A Phase 1/2 interventional study of Nivolumab in Solid Tumors, sponsored by Bristol-Myers Squibb. Completed at 2 sites in China. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2022-10-24.
Sponsored by Bristol-Myers Squibb · Phase 1/2, Interventional, and Treatment
The purpose of this study is to determine whether nivolumab is safe and effective in the treatment of advanced or recurrent solid tumors in Chinese subjects.
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Exclusion Criteria:
Nivolumab specified dose on specified days
Drug: Nivolumab
Nivolumab specified dose on specified days
Drug: Nivolumab
The Number of Participants Experiencing Drug-Related Grade 3-4 Adverse Events (AEs)
A drug related 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 drug that has a causal relationship with the treatment. AEs are graded according to National Cancer Institute Common Terminology Criteria for Adverse Events (Version 4.03) (NCI CTCAE) guidelines where Grade 3= Severe and Grade 4= Life-threatening.
Time frame: From first dose to 100 days after last dose (up to approximately 28 months)
The Number of Participants Experiencing Drug-Related Grade 3-4 Serious Adverse Events (SAEs)
A drug related serious adverse event (SAE) is any untoward medical occurrence that at any dose: results in death; is life-threatening; results in persistent or significant disability/incapacity; is a congenital anomaly/birth defect; or is an important medical event that has a casual relationship with the treatment. SAEs are graded according to National Cancer Institute Common Terminology Criteria for Adverse Events (Version 4.03) (NCI CTCAE) guidelines where Grade 3= Severe and Grade 4= Life-threatening.
Time frame: From first dose to 100 days after last dose (up to approximately 28 months)
The Number of Participants Experiencing Abnormal Hepatic Laboratory Test Results
The number of participants with the following laboratory abnormalities from the following on-treatment evaluations: * ALT or AST \> 3 x ULN, \> 5 x ULN, \> 10 x ULN and \> 20 x ULN * Total bilirubin \> 2 x ULN * Concurrent (within 1 day) ALT or AST \> 3 x ULN and total bilirubin \> 2 x ULN * Concurrent (within 30 days) ALT or AST \> 3 x ULN and total bilirubin \> 2 x ULN
Time frame: From first dose to 100 days after last dose (up to approximately 28 months)
The Number of Participants Experiencing Toxicity Grade 3-4 Laboratory Test Results
The number of participants with Grade 3-4 laboratory results according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 4.0. Note: Grade 4 Toxicities not included in the below table if there were no participants that experienced Grade 4 in that category. Grade 3: prolonged recurrence of symptoms following initial improvement; hospitalization indicated for other clinical sequelae \[e.g., renal impairment, pulmonary infiltrates\]. Grade 4: Life-threatening; pressor or ventilatory support indicated.
Time frame: From first dose to 100 days after last dose (up to approximately 28 months)
Best Overall Response (BOR)
Best overall response (BOR) was assessed by the investigator using Response Evaluation Criteria in Solid Tumor (RECIST v1.1). Complete Response (CR) is defined as a disappearance of all target lesions. Partial Response (PR) is defined as at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. Stable Disease (SD) is defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum diameters while on study. Progressive Disease (PD) is defined as at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study).
Time frame: From first dose up to approximately 28 months
Duration of Response (DOR)
Duration of response is defined as the time from the date of first response (CR or PR) to the date of the first documented tumor progression as determined using RECIST 1.1 or death due to any cause, whichever occurs first. Participants who remain alive and have not progressed will be censored on the date of their last tumor assessment. Participants who started subsequent therapy without a prior reported progression will be censored at the last tumor assessment prior to initiation of the subsequent anticancer therapy. Complete response (CR) is defined as a disappearance of all target lesions and partial response (PR) is defined as at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. Other tumor types include: gastric, melanoma, neuroblastoma, colorectal cancer, cervical cancer, duodenal papillary carcinoma, and gallbladder carcinoma.
Time frame: From the date of first response (CR or PR) to the date of the first documented tumor progression or death due to any cause, whichever occurs first. (Up to approximately 28 months)
Objective Response Rate (ORR)
Objective response rate (ORR) is defined as the percentage of all treated participants whose best overall response (BOR) is either a complete response (CR) or partial response (PR) by investigator using Response Evaluation Criteria in Solid Tumor (RECIST v1.1). Complete response (CR) is defined as a disappearance of all target lesions and partial response (PR) is defined as at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. Other tumor types include: gastric, melanoma, neuroblastoma, colorectal cancer, cervical cancer, duodenal papillary carcinoma, and gallbladder carcinoma.
Time frame: From first dose up to approximately 28 months
Response Rate at 24 Weeks
Response rate at 24 weeks is defined as the percentage of all treated participants who have CR or PR by 24 weeks. Complete response (CR) is defined as a disappearance of all target lesions and partial response (PR) is defined as at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. Other tumor types include: gastric, melanoma, neuroblastoma, colorectal cancer, cervical cancer, duodenal papillary carcinoma, and gallbladder carcinoma.
