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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Nivolumab monotherapy | Experimental | Nivolumab specified dose on specified days |
|
| Cohort Expansion | Experimental | Nivolumab specified dose on specified days |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Nivolumab | Drug |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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. | 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:
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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). |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Bristol Myers Squibb | Bristol-Myers Squibb | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Local Institution - 0001 | Guangzhou | Guangdong | 510060 | China | ||
| Local Institution |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 31048330 | Derived | Ma Y, Fang W, Zhang Y, Yang Y, Hong S, Zhao Y, Tendolkar A, Chen L, Xu D, Sheng J, Zhao H, Zhang L. A Phase I/II Open-Label Study of Nivolumab in Previously Treated Advanced or Recurrent Nasopharyngeal Carcinoma and Other Solid Tumors. Oncologist. 2019 Jul;24(7):891-e431. doi: 10.1634/theoncologist.2019-0284. Epub 2019 May 2. |
| Label | URL |
|---|---|
| BMS Clinical Trial Information | View source |
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| ID | Title | Description |
|---|---|---|
| FG000 | Cohort A: Nivolumab 3 mg/kg Q2W | Participants receive nivolumab (3 mg/kg) administered as 4 doses in each 8-week treatment cycle at Days 1, 15, 29 and 43. |
| FG001 | Cohort B: Nivolumab 240 mg Q2W | Participants receive a flat dose of nivolumab (240 mg) administered as 4 doses in each 8-week treatment cycle at Days 1, 15, 29 and 43. |
| FG002 | Cohort C: Nivolumab 360 mg Q3W | Participants receive a flat dose of nivolumab (360 mg) administered as one dose in each 3-week treatment cycle. |
| FG003 | Cohort D: Nivolumab 480 mg Q4W | Participants receive a flat dose of nivolumab (480 mg) administered as one dose in each 4-week treatment cycle |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | Cohort A: Nivolumab 3 mg/kg Q2W | Participants receive nivolumab (3 mg/kg) administered as 4 doses in each 8-week treatment cycle at Days 1, 15, 29 and 43. |
| BG001 | Cohort B: Nivolumab 240 mg Q2W |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | Count of 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 | 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. | All treated participants | Posted | Count of Participants | Participants | From first dose to 100 days after last dose (up to approximately 28 months) |
|
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)
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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 | Cohort A: Nivolumab 3 mg/kg Q2W | Participants receive nivolumab (3 mg/kg) administered as 4 doses in each 8-week treatment cycle at Days 1, 15, 29 and 43. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Pericardial effusion | Cardiac disorders | 24.1 | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | 24.1 | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Bristol-Myers Squibb Study Director | Bristol-Myers Squibb | Please email | Clinical.Trials@bms.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Aug 15, 2018 | Sep 26, 2022 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D000077594 | Nivolumab |
| ID | Term |
|---|---|
| D061067 | Antibodies, Monoclonal, Humanized |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
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| From first dose to 100 days after last dose (up to approximately 28 months) |
| 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. | 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. | 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. | 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. | 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:
| 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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). | 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. | 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. | 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. | 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. | 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) |
| Hangzhou |
| Zhejiang |
| 310016 |
| China |
| BMS Clinical Trial Patient Recruiting | View source |
| FDA Safety Alerts and Recalls | View source |
| Study drug toxicity |
|
| Adverse event unrelated to study drug |
|
| Participant request to discontinue study therapy |
|
| Other reasons |
|
Participants receive a flat dose of nivolumab (240 mg) administered as 4 doses in each 8-week treatment cycle at Days 1, 15, 29 and 43.
