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| ID | Type | Description | Link |
|---|---|---|---|
| MDX1106-01 | Other Identifier | BMS |
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To evaluate the safety, tolerability, efficacy, and pharmacokinetics of MDX-1106 when administered to patients with advanced non-small cell lung cancer, colorectal cancer, malignant melanoma, clear cell renal cell cancer or hormone refractory prostate cancer
Six patients enrolled at each dose level of 0.3, 1.0, 3.0 and 10mg/kg; the remaining 10 to 15 patients may subsequently be enrolled at a dose at or below the maximum tolerated dose (MTD) during the dose-escalation portion of the study. Patients who respond may receive additional doses of drug.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 0.3 mg/kg MDX-1106 drug | Experimental | 0.3 milligrams (mg) MDX-1106 drug (nivolumab) per kilogram (kg) of body weight (mg/kg) was administered in a single intravenous (IV) infusion. If criteria were met, 2 additional doses could be administered (1 every 4 weeks). |
|
| 1 mg/kg MDX-1106 drug | Experimental | 1 mg MDX-1106 drug (nivolumab) per kg of body weight (mg/kg) was administered in a single IV infusion. If criteria were met, 2 additional doses could be administered (1 every 4 weeks). |
|
| 3 mg/kg MDX-1106 drug | Experimental | 3 mgs MDX-1106 drug (nivolumab) per kg of body weight (mg/kg) was administered in a single IV infusion. If criteria were met, 2 additional doses could be administered (1 every 4 weeks). |
|
| 10 mg/kg MDX-1106 drug | Experimental | 10 mgs MDX-1106 drug (nivolumab) per kg of body weight (mg/kg) was administered in a single IV infusion. If criteria were met, 2 additional doses could be administered (1 every 4 weeks). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| MDX-1106 | Biological | patients will receive a single dose of MDX-1106 as a 60 minute infusion. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Severe Adverse Events (AEs), Serious Adverse Events (SAEs), Drug-Related AEs, Deaths, Discontinuation of Study Drug Due to AE, Dose-Limiting Toxicity (DLT) AE and Immune-related AEs (irAEs) in Safety Population | AE=any new unfavorable symptom, sign, or disease or worsening of a preexisting condition that may not have a causal relationship with treatment. SAE=a medical event that at any dose results in death, persistent or significant disability/incapacity, or drug dependency/abuse; is life-threatening, an important medical event, or a congenital anomaly/birth defect; or requires or prolongs hospitalization. Treatment-related=having certain, probable, possible, or missing relationship to study drug. Grade (Gr) 1=Mild, Gr 2=Moderate, Gr 3=Severe, Gr 4= Potentially Life-threatening or disabling. Severe=All Grade 3 or 4 events. Death=during the study and up to 28 days past study discontinuation. AEs graded using the Cancer Therapy Evaluation Program Common Terminology Criteria for Adverse Events (CTCAE), Version 3.0. irAEs=unknown etiology, associated with study drug and consistent with an immune phenomenon. DLT: ≥Gr 3 AE(s) or lab abnormality without alternative explanation other than drug. | Day 1 to 70 days post last dose of study drug; 28 days past study discontinuation |
| Geometric Mean Maximum Serum Concentration (Cmax) Observed Post-Single Dose | Nivolumab in human serum was assayed during the period of known analyte stability and reported as final data for this study by PPD® (Richmond, Virginia) using a cross-validated enzyme-linked immunosorbent assay (ELISA) method. For the single dose (Day 1), serum concentrations of nivolumab were assessed: prior to dosing, at 30 minutes (during dosing), immediately post-dose, and 30 minutes post-infusion end time; at 1, 2, 4, 6, 8, 24, 48, and 72 hours post-infusion end time; and on Days 8, 15, 22, 29, 43, 57, 71, and 85. The pharmacokinetic (PK) parameter of Cmax was measured in micrograms per milliliter (µg/mL). | Day 1 to Day 85 |
| Median Time at Which the Maximum Serum Concentration Occurred (Tmax) Post-Single Dose | Nivolumab in human serum was assayed during the period of known analyte stability and reported as final data for this study by PPD® (Richmond, Virginia) using a cross-validated ELISA method. For the single dose (Day 1), serum concentrations of nivolumab were assessed: prior to dosing, at 30 minutes (during dosing), immediately post-dose, and 30 minutes post-infusion end time; at 1, 2, 4, 6, 8, 24, 48, and 72 hours post-infusion end time; and on Days 8, 15, 22, 29, 43, 57, 71, and 85. The PK parameter of Tmax was measured in hours (h). |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Best Overall Response (BOR) by Category in Safety Population | Measurable and non-measurable disease/target lesions were evaluated according to National Cancer Institute standardized RECIST.Complete Response (CR)=disappearance of all target and non-target lesions and no new lesions; Partial Response=at least a 30% decrease in the sum of the longest diameter of target lesions, taking as reference the screening sum longest diameter; Stable disease (SD)=neither sufficient shrinkage to qualify for partial response nor sufficient increase to qualify for progressive disease (PD), taking as reference the smallest sum longest diameter since treatment; PD=at least a 20% increase in the sum of the longest diameter recorded since screening, or the appearance of one or more new lesions. BOR was recorded between the first tumor assessment and last tumor assessment. CR and PR had to be confirmed by repeat assessment no less than 4 weeks after the criteria were first met. SD assessment must have met the criteria at least once at or after Week 12. |
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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 |
|---|---|---|---|---|---|---|
| Johns Hopkins Unv., School of Medicine | Baltimore | Maryland | 21231 | United States | ||
| Henry Ford Health System |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 21917625 | Derived | George S, Pili R, Carducci MA, Kim JJ. Role of immunotherapy for renal cell cancer in 2011. J Natl Compr Canc Netw. 2011 Sep 1;9(9):1011-8. doi: 10.6004/jnccn.2011.0085. |
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39 participants were enrolled and 39 were treated with at least 1 dose or a partial dose of study drug.
Study from 25 October 2006 to 27 November 2009. After completion of a single dose (cycle 1), those meeting criteria could be re-treated with 2 additional doses (cycle 2); and additional cycles. Participants who had a complete response (CR) or partial response (PR) at end of re-treatment were followed-up until disease progression for 2 years.
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| ID | Title | Description |
|---|---|---|
| FG000 | 0.3 mg/kg Nivolumab | 0.3 milligrams (mg) of nivolumab per kilogram (kg) of body weight (mg/kg) was administered in a single intravenous (IV) infusion on Day 1 with 10% of the dose infused over 6 minutes and after a 1 hour observation period, the balance was administered over 60 minutes. Eligible participants could be re-treated and receive 2 more doses (1 dose every 4 weeks) at same dose as the single dose if: disease was stable, no drug intolerance was observed, no complete response (CR) or partial response (PR) was observed, or they had a positive immunogenicity sample within 4 weeks prior to re-treatment. Those who responded to therapy with a CR or PR were eligible for long-term follow-up until either progressive disease (PD) or 2 years elapsed. |
| FG001 | 1 mg/kg Nivolumab | 1 mg of nivolumab per kg of body weight was administered in a single IV infusion over 60 minutes on Day 1. Eligible participants could be re-treated and receive 2 more doses (1 dose every 4 weeks) at same dose as the single dose if: disease was stable, no drug intolerance was observed, no complete response (CR) or partial response (PR) was observed, or they had a positive immunogenicity sample within 4 weeks prior to re-treatment. Those who responded to therapy with a CR or PR were eligible for long-term follow-up until either progressive disease (PD) or 2 years elapsed. |
| FG002 | 3 mg/kg Nivolumab | 3 mg of nivolumab per kg of body weight was administered in a single IV infusion over 60 minutes on Day 1. Eligible participants could be re-treated and receive 2 more doses (1 dose every 4 weeks) at same dose as the single dose if: disease was stable, no drug intolerance was observed, no complete response (CR) or partial response (PR) was observed, or they had a positive immunogenicity sample within 4 weeks prior to re-treatment. Those who responded to therapy with a CR or PR were eligible for long-term follow-up until either progressive disease (PD) or 2 years elapsed. |
| FG003 | 10 mg/kg Nivolumab | 10 mg of nivolumab per kg of body weight was administered in a single IV infusion over 60 minutes on Day 1. Eligible participants could be re-treated and receive 2 more doses (1 dose every 4 weeks) at same dose as the single dose if: disease was stable, no drug intolerance was observed, no complete response (CR) or partial response (PR) was observed, or they had a positive immunogenicity sample within 4 weeks prior to re-treatment. Those who responded to therapy with a CR or PR were eligible for long-term follow-up until either progressive disease (PD) or 2 years elapsed. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
All participants who received at least 1 dose or any partial dose of study drug.
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| ID | Title | Description |
|---|---|---|
| BG000 | 0.3 mg/kg Nivolumab | 0.3 mg of nivolumab per kg of body weight (mg/kg) was administered in a single IV infusion on Day 1 with 10% of the dose infused over 6 minutes and after a 1 hour observation period, the balance was administered over 60 minutes. Eligible participants could be re-treated and receive 2 more doses (1 dose every 4 weeks) at same dose as the single dose if: disease was stable, no drug intolerance was observed, no complete response (CR) or partial response (PR) was observed, or they had a positive immunogenicity sample within 4 weeks prior to re-treatment. Those who responded to therapy with a CR or PR were eligible for long-term follow-up until either progressive disease (PD) or 2 years elapsed. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| 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 | Number of Participants With Severe Adverse Events (AEs), Serious Adverse Events (SAEs), Drug-Related AEs, Deaths, Discontinuation of Study Drug Due to AE, Dose-Limiting Toxicity (DLT) AE and Immune-related AEs (irAEs) in Safety Population | AE=any new unfavorable symptom, sign, or disease or worsening of a preexisting condition that may not have a causal relationship with treatment. SAE=a medical event that at any dose results in death, persistent or significant disability/incapacity, or drug dependency/abuse; is life-threatening, an important medical event, or a congenital anomaly/birth defect; or requires or prolongs hospitalization. Treatment-related=having certain, probable, possible, or missing relationship to study drug. Grade (Gr) 1=Mild, Gr 2=Moderate, Gr 3=Severe, Gr 4= Potentially Life-threatening or disabling. Severe=All Grade 3 or 4 events. Death=during the study and up to 28 days past study discontinuation. AEs graded using the Cancer Therapy Evaluation Program Common Terminology Criteria for Adverse Events (CTCAE), Version 3.0. irAEs=unknown etiology, associated with study drug and consistent with an immune phenomenon. DLT: ≥Gr 3 AE(s) or lab abnormality without alternative explanation other than drug. | Safety Population: All participants who received at least 1 dose or any partial dose of nivolumab were analyzed. | Posted | Number | participants | Day 1 to 70 days post last dose of study drug; 28 days past study discontinuation |
Day 1 through long-term follow-up until either progressive disease or 2 years elapsed.
