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Trial record 1 of 1 for:    CA017-003
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An Investigational Immuno-therapy Study of BMS-986205 Given in Combination With Nivolumab and in Combination With Both Nivolumab and Ipilimumab in Cancers That Are Advanced or Have Spread

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02658890
Recruitment Status : Active, not recruiting
First Posted : January 20, 2016
Last Update Posted : October 18, 2021
Sponsor:
Information provided by (Responsible Party):
Bristol-Myers Squibb

Tracking Information
First Submitted Date  ICMJE January 14, 2016
First Posted Date  ICMJE January 20, 2016
Last Update Posted Date October 18, 2021
Actual Study Start Date  ICMJE February 22, 2016
Estimated Primary Completion Date October 24, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 24, 2017)
  • Safety and tolerability of BMS-986205 as measured by a composite of the incidence of adverse events (AEs), serious adverse events (SAEs), AEs leading to discontinuation, deaths, and clinical laboratory test abnormalities. [ Time Frame: 100 days after the last dose of study therapy ]
    measured by incidence
  • Safety of BMS-986205 plus nivolumab as measured by a composite of the incidence of adverse events (AEs), serious adverse events (SAEs), AEs leading to discontinuation, deaths, and clinical laboratory test abnormalities. [ Time Frame: 100 days after the last dose of study therapy ]
    measured by incidence
  • Safety of BMS-986205 plus both nivolumab and ipilimumab as measured by incidence of adverse events (AEs), serious adverse events (SAEs), AEs leading to discontinuation, deaths, and clinical laboratory test abnormalities. [ Time Frame: 100 days after the last dose of study therapy ]
    measured by incidence
  • Anti-tumor activity of BMS 986205 administered in combination with nivolumab as measured by the best overall response (BOR) [ Time Frame: Approximately 3 years ]
    measured by CT scan
  • Anti-tumor activity of BMS 986205 administered in combination with nivolumab as measured by the duration of response (DOR) [ Time Frame: Approximately 3 years ]
    measured by CT scan
  • Anti-tumor activity of BMS 986205 administered in combination with nivolumab as measured by progression-free survival rates (PFSRs) [ Time Frame: Approximately 3 years ]
    measured by CT scan
  • Anti-tumor activity of BMS 986205 administered in combination with both nivolumab and ipilimumab as measured by the best overall response (BOR) [ Time Frame: Approximately 3 years ]
    measured by CT scan
  • Anti-tumor activity of BMS 986205 administered in combination with both nivolumab and ipilimumab as measured by the duration of response (DOR) [ Time Frame: Approximately 3 years ]
    measured by CT scan
  • Anti-tumor activity of BMS 986205 administered in combination with both nivolumab and ipilimumab as measured by progression-free survival rates (PFSRs) [ Time Frame: Approximately 3 years ]
    measured by CT scan
Original Primary Outcome Measures  ICMJE
 (submitted: January 15, 2016)
  • Safety of BMS-986205 as measured by incidence of adverse events (AEs), serious adverse events (SAEs), AEs leading to discontinuation, deaths, and clinical laboratory test abnormalities. [ Time Frame: 100 days after the last dose of study therapy ]
  • Safety of BMS-986205 plus nivolumab as measured by incidence of adverse events (AEs), serious adverse events (SAEs), AEs leading to discontinuation, deaths, and clinical laboratory test abnormalities. [ Time Frame: 100 days after the last dose of study therapy ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: May 24, 2017)
  • Maximum observed plasma concentration (Cmax) of BMS-986205 [ Time Frame: Approximately 3 years ]
    measured by plasma concentration
  • Time of maximum observed plasma concentration (Tmax) of BMS-986205 [ Time Frame: Approximately 3 years ]
    measured by plasma concentration
  • Area under the concentration-time curve from time zero extrapolated to infinite time [AUC(INF)] of BMS-986205 [ Time Frame: Approximately 3 years ]
    measured by plasma concentration
  • Area under the concentration-time curve from time zero to the time of the last quantifiable concentration [AUC(0-T)] of BMS-986205 [ Time Frame: Approximately 3 years ]
    measured by plasma concentration
  • Area under the concentration-time curve in 1 dosing interval [AUC(TAU)] of BMS-986205 [ Time Frame: Approximately 3 years ]
    measured by plasma concentration
  • Trough observed plasma concentration at the end of the dosing interval (Ctrough) of BMS-986205 [ Time Frame: Approximately 3 years ]
    measured by plasma concentration
  • Observed plasma concentration at 24 hours (C24) of BMS-986205 [ Time Frame: Approximately 3 years ]
    measured by plasma concentration
  • Apparent terminal phase half-life (T-HALF) of BMS-986205 [ Time Frame: Approximately 3 years ]
    measured by plasma concentration
  • Apparent total body clearance (CLT/F) of BMS-986205 [ Time Frame: Approximately 3 years ]
    measured by plasma concentration
  • Apparent renal clearance (CLR/F) of BMS-986205 [ Time Frame: Approximately 3 years ]
    measured by plasma concentration
  • Volume of distribution of terminal phase (Vz/F) of BMS-986205 [ Time Frame: Approximately 3 years ]
    measured by plasma concentration
  • Apparent volume of distribution at steady state (Vss/F) of BMS-986205 [ Time Frame: Approximately 3 years ]
    measured by plasma concentration
  • Accumulation index (AI) of BMS-986205 [ Time Frame: Approximately 3 years ]
    measured by plasma concentration
  • Percent urinary recovery (%UR) of BMS-986205 [ Time Frame: Approximately 3 years ]
    measured by urine concentration
  • Percent urinary recovery over 24 hours(%UR24) of BMS-986205 [ Time Frame: Approximately 3 years ]
    measured by urine concentration
  • Ratio of metabolite Cmax to parent Cmax, corrected for molecular weight (MR_Cmax) of BMS-986205 [ Time Frame: Approximately 3 years ]
