | Maximum Observed Concentration (Cmax) | 56.3 ng/mL | Geometric Coefficient of Variation 48.4 |
| CC-122 3mg + Nivolumab | Maximum Observed Concentration (Cmax) | 81.0 ng/mL | Geometric Coefficient of Variation 32.8 |
| CC-122 4mg + Nivolumab | Maximum Observed Concentration (Cmax) | 82.6 ng/mL | — |
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.
Time frame: up to 2 years
Population: All treated participants
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| CC-122 2mg + Nivolumab | Overall Survival (OS) by RECIST 1.1 | 320.0 Days |
| CC-122 3mg + Nivolumab | Overall Survival (OS) by RECIST 1.1 | 303.0 Days |
| CC-122 4mg + Nivolumab | Overall Survival (OS) by RECIST 1.1 | 135.0 Days |
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.
Time frame: up to 2 years
Population: All treated participants
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| CC-122 2mg + Nivolumab | Progression-Free Survival (PFS) by RECIST 1.1 | 130.0 Days |
| CC-122 3mg + Nivolumab | Progression-Free Survival (PFS) by RECIST 1.1 | 95.0 Days |
| CC-122 4mg + Nivolumab | Progression-Free Survival (PFS) by RECIST 1.1 | 122.0 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.
Time frame: 28 days
Population: 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.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| CC-122 2mg + Nivolumab | Terminal Half-life (T-HALF) | 8.4 hour | Geometric Coefficient of Variation 61.4 |
| CC-122 3mg + Nivolumab | Terminal Half-life (T-HALF) | 6.4 hour | Geometric Coefficient of Variation 42.1 |
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.
Time frame: 28 days
Population: 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.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| CC-122 2mg + Nivolumab | Time to Maximum Concentration (Tmax) | 0.5 hour |
| CC-122 3mg + Nivolumab | Time to Maximum Concentration (Tmax) | 1.0 hour |
| CC-122 4mg + Nivolumab | Time to Maximum Concentration (Tmax) | 1.0 hour |
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.
Time frame: up to 2 years
Population: All treated participants
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| CC-122 2mg + Nivolumab | Time to Progression (TTP) by RECIST 1.1 | NA Days |
| CC-122 3mg + Nivolumab | Time to Progression (TTP) by RECIST 1.1 | 95.0 Days |
| CC-122 4mg + Nivolumab | Time to Progression (TTP) by RECIST 1.1 | 166.0 Days |