Study was initiated in 2006 and completed in 2009
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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 | 0.3 mg/kg Nivolumab | 0.3 mg of nivolumab per kg of body weight was administered in a single IV infusion on Day 1 with 10% of the dose infused over 6 minutes and after a 1 hour observation period, the balance was administered over 60 minutes. Eligible participants could be re-treated and receive 2 more doses (1 dose every 4 weeks) at same dose as the single dose if: disease was stable, no drug intolerance was observed, no complete response (CR) or partial response (PR) was observed, or they had a positive immunogenicity sample within 4 weeks prior to re-treatment. Those who responded to therapy with a CR or PR were eligible for long-term follow-up until either progressive disease (PD) or 2 years elapsed. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anorexia | Metabolism and nutrition disorders | MedDRA 10.1 | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Abdominal pain lower | Gastrointestinal disorders | MedDRA 10.1 | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Bristol-Myers Squibb Study Director | Bristol-Myers Squibb | Clinical.Trials@bms.com |
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| ID | Term |
|---|---|
| D002289 | Carcinoma, Non-Small-Cell Lung |
| D015179 | Colorectal Neoplasms |
| D008545 | Melanoma |
| D007680 | Kidney Neoplasms |
| D011471 | Prostatic Neoplasms |
| D009369 | Neoplasms |
| D008175 | Lung Neoplasms |
| D000230 | Adenocarcinoma |
| D002292 | Carcinoma, Renal Cell |
| D002277 | Carcinoma |
| D012008 | Recurrence |
| ID | Term |
|---|---|
| D002283 | Carcinoma, Bronchogenic |
| D001984 | Bronchial Neoplasms |
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
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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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|
| Day 1 to Day 85 |
| Geometric Mean Area Under the Curve (AUC) From Time of Dosing to Time of Last Observation (0-T) and Extrapolated to Infinity (INF) Observed Post-Single Dose | AUC(0-T): Area under the concentration-time curve from the time of dosing to the time of the last observation. AUC(INF): Area under the curve from the time of dosing extrapolated to infinity. Nivolumab in human serum was assayed during the period of known analyte stability and reported as final data for this study by PPD® (Richmond, Virginia) using a cross-validated ELISA method. For the single dose (Day 1), serum concentrations of nivolumab were assessed: prior to dosing, at 30 minutes (during dosing), immediately post-dose, and 30 minutes post-infusion end time; at 1, 2, 4, 6, 8, 24, 48, and 72 hours post-infusion end time; and on Days 8, 15, 22, 29, 43, 57, 71, and 85. The PK parameters of AUC(0-T) and AUC (INF) were measured in micrograms*hours per milliliter (µg*h/mL). | Day 1 to Day 85 |
| Mean Elimination Half-life (T-HALF) Post-Single Dose | Nivolumab in human serum was assayed during the period of known analyte stability and reported as final data for this study by PPD® (Richmond, Virginia) using a cross-validated ELISA method. For the single dose (Day 1), serum concentrations of nivolumab were assessed: prior to dosing, at 30 minutes (during dosing), immediately post-dose, and 30 minutes post-infusion end time; at 1, 2, 4, 6, 8, 24, 48, and 72 hours post-infusion end time; and on Days 8, 15, 22, 29, 43, 57, 71, and 85. The PK parameter of T-HALF was measured in days. | Day 1 to Day 85 |
| Geometric Mean Total Body Clearance of Drug From Serum (CLT) Post-Single Dose | Nivolumab in human serum was assayed during the period of known analyte stability and reported as final data for this study by PPD® (Richmond, Virginia) using a cross-validated ELISA method. For the single dose (Day 1), serum concentrations of nivolumab were assessed: prior to dosing, at 30 minutes (during dosing), immediately post-dose, and 30 minutes post-infusion end time; at 1, 2, 4, 6, 8, 24, 48, and 72 hours post-infusion end time; and on Days 8, 15, 22, 29, 43, 57, 71, and 85. The PK parameter of CLT was measured in milliliters per hour per kilogram body weight (mL/h/kg). | Day 1 to Day 85 |
| Mean Volume of Distribution (Vz) Post-Single Dose | Nivolumab in human serum was assayed during the period of known analyte stability and reported as final data for this study by PPD® (Richmond, Virginia) using a cross-validated ELISA method. For the single dose (Day 1), serum concentrations of nivolumab were assessed: prior to dosing, at 30 minutes (during dosing), immediately post-dose, and 30 minutes post-infusion end time; at 1, 2, 4, 6, 8, 24, 48, and 72 hours post-infusion end time; and on Days 8, 15, 22, 29, 43, 57, 71, and 85. The PK parameter of Vz was measured in milliliters per kilogram of body weight (mL/kg). | Day 1 to Day 85 |
| Percent of Participants With Best Overall Response Rate in Safety Population and in Tumor Evaluable Population | The Best Overall Response Rate (BORR) was defined as the number of participants who had a confirmed complete response (CR) or partial response (PR) during the study divided by the total number of participants evaluated. Response was based on tumor assessment for both target and non-target lesions using: Clinical examination; Chest X-ray; Computed Tomography and Magnetic Resonance Imaging; Bone scan; Ultrasound. Per National Cancer Institute Response Evaluation Criteria in Solid Tumors (RECIST) v1.0, best overall response (BOR) for tumors was confirmed CR or PR. CR=disappearance of all target and non-target lesions; PR=at least a 30% decrease in the sum of the longest diameter of target lesions, taking as reference the screening sum longest diameter. Confidence intervals (CIs) were computed using the Clopper and Pearson method. | Day 1 up to 2 Years. |
| Percent of Participants With Prostate-Specific Antigen (PSA) Response After the First Dose by Day 85 In Participants With Hormone-Refractory Prostate Adenocarcinoma (HRPC) | The PSA response rate was defined as the number of participants who had at least a 50% decrease of the PSA value from the PSA reference value divided by the total number of participants evaluated (percent of participants). PSA reference value was the PSA concentration measured immediately prior to dosing on Day 1. PSA response was assessed using the Recommendations from the National Cancer Institute Prostate-Specific Antigen Working Group. A PSA response had to be confirmed at least 4 weeks after first response. 95% exact CIs were computed using the Clopper and Pearson method. | Day 1 to Day 85 |
| Day 1 to Day 85 |
| Percentage of Participants With Disease Control and Major Durable Disease Control | Disease control rate was defined as number of participants whose Best Overall Response (BOR) was complete response (CR), partial response (PR), or stable disease (SD) divided by the total number of participants. Major durable disease control rate was defined as the total number of participants whose BOR was CR, PR, or SD ≥24 weeks, divided by the total number of participants. Per RECIST v 1.0, BOR for tumors was confirmed CR or PR. CR=disappearance of all target and non-target lesions; PR=at least a 30% decrease in the sum of the longest diameter of target lesions, taking as reference the screening sum longest diameter since treatment; SD=neither sufficient shrinkage to qualify for partial response nor sufficient increase to qualify for PD. PD=at least a 20% increase in the sum of the longest diameter recorded since screening, or the appearance of one or more new lesions. 95% CIs were computed using the Clopper and Pearson method. | Day 1 to 2 Years |
| Median Time to Tumor Response and Duration of Tumor Response | Time to tumor response: from the date of first dose to the first date of tumor response (CR or PR confirmed at least 4 weeks later); for nonresponders, it was censored at the date of the maximum tumor assessment time in the dose cohort by the end of study. Duration of tumor response was calculated from the first date of response of CR or PR to the date of the first PD or the date of death if a participant died due to disease progression (whichever occurred first). Duration of response was censored at the last tumor assessment date by the end of study if a responder did not have PD or death. Nonresponders had the duration of response as an event of 0 days. | Day 1 to 2 Years |
| Time to Tumor Progression and Tumor Progression Free Survival | Time to tumor progression (TTP) was measured in days from date of the first dose to the date of the first PD or the date of death if due to PD. For those who died without PD it was censored at the date of death. TTP was censored at the last tumor assessment by the end of study if a participant did not have PD or death. Tumor progression free survival (PFS) was measured in days from the date of first dose to the date of the first disease progression or to the date of death. PFS was censored at the last tumor assessment date by the end of study if a participant did not have PD or death. | Day 1 to 2 Years |
| Median Time to PSA Progression in Days and Median PSA Progression Free Survival in Days in PSA Evaluable Population | Time to PSA progression: first dose to first PSA progression. Missing date of progression was censored: if death during the study, time to progression was right-censored at last PSA assessment; if no progression from first dose and still alive at end of study, time to progression was right-censored at last PSA assessment by end of study; if no PSA progression and one has discontinued from the study (other than death or PSA progression), time to progression was right-censored at last PSA assessment. PSA progression free survival (PFS): first dose to first PSA progression or death, whichever comes first. Missing date of progression was censored: if one did not have PSA progression from first dose and was still alive at end of study, PSA PFS was right-censored at last PSA assessment; if one does not have any progression and discontinued from the study for reasons other than death or progression, PFS was right-censored at last assessment. CI computed using Brookmeyer and Crowley method. | Day 1 to 2 Years |
| Mean Change From Baseline in PSA Relative Velocity at Days 29, 57, and 85 With Cycle 1 in PSA Evaluable Population | PSA relative velocity (PSA RV) was defined as = (d[PSA]/dt)/ [PSA], where [PSA] =concentration of PSA, and t= time, and in the limit reflects the instantaneous change in PSA levels as a fraction of total PSA level. Decreases in PSA RV may occur while measured [PSA] is still rising, and may indicate that continued therapy may lead to a treatment benefit, particularly in the setting of immunotherapy, where expansion of an effective immune response is likely to require weeks to mature. Baseline PSA RV was based on the velocity of last PSA measurement before the first infusion of study drug and the screening PSA measurement. | Day 29, Day 57, Day 85 |