Time frame: Week 24
Disease Control Rate (DCR) at 24 Weeks
Disease control rate (DCR) at 24 weeks is defined as the percentage of all treated participants who have CR, PR or SD by 24 weeks. Complete Response (CR) is defined as a disappearance of all target lesions. Partial Response (PR) is defined as at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. Stable Disease (SD) is defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum diameters while on study. Other tumor types include: gastric, melanoma, neuroblastoma, cervical cancer, duodenal papillary carcinoma, and gallbladder carcinoma.
Time frame: Week 24
The Number of Participants With Positive Anti Drug Antibody (ADA) Assessments at Baseline and Positive or Negative ADA Samples After Treatment
The number of participants with the following anti-drug responses: 1. Baseline ADA positive: all participants with baseline ADA positive samples. 2. ADA Positive: participants that have at least one ADA positive sample relative to baseline at any time after initiation of treatment. 3. ADA negative: participants that have no ADA positive samples after the initiation of treatment.
Time frame: From pre-dose on day 1 Cycle 1 up to participants end of study (up to approximately 28 months)
Cmax - Maximum Observed Serum Concentration
Nivolumab pharmacokinetic parameters are derived from serum concentration versus time data. Cmax is the maximum observed serum concentration over time.
Time frame: Day 1 Cycle 1, 3, 5, 6 (pre-dose, 0.5, 4, 8, 24, 48, 96, 168, hours post dose. Cohort C-D includes also 336 hours post dose)
Tmax - Time of Maximum Observed Serum Concentration
Nivolumab pharmacokinetic parameters are derived from serum concentration versus time data. Tmax is the time of maximum observed serum concentration.
Time frame: Day 1 Cycle 1, 3, 5, 6 (pre-dose, 0.5, 4, 8, 24, 48, 96, 168, hours post dose. Cohort C-D includes also 336 hours post dose)
AUC (0-T)-Area Under the Plasma Concentration-Time Curve
Nivolumab pharmacokinetic parameters are derived from serum concentration versus time data. AUC (0-T) is the area under the plasma concentration-time curve from time zero to the last time of the last quantifiable concentration.
Time frame: Day 1 Cycle 1, 3, 5, 6 (pre-dose, 0.5, 4, 8, 24, 48, 96, 168, hours post dose. Cohort C-D includes also 336 hours post dose)
AUC(TAU) - Area Under the Concentration-Time Curve in One Dosing Interval
Nivolumab pharmacokinetic parameters are derived from serum concentration versus time data. AUC (TAU) is the area under the plasma concentration-time curve in one dosing interval.
Time frame: Day 1 Cycle 1, 3, 5, 6 (pre-dose, 0.5, 4, 8, 24, 48, 96, 168, hours post dose. Cohort C-D includes also 336 hours post dose)
Ceoinf - Serum Concentration Achieved at the End of Study Drug Infusion
Nivolumab pharmacokinetic parameters are derived from serum concentration versus time data. Ceoinf is the serum concentration achieved at the end of study drug infusion.
Time frame: End of infusion on Day 1 of Cycle 1, 3, 5, 6
Ctrough - Trough Observed Serum Concentration at the End of Dosing Interval
Nivolumab pharmacokinetic parameters are derived from serum concentration versus time data. Ctrough is the trough observed serum concentration at the end of dosing interval.
Time frame: Day 1 Cycle 3, 5, 6 (168 hours post dose [Cohort A-B], 336 hours post dose [Cohort C-D])
Ctau - Concentration at the End of Dosing Interval
Nivolumab pharmacokinetic parameters are derived from serum concentration versus time data. Ctau is the concentration at the end of dosing interval.
Time frame: Day 1 Cycle 1, 3, 5, 6 (pre-dose, 0.5, 4, 8, 24, 48, 96, 168, hours post dose. Cohort C-D includes also 336 hours post dose)
T-HALFeff - Effective Elimination Half-Life
Nivolumab pharmacokinetic parameters are derived from serum concentration versus time data. T-HALFeff is the effective elimination half-life that explains the degree of observed AUC accumulation calculated based on ratio of an exposure measure at steady state to that after the first dose (exposure measure includes AUC(TAU), Cmax and Ctau).
Time frame: Day 1 Cycle 3, 5, 6 (pre-dose, 0.5, 4, 8, 24, 48, 96, 168, hours post dose. Cohort C-D includes also 336 hours post dose)
CLT - Total Body Clearance
Nivolumab pharmacokinetic parameters are derived from serum concentration versus time data. CLT is the total body clearance.
