Trial · NCT00730639
A Phase 1 Study of Nivolumab (BMS-936558) in Subjects With Advanced or Recurrent Malignancies
NCT00730639, Phase 1, Completed, Bristol-Myers Squibb; results first posted 2016-04-15
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. A Phase 1 Study of Nivolumab (BMS-936558) in Subjects With Advanced or Recurrent Malignancies. Trials, record NCT00730639. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00730639
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Phase 1 Study of Nivolumab (BMS-936558) in Subjects With Advanced or Recurrent Malignancies
- NCT number
- NCT00730639
- Status
- Completed
- Phases
- Phase 1
- Enrollment
- 395 participants, actual
- Lead sponsor
- Bristol-Myers Squibb
- Conditions
- Metastatic Castration-resistant Prostrate Cancer, Renal Cell Carcinoma, Metastatic Melanoma, Non-small Cell Lung Cancer
- Interventions
- BMS-936558 (MDX-1106), BMS-936558 (MDX-1106), BMS-936558 (MDX-1106), BMS-936558 (MDX-1106), BMS-936558 (MDX-1106)
- First posted
- 2008-08-08
- Last updated
- 2021-12-03
- Results first posted
- 2016-04-15
Source ClinicalTrials.gov
Registered outcomes11
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Participants With Severe Adverse Events (AEs), Serious Adverse Events (SAEs), Treatment-Related AEs, Deaths, Discontinuation of Study Drug Due to AEs | Day 1 to 70 days following last dose of study drug up to June 2013, approximately 4 years | 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. Death=during the study and up to 28 days past study discontinuation. The select AEs were determined using the Medical Dictionary for Regulatory Activities (MedDRA, v15.1) and graded using the Cancer Therapy Evaluation Program Common Terminology Criteria for Adverse Events (CTCAE), Version 3.0. |
| Primary | Number of Participants With Abnormal Serum Chemistry Laboratory Values | Day 1 up to June 2013, approximately 4 years | Alkaline phosphatase (ALP), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Creatinine and Total Bilirubin. National Cancer Institute Common Terminology Criteria (CTC) version (v) 3.0 was used to determine Grade (Gr). Abnormal values for ALP, ALT and AST were based on grades; Gr 1: \> 1.0 - 2.5 \* upper limits of normal (ULN); Gr 2: \> 2.5 - 5.0 \* ULN; Gr 3: \> 5.0 - 20.0 \* ULN; Gr 4: \> 20.0 \* ULN. Abnormal values for Creatinine were based on Gr 1: \> 1.0 - 1.5\*ULN; Gr 2: \> 1.5 - 3.0\*ULN; Gr 3: \> 3.0 - 6.0\*ULN; Gr 4: \> 6.0\*ULN. Abnormal values for Total Bilirubin were based on Gr 1: \> 1.0 - 1.5 \* upper limits of normal (ULN); Gr 2: \> 1.5 - 3.0 \* ULN; Gr 3: \> 3.0 - 10.0 \* ULN; Gr 4: \> 10.0 \* ULN. |
| Primary | Number of Participants With Abnormal Hematology Laboratory Values | Day 1 up to June 2013, approximately 4 years | Hemoglobin, Lymphocytes, Neutrophils, Platelets and Leukocytes. National Cancer Institute Common Terminology Criteria (CTC) version (v) 3.0 was used to determine Grade (Gr). Abnormal values for Hemoglobin were based on Gr 1: 10.0 - less than (\<) lower limit of normal (LLN); Gr 2: 8.0 - \< 10.0; Gr 3: 6.5 - \< 8.0; Gr 4: \< 6.5. Abnormal values for Lymphocytes were based on Gr 1: 0.8 - \< 1.5; Gr 2: 0.5 - \< 0.8; Gr 3): 0.2 - \< 0.5; Gr 4: \< 0.2. Abnormal values for Neutrophils were based on Gr 1: 1.5 - \< 2.0; Gr 2: 1.0 - \< 1.5; Gr 3: 0.5 - \< 1.0; Gr 4: \< 0.5. Abnormal values for Platelets were based on Gr 1: 75.0 - \< lower limits of normal (LLN); Gr 2: 50.0 - \< 75.0; Gr 3: 25.0 - \< 50.0; Gr 4: \< 25.0. Abnormal values for Leukocytes were based on Gr 1: 3.0 - \< LLN; Gr 2: 2.0 - \< 3.0; Gr 3: 1.0 - \< 2.0; Gr4: \< 1.0. |
