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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

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ClinicalTrials.gov Identifier: NCT02658890
Recruitment Status : Recruiting
First Posted : January 20, 2016
Last Update Posted : July 24, 2018
Sponsor:
Information provided by (Responsible Party):
Bristol-Myers Squibb

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
Advanced Cancer Melanoma Non-Small Cell Lung Cancer Drug: BMS-986205 Drug: Nivolumab Drug: Ipilimumab Phase 1 Phase 2

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 907 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 : February 18, 2016
Estimated Primary Completion Date : April 29, 2019
Estimated Study Completion Date : February 28, 2020

Resource links provided by the National Library of Medicine


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




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. [ Time Frame: 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. [ Time Frame: 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. [ Time Frame: 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) [ Time Frame: 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) [ Time Frame: 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) [ Time Frame: 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) [ Time Frame: 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) [ Time Frame: 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) [ Time Frame: Approximately 3 years ]
    measured by CT scan


Secondary Outcome Measures :
  1. Maximum observed plasma concentration (Cmax) of BMS-986205 [ Time Frame: Approximately 3 years ]
    measured by plasma concentration

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

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

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

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

  8. Apparent terminal phase half-life (T-HALF) of BMS-986205 [ Time Frame: Approximately 3 years ]
    measured by plasma concentration

  9. Apparent total body clearance (CLT/F) of BMS-986205 [ Time Frame: Approximately 3 years ]
    measured by plasma concentration

  10. Apparent renal clearance (CLR/F) of BMS-986205 [ Time Frame: Approximately 3 years ]
    measured by plasma concentration

  11. Volume of distribution of terminal phase (Vz/F) of BMS-986205 [ Time Frame: Approximately 3 years ]
    measured by plasma concentration

  12. Apparent volume of distribution at steady state (Vss/F) of BMS-986205 [ Time Frame: Approximately 3 years ]
    measured by plasma concentration

  13. Accumulation index (AI) of BMS-986205 [ Time Frame: Approximately 3 years ]
    measured by plasma concentration

  14. Percent urinary recovery (%UR) of BMS-986205 [ Time Frame: Approximately 3 years ]
    measured by urine concentration

  15. Percent urinary recovery over 24 hours(%UR24) of BMS-986205 [ Time Frame: Approximately 3 years ]
    measured by urine concentration

  16. 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

  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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: Approximately 3 years ]
    measured by plasma concentration

  20. 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

  21. 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



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 100 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02658890


Contacts
Contact: Recruiting sites have contact information. Please contact the sites directly. If there is no contact information, please email: Clinical.Trials@bms.com
Contact: First line of the email MUST contain NCT# and Site #.

  Show 52 Study Locations
Sponsors and Collaborators
Bristol-Myers Squibb
Investigators
Study Director: Bristol-Myers Squibb Bristol-Myers Squibb

Additional Information:
Responsible Party: Bristol-Myers Squibb
ClinicalTrials.gov Identifier: NCT02658890     History of Changes
Other Study ID Numbers: CA017-003
2015-004914-79 ( EudraCT Number )
First Posted: January 20, 2016    Key Record Dates
Last Update Posted: July 24, 2018
Last Verified: July 2018

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
Carcinoma, Bronchogenic
Bronchial Neoplasms
Lung Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
Nivolumab
Antibodies, Monoclonal
Antineoplastic Agents
Immunologic Factors
Physiological Effects of Drugs