Trial · NCT01358721
Phase I Biomarker Study (BMS-936558)
NCT01358721, Phase 1, Completed, Bristol-Myers Squibb; results first posted 2019-07-26
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Phase I Biomarker Study (BMS-936558). Trials, record NCT01358721. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01358721
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Phase I Biomarker Study (BMS-936558)
- NCT number
- NCT01358721
- Status
- Completed
- Phases
- Phase 1
- Enrollment
- 119 participants, actual
- Lead sponsor
- Bristol-Myers Squibb
- Conditions
- Renal Cell Carcinoma
- Interventions
- BMS-936558 (Anti-PD-1), BMS-936558 (Anti-PD-1), BMS-936558 (Anti-PD-1)
- First posted
- 2011-05-24
- Last updated
- 2021-10-28
- Other registries' IDs
- eudract:2011-005379-18
- Results first posted
- 2019-07-26
Source ClinicalTrials.gov
Registered outcomes11
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Percent Change From Baseline in Activated and Memory T Cells | Baseline, Cycle 1 Day 1, Cycle 1 Day 2, Cycle 1 Day 8, Cycle 2 Day 8, Cycle 4 Day 1 | The objective of the study was to investigate the pharmacodynamic immunomodulatory activity of anti-PD-1 antibody in activated and memory T cells with metastatic clear-cell Renal Cell Carcinoma (RCC) |
| Primary | Mean Serum Cytokines: CXCL9 | Baseline, Cycle 1 Day 1 3 Hrs Post, Cycle 1 Day 1 7 Hr Post, Cycle 1 Day 2 24 Hr Post, Cycle 2 Day 1 0 Hr Pre, Cycle 2 Day 8 168 Hrs Post, Cycle 4 Day 1 O Hr Pre (~39 months) | Objective is to investigate the pharmacodynamic immunomodulatory activity of serum chemokines (CXCL9, CXCL10) |
| Primary | Mean Serum Cytokines CXCL10 (IP10) | Baseline, Cycle 1 Day 1 3 Hrs Post, Cycle 1 Day 1 7 Hr Post, Cycle 1 Day 2 24 Hr Post, Cycle 2 Day 1 0 Hr Pre, Cycle 2 Day 8 168 Hrs Post, Cycle 4 Day 1 O Hr Pre (~39 months) | Objective is to investigate the pharmacodynamic immunomodulatory activity of serum chemokines (CXCL9, CXCL10) |
| Primary | Mean CD4 T Cell Infiltration | Cycle 2 Day 8 168 Hr post dose | The objective of the study was to investigate the pharmacodynamic immunomodulatory activity of anti-PD-1 antibody on circulating CD4 infiltrations in tumors in participants with metastatic clear-cell Renal Cell Carcinoma (RCC). |
| Primary | Mean CD8 T Cell Infiltration | 168 hour post does Cycle 2 Day 8 in evaluable participates (First active dose of study medication to cycle two day eight post injection) | The objective of the study was to investigate the pharmacodynamic immunomodulatory activity of anti-PD-1 antibody on circulating CD8 infiltrations in tumors in participants with metastatic clear-cell Renal Cell Carcinoma (RCC). |
| Secondary | Best Overall Response in the BMS-936558 Arms | Assessed at a minimum of every 3 weeks up to 70 days following discontinuation of study drug (up to approximately 39 months) | Baseline and post-nivolumab treatment modulation of serum levels of interferon-gamma stimulated chemokines CXCL9 and CXCL10 (IP10) were assessed. The participant's best response designation over the study as a whole, recorded between the date of first study drug administration and the date of objectively documented progression per Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST 1.1) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR |
| Secondary | Progression Free Survival Rate in BMS-936558 | Progression free survival rate will be assessed in each individual treatment arm by tumor assessments at 16, 24, and 48 weeks. From initial dose to end of study (assessed up to 39 months) | PFS is defined as the time from treatment arm assignment to the date of first documented disease progression. Participants who die without a reported prior progression will be considered to have progressed on the date of their death. Participants who did not progress or die will be censored on the date of their last tumor assessment. Participants who did not have any on study tumor assessments will be censored on the date they were assigned a treatment arm. PFS rate is the percentage of participants who did not have disease progression at particular time points (16 weeks, 24 weeks, 48 weeks) |
| Secondary | Objective Response Rate in BMS-936558 | Up to 22 months after study start | The total number of subjects whose best overall response (BOR) is either a complete response (CR) or partial response (PR) divided by the total number of participants in the population of interest, and expressed as a percentage. |