| Mean Change From Baseline in Electrocardiogram Parameters PR, QRS and QT in Safety Population | 12-lead ECGs were performed at screening, baseline, Day 2 and at completion of the dose cycle (Day 85 in first dose cycle). In those participants undergoing re-treatment, ECG was repeated at the completion of the re-treatment. Baseline was defined as the last measurement before the first dose of study drug, which was calculated from pre-dose or from screening if pre-dose was not available. PR, QRS and QT interval were measured in milliseconds (msec). | Baseline, Day 2, Day 85, Day 113 |
| Mean Diastolic Blood Pressure at Baseline and Post-Infusion Day 1 (Cycle 1) in 0.3 mg Cohort - Safety Population | Diastolic blood pressures (DBPs) measured in millimeters of mercury (mmHg) were obtained while the participant was seated. Post infusion DBPs are presented in the 0.3 mg cohort at: 21, 36, 51, 66, 82, 97, 112, 127, 157 minutes post infusion, and at 1, 2, 3, 4, 6, 8 hours post infusion. Baseline was defined as the last measurement before the first dose of study drug, which was calculated from pre-dose or from screening if pre-dose was not available. Mean DBP on Day 1 for first dose (cycle 1) are presented below. | Baseline, Day 1 |
| Mean Systolic Blood Pressure at Baseline and Post-Infusion Day 1 (Cycle 1) in 0.3 mg Cohort - Safety Population | Systolic blood pressures (SBPs) measured in millimeters of mercury (mmHg) were obtained while the participant was seated. Baseline, Infusion (0 minutes) and Post infusion SBPs are presented in the 0.3 mg cohort at: 21, 36, 51, 66, 82, 97, 112, 127, 157 minutes post infusion, and at 1, 2, 3, 4, 6, 8 hours post infusion. Baseline was defined as the last measurement before the first dose of study drug, which was calculated from pre-dose or from screening if pre-dose was not available. Mean SBP on Day 1 for first dose (cycle 1) are presented below. | Baseline, Day 1 |
| Mean Diastolic Blood Pressure at Baseline and Post-Infusion Day 1 (Cycle 1) in 1mg, 3mg, and 10 mg Cohorts - Safety Population | Diastolic blood pressures (DBPs) measured in millimeters of mercury (mmHg) were obtained while the participant was seated. Baseline, Infusion (0 minutes) and Post infusion DBPs are presented in the 1 mg, 3 mg and 10 mg cohorts at: 15, 30, 45, 60, 75, and 90 minutes post infusion and at 1, 2, 3, 4, 6, 8 hours post infusion. Baseline was defined as the last measurement before the first dose of study drug, which was calculated from pre-dose or from screening if pre-dose was not available. Mean DBP on Day 1 for first dose (cycle 1) are presented below. | Baseline, Day 1 |
| Mean Systolic Blood Pressure at Baseline and Post-Infusion Day 1 (Cycle 1) in in 1mg, 3mg, and 10 mg Cohorts - Safety Population | Systolic blood pressures (SBPs) measured in millimeters of mercury (mmHg) were obtained while the participant was seated. Baseline, Infusion (0 minutes) and Post infusion SBPs are presented in the 1 mg, 3 mg and 10 mg cohorts at: 15, 30, 45, 60, 75, and 90 minutes post infusion and at 1, 2, 3, 4, 6, 8 hours post infusion. Baseline was defined as the last measurement before the first dose of study drug, which was calculated from pre-dose or from screening if pre-dose was not available. Mean SBPs on Day 1 for first dose (cycle 1) are presented below. | Baseline, Day 1 |
| Detroit |
| Michigan |
| 48202 |
| United States |
| Washington University School of Medicine - Barnes Jewish Hospital | St Louis | Missouri | 63110 | United States |
| Carolina BioOncology Institute, PLLC | Huntersville | North Carolina | 28078 | United States |
| Lost to Follow-up |
|
| Sponsor Decision |
|
| Did not meet inclusion criteria |
|
| BG001 | 1 mg/kg Nivolumab | 1 mg of nivolumab per kg of body weight was administered in a single IV infusion over 60 minutes on Day 1. Eligible participants could be re-treated and receive 2 more doses (1 dose every 4 weeks) at same dose as the single dose if: disease was stable, no drug intolerance was observed, no complete response (CR) or partial response (PR) was observed, or they had a positive immunogenicity sample within 4 weeks prior to re-treatment. Those who responded to therapy with a CR or PR were eligible for long-term follow-up until either progressive disease (PD) or 2 years elapsed. |
| BG002 | 3 mg/kg Nivolumab | 3 mg of nivolumab per kg of body weight was administered in a single IV infusion over 60 minutes on Day 1. Eligible participants could be re-treated and receive 2 more doses (1 dose every 4 weeks) at same dose as the single dose if: disease was stable, no drug intolerance was observed, no complete response (CR) or partial response (PR) was observed, or they had a positive immunogenicity sample within 4 weeks prior to re-treatment. Those who responded to therapy with a CR or PR were eligible for long-term follow-up until either progressive disease (PD) or 2 years elapsed. |
| BG003 | 10 mg/kg Nivolumab | 10 mg of nivolumab per kg of body weight was administered in a single IV infusion over 60 minutes on Day 1. Eligible participants could be re-treated and receive 2 more doses (1 dose every 4 weeks) at same dose as the single dose if: disease was stable, no drug intolerance was observed, no complete response (CR) or partial response (PR) was observed, or they had a positive immunogenicity sample within 4 weeks prior to re-treatment. Those who responded to therapy with a CR or PR were eligible for long-term follow-up until either progressive disease (PD) or 2 years elapsed. |
| BG004 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Number | participants |
|
| Region of Enrollment | Number | participants |
|
| Body Weight in kilograms (kg) | Median | Full Range | kg |
|
| Time since initial diagnosis (years) | Median | Full Range | Years |
|
| Type of Malignancy | Number | participants |
|
| Stage of Malignancy at Screening Diagnosis | The investigator reported the screening malignancy stage for each type of cancer using the American Joint Committee on Cancer Classification (Stages I, II, III, and IV). | Number | participants |
|
|
|
|
| Primary | Geometric Mean Maximum Serum Concentration (Cmax) Observed Post-Single Dose | Nivolumab in human serum was assayed during the period of known analyte stability and reported as final data for this study by PPD® (Richmond, Virginia) using a cross-validated enzyme-linked immunosorbent assay (ELISA) method. For the single dose (Day 1), serum concentrations of nivolumab were assessed: prior to dosing, at 30 minutes (during dosing), immediately post-dose, and 30 minutes post-infusion end time; at 1, 2, 4, 6, 8, 24, 48, and 72 hours post-infusion end time; and on Days 8, 15, 22, 29, 43, 57, 71, and 85. The pharmacokinetic (PK) parameter of Cmax was measured in micrograms per milliliter (µg/mL). | All participants who received at least 1 dose or any partial dose of nivolumab and had adequate PK profiles were included in the summary statistics. | Posted | Geometric Mean | Geometric Coefficient of Variation | µg/mL | Day 1 to Day 85 |
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| Primary | Median Time at Which the Maximum Serum Concentration Occurred (Tmax) Post-Single Dose | Nivolumab in human serum was assayed during the period of known analyte stability and reported as final data for this study by PPD® (Richmond, Virginia) using a cross-validated ELISA method. For the single dose (Day 1), serum concentrations of nivolumab were assessed: prior to dosing, at 30 minutes (during dosing), immediately post-dose, and 30 minutes post-infusion end time; at 1, 2, 4, 6, 8, 24, 48, and 72 hours post-infusion end time; and on Days 8, 15, 22, 29, 43, 57, 71, and 85. The PK parameter of Tmax was measured in hours (h). | All participants who received at least 1 dose or any partial dose of nivolumab and had adequate PK profiles were included in the summary statistics. | Posted | Median | Full Range | h | Day 1 to Day 85 |
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| Primary | Geometric Mean Area Under the Curve (AUC) From Time of Dosing to Time of Last Observation (0-T) and Extrapolated to Infinity (INF) Observed Post-Single Dose | AUC(0-T): Area under the concentration-time curve from the time of dosing to the time of the last observation. AUC(INF): Area under the curve from the time of dosing extrapolated to infinity. Nivolumab in human serum was assayed during the period of known analyte stability and reported as final data for this study by PPD® (Richmond, Virginia) using a cross-validated ELISA method. For the single dose (Day 1), serum concentrations of nivolumab were assessed: prior to dosing, at 30 minutes (during dosing), immediately post-dose, and 30 minutes post-infusion end time; at 1, 2, 4, 6, 8, 24, 48, and 72 hours post-infusion end time; and on Days 8, 15, 22, 29, 43, 57, 71, and 85. The PK parameters of AUC(0-T) and AUC (INF) were measured in micrograms*hours per milliliter (µg*h/mL). | All participants who received at least 1 dose or any partial dose of nivolumab and had adequate PK profiles were included in the summary statistics. | Posted | Geometric Mean | Geometric Coefficient of Variation | µg*h/mL | Day 1 to Day 85 |
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| Primary | Mean Elimination Half-life (T-HALF) Post-Single Dose | Nivolumab in human serum was assayed during the period of known analyte stability and reported as final data for this study by PPD® (Richmond, Virginia) using a cross-validated ELISA method. For the single dose (Day 1), serum concentrations of nivolumab were assessed: prior to dosing, at 30 minutes (during dosing), immediately post-dose, and 30 minutes post-infusion end time; at 1, 2, 4, 6, 8, 24, 48, and 72 hours post-infusion end time; and on Days 8, 15, 22, 29, 43, 57, 71, and 85. The PK parameter of T-HALF was measured in days. | All participants who received at least 1 dose or any partial dose of nivolumab and had adequate PK profiles were included in the summary statistics. | Posted | Mean | Standard Deviation | days | Day 1 to Day 85 |