| BG002 | Cohort C: Nivolumab 360 mg Q3W | Participants receive a flat dose of nivolumab (360 mg) administered as one dose in each 3-week treatment cycle. |
| BG003 | Cohort D: Nivolumab 480 mg Q4W | Participants receive a flat dose of nivolumab (480 mg) administered as one dose in each 4-week treatment cycle |
| BG004 | Total | Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| OG001 | Cohort B: Nivolumab 240 mg Q2W | Participants receive a flat dose of nivolumab (240 mg) administered as 4 doses in each 8-week treatment cycle at Days 1, 15, 29 and 43. |
| OG002 | Cohort C: Nivolumab 360 mg Q3W | Participants receive a flat dose of nivolumab (360 mg) administered as one dose in each 3-week treatment cycle. |
| OG003 | Cohort D: Nivolumab 480 mg Q4W | Participants receive a flat dose of nivolumab (480 mg) administered as one dose in each 4-week treatment cycle |
|
|
| Primary | 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. | All treated participants | Posted | Count of Participants | Participants | From first dose to 100 days after last dose (up to approximately 28 months) |
|
|
|
| Primary | 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:
| All treated participants with least one on-treatment measurement of the corresponding laboratory parameter | Posted | Count of Participants | Participants | From first dose to 100 days after last dose (up to approximately 28 months) |
|
|
|
| Secondary | 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). | All treated participants | Posted | Count of Participants | Participants | From first dose up to approximately 28 months |
|
|
|
| Secondary | 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. | All treated participants with a BOR of CR or PR | Posted | Median | Full Range | Weeks | 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) |
|
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| Secondary | 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. | All treated participants | Posted | Number | 95% Confidence Interval | Percent of participants | From first dose up to approximately 28 months |
|
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| Secondary | 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. | All treated participants | Posted | Number | 95% Confidence Interval | Percent of participants | Week 24 |
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| Secondary | 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. | All treated participants | Posted | Number | 95% Confidence Interval | Percent of participants | Week 24 |
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| Secondary | 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:
| All Nivolumab Treated Participants with Baseline and at Least One Post-baseline Assessment | Posted | Count of Participants | Participants | From pre-dose on day 1 Cycle 1 up to participants end of study (up to approximately 28 months) |
|
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| Secondary | 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. | All treated participants with evaluable serum concentration data | Posted | Geometric Mean | Geometric Coefficient of Variation | ug/mL | 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) |
|
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| Secondary | 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. | All treated participants with evaluable serum concentration data | Posted | Median | Full Range | h | 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) |
|
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| Secondary | 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. | All treated participants with evaluable serum concentration data | Posted | Geometric Mean | Geometric Coefficient of Variation | h*ug/mL | 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) |
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| Secondary | 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. | All treated participants with evaluable serum concentration data | Posted | Geometric Mean | Geometric Coefficient of Variation | h*ug/mL | 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) |