    measured by plasma concentration
  • Ratio of metabolite AUC(0-T) to parent AUC(0-T), corrected for molecular weight (single dose in clinical pharmacology substudy only) [MR_AUC(0-T)] of BMS-986205 [ Time Frame: Approximately 3 years ]
    measured by plasma concentration
  • Ratio of metabolite AUC(TAU) to parent AUC(TAU), corrected for molecular weight [MR_AUC(TAU)] of BMS-986205 [ Time Frame: Approximately 3 years ]
    measured by plasma concentration
  • Ratio of metabolite AUC(INF) to parent AUC(INF), corrected for molecular weight (single dose in clinical pharmacology substudy only) [MR_AUC(INF)] of BMS-986205 [ Time Frame: Approximately 3 years ]
    measured by plasma concentration
  • Anti-drug antibody (ADA) response to Nivolumab in combination with BMS-986205 [ Time Frame: Approximately 3 years ]
    measured by immunoassay and liquid chromatography- mass spectrometry
  • Anti-drug antibody (ADA) response to Ipilimumab in combination with BMS-986205 [ Time Frame: Approximately 3 years ]
    measured by immunoassay and liquid chromatography- mass spectrometry
Original Secondary Outcome Measures  ICMJE
 (submitted: January 15, 2016)
  • Maximum observed plasma concentration (Cmax) of BMS-986205 [ Time Frame: Approximately 3 years ]
  • Time of maximum observed plasma concentration (Tmax) of BMS-986205 [ Time Frame: Approximately 3 years ]
  • Area under the concentration-time curve from time zero extrapolated to infinite time [AUC(INF)] of BMS-986205 [ Time Frame: Approximately 3 years ]
  • Area under the concentration-time curve from time zero to the time of the last quantifiable concentration [AUC(0-T)] of BMS-986205 [ Time Frame: Approximately 3 years ]
  • Area under the concentration-time curve in 1 dosing interval [AUC(TAU)] of BMS-986205 [ Time Frame: Approximately 3 years ]
  • Trough observed plasma concentration at the end of the dosing interval (Ctrough) of BMS-986205 [ Time Frame: Approximately 3 years ]
  • Observed plasma concentration at 24 hours (C24) of BMS-986205 [ Time Frame: Approximately 3 years ]
  • Apparent terminal phase half-life (T-HALF) of BMS-986205 [ Time Frame: Approximately 3 years ]
  • Apparent total body clearance (CLT/F) of BMS-986205 [ Time Frame: Approximately 3 years ]
  • Apparent renal clearance (CLR/F) of BMS-986205 [ Time Frame: Approximately 3 years ]
  • Volume of distribution of terminal phase (Vz/F) of BMS-986205 [ Time Frame: Approximately 3 years ]
  • Apparent volume of distribution at steady state (Vss/F) of BMS-986205 [ Time Frame: Approximately 3 years ]
  • Accumulation index (AI) of BMS-986205 [ Time Frame: Approximately 3 years ]
  • Percent urinary recovery (%UR) of BMS-986205 [ Time Frame: Approximately 3 years ]
  • Percent urinary recovery over 24 hours(%UR24) of BMS-986205 [ Time Frame: Approximately 3 years ]
  • Ratio of metabolite Cmax to parent Cmax, corrected for molecular weight (MR_Cmax) of BMS-986205 [ Time Frame: Approximately 3 years ]
  • Ratio of metabolite AUC(0-T) to parent AUC(0-T), corrected for molecular weight (single dose in clinical pharmacology substudy only) [MR_AUC(0-T)] of BMS-986205 [ Time Frame: Approximately 3 years ]
  • Ratio of metabolite AUC(TAU) to parent AUC(TAU), corrected for molecular weight [MR_AUC(TAU)] of BMS-986205 [ Time Frame: Approximately 3 years ]
  • Ratio of metabolite AUC(INF) to parent AUC(INF), corrected for molecular weight (single dose in clinical pharmacology substudy only) [MR_AUC(INF)] of BMS-986205 [ Time Frame: Approximately 3 years ]
  • Anti-drug antibody (ADA) response to Nivolumab in combination with BMS-986205 [ Time Frame: Approximately 3 years ]
  • Objective response rate (ORR) [ Time Frame: Approximately 3 years ]
  • Progression free survival rate (PFSR) [ Time Frame: Approximately 3 years ]
  • Duration of response(DOR) [ Time Frame: Approximately 3 years ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE An Investigational Immuno-therapy Study of BMS-986205 Given in Combination With Nivolumab and in Combination With Both Nivolumab and Ipilimumab in Cancers That Are Advanced or Have Spread
Official Title  ICMJE A Phase 1/2a Study of BMS-986205 Administered in Combination With Nivolumab (Anti-PD-1 Monoclonal Antibody) and in Combination With Both Nivolumab and Ipilimumab (Anti-CTLA-4 Monoclonal Antibody) in Advanced Malignant Tumors
Brief Summary The purpose of the study is to determine safety and effectiveness of experimental medication BMS-986205 when combined with Nivolumab and in combination with both Nivolumab and Ipilimumab in patients with cancers that are advanced or have spread. Pharmacokinetics and pharmacodynamics of BMS-986205 when combined with Nivolumab and in combination with Nivolumab and Ipilimumab in this patient population will also be assessed.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Advanced Cancer
  • Melanoma
  • Non-Small Cell Lung Cancer
Intervention  ICMJE
  • Drug: BMS-986205
  • Drug: Nivolumab
    Other Names:
    • BMS-936558
    • ANTI-PD1
  • Drug: Ipilimumab
    Other Names:
    • BMS-734016
    • ANTI-CTLA-4
Study Arms  ICMJE
  • Experimental: Combination Therapy (Dose Escalation)
    BMS 986205 + Nivolumab specified dose at specified intervals.
    Interventions:
    • Drug: BMS-986205
    • Drug: Nivolumab
  • Experimental: Combination Therapy (Dose Expansion)
    BMS 986205 + Nivolumab specified dose at specified intervals.
    Interventions:
    • Drug: BMS-986205
    • Drug: Nivolumab
  • Experimental: Combination Therapy 2 (Dose Expansion)
    BMS 986205 + both Nivolumab and ipilimumab specified dose at specified intervals
    Interventions:
    • Drug: BMS-986205
    • Drug: Nivolumab
    • Drug: Ipilimumab
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Active, not recruiting
Actual Enrollment  ICMJE
 (submitted: October 13, 2021)
630
Original Estimated Enrollment  ICMJE
 (submitted: January 15, 2016)
252
Estimated Study Completion Date  ICMJE October 25, 2021
Estimated Primary Completion Date October 24, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