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| Primary | Geometric Mean Total Body Clearance of Drug From Serum (CLT) Post-Single Dose | Nivolumab in human serum was assayed during the period of known analyte stability and reported as final data for this study by PPD® (Richmond, Virginia) using a cross-validated ELISA method. For the single dose (Day 1), serum concentrations of nivolumab were assessed: prior to dosing, at 30 minutes (during dosing), immediately post-dose, and 30 minutes post-infusion end time; at 1, 2, 4, 6, 8, 24, 48, and 72 hours post-infusion end time; and on Days 8, 15, 22, 29, 43, 57, 71, and 85. The PK parameter of CLT was measured in milliliters per hour per kilogram body weight (mL/h/kg). | All participants who received at least 1 dose or any partial dose of nivolumab and had adequate PK profiles were included in the summary statistics. | Posted | Geometric Mean | Geometric Coefficient of Variation | mL/h/kg | Day 1 to Day 85 |
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| Primary | Mean Volume of Distribution (Vz) Post-Single Dose | Nivolumab in human serum was assayed during the period of known analyte stability and reported as final data for this study by PPD® (Richmond, Virginia) using a cross-validated ELISA method. For the single dose (Day 1), serum concentrations of nivolumab were assessed: prior to dosing, at 30 minutes (during dosing), immediately post-dose, and 30 minutes post-infusion end time; at 1, 2, 4, 6, 8, 24, 48, and 72 hours post-infusion end time; and on Days 8, 15, 22, 29, 43, 57, 71, and 85. The PK parameter of Vz was measured in milliliters per kilogram of body weight (mL/kg). | All participants who received at least 1 dose or any partial dose of nivolumab and had adequate PK profiles were included in the summary statistics. | Posted | Mean | Standard Deviation | mL/kg | Day 1 to Day 85 |
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| Primary | Percent of Participants With Best Overall Response Rate in Safety Population and in Tumor Evaluable Population | The Best Overall Response Rate (BORR) was defined as the number of participants who had a confirmed complete response (CR) or partial response (PR) during the study divided by the total number of participants evaluated. Response was based on tumor assessment for both target and non-target lesions using: Clinical examination; Chest X-ray; Computed Tomography and Magnetic Resonance Imaging; Bone scan; Ultrasound. Per National Cancer Institute Response Evaluation Criteria in Solid Tumors (RECIST) v1.0, best overall response (BOR) for tumors was confirmed CR or PR. CR=disappearance of all target and non-target lesions; PR=at least a 30% decrease in the sum of the longest diameter of target lesions, taking as reference the screening sum longest diameter. Confidence intervals (CIs) were computed using the Clopper and Pearson method. | Safety Population: All participants who received at least 1 dose or any partial dose of nivolumab were analyzed. Tumor Evaluable Population: all participants who received complete dose(s) of nivolumab and had completed a major tumor assessment (a baseline and at least 1 post-baseline tumor assessment for either target and/or non-target assessments. | Posted | Number | 95% Confidence Interval | percentage of participants | Day 1 up to 2 Years. |
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| Primary | Percent of Participants With Prostate-Specific Antigen (PSA) Response After the First Dose by Day 85 In Participants With Hormone-Refractory Prostate Adenocarcinoma (HRPC) | The PSA response rate was defined as the number of participants who had at least a 50% decrease of the PSA value from the PSA reference value divided by the total number of participants evaluated (percent of participants). PSA reference value was the PSA concentration measured immediately prior to dosing on Day 1. PSA response was assessed using the Recommendations from the National Cancer Institute Prostate-Specific Antigen Working Group. A PSA response had to be confirmed at least 4 weeks after first response. 95% exact CIs were computed using the Clopper and Pearson method. | The PSA evaluable population was analyzed and included all HRPC participants who received complete dose(s) of nivolumab and had a baseline PSA assessment and at least one post baseline PSA assessment. A PSA evaluable participant could not have any major inclusion/exclusion violation, dosing violation, or protocol conduct violation. | Posted | Number | 95% Confidence Interval | percentage of participants | Day 1 to Day 85 |
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| Secondary | Number of Participants With Best Overall Response (BOR) by Category in Safety Population | Measurable and non-measurable disease/target lesions were evaluated according to National Cancer Institute standardized RECIST.Complete Response (CR)=disappearance of all target and non-target lesions and no new lesions; Partial Response=at least a 30% decrease in the sum of the longest diameter of target lesions, taking as reference the screening sum longest diameter; Stable disease (SD)=neither sufficient shrinkage to qualify for partial response nor sufficient increase to qualify for progressive disease (PD), taking as reference the smallest sum longest diameter since treatment; PD=at least a 20% increase in the sum of the longest diameter recorded since screening, or the appearance of one or more new lesions. BOR was recorded between the first tumor assessment and last tumor assessment. CR and PR had to be confirmed by repeat assessment no less than 4 weeks after the criteria were first met. SD assessment must have met the criteria at least once at or after Week 12. | Safety Population: All participants who received at least 1 dose or any partial dose of nivolumab were analyzed. | Posted | Number | participants | Day 1 to Day 85 |
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| Secondary | Percentage of Participants With Disease Control and Major Durable Disease Control | Disease control rate was defined as number of participants whose Best Overall Response (BOR) was complete response (CR), partial response (PR), or stable disease (SD) divided by the total number of participants. Major durable disease control rate was defined as the total number of participants whose BOR was CR, PR, or SD ≥24 weeks, divided by the total number of participants. Per RECIST v 1.0, BOR for tumors was confirmed CR or PR. CR=disappearance of all target and non-target lesions; PR=at least a 30% decrease in the sum of the longest diameter of target lesions, taking as reference the screening sum longest diameter since treatment; SD=neither sufficient shrinkage to qualify for partial response nor sufficient increase to qualify for PD. PD=at least a 20% increase in the sum of the longest diameter recorded since screening, or the appearance of one or more new lesions. 95% CIs were computed using the Clopper and Pearson method. | Safety Population was analyzed: All participants who received at least 1 dose or any partial dose of nivolumab. | Posted | Number | 95% Confidence Interval | percentage of participants | Day 1 to 2 Years |
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| Secondary | Median Time to Tumor Response and Duration of Tumor Response | Time to tumor response: from the date of first dose to the first date of tumor response (CR or PR confirmed at least 4 weeks later); for nonresponders, it was censored at the date of the maximum tumor assessment time in the dose cohort by the end of study. Duration of tumor response was calculated from the first date of response of CR or PR to the date of the first PD or the date of death if a participant died due to disease progression (whichever occurred first). Duration of response was censored at the last tumor assessment date by the end of study if a responder did not have PD or death. Nonresponders had the duration of response as an event of 0 days. | All participants who received at least 1 dose or any partial dose of nivolumab and were tumor responders were analyze. | Posted | Median | 95% Confidence Interval | days | Day 1 to 2 Years |
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| Secondary | Time to Tumor Progression and Tumor Progression Free Survival | Time to tumor progression (TTP) was measured in days from date of the first dose to the date of the first PD or the date of death if due to PD. For those who died without PD it was censored at the date of death. TTP was censored at the last tumor assessment by the end of study if a participant did not have PD or death. Tumor progression free survival (PFS) was measured in days from the date of first dose to the date of the first disease progression or to the date of death. PFS was censored at the last tumor assessment date by the end of study if a participant did not have PD or death. | All participants who received at least 1 dose or any partial dose of nivolumab were analyzed. | Posted | Median | 95% Confidence Interval | days | Day 1 to 2 Years |
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| Secondary | Median Time to PSA Progression in Days and Median PSA Progression Free Survival in Days in PSA Evaluable Population | Time to PSA progression: first dose to first PSA progression. Missing date of progression was censored: if death during the study, time to progression was right-censored at last PSA assessment; if no progression from first dose and still alive at end of study, time to progression was right-censored at last PSA assessment by end of study; if no PSA progression and one has discontinued from the study (other than death or PSA progression), time to progression was right-censored at last PSA assessment. PSA progression free survival (PFS): first dose to first PSA progression or death, whichever comes first. Missing date of progression was censored: if one did not have PSA progression from first dose and was still alive at end of study, PSA PFS was right-censored at last PSA assessment; if one does not have any progression and discontinued from the study for reasons other than death or progression, PFS was right-censored at last assessment. CI computed using Brookmeyer and Crowley method. | The PSA evaluable population include all participants in the study who received complete dose(s) of nivolumab and had a baseline PSA assessment and at least 1 post-baseline PSA assessment. | Posted | Median | 95% Confidence Interval | days | Day 1 to 2 Years |
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| Secondary | Mean Change From Baseline in PSA Relative Velocity at Days 29, 57, and 85 With Cycle 1 in PSA Evaluable Population | PSA relative velocity (PSA RV) was defined as = (d[PSA]/dt)/ [PSA], where [PSA] =concentration of PSA, and t= time, and in the limit reflects the instantaneous change in PSA levels as a fraction of total PSA level. Decreases in PSA RV may occur while measured [PSA] is still rising, and may indicate that continued therapy may lead to a treatment benefit, particularly in the setting of immunotherapy, where expansion of an effective immune response is likely to require weeks to mature. Baseline PSA RV was based on the velocity of last PSA measurement before the first infusion of study drug and the screening PSA measurement. | The PSA evaluable population includes all participants in the study who received complete dose(s) of nivolumab and has a baseline PSA assessment and at least 1 post-baseline PSA assessment. | Posted | Median | Full Range | percentage of total PSA level | Day 29, Day 57, Day 85 |