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| Secondary | 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. | All treated participants with evaluable serum concentration data | Posted | Geometric Mean | Geometric Coefficient of Variation | ug/mL | End of infusion on Day 1 of Cycle 1, 3, 5, 6 |
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| Secondary | 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. | All treated participants with evaluable serum concentration data | Posted | Geometric Mean | Geometric Coefficient of Variation | ug/mL | Day 1 Cycle 3, 5, 6 (168 hours post dose [Cohort A-B], 336 hours post dose [Cohort C-D]) |
|
|
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| Secondary | 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. | All treated participants with evaluable serum concentration data | Posted | Geometric Mean | Geometric Coefficient of Variation | ug/mL | 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) |
|
|
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| Secondary | 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). | All treated participants with evaluable serum concentration data | Posted | Geometric Mean | Geometric Coefficient of Variation | h | 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) |
|
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| Secondary | CLT - Total Body Clearance | Nivolumab pharmacokinetic parameters are derived from serum concentration versus time data. CLT is the total body clearance. | All treated participants with evaluable serum concentration data | Posted | Geometric Mean | Geometric Coefficient of Variation | mL/hr | 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) |
|
|
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| Secondary | 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. | All treated participants with evaluable serum concentration data | Posted | Geometric Mean | Geometric Coefficient of Variation | (ug/mL)/(ug/mL) | 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) |
|
|
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| Secondary | 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. | All treated participants with evaluable serum concentration data | Posted | Geometric Mean | Geometric Coefficient of Variation | (ug/mL)/(ug/mL) | 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) |
|
|
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| Secondary | 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. | All treated participants with evaluable serum concentration data | Posted | Geometric Mean | Geometric Coefficient of Variation | (hr*ug/mL)/(hr*ug/mL) | 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) |
|
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| Primary | 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. | All treated participants with least one on-treatment measurement of the corresponding laboratory parameter | Posted | Count of Participants | Participants | From first dose to 100 days after last dose (up to approximately 28 months) |
|
|
|
| 4 |
| 15 |
| 6 |
| 15 |
| 14 |
| 15 |
| EG001 | Cohort B: Nivolumab 240 mg Q2W | Participants receive a flat dose of nivolumab (240 mg) administered as 4 doses in each 8-week treatment cycle at Days 1, 15, 29 and 43. | 7 | 20 | 8 | 20 | 20 | 20 |
| EG002 | Cohort C: Nivolumab 360 mg Q3W | Participants receive a flat dose of nivolumab (360 mg) administered as one dose in each 3-week treatment cycle. | 0 | 11 | 2 | 11 | 11 | 11 |
| EG003 | Cohort D: Nivolumab 480 mg Q4W | Participants receive a flat dose of nivolumab (480 mg) administered as one dose in each 4-week treatment cycle | 1 | 12 | 7 | 12 | 12 | 12 |
| Hypothalamo-pituitary disorder | Endocrine disorders | 24.1 | Systematic Assessment |
|
| Optic neuropathy | Eye disorders | 24.1 | Systematic Assessment |
|
| Dysphagia | Gastrointestinal disorders | 24.1 | Systematic Assessment |
|
| Intestinal obstruction | Gastrointestinal disorders | 24.1 | Systematic Assessment |
|
| Pancreatitis | Gastrointestinal disorders | 24.1 | Systematic Assessment |
|
| Asthenia | General disorders | 24.1 | Systematic Assessment |
|
| Jaundice cholestatic | Hepatobiliary disorders | 24.1 | Systematic Assessment |
|
| Appendicitis | Infections and infestations | 24.1 | Systematic Assessment |
|
| Pneumonia | Infections and infestations | 24.1 | Systematic Assessment |
|
| Septic shock | Infections and infestations | 24.1 | Systematic Assessment |
|
| Tracheal haemorrhage | Injury, poisoning and procedural complications | 24.1 | Systematic Assessment |
|
| Platelet count decreased | Investigations | 24.1 | Systematic Assessment |
|
| Decreased appetite | Metabolism and nutrition disorders | 24.1 | Systematic Assessment |
|
| Hyponatraemia | Metabolism and nutrition disorders | 24.1 | Systematic Assessment |
|
| Muscular weakness | Musculoskeletal and connective tissue disorders | 24.1 | Systematic Assessment |
|
| Malignant neoplasm progression | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | 24.1 | Systematic Assessment |
|
| Brain oedema | Nervous system disorders | 24.1 | Systematic Assessment |
|
| Cerebellar haemorrhage | Nervous system disorders | 24.1 | Systematic Assessment |
|
| Paraplegia | Nervous system disorders | 24.1 | Systematic Assessment |
|
| Urinary tract obstruction | Renal and urinary disorders | 24.1 | Systematic Assessment |
|
| Asphyxia | Respiratory, thoracic and mediastinal disorders | 24.1 | Systematic Assessment |
|
| Respiratory failure | Respiratory, thoracic and mediastinal disorders | 24.1 | Systematic Assessment |
|
| Granulocytosis | Blood and lymphatic system disorders | 24.1 | Systematic Assessment |
|
| Leukocytosis | Blood and lymphatic system disorders | 24.1 | Systematic Assessment |
|
| Leukopenia | Blood and lymphatic system disorders | 24.1 | Systematic Assessment |
|
| Lymphopenia | Blood and lymphatic system disorders | 24.1 | Systematic Assessment |
|
| Neutropenia | Blood and lymphatic system disorders | 24.1 | Systematic Assessment |
|
| Thrombocytopenia | Blood and lymphatic system disorders | 24.1 | Systematic Assessment |
|
| Thrombocytosis | Blood and lymphatic system disorders | 24.1 | Systematic Assessment |
|
| Cardiac discomfort | Cardiac disorders | 24.1 | Systematic Assessment |
|
| Sinus bradycardia | Cardiac disorders | 24.1 | Systematic Assessment |
|
| Ventricular arrhythmia | Cardiac disorders | 24.1 | Systematic Assessment |
|
| Ear discomfort | Ear and labyrinth disorders | 24.1 | Systematic Assessment |
|
| Tinnitus | Ear and labyrinth disorders | 24.1 | Systematic Assessment |
|
| Vertigo | Ear and labyrinth disorders | 24.1 | Systematic Assessment |
|
| Hyperthyroidism | Endocrine disorders | 24.1 | Systematic Assessment |
|
| Hypothyroidism | Endocrine disorders | 24.1 | Systematic Assessment |
|
| Vision blurred | Eye disorders | 24.1 | Systematic Assessment |
|
| Visual impairment | Eye disorders | 24.1 | Systematic Assessment |
|
| Vitreous floaters | Eye disorders | 24.1 | Systematic Assessment |
|
| Abdominal discomfort | Gastrointestinal disorders | 24.1 | Systematic Assessment |
|
| Abdominal distension | Gastrointestinal disorders | 24.1 | Systematic Assessment |
|
| Abdominal pain | Gastrointestinal disorders | 24.1 | Systematic Assessment |
|
| Abdominal pain upper | Gastrointestinal disorders | 24.1 | Systematic Assessment |
|
| Abnormal faeces | Gastrointestinal disorders | 24.1 | Systematic Assessment |
|
| Constipation | Gastrointestinal disorders | 24.1 | Systematic Assessment |
|
| Diarrhoea | Gastrointestinal disorders | 24.1 | Systematic Assessment |
|
| Dyspepsia | Gastrointestinal disorders | 24.1 | Systematic Assessment |
|
| Dysphagia | Gastrointestinal disorders | 24.1 | Systematic Assessment |
|
| Epigastric discomfort | Gastrointestinal disorders | 24.1 | Systematic Assessment |
|
| Gastrointestinal disorder | Gastrointestinal disorders | 24.1 | Systematic Assessment |
|
| Intestinal obstruction | Gastrointestinal disorders | 24.1 | Systematic Assessment |
|
| Mouth ulceration | Gastrointestinal disorders | 24.1 | Systematic Assessment |
|
| Nausea | Gastrointestinal disorders | 24.1 | Systematic Assessment |
|
| Toothache | Gastrointestinal disorders | 24.1 | Systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | 24.1 | Systematic Assessment |
|
| Asthenia | General disorders | 24.1 | Systematic Assessment |
|
| Chest discomfort | General disorders | 24.1 | Systematic Assessment |
|
| Chest pain | General disorders | 24.1 | Systematic Assessment |
|