Time frame: Day 1 Cycle 3, 5, 6 (pre-dose, 0.5, 4, 8, 24, 48, 96, 168, hours post dose. Cohort C-D includes also 336 hours post dose)
AI - Accumulation Index (Cmax)
Nivolumab pharmacokinetic parameters are derived from serum concentration versus time data. AI of Cmax refers to the accumulation index calculated based on ratio of an exposure measure of Cmax at steady state to that after the first dose.
Time frame: Day 1 Cycle 3, 5, 6 (pre-dose, 0.5, 4, 8, 24, 48, 96, 168, hours post dose. Cohort C-D includes also 336 hours post dose)
AI - Accumulation Index (Ctau)
Nivolumab pharmacokinetic parameters are derived from serum concentration versus time data. AI of Ctau refers to the accumulation index calculated based on ratio of an exposure measure of Ctau at steady state to that after the first dose.
Time frame: Day 1 Cycle 3, 5, 6 (pre-dose, 0.5, 4, 8, 24, 48, 96, 168, hours post dose. Cohort C-D includes also 336 hours post dose)
AI - Accumulation Index (AUC)
Nivolumab pharmacokinetic parameters are derived from serum concentration versus time data. AI of AUC refers to the accumulation index calculated based on ratio of an exposure measure of AUC at steady state to that after the first dose.
Time frame: Day 1 Cycle 3, 5, 6 (pre-dose, 0.5, 4, 8, 24, 48, 96, 168, hours post dose. Cohort C-D includes also 336 hours post dose)
| Milestone | Cohort A: Nivolumab 3 mg/kg Q2W | Cohort B: Nivolumab 240 mg Q2W | Cohort C: Nivolumab 360 mg Q3W | Cohort D: Nivolumab 480 mg Q4W |
|---|---|---|---|---|
| Started | 15 | 20 | 11 | 12 |
| Completed | 0 | 0 | 0 | 0 |
| Not completed | 15 | 20 | 11 | 12 |
| Withdrew: Disease progression | 12 | 16 | 10 | 7 |
| Withdrew: Study drug toxicity | 1 | 0 | 0 | 0 |
| Withdrew: Adverse event unrelated to study drug | 1 | 1 | 1 | 0 |
| Withdrew: Participant request to discontinue study therapy | 0 | 2 | 0 | 0 |
| Withdrew: Other reasons | 1 | 1 | 0 | 5 |
A drug related 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 drug that has a causal relationship with the treatment. AEs are graded according to National Cancer Institute Common Terminology Criteria for Adverse Events (Version 4.03) (NCI CTCAE) guidelines where Grade 3= Severe and Grade 4= Life-threatening.
| Participants | Cohort A: Nivolumab 3 mg/kg Q2W | Cohort B: Nivolumab 240 mg Q2W | Cohort C: Nivolumab 360 mg Q3W | Cohort D: Nivolumab 480 mg Q4W |
|---|---|---|---|---|
| The Number of Participants Experiencing Drug-Related Grade 3-4 Adverse Events (AEs) | 1 | 1 | 0 | 0 |
A drug related serious adverse event (SAE) is any untoward medical occurrence that at any dose: results in death; is life-threatening; results in persistent or significant disability/incapacity; is a congenital anomaly/birth defect; or is an important medical event that has a casual relationship with the treatment. SAEs are graded according to National Cancer Institute Common Terminology Criteria for Adverse Events (Version 4.03) (NCI CTCAE) guidelines where Grade 3= Severe and Grade 4= Life-threatening.
| Participants | Cohort A: Nivolumab 3 mg/kg Q2W | Cohort B: Nivolumab 240 mg Q2W | Cohort C: Nivolumab 360 mg Q3W | Cohort D: Nivolumab 480 mg Q4W |
|---|---|---|---|---|
| The Number of Participants Experiencing Drug-Related Grade 3-4 Serious Adverse Events (SAEs) | 0 | 1 | 0 | 0 |
The number of participants with the following laboratory abnormalities from the following on-treatment evaluations: * ALT or AST \> 3 x ULN, \> 5 x ULN, \> 10 x ULN and \> 20 x ULN * Total bilirubin \> 2 x ULN * Concurrent (within 1 day) ALT or AST \> 3 x ULN and total bilirubin \> 2 x ULN * Concurrent (within 30 days) ALT or AST \> 3 x ULN and total bilirubin \> 2 x ULN
| Participants | Cohort A: Nivolumab 3 mg/kg Q2W | Cohort B: Nivolumab 240 mg Q2W | Cohort C: Nivolumab 360 mg Q3W | Cohort D: Nivolumab 480 mg Q4W |
|---|---|---|---|---|
| ALT OR AST > 3XULN | 0 | 3 | 0 | 1 |
| ALT OR AST> 5XULN | 0 | 2 | 0 | 0 |
| ALT OR AST> 10XULN | 0 | 1 | 0 | 0 |
| ALT OR AST > 20XULN | 0 | 0 | 0 | 0 |
| TOTAL BILIRUBIN > 2XULN | 0 | 3 | 1 | 0 |
| ALT/AST ELEV>3XULN;TOTAL BILIRUBIN>2XULN IN 1 DAY | 0 | 3 | 0 | 0 |
| ALT/AST ELEV>3XULN;TOTAL BILIRUBIN>2XULN IN 30 DAYS | 0 | 3 | 0 | 0 |
Best overall response (BOR) was assessed by the investigator using Response Evaluation Criteria in Solid Tumor (RECIST v1.1). Complete Response (CR) is defined as a disappearance of all target lesions. Partial Response (PR) is defined as at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. Stable Disease (SD) is defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum diameters while on study. Progressive Disease (PD) is defined as at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study).