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| Secondary | Mean Change From Baseline in Electrocardiogram Parameters PR, QRS and QT in Safety Population | 12-lead ECGs were performed at screening, baseline, Day 2 and at completion of the dose cycle (Day 85 in first dose cycle). In those participants undergoing re-treatment, ECG was repeated at the completion of the re-treatment. Baseline was defined as the last measurement before the first dose of study drug, which was calculated from pre-dose or from screening if pre-dose was not available. PR, QRS and QT interval were measured in milliseconds (msec). | All participants who received at least 1 dose or any partial dose of nivolumab and had available ECG at baseline and on the specified post treatment study day were analyzed. | Posted | Mean | Standard Deviation | msec | Baseline, Day 2, Day 85, Day 113 |
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| Secondary | Mean Diastolic Blood Pressure at Baseline and Post-Infusion Day 1 (Cycle 1) in 0.3 mg Cohort - Safety Population | Diastolic blood pressures (DBPs) measured in millimeters of mercury (mmHg) were obtained while the participant was seated. Post infusion DBPs are presented in the 0.3 mg cohort at: 21, 36, 51, 66, 82, 97, 112, 127, 157 minutes post infusion, and at 1, 2, 3, 4, 6, 8 hours post infusion. Baseline was defined as the last measurement before the first dose of study drug, which was calculated from pre-dose or from screening if pre-dose was not available. Mean DBP on Day 1 for first dose (cycle 1) are presented below. | All participants who received at least 1 dose or any partial dose of nivolumab and had available blood pressure at baseline and post-infusion were analyzed. | Posted | Mean | Standard Deviation | mmHg | Baseline, Day 1 |
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| Secondary | Mean Systolic Blood Pressure at Baseline and Post-Infusion Day 1 (Cycle 1) in 0.3 mg Cohort - Safety Population | Systolic blood pressures (SBPs) measured in millimeters of mercury (mmHg) were obtained while the participant was seated. Baseline, Infusion (0 minutes) and Post infusion SBPs are presented in the 0.3 mg cohort at: 21, 36, 51, 66, 82, 97, 112, 127, 157 minutes post infusion, and at 1, 2, 3, 4, 6, 8 hours post infusion. Baseline was defined as the last measurement before the first dose of study drug, which was calculated from pre-dose or from screening if pre-dose was not available. Mean SBP on Day 1 for first dose (cycle 1) are presented below. | All participants who received at least 1 dose or any partial dose of nivolumab and had available blood pressure at baseline and post-infusion were analyzed. | Posted | Mean | Standard Deviation | mmHg | Baseline, Day 1 |
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| Secondary | Mean Diastolic Blood Pressure at Baseline and Post-Infusion Day 1 (Cycle 1) in 1mg, 3mg, and 10 mg Cohorts - Safety Population | Diastolic blood pressures (DBPs) measured in millimeters of mercury (mmHg) were obtained while the participant was seated. Baseline, Infusion (0 minutes) and Post infusion DBPs are presented in the 1 mg, 3 mg and 10 mg cohorts at: 15, 30, 45, 60, 75, and 90 minutes post infusion and at 1, 2, 3, 4, 6, 8 hours post infusion. Baseline was defined as the last measurement before the first dose of study drug, which was calculated from pre-dose or from screening if pre-dose was not available. Mean DBP on Day 1 for first dose (cycle 1) are presented below. | All participants who received at least 1 dose or any partial dose of nivolumab and had available blood pressure at baseline and post-infusion were analyzed. | Posted | Mean | Standard Deviation | mmHg | Baseline, Day 1 |
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| Secondary | Mean Systolic Blood Pressure at Baseline and Post-Infusion Day 1 (Cycle 1) in in 1mg, 3mg, and 10 mg Cohorts - Safety Population | Systolic blood pressures (SBPs) measured in millimeters of mercury (mmHg) were obtained while the participant was seated. Baseline, Infusion (0 minutes) and Post infusion SBPs are presented in the 1 mg, 3 mg and 10 mg cohorts at: 15, 30, 45, 60, 75, and 90 minutes post infusion and at 1, 2, 3, 4, 6, 8 hours post infusion. Baseline was defined as the last measurement before the first dose of study drug, which was calculated from pre-dose or from screening if pre-dose was not available. Mean SBPs on Day 1 for first dose (cycle 1) are presented below. | All participants who received at least 1 dose or any partial dose of nivolumab and had available blood pressure at baseline and post-infusion were analyzed. | Posted | Mean | Standard Deviation | mmHg | Baseline, Day 1 |
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| 3 |
| 6 |
| 6 |
| 6 |
| EG001 | 1 mg/kg Nivolumab | 1 mg of nivolumab per kg of body weight was administered in a single IV infusion over 60 minutes on Day 1. Eligible participants could be re-treated and receive 2 more doses (1 dose every 4 weeks) at same dose as the single dose if: disease was stable, no drug intolerance was observed, no complete response (CR) or partial response (PR) was observed, or they had a positive immunogenicity sample within 4 weeks prior to re-treatment. Those who responded to therapy with a CR or PR were eligible for long-term follow-up until either progressive disease (PD) or 2 years elapsed. | 5 | 6 | 6 | 6 |
| EG002 | 3 mg/kg Nivolumab | 3 mg of nivolumab per kg of body weight was administered in a single IV infusion over 60 minutes on Day 1. Eligible participants could be re-treated and receive 2 more doses (1 dose every 4 weeks) at same dose as the single dose if: disease was stable, no drug intolerance was observed, no complete response (CR) or partial response (PR) was observed, or they had a positive immunogenicity sample within 4 weeks prior to re-treatment. Those who responded to therapy with a CR or PR were eligible for long-term follow-up until either progressive disease (PD) or 2 years elapsed. | 4 | 6 | 6 | 6 |
| EG003 | 10 mg/kg Nivolumab | 10 mg of nivolumab per kg of body weight was administered in a single IV infusion over 60 minutes on Day 1. Eligible participants could be re-treated and receive 2 more doses (1 dose every 4 weeks) at same dose as the single dose if: disease was stable, no drug intolerance was observed, no complete response (CR) or partial response (PR) was observed, or they had a positive immunogenicity sample within 4 weeks prior to re-treatment. Those who responded to therapy with a CR or PR were eligible for long-term follow-up until either progressive disease (PD) or 2 years elapsed. | 11 | 21 | 21 | 21 |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 10.1 | Systematic Assessment |
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| Confusional state | Psychiatric disorders | MedDRA 10.1 | Systematic Assessment |
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| Abdominal pain upper | Gastrointestinal disorders | MedDRA 10.1 | Systematic Assessment |
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| Central nervous system lesion | Nervous system disorders | MedDRA 10.1 | Systematic Assessment |
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| Fracture | Injury, poisoning and procedural complications | MedDRA 10.1 | Systematic Assessment |
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| Pelvic pain | Reproductive system and breast disorders | MedDRA 10.1 | Systematic Assessment |
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| Renal failure | Renal and urinary disorders | MedDRA 10.1 | Systematic Assessment |
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| Chronic obstructive pulmonary disease | Respiratory, thoracic and mediastinal disorders | MedDRA 10.1 | Systematic Assessment |
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| Myoclonus | Nervous system disorders | MedDRA 10.1 | Systematic Assessment |
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| Pneumonia | Infections and infestations | MedDRA 10.1 | Systematic Assessment |
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| Anaemia | Blood and lymphatic system disorders | MedDRA 10.1 | Systematic Assessment |
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| Brain oedema | Nervous system disorders | MedDRA 10.1 | Systematic Assessment |
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| Dehydration | Metabolism and nutrition disorders | MedDRA 10.1 | Systematic Assessment |
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| Flank pain | Musculoskeletal and connective tissue disorders | MedDRA 10.1 | Systematic Assessment |
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| Ileus | Gastrointestinal disorders | MedDRA 10.1 | Systematic Assessment |
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| Metastatic pain | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 10.1 | Systematic Assessment |
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| Pain | General disorders | MedDRA 10.1 | Systematic Assessment |
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| Respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA 10.1 | Systematic Assessment |
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| Sepsis | Infections and infestations | MedDRA 10.1 | Systematic Assessment |
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| Ureteric obstruction | Renal and urinary disorders | MedDRA 10.1 | Systematic Assessment |
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| Alanine aminotransferase increased | Investigations | MedDRA 10.1 | Systematic Assessment |
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| Dizziness | Nervous system disorders | MedDRA 10.1 | Systematic Assessment |
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| Hyperkalaemia | Metabolism and nutrition disorders | MedDRA 10.1 | Systematic Assessment |
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| Malignant neoplasm progression | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 10.1 | Systematic Assessment |
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| Metastases to central nervous system | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 10.1 | Systematic Assessment |