| Secondary | Immunogenicity Assessment | Day 1 up to June 2013, approximately 4 years | Classification of participants host immune response was based on the following definitions: Anti-Drug Antibody (ADA) Positive Subjects have with at least one ADA positive sample at any time after initiation of treatment. ADA positive subjects were further classified into categories with Persistent Positive defined as an ADA positive sample at 2 or more sequential timepoints at least 8 weeks apart. |
| Secondary | Objective Response Rate | Day 1 up to June 2013, approximately 4 years | Tumor response was evaluated by the sponsor based on tumor assessments by the investigator according to Response Evaluation Criteria in Solid Tumors (RECIST) v1.0. Objective response rate (ORR) was defined as the proportion of participants who's confirmed best overall response (BOR) is either complete (CR) or partial (PR), where the denominator is the number of treated participants in the population of interest. Response was based on tumor measurements. Responders= complete response (CR) or partial response (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. 95% Confidence intervals (CIs) were computed using the Clopper Pearson method. |
| Secondary | Duration of Tumor Response | Day 1 up to June 2013, approximately 4 years | Duration of tumor response (DOR) was calculated from the first date of response of complete response (CR) or partial response (PR) to the date of the first progressive disease (PD) or the date of death. Duration of response was censored at the last tumor assessment date if a responder did not have PD or death. Nonresponders were not included in the analysis. Median DOR was estimated by Kaplan-Meier analysis. |
| Secondary | Geometric Mean Maximum Serum Concentration (Cmax) | 1,4,8,24,48 and 96 hours post-dose timepoints on Day 1 of cycles 1 and 3 | Nivolumab in human serum was assayed by PPD® (Richmond, Virginia) using a cross-validated enzyme-linked immunosorbent assay (ELISA). Blood samples were assessed at all doses from a subset of participants. The pharmacokinetic (PK) parameter of Cmax was measured in micrograms per milliliter (µg/mL). |
| Secondary | Median Time of Maximum Serum Concentration (Tmax) | 1,4,8,24,48 and 96 hours post-dose timepoints on Day 1 of cycles 1 and 3 | Nivolumab in human serum was assayed by PPD® (Richmond, Virginia) using a cross-validated ELISA. Blood samples were assessed Blood samples were assessed at all doses from a subset of participants. The PK parameter of Tmax was measured in hours (h). |
| Secondary | Geometric Mean Area Under the Curve (AUC[TAU]) in One Dosing Interval Observed Post-Single Dose | 1,4,8,24,48 and 96 hours post-dose timepoints on Day 1 of cycles 1 and 3 | Nivolumab in human serum was assayed by PPD® (Richmond, Virginia) using a cross-validated ELISA. Blood samples were assessed at all doses from a subset of participants. The PK parameter of AUC was measured in micrograms\*hours per milliliter (μg\*h/mL). |
| Secondary | Geometric Mean Total Body Clearance of Drug From Serum (CLT) | 1,4,8,24,48 and 96 hours post-dose timepoints on Day 1 of cycle 3 | Nivolumab in human serum was assayed by PPD® (Richmond, Virginia) using a cross-validated ELISA. Blood samples Blood samples were assessed at all doses from a subset of participants. The PK parameter of CLT was measured in milliliters per hour (mL/h). |
1 to 10 of 11Source ClinicalTrials.gov
See all 11 registered outcomesOutcomes11
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Number of Participants With Severe Adverse Events (AEs), Serious Adverse Events (SAEs), Treatment-Related AEs, Deaths, Discontinuation of Study Drug Due to AEs | Day 1 to 70 days following last dose of study drug up to June 2013, approximately 4 years | All participants who received at least 1 dose or any partial dose of nivolumab were analyzed. | participants | NUMBER |