| Participants | Cohort A: Nivolumab 3 mg/kg Q2W | Cohort B: Nivolumab 240 mg Q2W | Cohort C: Nivolumab 360 mg Q3W | Cohort D: Nivolumab 480 mg Q4W |
|---|---|---|---|---|
| Complete Response | 0 | 0 | 0 | 0 |
| Partial Response | 3 | 2 | 1 | 2 |
| Stable Disease | 2 | 12 | 6 | 6 |
| Progressive Disease | 9 | 5 | 4 | 4 |
| Unable to Determine | 1 | 1 | 0 | 0 |
Duration of response is defined as the time from the date of first response (CR or PR) to the date of the first documented tumor progression as determined using RECIST 1.1 or death due to any cause, whichever occurs first. Participants who remain alive and have not progressed will be censored on the date of their last tumor assessment. Participants who started subsequent therapy without a prior reported progression will be censored at the last tumor assessment prior to initiation of the subsequent anticancer therapy. Complete response (CR) is defined as a disappearance of all target lesions and partial response (PR) is defined as at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. Other tumor types include: gastric, melanoma, neuroblastoma, colorectal cancer, cervical cancer, duodenal papillary carcinoma, and gallbladder carcinoma.
| Weeks | Cohort A: Nivolumab 3 mg/kg Q2W | Cohort B: Nivolumab 240 mg Q2W | Cohort C: Nivolumab 360 mg Q3W | Cohort D: Nivolumab 480 mg Q4W |
|---|---|---|---|---|
| Hepatocellular carcinoma | — | — | — | NA (95.3 to 95.3) |
| Non-small cell lung carcinoma (NSCLC) | NA (8.3 to 8.3) | — | 6.1 (6.1 to 6.1) | — |
| Nasopharyngeal carcinoma | NA (48.7 to 75.7) | NA (34.1 to 81.1) | — | NA (83.3 to 83.3) |
Objective response rate (ORR) is defined as the percentage of all treated participants whose best overall response (BOR) is either a complete response (CR) or partial response (PR) by investigator using Response Evaluation Criteria in Solid Tumor (RECIST v1.1). Complete response (CR) is defined as a disappearance of all target lesions and partial response (PR) is defined as at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. Other tumor types include: gastric, melanoma, neuroblastoma, colorectal cancer, cervical cancer, duodenal papillary carcinoma, and gallbladder carcinoma.
| Percent of participants | Cohort A: Nivolumab 3 mg/kg Q2W | Cohort B: Nivolumab 240 mg Q2W | Cohort C: Nivolumab 360 mg Q3W | Cohort D: Nivolumab 480 mg Q4W |
|---|---|---|---|---|
| Hepatocellular carcinoma | — | 0 (NA to NA) | — | 100 (NA to NA) |
| Non-small cell lung carcinoma (NSCLC) | 11.1 (NA to NA) | 0 (NA to NA) | 100 (NA to NA) | 0 (NA to NA) |
| Nasopharyngeal carcinoma | 33.3 (NA to NA) | 11.8 (1.5 to 36.4) | 0 (0.0 to 30.8) | 100 (NA to NA) |
| Other tumor types | — | — | — | 0 (NA to NA) |
Response rate at 24 weeks is defined as the percentage of all treated participants who have CR or PR by 24 weeks. Complete response (CR) is defined as a disappearance of all target lesions and partial response (PR) is defined as at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. Other tumor types include: gastric, melanoma, neuroblastoma, colorectal cancer, cervical cancer, duodenal papillary carcinoma, and gallbladder carcinoma.