| Secondary | Duration of Objective Response for BMS-936558 | The time when the measurement criteria are first met for PR or CR (whichever is reported first) until the date of documented disease progression or death (assessed up to 39 months) | The duration of response is defined as the time when the measurement criteria are first met for PR or CR (whichever is reported first) until the date of documented disease progression or death. For subjects who neither progress nor die, the duration of response will be censored at the date of their last tumor assessment. |
| Secondary | Duration of Stable Disease for BMS-936558 as Measured in Participants Whose Best Overall Response is Stable Disease as the Time From Baseline Until the Date of Documented Disease Progression or Death | The time from treatment arm assignment until the criteria for progression are met or death (whichever occurs first)(assessed up to 39 months) | Duration of stable disease (SD) is defined in participants whose BOR is SD at the time from treatment arm assignment until the criteria for progression are met or death (whichever occurs first). Participants who die without a reported prior progression will be considered to have progressed on the date of their death. Participants who did not progress or die will be censored on the date of their last tumor assessment |
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 | Percent Change From Baseline in Activated and Memory T Cells | Baseline, Cycle 1 Day 1, Cycle 1 Day 2, Cycle 1 Day 8, Cycle 2 Day 8, Cycle 4 Day 1 | All participants in the biomarker data set with baseline measurement and at least one on treatment measurement were included in pharmacodynamic analyses. | Percentage | MEAN |
| PRIMARY | Mean Serum Cytokines: CXCL9 | Baseline, Cycle 1 Day 1 3 Hrs Post, Cycle 1 Day 1 7 Hr Post, Cycle 1 Day 2 24 Hr Post, Cycle 2 Day 1 0 Hr Pre, Cycle 2 Day 8 168 Hrs Post, Cycle 4 Day 1 O Hr Pre (~39 months) | Biomarker evaluable population: All treated participants with at least one measurement for a specific marker were included in the data set for that marker. | pg/mL | MEAN |
| PRIMARY | Mean Serum Cytokines CXCL10 (IP10) | Baseline, Cycle 1 Day 1 3 Hrs Post, Cycle 1 Day 1 7 Hr Post, Cycle 1 Day 2 24 Hr Post, Cycle 2 Day 1 0 Hr Pre, Cycle 2 Day 8 168 Hrs Post, Cycle 4 Day 1 O Hr Pre (~39 months) | Biomarker evaluable population: All treated participants with at least one measurement for a specific marker were included in the data set for that marker. | pg/mL | MEAN |
| PRIMARY | Mean CD4 T Cell Infiltration | Cycle 2 Day 8 168 Hr post dose | Biomarker evaluable population: All treated participants with at least one measurement for a specific marker were included in the data set for that marker. | Number of CD4+ Cells | MEAN |
| PRIMARY | Mean CD8 T Cell Infiltration | 168 hour post does Cycle 2 Day 8 in evaluable participates (First active dose of study medication to cycle two day eight post injection) | Biomarker evaluable population: All treated participants at least one measurement for a specific marker were included in the data set for that marker. | Number of CD8 cells | MEAN |
| SECONDARY | Best Overall Response in the BMS-936558 Arms | Assessed at a minimum of every 3 weeks up to 70 days following discontinuation of study drug (up to approximately 39 months) | All treated participants | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Progression Free Survival Rate in BMS-936558 | Progression free survival rate will be assessed in each individual treatment arm by tumor assessments at 16, 24, and 48 weeks. From initial dose to end of study (assessed up to 39 months) | All treated participants | percent | NUMBER |
| SECONDARY | Objective Response Rate in BMS-936558 | Up to 22 months after study start | All treated participants | percent | NUMBER |
| SECONDARY | Duration of Objective Response for BMS-936558 | The time when the measurement criteria are first met for PR or CR (whichever is reported first) until the date of documented disease progression or death (assessed up to 39 months) | All treated participants | weeks | MEDIAN |
| SECONDARY | Duration of Stable Disease for BMS-936558 as Measured in Participants Whose Best Overall Response is Stable Disease as the Time From Baseline Until the Date of Documented Disease Progression or Death | The time from treatment arm assignment until the criteria for progression are met or death (whichever occurs first)(assessed up to 39 months) | All treated participants | weeks | MEDIAN |
1 to 10 of 11Source ClinicalTrials.gov