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| Pulmonary embolism | Respiratory, thoracic and mediastinal disorders | MedDRA 10.1 | Systematic Assessment |
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| Spinal cord compression | Nervous system disorders | MedDRA 10.1 | Systematic Assessment |
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| Ascites | Gastrointestinal disorders | MedDRA 10.1 | Systematic Assessment |
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| Colitis | Gastrointestinal disorders | MedDRA 10.1 | Systematic Assessment |
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| Mood altered | Psychiatric disorders | MedDRA 10.1 | Systematic Assessment |
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| Small intestinal obstruction | Gastrointestinal disorders | MedDRA 10.1 | Systematic Assessment |
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| Acute hepatic failure | Hepatobiliary disorders | MedDRA 10.1 | Systematic Assessment |
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| Bladder obstruction | Renal and urinary disorders | MedDRA 10.1 | Systematic Assessment |
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| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 10.1 | Systematic Assessment |
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| Gastritis | Gastrointestinal disorders | MedDRA 10.1 | Systematic Assessment |
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| Gastrointestinal haemorrhage | Gastrointestinal disorders | MedDRA 10.1 | Systematic Assessment |
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| Hyperglycaemia | Metabolism and nutrition disorders | MedDRA 10.1 | Systematic Assessment |
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| Intestinal obstruction | Gastrointestinal disorders | MedDRA 10.1 | Systematic Assessment |
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| Metastases to spine | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 10.1 | Systematic Assessment |
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| Pleural effusion | Respiratory, thoracic and mediastinal disorders | MedDRA 10.1 | Systematic Assessment |
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| Rectal haemorrhage | Gastrointestinal disorders | MedDRA 10.1 | Systematic Assessment |
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| Abdominal pain | Gastrointestinal disorders | MedDRA 10.1 | Systematic Assessment |
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| Anxiety | Psychiatric disorders | MedDRA 10.1 | Systematic Assessment |
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| Aphasia | Nervous system disorders | MedDRA 10.1 | Systematic Assessment |
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| Nephrolithiasis | Renal and urinary disorders | MedDRA 10.1 | Systematic Assessment |
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| Osteoarthritis | Musculoskeletal and connective tissue disorders | MedDRA 10.1 | Systematic Assessment |
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| Anorexia | Metabolism and nutrition disorders | MedDRA 10.1 | Systematic Assessment |
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| Back injury | Injury, poisoning and procedural complications | MedDRA 10.1 | Systematic Assessment |
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| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 10.1 | Systematic Assessment |
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| Blood chloride decreased | Investigations | MedDRA 10.1 | Systematic Assessment |
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| Blood thyroid stimulating hormone increased | Investigations | MedDRA 10.1 | Systematic Assessment |
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| Carbon dioxide decreased | Investigations | MedDRA 10.1 | Systematic Assessment |
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| Confusional state | Psychiatric disorders | MedDRA 10.1 | Systematic Assessment |
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| Crystal urine present | Investigations | MedDRA 10.1 | Systematic Assessment |
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| Dermatitis | Skin and subcutaneous tissue disorders | MedDRA 10.1 | Systematic Assessment |
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| Electrocardiogram ST-T change | Investigations | MedDRA 10.1 | Systematic Assessment |
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| Electrocardiogram abnormal | Investigations | MedDRA 10.1 | Systematic Assessment |
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| Flatulence | Gastrointestinal disorders | MedDRA 10.1 | Systematic Assessment |
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| Glucose urine | Investigations | MedDRA 10.1 | Systematic Assessment |
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| Hyperhidrosis | Skin and subcutaneous tissue disorders | MedDRA 10.1 | Systematic Assessment |
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| Hypoaesthesia | Nervous system disorders | MedDRA 10.1 | Systematic Assessment |
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| Hypocalcaemia | Metabolism and nutrition disorders | MedDRA 10.1 | Systematic Assessment |
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| Hypotension | Vascular disorders | MedDRA 10.1 | Systematic Assessment |
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| Infection | Infections and infestations | MedDRA 10.1 | Systematic Assessment |
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| Leukopenia | Blood and lymphatic system disorders | MedDRA 10.1 | Systematic Assessment |
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| Muscle spasms | Musculoskeletal and connective tissue disorders | MedDRA 10.1 | Systematic Assessment |
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| Musculoskeletal chest pain | Musculoskeletal and connective tissue disorders | MedDRA 10.1 | Systematic Assessment |
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| Non-cardiac chest pain | General disorders | MedDRA 10.1 | Systematic Assessment |
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| Oral candidiasis | Infections and infestations | MedDRA 10.1 | Systematic Assessment |
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| Pain in jaw | Musculoskeletal and connective tissue disorders | MedDRA 10.1 | Systematic Assessment |
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| Procedural pain | Injury, poisoning and procedural complications | MedDRA 10.1 | Systematic Assessment |
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| Sinus headache | Nervous system disorders | MedDRA 10.1 | Systematic Assessment |
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| Type 2 diabetes mellitus | Metabolism and nutrition disorders | MedDRA 10.1 | Systematic Assessment |
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| Urinary tract infection | Infections and infestations | MedDRA 10.1 | Systematic Assessment |
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| Vomiting | Gastrointestinal disorders | MedDRA 10.1 | Systematic Assessment |
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| Weight decreased | Investigations | MedDRA 10.1 | Systematic Assessment |
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| Abdominal pain upper | Gastrointestinal disorders | MedDRA 10.1 | Systematic Assessment |
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| Blood uric acid decreased | Investigations | MedDRA 10.1 | Systematic Assessment |
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| CD4 lymphocytes decreased | Investigations | MedDRA 10.1 | Systematic Assessment |
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| Crystal urine | Investigations | MedDRA 10.1 | Systematic Assessment |
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| Depression | Psychiatric disorders | MedDRA 10.1 | Systematic Assessment |
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| Diarrhoea haemorrhagic | Gastrointestinal disorders | MedDRA 10.1 | Systematic Assessment |
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| Dry mouth | Gastrointestinal disorders | MedDRA 10.1 | Systematic Assessment |
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| Dysphagia | Gastrointestinal disorders | MedDRA 10.1 | Systematic Assessment |
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| Eosinophil count increased | Investigations | MedDRA 10.1 | Systematic Assessment |
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| Erythema | Skin and subcutaneous tissue disorders | MedDRA 10.1 | Systematic Assessment |
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| Frequent bowel movements | Gastrointestinal disorders | MedDRA 10.1 | Systematic Assessment |
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| Groin pain | Musculoskeletal and connective tissue disorders | MedDRA 10.1 | Systematic Assessment |
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| Hyperphosphataemia | Metabolism and nutrition disorders | MedDRA 10.1 | Systematic Assessment |
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| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA 10.1 | Systematic Assessment |
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| Night sweats | Skin and subcutaneous tissue disorders | MedDRA 10.1 | Systematic Assessment |
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| Pruritus | Skin and subcutaneous tissue disorders | MedDRA 10.1 | Systematic Assessment |
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| Skin lesion | Skin and subcutaneous tissue disorders | MedDRA 10.1 | Systematic Assessment |
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| T-lymphocyte count decreased | Investigations | MedDRA 10.1 | Systematic Assessment |
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| Tachycardia | Cardiac disorders | MedDRA 10.1 | Systematic Assessment |
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| Wound secretion | Injury, poisoning and procedural complications | MedDRA 10.1 | Systematic Assessment |
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| Abdominal distension | Gastrointestinal disorders | MedDRA 10.1 | Systematic Assessment |
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| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 10.1 | Systematic Assessment |
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| Atrial fibrillation | Cardiac disorders | MedDRA 10.1 | Systematic Assessment |
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| B-lymphocyte count increased | Investigations | MedDRA 10.1 | Systematic Assessment |
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| Bacteria urine | Investigations | MedDRA 10.1 | Systematic Assessment |
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| Bacteriuria | Infections and infestations | MedDRA 10.1 | Systematic Assessment |
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| Blood creatinine increased | Investigations | MedDRA 10.1 | Systematic Assessment |
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| Blood phosphorus increased | Investigations | MedDRA 10.1 | Systematic Assessment |
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| Blood potassium decreased | Investigations | MedDRA 10.1 | Systematic Assessment |
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| Blood urine present | Investigations | MedDRA 10.1 | Systematic Assessment |
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| Candidiasis | Infections and infestations | MedDRA 10.1 | Systematic Assessment |
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| Chills | General disorders | MedDRA 10.1 | Systematic Assessment |
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| Chronic obstructive pulmonary disease | Respiratory, thoracic and mediastinal disorders | MedDRA 10.1 | Systematic Assessment |
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| Decreased appetite | Metabolism and nutrition disorders | MedDRA 10.1 | Systematic Assessment |
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| Dysphonia | Respiratory, thoracic and mediastinal disorders | MedDRA 10.1 | Systematic Assessment |
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| Dysuria | Renal and urinary disorders | MedDRA 10.1 | Systematic Assessment |
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| Eosinophil count decreased | Investigations | MedDRA 10.1 | Systematic Assessment |
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| Eye pain | Eye disorders | MedDRA 10.1 | Systematic Assessment |
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| Haematocrit decreased | Investigations | MedDRA 10.1 | Systematic Assessment |
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| Haemoglobin decreased | Investigations | MedDRA 10.1 | Systematic Assessment |
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| Herpes zoster | Infections and infestations | MedDRA 10.1 | Systematic Assessment |
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| Hypercalcaemia | Metabolism and nutrition disorders | MedDRA 10.1 | Systematic Assessment |
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| Hypergammaglobulinaemia | Blood and lymphatic system disorders | MedDRA 10.1 | Systematic Assessment |
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| Hypersensitivity | Immune system disorders | MedDRA 10.1 | Systematic Assessment |
|
| Hypoalbuminaemia | Metabolism and nutrition disorders | MedDRA 10.1 | Systematic Assessment |
|
| Hypokalaemia | Metabolism and nutrition disorders | MedDRA 10.1 | Systematic Assessment |
|
| Hyponatraemia | Metabolism and nutrition disorders | MedDRA 10.1 | Systematic Assessment |
|
| Influenza like illness | General disorders | MedDRA 10.1 | Systematic Assessment |
|
| Insomnia | Psychiatric disorders | MedDRA 10.1 | Systematic Assessment |
|
| Mean cell volume decreased | Investigations | MedDRA 10.1 | Systematic Assessment |
|
| Monocyte count increased | Investigations | MedDRA 10.1 | Systematic Assessment |
|
| Musculoskeletal pain | Musculoskeletal and connective tissue disorders | MedDRA 10.1 | Systematic Assessment |
|
| Neutropenia | Blood and lymphatic system disorders | MedDRA 10.1 | Systematic Assessment |
|
| Nocturia | Renal and urinary disorders | MedDRA 10.1 | Systematic Assessment |
|
| Pruritus ani | Gastrointestinal disorders | MedDRA 10.1 | Systematic Assessment |
|
| Rash erythematous | Skin and subcutaneous tissue disorders | MedDRA 10.1 | Systematic Assessment |
|
| Rash pruritic | Skin and subcutaneous tissue disorders | MedDRA 10.1 | Systematic Assessment |
|
| Rash pustular | Infections and infestations | MedDRA 10.1 | Systematic Assessment |
|
| Rheumatoid factor | Investigations | MedDRA 10.1 | Systematic Assessment |
|
| Rheumatoid factor positive | Investigations | MedDRA 10.1 | Systematic Assessment |
|
| White blood cell count increased | Investigations | MedDRA 10.1 | Systematic Assessment |
|
| White blood cells urine | Investigations | MedDRA 10.1 | Systematic Assessment |
|
| Anaemia | Blood and lymphatic system disorders | MedDRA 10.1 | Systematic Assessment |
|
| Blood bicarbonate decreased | Investigations | MedDRA 10.1 | Systematic Assessment |
|
| Blood bilirubin increased | Investigations | MedDRA 10.1 | Systematic Assessment |
|
| Blood lactate dehydrogenase increased | Investigations | MedDRA 10.1 | Systematic Assessment |
|
| Blood magnesium decreased | Investigations | MedDRA 10.1 | Systematic Assessment |
|
| C-reactive protein increased | Investigations | MedDRA 10.1 | Systematic Assessment |
|
| Catheter site erythema | General disorders | MedDRA 10.1 | Systematic Assessment |
|
| Dehydration | Metabolism and nutrition disorders | MedDRA 10.1 | Systematic Assessment |
|
| Flank pain | Musculoskeletal and connective tissue disorders | MedDRA 10.1 | Systematic Assessment |
|
| Folliculitis | Infections and infestations | MedDRA 10.1 | Systematic Assessment |
|
| Gingival pain | Gastrointestinal disorders | MedDRA 10.1 | Systematic Assessment |
|
| Hepatomegaly | Hepatobiliary disorders | MedDRA 10.1 | Systematic Assessment |
|
| Injection site reaction | General disorders | MedDRA 10.1 | Systematic Assessment |
|
| Joint stiffness | Musculoskeletal and connective tissue disorders | MedDRA 10.1 | Systematic Assessment |
|
| Metastatic pain | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 10.1 | Systematic Assessment |
|
| Mouth ulceration | Gastrointestinal disorders | MedDRA 10.1 | Systematic Assessment |
|
| Palpitations | Cardiac disorders | MedDRA 10.1 | Systematic Assessment |
|
| Protein total decreased | Investigations | MedDRA 10.1 | Systematic Assessment |
|
| Rash | Skin and subcutaneous tissue disorders | MedDRA 10.1 | Systematic Assessment |
|
| Scrotal swelling | Reproductive system and breast disorders | MedDRA 10.1 | Systematic Assessment |
|
| Skin exfoliation | Skin and subcutaneous tissue disorders | MedDRA 10.1 | Systematic Assessment |
|
| Stomatitis | Gastrointestinal disorders | MedDRA 10.1 | Systematic Assessment |
|
| Thyroxine decreased | Investigations | MedDRA 10.1 | Systematic Assessment |
|
| Tremor | Nervous system disorders | MedDRA 10.1 | Systematic Assessment |
|
| Tumour pain | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 10.1 | Systematic Assessment |
|
| Urinary incontinence | Renal and urinary disorders | MedDRA 10.1 | Systematic Assessment |
|
| Urinary retention | Renal and urinary disorders | MedDRA 10.1 | Systematic Assessment |
|
| Urine colour abnormal | Investigations | MedDRA 10.1 | Systematic Assessment |
|
| Weight increased | Investigations | MedDRA 10.1 | Systematic Assessment |
|
| Alanine aminotransferase increased | Investigations | MedDRA 10.1 | Systematic Assessment |
|
| Arthritis | Musculoskeletal and connective tissue disorders | MedDRA 10.1 | Systematic Assessment |
|
| Arthropod bite | Injury, poisoning and procedural complications | MedDRA 10.1 | Systematic Assessment |
|
| Ataxia | Nervous system disorders | MedDRA 10.1 | Systematic Assessment |
|
| B-lymphocyte count decreased | Investigations | MedDRA 10.1 | Systematic Assessment |
|
| Blood sodium decreased | Investigations | MedDRA 10.1 | Systematic Assessment |
|
| Blood urea decreased | Investigations | MedDRA 10.1 | Systematic Assessment |
|
| CD8 lymphocytes decreased | Investigations | MedDRA 10.1 | Systematic Assessment |
|
| Carbon dioxide increased | Investigations | MedDRA 10.1 | Systematic Assessment |
|
| Chest pain | General disorders | MedDRA 10.1 | Systematic Assessment |
|
| Dizziness | Nervous system disorders | MedDRA 10.1 | Systematic Assessment |
|
| Dyspepsia | Gastrointestinal disorders | MedDRA 10.1 | Systematic Assessment |
|
| Eustachian tube dysfunction | Ear and labyrinth disorders | MedDRA 10.1 | Systematic Assessment |
|
| Furuncle | Infections and infestations | MedDRA 10.1 | Systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA 10.1 | Systematic Assessment |
|
| Hyperbilirubinaemia | Hepatobiliary disorders | MedDRA 10.1 | Systematic Assessment |
|
| Hyperkalaemia | Metabolism and nutrition disorders | MedDRA 10.1 | Systematic Assessment |
|
| Hypophosphataemia | Metabolism and nutrition disorders | MedDRA 10.1 | Systematic Assessment |
|
| Infusion site oedema | General disorders | MedDRA 10.1 | Systematic Assessment |
|
| Lipase increased | Investigations | MedDRA 10.1 | Systematic Assessment |
|
| Melaena | Gastrointestinal disorders | MedDRA 10.1 | Systematic Assessment |
|
| Monocyte count decreased | Investigations | MedDRA 10.1 | Systematic Assessment |
|
| Nasal congestion | Respiratory, thoracic and mediastinal disorders | MedDRA 10.1 | Systematic Assessment |
|
| Neutrophil count increased | Investigations | MedDRA 10.1 | Systematic Assessment |
|
| Oedema | General disorders | MedDRA 10.1 | Systematic Assessment |
|
| Oedema peripheral | General disorders | MedDRA 10.1 | Systematic Assessment |
|
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA 10.1 | Systematic Assessment |
|
| Productive cough | Respiratory, thoracic and mediastinal disorders | MedDRA 10.1 | Systematic Assessment |
|
| Pyrexia | General disorders | MedDRA 10.1 | Systematic Assessment |
|
| Sinus disorder | Respiratory, thoracic and mediastinal disorders | MedDRA 10.1 | Systematic Assessment |
|
| Urinary sediment present | Investigations | MedDRA 10.1 | Systematic Assessment |
|
| Apraxia | Nervous system disorders | MedDRA 10.1 | Systematic Assessment |
|
| Ascites | Gastrointestinal disorders | MedDRA 10.1 | Systematic Assessment |
|
| Aspartate aminotransferase increased | Investigations | MedDRA 10.1 | Systematic Assessment |
|
| Asthenia | General disorders | MedDRA 10.1 | Systematic Assessment |
|
| Blood alkaline phosphatase increased | Investigations | MedDRA 10.1 | Systematic Assessment |
|
| Breath sounds abnormal | Investigations | MedDRA 10.1 | Systematic Assessment |
|
| CD4 lymphocytes increased | Investigations | MedDRA 10.1 | Systematic Assessment |
|
| Cheilitis | Gastrointestinal disorders | MedDRA 10.1 | Systematic Assessment |
|
| Colitis | Gastrointestinal disorders | MedDRA 10.1 | Systematic Assessment |
|
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 10.1 | Systematic Assessment |
|
| Dyspnoea exertional | Respiratory, thoracic and mediastinal disorders | MedDRA 10.1 | Systematic Assessment |