| Percent of participants | Cohort A: Nivolumab 3 mg/kg Q2W | Cohort B: Nivolumab 240 mg Q2W | Cohort C: Nivolumab 360 mg Q3W | Cohort D: Nivolumab 480 mg Q4W |
|---|---|---|---|---|
| Hepatocellular carcinoma | — | 0 (NA to NA) | — | 100 (NA to NA) |
| Non-small cell lung carcinoma (NSCLC) | 11.1 (NA to NA) | 0 (NA to NA) | 100 (NA to NA) | 0 (NA to NA) |
| Nasopharyngeal carcinoma | 33.3 (NA to NA) | 5.9 (0.1 to 28.7) | 0 (0.0 to 30.8) | 100 (NA to NA) |
| Other tumor types | — | — | — | 0 (NA to NA) |
Disease control rate (DCR) at 24 weeks is defined as the percentage of all treated participants who have CR, PR or SD by 24 weeks. Complete Response (CR) is defined as a disappearance of all target lesions. Partial Response (PR) is defined as at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. Stable Disease (SD) is defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum diameters while on study. Other tumor types include: gastric, melanoma, neuroblastoma, cervical cancer, duodenal papillary carcinoma, and gallbladder carcinoma.
| Percent of participants | Cohort A: Nivolumab 3 mg/kg Q2W | Cohort B: Nivolumab 240 mg Q2W | Cohort C: Nivolumab 360 mg Q3W | Cohort D: Nivolumab 480 mg Q4W |
|---|---|---|---|---|
| Colorectal Cancer | — | — | — | 100 (NA to NA) |
| Hepatocellular carcinoma | — | 0 (NA to NA) | — | 100 (NA to NA) |
| Non-small cell lung carcinoma (NSCLC) | 11.1 (NA to NA) | 0 (NA to NA) | 100 (NA to NA) | 66.7 (NA to NA) |
| Nasopharyngeal carcinoma | 33.3 (NA to NA) | 23.5 (6.8 to 49.9) | 20.0 (2.5 to 55.6) | 100 (NA to NA) |
| Other tumor types | — | — | — | 0 (NA to NA) |
The number of participants with the following anti-drug responses: 1. Baseline ADA positive: all participants with baseline ADA positive samples. 2. ADA Positive: participants that have at least one ADA positive sample relative to baseline at any time after initiation of treatment. 3. ADA negative: participants that have no ADA positive samples after the initiation of treatment.
| Participants | Cohort A: Nivolumab 3 mg/kg Q2W | Cohort B: Nivolumab 240 mg Q2W | Cohort C: Nivolumab 360 mg Q3W | Cohort D: Nivolumab 480 mg Q4W |
|---|---|---|---|---|
| ADA positive sample at baseline | 1 | 4 | 0 | 0 |
| ADA positive sample after initiation of treatment | 1 | 0 | 0 | 2 |
| ADA Negative sample after initiation of treatment | 12 | 19 | 10 | 10 |
Nivolumab pharmacokinetic parameters are derived from serum concentration versus time data. Cmax is the maximum observed serum concentration over time.
| ug/mL | Cohort A: Nivolumab 3 mg/kg Q2W | Cohort B: Nivolumab 240 mg Q2W | Cohort C: Nivolumab 360 mg Q3W | Cohort D: Nivolumab 480 mg Q4W |
|---|---|---|---|---|
| Cycle 1 Day 1 | 57.025 ± NA | 77.674 ± NA | 108.455 ± NA | 206.630 ± NA |
| Cycle 3 Day 1 | 132.222 ± NA | 171.604 ± NA | — | — |
| Cycle 5 Day 1 | — | — | — | 265.550 ± NA |
| Cycle 6 Day 1 | — | — | 165.369 ± NA | — |
Nivolumab pharmacokinetic parameters are derived from serum concentration versus time data. Tmax is the time of maximum observed serum concentration.
| h | Cohort A: Nivolumab 3 mg/kg Q2W | Cohort B: Nivolumab 240 mg Q2W | Cohort C: Nivolumab 360 mg Q3W | Cohort D: Nivolumab 480 mg Q4W |
|---|---|---|---|---|
| Cycle 1 Day 1 | 4.00 (0.5 to 4.0) | 4.00 (0.5 to 8.0) | 4.0 (4.0 to 8.0) | 4.01 (0.5 to 8.0) |
| Cycle 3 Day 1 | 8.00 (4.0 to 48.2) | 8.00 (4.0 to 48.0) | — | — |
| Cycle 5 Day 1 | — | — | — | 2.26 (0.5 to 8.0) |
| Cycle 6 Day 1 | — | — | 8.00 (0.5 to 24.1) | — |
Nivolumab pharmacokinetic parameters are derived from serum concentration versus time data. AUC (0-T) is the area under the plasma concentration-time curve from time zero to the last time of the last quantifiable concentration.
