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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

Sponsor
Bristol-Myers Squibb (Industry)
Overall Status
Completed
CT.gov ID
NCT02658890
Collaborator
(none)
627
Enrollment
47
Locations
3
Arms
68.1
Actual Duration (Months)
13.3
Patients Per Site
0.2
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
Phase 1/Phase 2

Study Design

Study Type:
Interventional
Actual Enrollment :
627 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
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
Actual Study Start Date :
Feb 22, 2016
Actual Primary Completion Date :
Oct 26, 2021
Actual Study Completion Date :
Oct 26, 2021

Arms and Interventions

Arm Intervention/Treatment
Experimental: Combination Therapy (Dose Escalation)

BMS 986205 + Nivolumab specified dose at specified intervals.

Drug: BMS-986205

Drug: Nivolumab
Other Names:
  • BMS-936558
  • ANTI-PD1

    		•
    Experimental: Combination Therapy (Dose Expansion)

    BMS 986205 + Nivolumab specified dose at specified intervals.

    Drug: BMS-986205

    Drug: Nivolumab
    Other Names:
  • BMS-936558
  • ANTI-PD1

    		•
    Experimental: Combination Therapy 2 (Dose Expansion)

    BMS 986205 + both Nivolumab and ipilimumab specified dose at specified intervals

    Drug: BMS-986205

    Drug: Nivolumab
    Other Names:
  • BMS-936558
  • ANTI-PD1

    • Drug: Ipilimumab
    Other Names:
  • BMS-734016
  • ANTI-CTLA-4

    		•

    Outcome Measures

    Primary Outcome Measures

    1. 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. [100 days after the last dose of study therapy]

      measured by incidence

    2. 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. [100 days after the last dose of study therapy]

      measured by incidence

    3. 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. [100 days after the last dose of study therapy]

      measured by incidence

    4. Anti-tumor activity of BMS 986205 administered in combination with nivolumab as measured by the best overall response (BOR) [Approximately 3 years]

      measured by CT scan

    5. Anti-tumor activity of BMS 986205 administered in combination with nivolumab as measured by the duration of response (DOR) [Approximately 3 years]

      measured by CT scan

    6. Anti-tumor activity of BMS 986205 administered in combination with nivolumab as measured by progression-free survival rates (PFSRs) [Approximately 3 years]

      measured by CT scan

    7. Anti-tumor activity of BMS 986205 administered in combination with both nivolumab and ipilimumab as measured by the best overall response (BOR) [Approximately 3 years]

      measured by CT scan

    8. Anti-tumor activity of BMS 986205 administered in combination with both nivolumab and ipilimumab as measured by the duration of response (DOR) [Approximately 3 years]

      measured by CT scan

    9. Anti-tumor activity of BMS 986205 administered in combination with both nivolumab and ipilimumab as measured by progression-free survival rates (PFSRs) [Approximately 3 years]

      measured by CT scan

    Secondary Outcome Measures

    1. Maximum observed plasma concentration (Cmax) of BMS-986205 [Approximately 3 years]

      measured by plasma concentration

    2. Time of maximum observed plasma concentration (Tmax) of BMS-986205 [Approximately 3 years]

      measured by plasma concentration

    3. Area under the concentration-time curve from time zero extrapolated to infinite time [AUC(INF)] of BMS-986205 [Approximately 3 years]

      measured by plasma concentration

    4. Area under the concentration-time curve from time zero to the time of the last quantifiable concentration [AUC(0-T)] of BMS-986205 [Approximately 3 years]

      measured by plasma concentration

    5. Area under the concentration-time curve in 1 dosing interval [AUC(TAU)] of BMS-986205 [Approximately 3 years]

      measured by plasma concentration

    6. Trough observed plasma concentration at the end of the dosing interval (Ctrough) of BMS-986205 [Approximately 3 years]

      measured by plasma concentration

    7. Observed plasma concentration at 24 hours (C24) of BMS-986205 [Approximately 3 years]

      measured by plasma concentration

    8. Apparent terminal phase half-life (T-HALF) of BMS-986205 [Approximately 3 years]

      measured by plasma concentration

    9. Apparent total body clearance (CLT/F) of BMS-986205 [Approximately 3 years]

      measured by plasma concentration

    10. Apparent renal clearance (CLR/F) of BMS-986205 [Approximately 3 years]

      measured by plasma concentration

    11. Volume of distribution of terminal phase (Vz/F) of BMS-986205 [Approximately 3 years]

      measured by plasma concentration

    12. Apparent volume of distribution at steady state (Vss/F) of BMS-986205 [Approximately 3 years]

      measured by plasma concentration

    13. Accumulation index (AI) of BMS-986205 [Approximately 3 years]

      measured by plasma concentration

    14. Percent urinary recovery (%UR) of BMS-986205 [Approximately 3 years]

      measured by urine concentration

    15. Percent urinary recovery over 24 hours(%UR24) of BMS-986205 [Approximately 3 years]

      measured by urine concentration

    16. Ratio of metabolite Cmax to parent Cmax, corrected for molecular weight (MR_Cmax) of BMS-986205 [Approximately 3 years]

