Phase 1
N=91
Phase I Biomarker Study (BMS-936558)
Renal Cell Carcinoma
Bottom Line
View on ClinicalTrials.gov: NCT01358721 ↗Enrolled (actual)
91
Serious AEs
53.8%
Results posted
Jul 2019
Primary outcome: Primary: Percent Change From Baseline in Activated and Memory T Cells — NA; NA; NA; NA Percentage
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 1
- Interventions
- BMS-936558 (Anti-PD-1) (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Bristol-Myers Squibb
- Primary completion
- Dec 2014
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percent Change From Baseline in Activated and Memory T Cells |
NA; NA; NA; NA; NA; NA | — |
| PRIMARY Mean Serum Cytokines: CXCL9 |
2859.1; 2294.3; 1906.6; 2203.6; 3287.7; 2567.1 | — |
| PRIMARY Mean Serum Cytokines CXCL10 (IP10) |
525.5; 523.4; 422.0; 450.7; 591.4; 727.7 | — |
| PRIMARY Mean CD4 T Cell Infiltration |
34.1; 10.4; 35.2; 53.2; 64.8; 28.2 | — |
| PRIMARY Mean CD8 T Cell Infiltration |
10.2; 7.8; 11.9; 14.4; 14.9; 18.9 | — |
| SECONDARY Best Overall Response in the BMS-936558 Arms |
0; 0; 0; 2; 2; 4 | — |
| SECONDARY Progression Free Survival Rate in BMS-936558 |
0.29; 0.49; 0.63; 0.55; 0; 0.44 | — |
| SECONDARY Objective Response Rate in BMS-936558 |
9.1; 18.2; 21.7; 12.5 | — |
| SECONDARY Duration of Objective Response for BMS-936558 |
30; NA; 48.1; NA | — |
| 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 |
16.5; 31.4; 41.3; 35.1 | — |
| SECONDARY Immunogenicity of BMS-936558 as Measured by the Detection of Human Antibodies Against BMS-936558 |
11.8; 15.8; 13.6; 0; 88.2; 84.2 | — |
Summary
The purpose of this study is to evaluate the pharmacodynamic and biologic properties of BMS-936558 in subjects with metastatic renal cell carcinoma.
Eligibility Criteria
For more information regarding BMS clinical trial participation, please visit www.BMSStudyConnect.com
Inclusion Criteria
- Women and men ≥ 18 years of age.
- Histologic confirmation of renal cell carcinoma with a clear cell component.
- Measurable disease as defined by Response Evaluation Criteria in Solid Tumors (RECIST).
- Tumor sites that can be accessed for repeat biopsies at acceptable clinical risk.
- Previously treated subjects must have failed at least 1 prior anti-angiogenic agent and can have a maximum of 3 prior systemic treatments for renal cell cancer.
- Subjects in the treatment naive arm cannot have received prior systemic therapy for their renal cell carcinoma.
Exclusion Criteria
- Active or progressing brain metastases.
- Active concomitant.
- Active or history of autoimmune disease.
- Active use of systemic corticosteroids.
- Prior therapy with Cytotoxic T lymphocyte-associated antigen 4 (anti-CTLA4), anti Programmed death-1 (anti-PD1), anti Programmed death ligand 1 (anti-PD-L1), anti Programmed death ligand 2 (anti-PD-L2), anti-CD137, anti-CD40, anti-OX40 antibodies.
Data sourced from ClinicalTrials.gov (NCT01358721). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.