| h*ug/mL | Cohort A: Nivolumab 3 mg/kg Q2W | Cohort B: Nivolumab 240 mg Q2W | Cohort C: Nivolumab 360 mg Q3W | Cohort D: Nivolumab 480 mg Q4W |
|---|---|---|---|---|
| Cycle 1 Day 1 | 8353.429 ± NA | 11646.854 ± NA | 23567.315 ± NA | 49115.208 ± NA |
| Cycle 3 Day 1 | 28442.153 ± NA | 35649.049 ± NA | — | — |
| Cycle 5 Day 1 | — | — | — | 91967.438 ± NA |
| Cycle 6 Day 1 | — | — | 51087.588 ± NA | — |
Nivolumab pharmacokinetic parameters are derived from serum concentration versus time data. AUC (TAU) is the area under the plasma concentration-time curve in one dosing interval.
| h*ug/mL | Cohort A: Nivolumab 3 mg/kg Q2W | Cohort B: Nivolumab 240 mg Q2W | Cohort C: Nivolumab 360 mg Q3W | Cohort D: Nivolumab 480 mg Q4W |
|---|---|---|---|---|
| Cycle 1 Day 1 | 8732.232 ± NA | 12112.137 ± NA | 23567.315 ± NA | 49115.208 ± NA |
| Cycle 3 Day 1 | 30823.993 ± NA | 37794.083 ± NA | — | — |
| Cycle 5 Day 1 | — | — | — | 100655.626 ± NA |
| Cycle 6 Day 1 | — | — | 53162.102 ± NA | — |
Nivolumab pharmacokinetic parameters are derived from serum concentration versus time data. Ceoinf is the serum concentration achieved at the end of study drug infusion.
| ug/mL | Cohort A: Nivolumab 3 mg/kg Q2W | Cohort B: Nivolumab 240 mg Q2W | Cohort C: Nivolumab 360 mg Q3W | Cohort D: Nivolumab 480 mg Q4W |
|---|---|---|---|---|
| Cycle 1 Day 1 | 55.020 ± NA | 66.746 ± NA | 93.168 ± NA | 171.494 ± NA |
| Cycle 3 Day 1 | 122.051 ± NA | 152.058 ± NA | — | — |
| Cycle 5 Day 1 | — | — | — | 254.704 ± NA |
| Cycle 6 Day 1 | — | — | 155.811 ± NA | — |
Nivolumab pharmacokinetic parameters are derived from serum concentration versus time data. Ctrough is the trough observed serum concentration at the end of dosing interval.
| ug/mL | Cohort A: Nivolumab 3 mg/kg Q2W | Cohort B: Nivolumab 240 mg Q2W | Cohort C: Nivolumab 360 mg Q3W | Cohort D: Nivolumab 480 mg Q4W |
|---|---|---|---|---|
| Cycle 3 Day 1 | 62.417 ± NA | 62.115 ± NA | — | — |
| Cycle 5 Day 1 | — | — | — | 92.796 ± NA |
| Cycle 6 Day 1 | — | — | 61.530 ± NA | — |
Nivolumab pharmacokinetic parameters are derived from serum concentration versus time data. Ctau is the concentration at the end of dosing interval.
| ug/mL | Cohort A: Nivolumab 3 mg/kg Q2W | Cohort B: Nivolumab 240 mg Q2W | Cohort C: Nivolumab 360 mg Q3W | Cohort D: Nivolumab 480 mg Q4W |
|---|---|---|---|---|
| Cycle 1 Day 1 | 16.430 ± NA | 20.788 ± NA | 26.143 ± NA | 40.910 ± NA |
| Cycle 3 Day 1 | 65.286 ± NA | 78.278 ± NA | — | — |
| Cycle 5 Day 1 | — | — | — | 90.201 ± NA |
| Cycle 6 Day 1 | — | — | 65.762 ± NA | — |
Nivolumab pharmacokinetic parameters are derived from serum concentration versus time data. T-HALFeff is the effective elimination half-life that explains the degree of observed AUC accumulation calculated based on ratio of an exposure measure at steady state to that after the first dose (exposure measure includes AUC(TAU), Cmax and Ctau).
| h | Cohort A: Nivolumab 3 mg/kg Q2W | Cohort B: Nivolumab 240 mg Q2W | Cohort C: Nivolumab 360 mg Q3W | Cohort D: Nivolumab 480 mg Q4W |
|---|---|---|---|---|
| Cycle 3 Day 1 | 551.194 ± NA | 510.262 ± NA | — | — |
| Cycle 5 Day 1 | — | — | — | 732.44 ± NA |
| Cycle 6 Day 1 | — | — | 677.642 ± NA | — |
Nivolumab pharmacokinetic parameters are derived from serum concentration versus time data. CLT is the total body clearance.