| Chills | General disorders | 24.1 | Systematic Assessment |
|
| Fatigue | General disorders | 24.1 | Systematic Assessment |
|
| Influenza like illness | General disorders | 24.1 | Systematic Assessment |
|
| Malaise | General disorders | 24.1 | Systematic Assessment |
|
| Oedema peripheral | General disorders | 24.1 | Systematic Assessment |
|
| Pain | General disorders | 24.1 | Systematic Assessment |
|
| Pyrexia | General disorders | 24.1 | Systematic Assessment |
|
| Bronchitis | Infections and infestations | 24.1 | Systematic Assessment |
|
| Conjunctivitis | Infections and infestations | 24.1 | Systematic Assessment |
|
| Dacryocystitis | Infections and infestations | 24.1 | Systematic Assessment |
|
| Herpes zoster | Infections and infestations | 24.1 | Systematic Assessment |
|
| Nasopharyngitis | Infections and infestations | 24.1 | Systematic Assessment |
|
| Otitis media | Infections and infestations | 24.1 | Systematic Assessment |
|
| Pharyngitis | Infections and infestations | 24.1 | Systematic Assessment |
|
| Pneumonia | Infections and infestations | 24.1 | Systematic Assessment |
|
| Upper respiratory tract infection | Infections and infestations | 24.1 | Systematic Assessment |
|
| Limb injury | Injury, poisoning and procedural complications | 24.1 | Systematic Assessment |
|
| Rib fracture | Injury, poisoning and procedural complications | 24.1 | Systematic Assessment |
|
| Skin injury | Injury, poisoning and procedural complications | 24.1 | Systematic Assessment |
|
| Skin laceration | Injury, poisoning and procedural complications | 24.1 | Systematic Assessment |
|
| Alanine aminotransferase increased | Investigations | 24.1 | Systematic Assessment |
|
| Aspartate aminotransferase increased | Investigations | 24.1 | Systematic Assessment |
|
| Blood albumin decreased | Investigations | 24.1 | Systematic Assessment |
|
| Blood bilirubin increased | Investigations | 24.1 | Systematic Assessment |
|
| Blood creatinine increased | Investigations | 24.1 | Systematic Assessment |
|
| Blood thyroid stimulating hormone increased | Investigations | 24.1 | Systematic Assessment |
|
| C-reactive protein increased | Investigations | 24.1 | Systematic Assessment |
|
| Granulocyte count increased | Investigations | 24.1 | Systematic Assessment |
|
| Haemoglobin decreased | Investigations | 24.1 | Systematic Assessment |
|
| Lymphocyte count decreased | Investigations | 24.1 | Systematic Assessment |
|
| Neutrophil count decreased | Investigations | 24.1 | Systematic Assessment |
|
| Platelet count decreased | Investigations | 24.1 | Systematic Assessment |
|
| Platelet count increased | Investigations | 24.1 | Systematic Assessment |
|
| Protein urine present | Investigations | 24.1 | Systematic Assessment |
|
| Urinary occult blood | Investigations | 24.1 | Systematic Assessment |
|
| Weight decreased | Investigations | 24.1 | Systematic Assessment |
|
| White blood cell count decreased | Investigations | 24.1 | Systematic Assessment |
|
| Decreased appetite | Metabolism and nutrition disorders | 24.1 | Systematic Assessment |
|
| Hypermagnesaemia | Metabolism and nutrition disorders | 24.1 | Systematic Assessment |
|
| Hypertriglyceridaemia | Metabolism and nutrition disorders | 24.1 | Systematic Assessment |
|
| Hyperuricaemia | Metabolism and nutrition disorders | 24.1 | Systematic Assessment |
|
| Hypoalbuminaemia | Metabolism and nutrition disorders | 24.1 | Systematic Assessment |
|
| Hypocalcaemia | Metabolism and nutrition disorders | 24.1 | Systematic Assessment |
|
| Hypochloraemia | Metabolism and nutrition disorders | 24.1 | Systematic Assessment |
|
| Hypokalaemia | Metabolism and nutrition disorders | 24.1 | Systematic Assessment |
|
| Hypomagnesaemia | Metabolism and nutrition disorders | 24.1 | Systematic Assessment |
|
| Hyponatraemia | Metabolism and nutrition disorders | 24.1 | Systematic Assessment |
|
| Hypophosphataemia | Metabolism and nutrition disorders | 24.1 | Systematic Assessment |
|
| Malnutrition | Metabolism and nutrition disorders | 24.1 | Systematic Assessment |
|
| Back pain | Musculoskeletal and connective tissue disorders | 24.1 | Systematic Assessment |
|
| Joint swelling | Musculoskeletal and connective tissue disorders | 24.1 | Systematic Assessment |