| PRIMARY | Number of Participants With Abnormal Serum Chemistry Laboratory Values | Day 1 up to June 2013, approximately 4 years | All participants who received at least 1 dose or any partial dose of nivolumab who underwent the laboratory test. | participants | NUMBER |
| SECONDARY | Immunogenicity Assessment | Day 1 up to June 2013, approximately 4 years | All participants who received at least 1 dose or any partial dose of nivolumab and were ADA-evaluable were analyzed. | participants | NUMBER |
| SECONDARY | Objective Response Rate | Day 1 up to June 2013, approximately 4 years | All participants who received at least 1 dose or any partial dose of nivolumab with an evaluable tumor response were analyzed. | percentage of participants | NUMBER |
| SECONDARY | Duration of Tumor Response | Day 1 up to June 2013, approximately 4 years | All participants who received at least 1 dose or any partial dose of nivolumab with a measurable tumor response were analyzed. | months | MEDIAN |
| SECONDARY | Geometric Mean Maximum Serum Concentration (Cmax) | 1,4,8,24,48 and 96 hours post-dose timepoints on Day 1 of cycles 1 and 3 | All participants who received at least 1 dose or any partial dose of nivolumab and had adequate PK profiles. | micrograms per milliliter (µg/mL) | GEOMETRIC_MEAN |
| PRIMARY | Number of Participants With Abnormal Hematology Laboratory Values | Day 1 up to June 2013, approximately 4 years | All participants who received at least 1 dose or any partial dose of nivolumab who underwent the laboratory test. | participants | NUMBER |
| SECONDARY | Median Time of Maximum Serum Concentration (Tmax) | 1,4,8,24,48 and 96 hours post-dose timepoints on Day 1 of cycles 1 and 3 | All participants who received at least 1 dose or any partial dose of nivolumab and had adequate PK profiles. | hours (h) | MEDIAN |
| SECONDARY | Geometric Mean Area Under the Curve (AUC[TAU]) in One Dosing Interval Observed Post-Single Dose | 1,4,8,24,48 and 96 hours post-dose timepoints on Day 1 of cycles 1 and 3 | All participants who received at least 1 dose or any partial dose of nivolumab and had adequate PK profiles. | micrograms*hours per milliliter (μg*h/mL | GEOMETRIC_MEAN |
| SECONDARY | Geometric Mean Total Body Clearance of Drug From Serum (CLT) | 1,4,8,24,48 and 96 hours post-dose timepoints on Day 1 of cycle 3 | All participants who received at least 1 dose or any partial dose of nivolumab and had adequate PK profiles. | milliliters per hour (mL/h) | GEOMETRIC_MEAN |
1 to 10 of 11Source ClinicalTrials.gov
See all 11 outcomesResults by group235
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Number of Participants With Severe Adverse Events (AEs), Serious Adverse Events (SAEs), Treatment-Related AEs, Deaths, Discontinuation of Study Drug Due to AEs | 0.1 mg/kg Nivolumab | SAE | 9 | participants | |
| Number of Participants With Severe Adverse Events (AEs), Serious Adverse Events (SAEs), Treatment-Related AEs, Deaths, Discontinuation of Study Drug Due to AEs | 0.3 mg/kg Nivolumab | SAE | 8 | participants | |
| Number of Participants With Severe Adverse Events (AEs), Serious Adverse Events (SAEs), Treatment-Related AEs, Deaths, Discontinuation of Study Drug Due to AEs | 1.0 mg/kg Nivolumab | SAE | 37 | participants | |
| Number of Participants With Severe Adverse Events (AEs), Serious Adverse Events (SAEs), Treatment-Related AEs, Deaths, Discontinuation of Study Drug Due to AEs | 3.0 mg/kg Nivolumab | SAE | 26 | participants | |
| Number of Participants With Severe Adverse Events (AEs), Serious Adverse Events (SAEs), Treatment-Related AEs, Deaths, Discontinuation of Study Drug Due to AEs | 10 mg/kg Nivolumab | SAE | 79 | participants | |