| mL/hr | Cohort A: Nivolumab 3 mg/kg Q2W | Cohort B: Nivolumab 240 mg Q2W | Cohort C: Nivolumab 360 mg Q3W | Cohort D: Nivolumab 480 mg Q4W |
|---|---|---|---|---|
| Cycle 3 Day 1 | 5.732 ± NA | 6.350 ± NA | — | — |
| Cycle 5 Day 1 | — | — | — | 4.769 ± NA |
| Cycle 6 Day 1 | — | — | 6.772 ± NA | — |
Nivolumab pharmacokinetic parameters are derived from serum concentration versus time data. AI of Cmax refers to the accumulation index calculated based on ratio of an exposure measure of Cmax at steady state to that after the first dose.
| (ug/mL)/(ug/mL) | Cohort A: Nivolumab 3 mg/kg Q2W | Cohort B: Nivolumab 240 mg Q2W | Cohort C: Nivolumab 360 mg Q3W | Cohort D: Nivolumab 480 mg Q4W |
|---|---|---|---|---|
| Cycle 3 Day 1 | 2.150 ± NA | 2.034 ± NA | — | — |
| Cycle 5 Day 1 | — | — | — | 1.255 ± NA |
| Cycle 6 Day 1 | — | — | 1.613 ± NA | — |
Nivolumab pharmacokinetic parameters are derived from serum concentration versus time data. AI of Ctau refers to the accumulation index calculated based on ratio of an exposure measure of Ctau at steady state to that after the first dose.
| (ug/mL)/(ug/mL) | Cohort A: Nivolumab 3 mg/kg Q2W | Cohort B: Nivolumab 240 mg Q2W | Cohort C: Nivolumab 360 mg Q3W | Cohort D: Nivolumab 480 mg Q4W |
|---|---|---|---|---|
| Cycle 3 Day 1 | 3.333 ± NA | 3.215 ± NA | — | — |
| Cycle 5 Day 1 | — | — | — | 2.053 ± NA |
| Cycle 6 Day 1 | — | — | 2.675 ± NA | — |
Nivolumab pharmacokinetic parameters are derived from serum concentration versus time data. AI of AUC refers to the accumulation index calculated based on ratio of an exposure measure of AUC at steady state to that after the first dose.
| (hr*ug/mL)/(hr*ug/mL) | Cohort A: Nivolumab 3 mg/kg Q2W | Cohort B: Nivolumab 240 mg Q2W | Cohort C: Nivolumab 360 mg Q3W | Cohort D: Nivolumab 480 mg Q4W |
|---|---|---|---|---|
| Cycle 3 Day 1 | 2.942 ± NA | 2.707 ± NA | — | — |
| Cycle 5 Day 1 | — | — | — | 2.033 ± NA |
| Cycle 6 Day 1 | — | — | 2.389 ± NA | — |
The number of participants with Grade 3-4 laboratory results according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 4.0. Note: Grade 4 Toxicities not included in the below table if there were no participants that experienced Grade 4 in that category. Grade 3: prolonged recurrence of symptoms following initial improvement; hospitalization indicated for other clinical sequelae \[e.g., renal impairment, pulmonary infiltrates\]. Grade 4: Life-threatening; pressor or ventilatory support indicated.
| Participants | Cohort A: Nivolumab 3 mg/kg Q2W | Cohort B: Nivolumab 240 mg Q2W | Cohort C: Nivolumab 360 mg Q3W | Cohort D: Nivolumab 480 mg Q4W |
|---|---|---|---|---|
| HEMOGLOBIN (Grade 3) | 1 | 2 | 0 | 1 |
| PLATELET COUNT (Grade 3) | 0 | 0 | 0 | 1 |
| PLATELET COUNT (Grade 4) | 0 | 0 | 0 | 1 |
| LEUKOCYTES (Grade 3) | 0 | 0 | 2 | 0 |
| LYMPHOCYTES (ABSOLUTE) (Grade 3) | 0 | 2 | 0 | 1 |
| ABSOLUTE NEUTROPHIL COUNT (Grade 3) | 0 | 0 | 2 | 0 |
| ALKALINE PHOSPHATASE (Grade 3) | 2 | 3 | 0 | 0 |
| ASPARTATE AMINOTRANSFERASE (Grade 3) | 0 | 2 | 0 | 0 |
| ALANINE AMINOTRANSFERASE (Grade 3) | 0 | 2 | 0 | 0 |
| BILIRUBIN, TOTAL (Grade 3) | 0 | 1 | 1 | 0 |
| BILIRUBIN, TOTAL (Grade 4) | 0 | 1 | 0 | 0 |
Collected over All-cause mortality was assessed from participants first dose to their study completion (up to approximately 28 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to an approximately 14 months, maximum of 28 months). Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Cohort A: Nivolumab 3 mg/kg Q2W | 4/15 (26.7%) | 6/15 (40%) | 14/15 (93.3%) |