      measured by plasma concentration

    17. 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 [Approximately 3 years]

      measured by plasma concentration

    18. Ratio of metabolite AUC(TAU) to parent AUC(TAU), corrected for molecular weight [MR_AUC(TAU)] of BMS-986205 [Approximately 3 years]

      measured by plasma concentration

    19. 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 [Approximately 3 years]

      measured by plasma concentration

    20. Anti-drug antibody (ADA) response to Nivolumab in combination with BMS-986205 [Approximately 3 years]

      measured by immunoassay and liquid chromatography- mass spectrometry

    21. Anti-drug antibody (ADA) response to Ipilimumab in combination with BMS-986205 [Approximately 3 years]

      measured by immunoassay and liquid chromatography- mass spectrometry

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 100 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No

    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 University of Arizona Cancer Center Tucson Arizona United States 85724-5024
    2 Local Institution - 0026 La Jolla California United States 92093-0698
    3 Local Institution - 0035 Tampa Florida United States 33612-9497
    4 Emory Winship Cancer Institute Atlanta Georgia United States 30322
    5 Northside Hospital, Inc Atlanta Georgia United States 30342
    6 Local Institution - 0027 Chicago Illinois United States 60637
    7 Sidney Kimmel Comprehensive Cancer Center At Johns Hopkins Lutherville Maryland United States 21093
    8 Barbara Ann Karmanos Cancer Institute Detroit Michigan United States 48201
    9 Local Institution - 0006 Saint Louis Missouri United States 63110
    10 Hackensack University Medical Center Hackensack New Jersey United States 07601
    11 New York University New York New York United States 10016
    12 Cleveland Clinic Cleveland Ohio United States 44195
    13 Local Institution - 0034 Philadelphia Pennsylvania United States 19111-2412
    14 UPMC Hillman Cancer Center Pittsburgh Pennsylvania United States 15232
    15 Vanderbilt University Medical Center Nashville Tennessee United States 37232
    16 St Vincent'S Hospital (Nsw) Darlinghurst Australian Capital Territory Australia 2010
    17 Local Institution - 0045 North Sydney New South Wales Australia 2146
    18 Local Institution Westmead New South Wales Australia 2145
    19 Princess Alexandra Hospital Brisbane Queensland Australia 4102
    20 Local Institution Clayton Victoria Australia 3168
    21 Local Institution - 0004 Melbourne Victoria Australia 3000
    22 Linear Clinical Research Ltd Nedlands Western Australia Australia 6009
    23 Cross Cancer Institute Edmonton Alberta Canada T6G 1Z2
    24 Local Institution Vancouver British Columbia Canada V5Z 4E6
    25 Local Institution Toronto Ontario Canada M5G 1Z5
    26 Local Institution Greenfield Park Quebec Canada J4V 2H1
    27 Local Institution - 0036 Montreal Quebec Canada H3T 1E2
    28 Local Institution Helsinki Finland 00180
    29 Hopital Claude Huriez Lille CEDEX France 59037
    30 Local Institution Lyon Cedex 08 France 69373
    31 Local Institution Marseille Cedex 5 France 13385
    32 Hotel Dieu - Chu De Nantes Nantes Cedex 01 France 44093
    33 Local Institution Paris France 75005
    34 Local Institution Toulouse France 31100
    35 Local Institution - 0022 Villejuif France 94800
    36 Local Institution Essen Germany 45147
    37 Local Institution Heilbronn Germany 74078
    38 Ospedale San Raffaele Milano Italy 20132
    39 IRCCS Istituto Nazionale Tumori Milano Milano Italy 20133
    40 Istituto Europeo Di Oncologia Milano Italy 20141
    41 Local Institution - 0009 Rozzano MI Italy 20089
    42 Local Institution Oslo Norway 0424
    43 Oddzial Badan Wczesnych Faz Warszawa Mazowieckie Poland 02-781
    44 Local Institution - 0017 Barcelona Spain 08035
    45 Local Institution Madrid Spain 28040
    46 Local Institution Madrid Spain 28050
    47 Local Institution Solna Sweden 171 64

    Sponsors and Collaborators

    • Bristol-Myers Squibb

    Investigators

    • Study Director: Bristol-Myers Squibb, Bristol-Myers Squibb

    Study Documents (Full-Text)

    None provided.

    More Information

    Additional Information:

    Publications

    None provided.
    Responsible Party:
    Bristol-Myers Squibb
    ClinicalTrials.gov Identifier:
    NCT02658890
    Other Study ID Numbers:
    • CA017-003
    • 2015-004914-79
    First Posted:
    Jan 20, 2016
    Last Update Posted:
    Aug 19, 2022
    Last Verified:
    Aug 1, 2022
    Studies a U.S. FDA-regulated Drug Product:
    Yes
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Carcinoma, Non-Small-Cell Lung
    Nivolumab
    Ipilimumab
    Linrodostat

    Study Results

    No Results Posted as of Aug 19, 2022