| Number of Participants With Severe Adverse Events (AEs), Serious Adverse Events (SAEs), Treatment-Related AEs, Deaths, Discontinuation of Study Drug Due to AEs | 0.1 mg/kg Nivolumab | Treatment-Related AE | 13 | participants | |
| Number of Participants With Severe Adverse Events (AEs), Serious Adverse Events (SAEs), Treatment-Related AEs, Deaths, Discontinuation of Study Drug Due to AEs | 0.3 mg/kg Nivolumab | Treatment-Related AE | 14 | participants | |
| Number of Participants With Severe Adverse Events (AEs), Serious Adverse Events (SAEs), Treatment-Related AEs, Deaths, Discontinuation of Study Drug Due to AEs | 1.0 mg/kg Nivolumab | Treatment-Related AE | 70 | participants | |
| Number of Participants With Severe Adverse Events (AEs), Serious Adverse Events (SAEs), Treatment-Related AEs, Deaths, Discontinuation of Study Drug Due to AEs | 3.0 mg/kg Nivolumab | Treatment-Related AE | 40 | participants | |
| Number of Participants With Severe Adverse Events (AEs), Serious Adverse Events (SAEs), Treatment-Related AEs, Deaths, Discontinuation of Study Drug Due to AEs | 10 mg/kg Nivolumab | Treatment-Related AE | 93 | participants |
1 to 10 of 235Source ClinicalTrials.gov
See all 235 results by groupParticipant flow15
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | 0.1 mg/kg Nivolumab | 17 | |
| Overall Study | STARTED | 0.3 mg/kg Nivolumab | 18 | |
| Overall Study | STARTED | 1.0 mg/kg Nivolumab | 86 | |
| Overall Study | STARTED | 3.0 mg/kg Nivolumab | 54 | |
| Overall Study | STARTED | 10 mg/kg Nivolumab | 131 | |
| Overall Study | COMPLETED | 0.1 mg/kg Nivolumab | 0 | |
| Overall Study | COMPLETED | 0.3 mg/kg Nivolumab | 0 | |
| Overall Study | COMPLETED | 1.0 mg/kg Nivolumab | 0 | |
| Overall Study | COMPLETED | 3.0 mg/kg Nivolumab | 0 | |
| Overall Study | COMPLETED | 10 mg/kg Nivolumab | 0 |
1 to 10 of 15Source ClinicalTrials.gov
See all 15 participant flowAdverse events2,070
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Abdominal pain lower | Gastrointestinal disorders | 0.1 mg/kg Nivolumab | 1 | 17 | |
| other | Abdominal pain lower | Gastrointestinal disorders | 0.3 mg/kg Nivolumab | 1 | 18 | |
| other | Abdominal pain lower | Gastrointestinal disorders | 1 mg/kg Nivolumab | 3 | 86 | |
| other | Abdominal pain lower | Gastrointestinal disorders | 3 mg/kg Nivolumab | 1 | 54 | |
| other | Abdominal pain lower | Gastrointestinal disorders | 10 mg/kg Nivolumab | 4 | 131 | |
| other | Anaemia | Blood and lymphatic system disorders | 0.1 mg/kg Nivolumab | 0 | 17 | |
| other | Anaemia | Blood and lymphatic system disorders | 0.3 mg/kg Nivolumab | 3 | 18 | |
| other | Anaemia | Blood and lymphatic system disorders | 1 mg/kg Nivolumab | 7 | 86 | |
| other | Anaemia | Blood and lymphatic system disorders | 3 mg/kg Nivolumab | 4 | 54 | |
| other | Anaemia | Blood and lymphatic system disorders | 10 mg/kg Nivolumab | 18 | 131 |
1 to 10 of 2,070Source ClinicalTrials.gov
See all 2,070 adverse eventsAdverse event totals15
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | 0.1 mg/kg Nivolumab | ||
| Total, all-cause mortality | 0.3 mg/kg Nivolumab | ||
| Total, all-cause mortality | 1 mg/kg Nivolumab | ||
| Total, all-cause mortality | 3 mg/kg Nivolumab | ||
| Total, all-cause mortality | 10 mg/kg Nivolumab | ||
| Total, other adverse events | 0.1 mg/kg Nivolumab | 17 | 17 |
| Total, other adverse events | 0.3 mg/kg Nivolumab | 17 | 18 |
| Total, other adverse events | 1 mg/kg Nivolumab | 83 | 86 |
| Total, other adverse events | 3 mg/kg Nivolumab | 51 | 54 |
| Total, other adverse events | 10 mg/kg Nivolumab | 130 | 131 |
1 to 10 of 15Source ClinicalTrials.gov
See all 15 adverse event totalsPapers4
The papers the trial lists on ClinicalTrials.gov.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT00730639
GET https://conductscience.org/api/trials/v1/NCT00730639/results?page=2