| Cohort B: Nivolumab 240 mg Q2W | 7/20 (35%) | 8/20 (40%) | 20/20 (100%) |
| Cohort C: Nivolumab 360 mg Q3W | 0/11 (0%) | 2/11 (18.2%) | 11/11 (100%) |
| Cohort D: Nivolumab 480 mg Q4W | 1/12 (8.3%) | 7/12 (58.3%) | 12/12 (100%) |
| Event | Cohort A: Nivolumab 3 mg/kg Q2W | Cohort B: Nivolumab 240 mg Q2W | Cohort C: Nivolumab 360 mg Q3W | Cohort D: Nivolumab 480 mg Q4W |
|---|---|---|---|---|
| Malignant neoplasm progressionNeoplasms benign, malignant and unspecified (incl cysts and polyps) | 3/15 | 4/20 | 0/11 | 1/12 |
| PneumoniaInfections and infestations | 0/15 | 2/20 | 0/11 | 1/12 |
| AppendicitisInfections and infestations | 0/15 | 0/20 | 1/11 | 0/12 |
| Muscular weaknessMusculoskeletal and connective tissue disorders | 0/15 | 0/20 | 1/11 | 0/12 |
| Optic neuropathyEye disorders | 0/15 | 0/20 | 0/11 | 1/12 |
| Intestinal obstructionGastrointestinal disorders | 0/15 | 0/20 | 0/11 | 1/12 |
| AstheniaGeneral disorders | 0/15 | 0/20 | 0/11 | 1/12 |
| Tracheal haemorrhageInjury, poisoning and procedural complications | 0/15 | 0/20 | 0/11 | 1/12 |
| Platelet count decreasedInvestigations | 0/15 | 0/20 | 0/11 | 1/12 |
| Decreased appetiteMetabolism and nutrition disorders | 0/15 | 0/20 | 0/11 | 1/12 |
| Event | Cohort A: Nivolumab 3 mg/kg Q2W | Cohort B: Nivolumab 240 mg Q2W | Cohort C: Nivolumab 360 mg Q3W | Cohort D: Nivolumab 480 mg Q4W |
|---|---|---|---|---|
| HypothyroidismEndocrine disorders | 2/15 | 6/20 | 6/11 | 0/12 |
| PyrexiaGeneral disorders | 1/15 | 4/20 | 4/11 | 2/12 |
| C-reactive protein increasedInvestigations | 0/15 | 2/20 | 4/11 | 0/12 |
| RashSkin and subcutaneous tissue disorders | 5/15 | 3/20 | 4/11 | 1/12 |
| AnaemiaBlood and lymphatic system disorders | 3/15 | 4/20 | 3/11 | 4/12 |
| Decreased appetiteMetabolism and nutrition disorders | 5/15 | 2/20 | 1/11 | 1/12 |
| MalaiseGeneral disorders | 3/15 | 6/20 | 0/11 | 0/12 |
| Upper respiratory tract infectionInfections and infestations | 1/15 | 6/20 | 1/11 | 1/12 |
| Alanine aminotransferase increasedInvestigations | 3/15 | 6/20 | 1/11 | 2/12 |
| Aspartate aminotransferase increasedInvestigations | 1/15 | 6/20 | 1/11 | 2/12 |
| Age, Customized(Participants) | Cohort A: Nivolumab 3 mg/kg Q2W | Cohort B: Nivolumab 240 mg Q2W | Cohort C: Nivolumab 360 mg Q3W | Cohort D: Nivolumab 480 mg Q4W | Total |
|---|---|---|---|---|---|
| > 65 | 15 | 20 | 10 | 9 | 54 |
| >= 65 | 0 | 0 | 1 | 3 | 4 |
| Sex: Female, Male(Participants) | Cohort A: Nivolumab 3 mg/kg Q2W | Cohort B: Nivolumab 240 mg Q2W | Cohort C: Nivolumab 360 mg Q3W | Cohort D: Nivolumab 480 mg Q4W | Total |
|---|---|---|---|---|---|
| Female | 4 | 7 | 4 | 5 | 20 |
| Male | 11 | 13 | 7 | 7 | 38 |
| Race (NIH/OMB)(Participants) | Cohort A: Nivolumab 3 mg/kg Q2W | Cohort B: Nivolumab 240 mg Q2W | Cohort C: Nivolumab 360 mg Q3W | Cohort D: Nivolumab 480 mg Q4W | Total |
|---|---|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 | 0 | 0 |
| Asian | 15 | 20 | 11 | 12 | 58 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 | 0 | 0 |
| Black or African American | 0 | 0 | 0 | 0 | 0 |
| White | 0 | 0 | 0 | 0 | 0 |
| More than one race | 0 | 0 | 0 | 0 | 0 |
| Unknown or Not Reported | 0 | 0 | 0 | 0 | 0 |
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Bristol-Myers Squibb