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A Study of BMS-986207 Given Alone and in Combination With Nivolumab or With Nivolumab and Ipilimumab in Advanced Solid Tumors

  • Clinicaltrials.gov identifier

    NCT02913313

  • Recruitment Status

    Recruiting

  • First Posted

    September 23, 2016

  • Last update posted

    April 28, 2022

Study Description

Brief summary:

The purpose of this study is to evaluate the safety and effectiveness of experimental medication BMS-986207 by itself, in combination with Nivolumab, and in combination with both nivolumab and ipilimumab in participants with solid cancers that are advanced or have spread.

  • Condition or Disease:Broad Solid Tumor
  • Intervention/Treatment: Drug: BMS-986207
    Biological: Nivolumab
    Biological: Ipilimumab
  • Phase: Phase 1/Phase 2

Detailed Description

N/A

Study Design

  • Study Type: Interventional
  • Estimated Enrollment: 241 participants
  • Allocation: Non-Randomized
  • Intervention Model: Parallel Assignment
  • Masking: None (Open Label) ()
  • Primary Purpose: Treatment
  • Official Title: A Study of BMS-986207 Given Alone and in Combination With Nivolumab or With Nivolumab and Ipilimumab in Advanced Solid Tumors
  • Actual Study Start Date: November 2016
  • Estimated Primary Completion Date: March 2024
  • Estimated Study Completion Date: February 2026

Arms and interventions

Arm Intervention/treatment
Experimental: Part 1A: Dose Escalation Monotherapy
Drug: BMS-986207
Specified dose on specified days
Experimental: Part 1B: Dose Escalation Combination Therapy
Drug: BMS-986207
Specified dose on specified days

Biological: Nivolumab
Specified dose on specified days
Experimental: Part 1C: Triplet Cohort
Drug: BMS-986207
Specified dose on specified days

Biological: Nivolumab
Specified dose on specified days

Biological: Ipilimumab
Specified dose on specified days
Experimental: Part 2A: Expansion Monotherapy
Drug: BMS-986207
Specified dose on specified days
Experimental: Part 2B: Expansion Combination Therapy
Drug: BMS-986207
Specified dose on specified days

Biological: Nivolumab
Specified dose on specified days
Experimental: Part 2C: Triplet Expansion
Drug: BMS-986207
Specified dose on specified days

Biological: Nivolumab
Specified dose on specified days

Biological: Ipilimumab
Specified dose on specified days

Outcome Measures

  • Primary Outcome Measures: 1. Incidence of Adverse Events (AEs) [ Time Frame: Up to 27 months ]
  • 2. Incidence of Serious Adverse Events (SAEs) [ Time Frame: Up to 27 months ]
  • 3. Incidence of AEs meeting protocol-defined dose limiting toxicity (DLT) criteria [ Time Frame: Up to 6 weeks ]
  • 4. Incidence of AEs leading to discontinuation [ Time Frame: Up to 27 months ]
  • 5. Incidence of deaths [ Time Frame: Up to 27 months ]
  • 6. Number of participants with laboratory abnormalities [ Time Frame: Up to 27 months ]
  • 7. Objective response rate (ORR) [ Time Frame: Up to 36 months ]
  • 8. Median duration of response (mDOR) [ Time Frame: Up to 36 months ]
  • 9. Progression-free survival rate (PFSR) at 24 weeks by Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 by Investigator [ Time Frame: At 24 weeks ]
  • Secondary Outcome Measures: 1. Objective response rate (ORR) [ Time Frame: Up to 36 months ]
  • 2. Median duration of response (mDOR) [ Time Frame: Up to 36 months ]
  • 3. Progression-free survival rate (PFSR) at 24 weeks by RECIST v1.1 [ Time Frame: At 24 Weeks ]
  • 4. Maximum observed serum concentration (Cmax) [ Time Frame: Up to 27 months ]
  • 5. Time of maximum observed serum concentration (Tmax) [ Time Frame: Up to 27 months ]
  • 6. Area under the serum concentration-time curve from time zero to time of last quantifiable concentration AUC(0-T) [ Time Frame: Up to 27 months ]
  • 7. Incidence of anti-drug antibody (ADA) [ Time Frame: Up to 27 months ]

Eligibility Criteria

  • Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
  • Sexes Eligible for Study: All
  • Accepts Healthy Volunteers: No

Criteria

Inclusion Criteria: Must have pre-existing or prior programmed death-ligand 1 (PD-L1) immunohistochemistry (IHC) results within 3 months of enrollment from testing of tumor tissue; PD-L1 expression must be tumor cell positive ≥ 1% for a participant to be eligible for enrollment Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 Measurable disease by computed tomography (CT) or magnetic resonance imaging (MRI) per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 criteria; radiographic tumor assessment performed within 28 days before randomization Exclusion Criteria: Primary central nervous system (CNS) disease, or tumors with CNS metastases as the only site of disease. Controlled brain metastases will be allowed to enroll Other active malignancy requiring concurrent intervention Uncontrolled or significant cardiovascular disease Active, known, or suspected autoimmune disease NSCLC without prior treatment in the advanced or metastatic setting (Part 2C) Other protocol-defined inclusion/exclusion criteria apply

Contacts and Locations

Contacts

Contact: BMS Study Connect Contact Center www.BMSStudyConnect.com 855-907-3286 Clinical.Trials@bms.com

Contact: First line of the email MUST contain NCT# and Site #.

Locations

United States, New Jersey
John Theurer Cancer Center at Hackensack University Medical Center
Hackensack

United States, New York
Columbia University Medical Center (Cumc)
New York

United States, Pennsylvania
University Of Pennsylvania
Philadelphia

United States, Pennsylvania
Fox Chase Cancer Center
Philadelphia

United States, Pennsylvania
UPMC Cancer Center
Pittsburgh

United States, Utah
Local Institution - 0010
Salt Lake City

Argentina, Distrito Federal
Local Institution
Buenos Aires

Argentina, Distrito Federal
Local Institution
Caba

Argentina
Local Institution
Cordoba

Australia, Western Australia
Linear Clinical Research Ltd
Nedlands

Canada, Ontario
The Ottawa Hospital Cancer Centre
Ottawa

Canada, Ontario
University Health Network - Princess Margaret Cancer Centre
Toronto

Chile, Metropolitana
Local Institution - 0021
Santiago

Japan, Chiba
National Cancer Center Hospital East
Kashiwa-shi

Japan, Tokyo
Local Institution - 0005
Chuo-ku

Romania
Local Institution
Bucharest

Romania
Local Institution
Cluj-Napoca

Romania
Local Institution
Craiova

Romania
Local Institution
Floresti/ Cluj

Singapore
Local Institution
Singapore

Sponsors and Collaborators

Bristol-Myers Squibb

Ono Pharmaceutical Co. Ltd

Investigators

Study Director: Bristol-Myers Squibb Bristol-Myers Squibb

More Information

  • Responsible Party: Bristol-Myers Squibb
  • ClinicalTrials.gov Identifier: NCT02913313 History of Changes
  • Other Study ID Numbers: CA020-002, 2016-002263-34
  • First Posted: September 23, 2016 Key Record Dates
  • Last Update Posted: April 28, 2022
  • Last Verified: April 2022
  • Studies a U.S. FDA-regulated Drug Product: Yes
  • Studies a U.S. FDA-regulated Device Product: No
  • Keywords provided by Bristol-Myers Squibb: First line NSCLC
  • Additional relevant MeSH terms: Neoplasms