See all 11 outcomesResults by group144
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Percent Change From Baseline in Activated and Memory T Cells | Nivolumab 0.3 mg/kg (Previously-treated) | Cycle 1 Day 1 | NA | 95% Confidence Interval NA to NA | Percentage |
| Percent Change From Baseline in Activated and Memory T Cells | Nivolumab 2 mg/kg (Previously-treated) | Cycle 1 Day 1 | NA | 95% Confidence Interval NA to NA | Percentage |
| Percent Change From Baseline in Activated and Memory T Cells | Nivolumab 10 mg/kg (Previously-treated) | Cycle 1 Day 1 | NA | 95% Confidence Interval NA to NA | Percentage |
| Percent Change From Baseline in Activated and Memory T Cells | Nivolumab 10 mg/kg (Treatment-naive) | Cycle 1 Day 1 | NA | 95% Confidence Interval NA to NA | Percentage |
| Percent Change From Baseline in Activated and Memory T Cells | Nivolumab 0.3 mg/kg (Previously-treated) | Cycle 1 Day 2 | NA | 95% Confidence Interval NA to NA | Percentage |
| Percent Change From Baseline in Activated and Memory T Cells | Nivolumab 2 mg/kg (Previously-treated) | Cycle 1 Day 2 | NA | 95% Confidence Interval NA to NA | Percentage |
| Percent Change From Baseline in Activated and Memory T Cells | Nivolumab 10 mg/kg (Previously-treated) | Cycle 1 Day 2 | NA | 95% Confidence Interval NA to NA | Percentage |
| Percent Change From Baseline in Activated and Memory T Cells | Nivolumab 10 mg/kg (Treatment-naive) | Cycle 1 Day 2 | NA | 95% Confidence Interval NA to NA | Percentage |
| Percent Change From Baseline in Activated and Memory T Cells | Nivolumab 0.3 mg/kg (Previously-treated) | Cycle 1 Day 8 | NA | 95% Confidence Interval NA to NA | Percentage |
| Percent Change From Baseline in Activated and Memory T Cells | Nivolumab 2 mg/kg (Previously-treated) | Cycle 1 Day 8 | NA | 95% Confidence Interval NA to NA | Percentage |
1 to 10 of 144Source ClinicalTrials.gov
See all 144 results by groupParticipant flow12
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Nivolumab 0.3 mg/kg (Previously-treated) | 22 | |
| Overall Study | STARTED | Nivolumab 2 mg/kg (Previously-treated) | 22 | |
| Overall Study | STARTED | Nivolumab 10 mg/kg (Previously-treated) | 23 | |
| Overall Study | STARTED | Nivolumab 10 mg/kg (Treatment-naive) | 24 | |
| Overall Study | COMPLETED | Nivolumab 0.3 mg/kg (Previously-treated) | 1 | |
| Overall Study | COMPLETED | Nivolumab 2 mg/kg (Previously-treated) | 0 | |
| Overall Study | COMPLETED | Nivolumab 10 mg/kg (Previously-treated) | 1 | |
| Overall Study | COMPLETED | Nivolumab 10 mg/kg (Treatment-naive) | 0 | |
| Overall Study | NOT COMPLETED | Nivolumab 0.3 mg/kg (Previously-treated) | 21 | |
| Overall Study | NOT COMPLETED | Nivolumab 2 mg/kg (Previously-treated) | 22 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 participant flowAdverse events600
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 | Anaemia | Blood and lymphatic system disorders | BMS 0.3 mg/kg | 6 | 22 | |
| other | Anaemia | Blood and lymphatic system disorders | BMS 2 mg/kg | 1 | 22 | |
| other | Anaemia | Blood and lymphatic system disorders | BMS 10 mg/kg | 6 | 23 | |
| other | Anaemia | Blood and lymphatic system disorders | BMS 10 mg/Kg-N | 4 | 24 | |
| other | Hypothyroidism | Endocrine disorders | BMS 0.3 mg/kg | 1 | 22 | |
| other | Hypothyroidism | Endocrine disorders | BMS 2 mg/kg | 1 | 22 | |
| other | Hypothyroidism | Endocrine disorders | BMS 10 mg/kg | 4 | 23 | |
| other | Hypothyroidism | Endocrine disorders | BMS 10 mg/Kg-N | 2 | 24 | |
| other | Eye pruritus | Eye disorders | BMS 0.3 mg/kg | 0 | 22 | |
| other | Eye pruritus | Eye disorders | BMS 2 mg/kg | 1 | 22 |
1 to 10 of 600Source ClinicalTrials.gov
See all 600 adverse eventsAdverse event totals12
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | BMS 0.3 mg/kg | ||
| Total, all-cause mortality | BMS 2 mg/kg | ||
| Total, all-cause mortality | BMS 10 mg/kg | ||
| Total, all-cause mortality | BMS 10 mg/Kg-N | ||
| Total, other adverse events | BMS 0.3 mg/kg | 22 | 22 |
| Total, other adverse events | BMS 2 mg/kg | 22 | 22 |
| Total, other adverse events | BMS 10 mg/kg | 23 | 23 |
| Total, other adverse events | BMS 10 mg/Kg-N | 24 | 24 |
| Total, serious adverse events | BMS 0.3 mg/kg | 13 | 22 |
| Total, serious adverse events | BMS 2 mg/kg | 11 | 22 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 adverse event totalsPapers2
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/NCT01358721
GET https://conductscience.org/api/trials/v1/NCT01358721/results?page=2