For more information regarding Bristol-Myers Squibb (BMS) Clinical Trial participation, please visit www.BMSStudyConnect.com

Inclusion Criteria:

  • During dose escalation, subjects with advanced solid tumors that have progressed following at least one standard regimen
  • During cohort expansion, subjects with advanced cancer that either have received at least one prior therapy or are treatment naive, depending on the specified tumor type
  • Subjects must have measurable disease
  • Subject must consent to provide previously collected tumor tissue and a tumor biopsy during screening.
  • At least 4 weeks since any previous treatment for cancer
  • Must be able to swallow pills or capsules
  • Eastern Cooperative Oncology Group(ECOG) Performance Status 0-1

Exclusion Criteria:

  • Active or chronic autoimmune diseases
  • Uncontrolled or significant cardiovascular disease
  • History of any chronic Hepatitis, active Hepatitis B or C, human immunodeficiency virus (HIV), or acquired immune deficiency syndrome (AIDS)
  • Chronic hepatitis: Positive test for Hepatitis B virus surface antigen or Hepatitis C antibody (except for subjects with hepatocellular carcinoma)
  • Active central nervous system (CNS) metastases and CNS metastases as the only sites of disease
  • Active infection

Other protocol defined inclusion/exclusion criteria could apply

Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 100 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Australia,   Canada,   Finland,   France,   Germany,   Italy,   Norway,   Poland,   Spain,   Sweden,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02658890
Other Study ID Numbers  ICMJE CA017-003
2015-004914-79 ( EudraCT Number )
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Bristol-Myers Squibb
Study Sponsor  ICMJE Bristol-Myers Squibb
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Bristol-Myers Squibb Bristol-Myers Squibb
PRS Account Bristol-Myers Squibb
Verification Date October 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP