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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01358721
Other study ID # CA209-009
Secondary ID 2011-005379-18
Status Completed
Phase Phase 1
First received
Last updated
Start date September 23, 2011
Est. completion date May 22, 2019

Study information

Verified date October 2021
Source Bristol-Myers Squibb
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The purpose of this study is to evaluate the pharmacodynamic and biologic properties of BMS-936558 in subjects with metastatic renal cell carcinoma.


Description:

Intervention Model: Parallel Dose Comparison


Recruitment information / eligibility

Status Completed
Enrollment 119
Est. completion date May 22, 2019
Est. primary completion date December 1, 2014
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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.

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
BMS-936558 (Anti-PD-1)
Solution, Intravenous infusion, 0.3 mg/kg, Every 3 weeks, Indefinitely depending on response
BMS-936558 (Anti-PD-1)
Solution, Intravenous infusion, 2 mg/kg, Every 3 weeks, Indefinitely depending on response
BMS-936558 (Anti-PD-1)
Solution, Intravenous infusion, 10 mg/kg, Every 3 weeks, Indefinitely depending on response

Locations

Country Name City State
France Local Institution Villejuif Cedex
Spain Local Institution Pamplona
United States The Bunting-Blaustein Cancer Research Building Baltimore Maryland
United States Dana Farber Cancer Inst Boston Massachusetts
United States Dana Farber Cancer Institute Boston Massachusetts
United States University Of Chicago Medical Center Chicago Illinois
United States Duke University Medical Center Durham North Carolina
United States University Of Wisconsin Carbone Cancer Center Madison Wisconsin
United States Yale University School Of Medicine New Haven Connecticut
United States Fox Chase Cancer Center Philadelphia Pennsylvania
United States Upmc Cancer Pavilion Pittsburgh Pennsylvania
United States Providence Portland Med Ctr Portland Oregon
United States Ucsf Helen Diller Family Comprehensive Cancer Center San Francisco California
United States H. Lee Moffitt Cancer Center Tampa Florida

Sponsors (2)

Lead Sponsor Collaborator
Bristol-Myers Squibb Ono Pharma USA Inc

Countries where clinical trial is conducted

United States,  France,  Spain, 

Outcome

Type Measure Description Time frame Safety issue
Primary Percent Change From Baseline in Activated and Memory T Cells 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) Baseline, Cycle 1 Day 1, Cycle 1 Day 2, Cycle 1 Day 8, Cycle 2 Day 8, Cycle 4 Day 1
Primary Mean Serum Cytokines: CXCL9 Objective is to investigate the pharmacodynamic immunomodulatory activity of serum chemokines (CXCL9, CXCL10) 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)
Primary Mean Serum Cytokines CXCL10 (IP10) Objective is to investigate the pharmacodynamic immunomodulatory activity of serum chemokines (CXCL9, CXCL10) 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)
Primary Mean CD4 T Cell Infiltration 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). Cycle 2 Day 8 168 Hr post dose
Primary Mean CD8 T Cell Infiltration 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). 168 hour post does Cycle 2 Day 8 in evaluable participates (First active dose of study medication to cycle two day eight post injection)
Secondary Best Overall Response in the BMS-936558 Arms 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 Assessed at a minimum of every 3 weeks up to 70 days following discontinuation of study drug (up to approximately 39 months)
Secondary Progression Free Survival Rate in BMS-936558 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) 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)
Secondary Objective Response Rate in BMS-936558 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. Up to 22 months after study start
Secondary Duration of Objective Response for BMS-936558 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. 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)
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 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 The time from treatment arm assignment until the criteria for progression are met or death (whichever occurs first)(assessed up to 39 months)
Secondary Immunogenicity of BMS-936558 as Measured by the Detection of Human Antibodies Against BMS-936558 Blood samples to evaluate the development of a positive anti-drug antibodies (ADA) response at the doses tested will be collected at time-points pre-dose, C4D1, C8D1 and during follow-up. Pre-dose, Cycle 4 Day 1, Cycle 8 Day 1 and during follow-up.
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