|
| Muscular weakness | Musculoskeletal and connective tissue disorders | 24.1 | Systematic Assessment |
|
| Musculoskeletal chest pain | Musculoskeletal and connective tissue disorders | 24.1 | Systematic Assessment |
|
| Myalgia | Musculoskeletal and connective tissue disorders | 24.1 | Systematic Assessment |
|
| Neck pain | Musculoskeletal and connective tissue disorders | 24.1 | Systematic Assessment |
|
| Cancer pain | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | 24.1 | Systematic Assessment |
|
| Brain oedema | Nervous system disorders | 24.1 | Systematic Assessment |
|
| Dizziness | Nervous system disorders | 24.1 | Systematic Assessment |
|
| Headache | Nervous system disorders | 24.1 | Systematic Assessment |
|
| Hypoaesthesia | Nervous system disorders | 24.1 | Systematic Assessment |
|
| Loss of consciousness | Nervous system disorders | 24.1 | Systematic Assessment |
|
| Insomnia | Psychiatric disorders | 24.1 | Systematic Assessment |
|
| Poor quality sleep | Psychiatric disorders | 24.1 | Systematic Assessment |
|
| Micturition disorder | Renal and urinary disorders | 24.1 | Systematic Assessment |
|
| Proteinuria | Renal and urinary disorders | 24.1 | Systematic Assessment |
|
| Bronchial haemorrhage | Respiratory, thoracic and mediastinal disorders | 24.1 | Systematic Assessment |
|
| Cough | Respiratory, thoracic and mediastinal disorders | 24.1 | Systematic Assessment |
|
| Dysphonia | Respiratory, thoracic and mediastinal disorders | 24.1 | Systematic Assessment |
|
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | 24.1 | Systematic Assessment |
|
| Epistaxis | Respiratory, thoracic and mediastinal disorders | 24.1 | Systematic Assessment |
|
| Haemoptysis | Respiratory, thoracic and mediastinal disorders | 24.1 | Systematic Assessment |
|
| Laryngeal discomfort | Respiratory, thoracic and mediastinal disorders | 24.1 | Systematic Assessment |
|
| Nasal congestion | Respiratory, thoracic and mediastinal disorders | 24.1 | Systematic Assessment |
|
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | 24.1 | Systematic Assessment |
|
| Productive cough | Respiratory, thoracic and mediastinal disorders | 24.1 | Systematic Assessment |
|
| Respiratory tract congestion | Respiratory, thoracic and mediastinal disorders | 24.1 | Systematic Assessment |
|
| Alopecia | Skin and subcutaneous tissue disorders | 24.1 | Systematic Assessment |
|
| Hyperhidrosis | Skin and subcutaneous tissue disorders | 24.1 | Systematic Assessment |
|
| Leukoderma | Skin and subcutaneous tissue disorders | 24.1 | Systematic Assessment |
|
| Night sweats | Skin and subcutaneous tissue disorders | 24.1 | Systematic Assessment |
|
| Papule | Skin and subcutaneous tissue disorders | 24.1 | Systematic Assessment |
|
| Pruritus | Skin and subcutaneous tissue disorders | 24.1 | Systematic Assessment |
|
| Purpura | Skin and subcutaneous tissue disorders | 24.1 | Systematic Assessment |
|
| Rash | Skin and subcutaneous tissue disorders | 24.1 | Systematic Assessment |
|
| Skin exfoliation | Skin and subcutaneous tissue disorders | 24.1 | Systematic Assessment |
|
| Skin irritation | Skin and subcutaneous tissue disorders | 24.1 | Systematic Assessment |
|
| Telangiectasia | Skin and subcutaneous tissue disorders | 24.1 | Systematic Assessment |
|
| Urticaria | Skin and subcutaneous tissue disorders | 24.1 | Systematic Assessment |
|
| Hot flush | Vascular disorders | 24.1 | Systematic Assessment |
|
| Hypertension | Vascular disorders | 24.1 | Systematic Assessment |
|
| Hypotension | Vascular disorders | 24.1 | Systematic Assessment |
|
| Phlebitis | Vascular disorders | 24.1 | Systematic Assessment |
|
| Venous thrombosis limb | Vascular disorders | 24.1 | Systematic Assessment |
|
Bristol-Myers Squibb Co. agreements with investigators vary; constant is our right to embargo communications regarding trial results prior to public release for a period ≤60 days from submittal for review. We will not prohibit investigators from publishing, but will prohibit the disclosure of previously undisclosed confidential information other than study results, and request postponement of single-center publications until after disclosure of the clinical trial's primary publication.