|
| Ecchymosis | Skin and subcutaneous tissue disorders | MedDRA 10.1 | Systematic Assessment |
|
| Fatigue | General disorders | MedDRA 10.1 | Systematic Assessment |
|
| Haematuria | Renal and urinary disorders | MedDRA 10.1 | Systematic Assessment |
|
| Haemoptysis | Respiratory, thoracic and mediastinal disorders | MedDRA 10.1 | Systematic Assessment |
|
| Hypermagnesaemia | Metabolism and nutrition disorders | MedDRA 10.1 | Systematic Assessment |
|
| Hypertension | Vascular disorders | MedDRA 10.1 | Systematic Assessment |
|
| Hypochromasia | Blood and lymphatic system disorders | MedDRA 10.1 | Systematic Assessment |
|
| Lethargy | Nervous system disorders | MedDRA 10.1 | Systematic Assessment |
|
| Mean cell haemoglobin concentration decreased | Investigations | MedDRA 10.1 | Systematic Assessment |
|
| Microcytosis | Blood and lymphatic system disorders | MedDRA 10.1 | Systematic Assessment |
|
| Nausea | Gastrointestinal disorders | MedDRA 10.1 | Systematic Assessment |
|
| Proteinuria | Renal and urinary disorders | MedDRA 10.1 | Systematic Assessment |
|
| Red blood cell count decreased | Investigations | MedDRA 10.1 | Systematic Assessment |
|
| Red blood cells urine | Investigations | MedDRA 10.1 | Systematic Assessment |
|
| Rheumatoid factor increased | Investigations | MedDRA 10.1 | Systematic Assessment |
|
| Sinusitis | Infections and infestations | MedDRA 10.1 | Systematic Assessment |
|
| Specific gravity urine increased | Investigations | MedDRA 10.1 | Systematic Assessment |
|
| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA 10.1 | Systematic Assessment |
|
| Upper respiratory tract infection | Infections and infestations | MedDRA 10.1 | Systematic Assessment |
|
| White blood cells urine positive | Investigations | MedDRA 10.1 | Systematic Assessment |
|
| Blood albumin decreased | Investigations | MedDRA 10.1 | Systematic Assessment |
|
| Blood calcium decreased | Investigations | MedDRA 10.1 | Systematic Assessment |
|
| Blood chloride increased | Investigations | MedDRA 10.1 | Systematic Assessment |
|
| Blood creatine phosphokinase increased | Investigations | MedDRA 10.1 | Systematic Assessment |
|
| Blood glucose increased | Investigations | MedDRA 10.1 | Systematic Assessment |
|
| Blood urea increased | Investigations | MedDRA 10.1 | Systematic Assessment |
|
| Blood uric acid increased | Investigations | MedDRA 10.1 | Systematic Assessment |
|
| Diarrhoea | Gastrointestinal disorders | MedDRA 10.1 | Systematic Assessment |
|
| Dry skin | Skin and subcutaneous tissue disorders | MedDRA 10.1 | Systematic Assessment |
|
| Dysgeusia | Nervous system disorders | MedDRA 10.1 | Systematic Assessment |
|
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 10.1 | Systematic Assessment |
|
| Facial wasting | Skin and subcutaneous tissue disorders | MedDRA 10.1 | Systematic Assessment |
|
| Gait disturbance | General disorders | MedDRA 10.1 | Systematic Assessment |
|
| Gastritis | Gastrointestinal disorders | MedDRA 10.1 | Systematic Assessment |
|
| Haemorrhoids | Gastrointestinal disorders | MedDRA 10.1 | Systematic Assessment |
|
| Hordeolum | Infections and infestations | MedDRA 10.1 | Systematic Assessment |
|
| Hot flush | Vascular disorders | MedDRA 10.1 | Systematic Assessment |
|
| Hyperglycaemia | Metabolism and nutrition disorders | MedDRA 10.1 | Systematic Assessment |
|
| Hypoglycaemia | Metabolism and nutrition disorders | MedDRA 10.1 | Systematic Assessment |
|
| Leukocytosis | Blood and lymphatic system disorders | MedDRA 10.1 | Systematic Assessment |
|
| Liver disorder | Hepatobiliary disorders | MedDRA 10.1 | Systematic Assessment |
|
| Lymphopenia | Blood and lymphatic system disorders | MedDRA 10.1 | Systematic Assessment |
|
| Mean cell haemoglobin decreased | Investigations | MedDRA 10.1 | Systematic Assessment |
|
| Peripheral sensory neuropathy | Nervous system disorders | MedDRA 10.1 | Systematic Assessment |
|
| Pharyngolaryngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA 10.1 | Systematic Assessment |
|
| Platelet count increased | Investigations | MedDRA 10.1 | Systematic Assessment |
|
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | MedDRA 10.1 | Systematic Assessment |
|
| Pulmonary fibrosis | Respiratory, thoracic and mediastinal disorders | MedDRA 10.1 | Systematic Assessment |
|
| Rectal haemorrhage | Gastrointestinal disorders | MedDRA 10.1 | Systematic Assessment |
|
| Troponin increased | Investigations | MedDRA 10.1 | Systematic Assessment |
|
| Vision blurred | Eye disorders | MedDRA 10.1 | Systematic Assessment |
|
| Abdominal pain | Gastrointestinal disorders | MedDRA 10.1 | Systematic Assessment |
|
| Alopecia | Skin and subcutaneous tissue disorders | MedDRA 10.1 | Systematic Assessment |
|
| Antinuclear antibody positive | Investigations | MedDRA 10.1 | Systematic Assessment |
|
| Anxiety | Psychiatric disorders | MedDRA 10.1 | Systematic Assessment |
|
| Blood phosphorus decreased | Investigations | MedDRA 10.1 | Systematic Assessment |
|
| Blood potassium increased | Investigations | MedDRA 10.1 | Systematic Assessment |
|
| Blood thyroid stimulating hormone decreased | Investigations | MedDRA 10.1 | Systematic Assessment |
|
| Bone pain | Musculoskeletal and connective tissue disorders | MedDRA 10.1 | Systematic Assessment |
|
| Bronchitis | Infections and infestations | MedDRA 10.1 | Systematic Assessment |
|
| Constipation | Gastrointestinal disorders | MedDRA 10.1 | Systematic Assessment |
|
| Contusion | Injury, poisoning and procedural complications | MedDRA 10.1 | Systematic Assessment |
|
| Hyperuricaemia | Metabolism and nutrition disorders | MedDRA 10.1 | Systematic Assessment |
|
| Hypoaesthesia facial | Skin and subcutaneous tissue disorders | MedDRA 10.1 | Systematic Assessment |
|
| Interleukin level increased | Investigations | MedDRA 10.1 | Systematic Assessment |
|
| Jaundice | Hepatobiliary disorders | MedDRA 10.1 | Systematic Assessment |
|
| Lymphocyte count decreased | Investigations | MedDRA 10.1 | Systematic Assessment |
|
| Muscle atrophy | Musculoskeletal and connective tissue disorders | MedDRA 10.1 | Systematic Assessment |
|
| Muscle strain | Injury, poisoning and procedural complications | MedDRA 10.1 | Systematic Assessment |
|
| Muscular weakness | Musculoskeletal and connective tissue disorders | MedDRA 10.1 | Systematic Assessment |
|
| Postnasal drip | Respiratory, thoracic and mediastinal disorders | MedDRA 10.1 | Systematic Assessment |
|
| Rhinitis | Infections and infestations | MedDRA 10.1 | Systematic Assessment |
|
| Rhinorrhoea | Respiratory, thoracic and mediastinal disorders | MedDRA 10.1 | Systematic Assessment |
|
| Sunburn | Injury, poisoning and procedural complications | MedDRA 10.1 | Systematic Assessment |
|
| Thyroxine free increased | Investigations | MedDRA 10.1 | Systematic Assessment |
|
| White blood cell count decreased | Investigations | MedDRA 10.1 | 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.
| D009371 | Neoplasms by Site |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D007414 | Intestinal Neoplasms |
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
| D012002 | Rectal Diseases |
| D018358 | Neuroendocrine Tumors |
| D017599 | Neuroectodermal Tumors |
| D009373 | Neoplasms, Germ Cell and Embryonal |
| D009370 | Neoplasms by Histologic Type |
| D009380 | Neoplasms, Nerve Tissue |
| D018326 | Nevi and Melanomas |
| D012878 | Skin Neoplasms |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D014571 | Urologic Neoplasms |
| D014565 | Urogenital Neoplasms |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052801 | Male Urogenital Diseases |
| D005834 | Genital Neoplasms, Male |
| D005832 | Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D011469 | Prostatic Diseases |
| D009375 | Neoplasms, Glandular and Epithelial |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D007162 |
| Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |
| AUC (INF); n=3, 4, 5, 19 |
|
| Tumor Evaluable Population (n=6,5,6,20) |
|
| Partial Response |
|
| Stable Disease |
|
| Progressive Disease |
|
| Unknown |
|
| Missing |
|
| Major Durable Disease Control Rate ≥24 weeks |
|
| Tumor Progression Free Survival |
|
| PSA Progression Free Survival |
|
| Cycle 1 Day 57 (n=0, 1, 2, 5) |
|
| Cycle 1 Day 85 (n=0, 1, 2, 4) |
|
| QRS at Day 2 (n=6,6,6,21) |
|
| QT at Day 2 (n=6,6,6,21) |
|
| PR at Day 57 (n=0,0,0,3) |
|
| QRS at Day 57 (n=0,0,0,3) |
|
| QT at Day 57 (n=0,0,0,3) |
|
| PR at Day 85 (n=0,4,4,11) |
|
| QRS at Day 85 (n=0,4,4,11) |
|
| QT at Day 85 (n=0,4,4,11) |
|
| PR at Day 113 (n=0,0,2,3) |
|
| QRS at Day 113 (n=0,0,2,3) |
|
| QT at Day 113 (n=0,0,2,3) |
|
| Title | Measurements |
|---|---|
|
| 36 minutes post infusion (n=6) |
|
| 51 minutes post infusion (n=6) |
|
| 66 minutes post infusion (n=6) |
|
| 82 minutes post infusion (n=6) |
|
| 97 minutes post infusion (n=6) |
|
| 112 minutes post infusion (n=6) |
|
| 127 minutes post infusion (n=6) |
|
| 157 minutes post infusion (n=2) |
|
| 1 hour post infusion (n=6) |
|
| 2 hour post infusion (n=6) |
|
| 3 hour post infusion (n=6) |
|
| 4 hour post infusion (n=6) |
|
| 6 hour post infusion (n=6) |
|
| 8 hour post infusion (n=6) |
|
| Title | Measurements |
|---|---|
|
| 36 minutes post infusion (n=6) |
|
| 51 minutes post infusion (n=6) |
|
| 66 minutes post infusion (n=6) |
|
| 82 minutes post infusion (n=6) |
|
| 97 minutes post infusion (n=6) |
|
| 112 minutes post infusion (n=6) |
|
| 127 minutes post infusion (n=6) |
|
| 157 minutes post infusion (n=2) |
|
| 1 hour post infusion (n=6) |
|
| 2 hour post infusion (n=6) |
|
| 3 hour post infusion (n=6) |
|
| 4 hour post infusion (n=6) |
|
| 6 hour post infusion (n=6) |
|
| 8 hour post infusion (n=6) |
|
|
| 15 minutes post infusion (n=6,6,21) |
|
| 30 minutes post infusion (n=6,6,21) |
|
| 45 minutes post infusion (n=6,6,21) |
|
| 60 minutes post infusion (n=6,6,21) |
|
| 75 minutes post infusion (n=5,3,12) |
|
| 90 minutes post infusion (n=4,4,14) |
|
| 1 hour post infusion (n= 6,5,21) |
|
| 2 hour post infusion (n= 6,6,21) |
|
| 3 hour post infusion (n= 6,5,19) |
|
| 4 hour post infusion (n= 6,6,21) |
|
| 6 hour post infusion (n= 6,6,21) |
|
| 8 hour post infusion (n= 5,5,21) |
|
|
| 15 minutes post infusion (n=6,6,21) |
|
| 30 minutes post infusion (n=6,6,21) |
|
| 45 minutes post infusion (n=6,6,21) |
|
| 60 minutes post infusion (n=6,6,21) |
|
| 75 minutes post infusion (n=5,3,12) |
|
| 90 minutes post infusion (n=4,4,14) |
|
| 1 hour post infusion (n= 6,5,21) |
|
| 2 hour post infusion (n= 6,6,21) |
|
| 3 hour post infusion (n= 6,5,19) |
|
| 4 hour post infusion (n= 6,6,21) |
|
| 6 hour post infusion (n= 6,6,21) |
|
| 8 hour post infusion (n= 5,5,21) |
|