Trial · NCT01358721
Outcomes11
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
1 to 11 of 11
Download this page as JSON| 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 |
| SECONDARY | Immunogenicity of BMS-936558 as Measured by the Detection of Human Antibodies Against BMS-936558 | Pre-dose, Cycle 4 Day 1, Cycle 8 Day 1 and during follow-up. | ADA-Positive Subject: A subject with at least one ADA-positive sample at any time after initiation of treatment.~ADA-Negative Subject: A subject with no ADA-positive sample after the initiation of treatment | percentage | NUMBER |
Source ClinicalTrials.govtrials-2026-11-12-0.5.0
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 list from software.
Twenty rows a page, as JSON. No key.
GET https://conductscience.org/api/trials/v1/NCT01358721/outcomes