| D007162 |
| Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |
| ALT OR AST> 5XULN |
|
| ALT OR AST> 10XULN |
|
| ALT OR AST > 20XULN |
|
| TOTAL BILIRUBIN > 2XULN |
|
| ALT/AST ELEV>3XULN;TOTAL BILIRUBIN>2XULN IN 1 DAY |
|
| ALT/AST ELEV>3XULN;TOTAL BILIRUBIN>2XULN IN 30 DAYS |
|
| Partial Response |
|
| Stable Disease |
|
| Progressive Disease |
|
| Unable to Determine |
|
|
| Non-small cell lung carcinoma (NSCLC) |
|
|
| Nasopharyngeal carcinoma |
|
|
| Other tumor types |
|
|
| Non-small cell lung carcinoma (NSCLC) |
|
|
| Nasopharyngeal carcinoma |
|
|
| Other tumor types |
|
|
|
| Non-small cell lung carcinoma (NSCLC) |
|
|
| Nasopharyngeal carcinoma |
|
|
| Other tumor types |
|
|
|
| Hepatocellular carcinoma |
|
|
| Non-small cell lung carcinoma (NSCLC) |
|
|
| Nasopharyngeal carcinoma |
|
|
| Other tumor types |
|
|
| ADA positive sample after initiation of treatment |
|
| ADA Negative sample after initiation of treatment |
|
|
| Cycle 3 Day 1 |
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| Cycle 5 Day 1 |
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| Cycle 6 Day 1 |
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| Cycle 3 Day 1 |
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| Cycle 5 Day 1 |
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| Cycle 6 Day 1 |
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| Cycle 3 Day 1 |
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| Cycle 5 Day 1 |
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| Cycle 6 Day 1 |
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| Cycle 3 Day 1 |
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| Cycle 5 Day 1 |
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| Cycle 6 Day 1 |
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| Cycle 3 Day 1 |
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| Cycle 5 Day 1 |
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| Cycle 6 Day 1 |
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| Cycle 5 Day 1 |
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| Cycle 6 Day 1 |
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| Cycle 3 Day 1 |
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| Cycle 5 Day 1 |
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| Cycle 6 Day 1 |
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| Cycle 5 Day 1 |
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| Cycle 6 Day 1 |
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| Cycle 5 Day 1 |
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| Cycle 6 Day 1 |
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| Cycle 5 Day 1 |
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| Cycle 6 Day 1 |
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| Cycle 5 Day 1 |
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| Cycle 6 Day 1 |
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| Cycle 5 Day 1 |
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| Cycle 6 Day 1 |
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| PLATELET COUNT (Grade 3) |
|
| PLATELET COUNT (Grade 4) |
|
| LEUKOCYTES (Grade 3) |
|
| LYMPHOCYTES (ABSOLUTE) (Grade 3) |
|
| ABSOLUTE NEUTROPHIL COUNT (Grade 3) |
|
| ALKALINE PHOSPHATASE (Grade 3) |
|
| ASPARTATE AMINOTRANSFERASE (Grade 3) |
|
| ALANINE AMINOTRANSFERASE (Grade 3) |
|
| BILIRUBIN, TOTAL (Grade 3) |
|
| BILIRUBIN, TOTAL (Grade 4) |
|