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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.

This study is currently recruiting participants.
Verified November 2017 by Bristol-Myers Squibb
Sponsor:
ClinicalTrials.gov Identifier:
NCT02658890
First Posted: January 20, 2016
Last Update Posted: November 17, 2017
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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Information provided by (Responsible Party):
Bristol-Myers Squibb
  Purpose
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 Intervention Phase
Advanced Cancer Melanoma Non-Small Cell Lung Cancer Drug: BMS-986205 Drug: Nivolumab Drug: Ipilimumab Phase 1 Phase 2

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:


Further study details as provided by Bristol-Myers Squibb:

Primary Outcome Measures:
  • 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


Secondary Outcome Measures:
  • 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


Estimated Enrollment: 907
Actual Study Start Date: February 18, 2016
Estimated Study Completion Date: February 28, 2020
Estimated Primary Completion Date: April 29, 2019 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 100 Years   (Adult, Senior)
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

  Contacts and Locations
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 51 Study Locations
Sponsors and Collaborators
Bristol-Myers Squibb
Investigators
Study Director: Bristol-Myers Squibb Bristol-Myers Squibb
  More Information

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 Submitted: January 14, 2016
First Posted: January 20, 2016
Last Update Posted: November 17, 2017
Last Verified: November 2017

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