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At Bolder Science, we want your clinical trial search experience to be the best it can be. Complete the following prompts to easily find the trials you are interested in and see trials recruiting near you. You can adjust these selections in your dashboard after creating your account.

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First-In-Human Study of Monoclonal Antibody BMS-986218 by Itself and in Combination With Nivolumab in Participants With Advanced Solid Tumors

  • Clinicaltrials.gov identifier

    NCT03110107

  • Recruitment Status

    Recruiting

  • First Posted

    April 12, 2017

  • Last update posted

    July 12, 2021

Study Description

Brief summary:

The purpose of this study is to determine whether a Monoclonal Antibody both by itself and in combination with Nivolumab is safe and tolerable in the treatment of advanced solid tumors

  • Condition or Disease:Advanced Cancer
  • Intervention/Treatment: Biological: Ipilimumab
    Biological: BMS-986218
    Biological: Nivolumab
  • Phase: Phase 1/Phase 2

Detailed Description

N/A

Study Design

  • Study Type: Interventional
  • Estimated Enrollment: 390 participants
  • Allocation: Randomized
  • Intervention Model: Parallel Assignment
  • Masking: None (Open Label) ()
  • Primary Purpose: Treatment
  • Official Title: Phase 1/2a First-In-Human Study of BMS-986218 Monoclonal Antibody Alone and in Combination With Nivolumab in Advanced Solid Tumors
  • Actual Study Start Date: May 2017
  • Estimated Primary Completion Date: March 2023
  • Estimated Study Completion Date: November 2023

Arms and interventions

Arm Intervention/treatment
Experimental: Part 2A: Monotherapy (BMS-986218 OR Ipilimumab)
Biological: Ipilimumab
Specified dose on specified days

Biological: BMS-986218
Specified dose on specified days
Experimental: Part 1A: Monotherapy (BMS-986218)
Biological: BMS-986218
Specified dose on specified days
Experimental: Part 1B: Combination Therapy (BMS-986218 + Nivolumab)
Biological: BMS-986218
Specified dose on specified days

Biological: Nivolumab
Specified dose on specified days
Experimental: Part 2B: Monotherapy (BMS-986218)
Biological: BMS-986218
Specified dose on specified days

Outcome Measures

  • Primary Outcome Measures: 1. Incidence of Adverse Events (AEs) [ Time Frame: Up to 4 years ]
  • 2. Incidence of Serious Adverse Events (SAEs) [ Time Frame: Up to 4 years ]
  • 3. Incidence of AEs meeting protocol- defined dose-limiting toxicity (DLT) criteria [ Time Frame: Up to 4 years ]
  • 4. Incidence of AEs leading to discontinuation [ Time Frame: Up to 4 years ]
  • 5. Incidence of death [ Time Frame: Up to 4 years ]
  • 6. Incidence of clinically significant changes in clinical laboratory results: Hematology tests [ Time Frame: Up to 4 years ]
  • 7. Incidence of clinically significant changes in clinical laboratory results: Clinical Chemistry tests [ Time Frame: Up to 4 years ]
  • 8. Incidence of clinically significant changes in clinical laboratory results: Urinalysis [ Time Frame: Up to 4 years ]
  • 9. Objective Response Rate (ORR) [ Time Frame: Up to 4 years ]
  • 10. Median Duration of Response (mDOR) [ Time Frame: Up to 4 years ]
  • 11. Progression Free Survival Rate (PFSR) by Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 [ Time Frame: Up to 4 years ]
  • Secondary Outcome Measures: 1. Average serum concentration over a dosing interval (AUC[TAU]/tau) at steady state (Css-avg) [ Time Frame: Up to 4 years ]
  • 2. ORR of BMS-986218 alone or in combination with Nivolumab [ Time Frame: Up to 4 years ]
  • 3. mDOR of BMS-986218 alone or in combination with Nivolumab [ Time Frame: Up to 4 years ]
  • 4. PFS of BMS-986218 alone or in combination with Nivolumab [ Time Frame: Up to 4 years ]
  • 5. Incidence of anti-drug antibody (ADA) to BMS-986218 [ Time Frame: Up to 4 years ]
  • 6. Maximum observed serum concentration (Cmax) [ Time Frame: Up to 4 years ]
  • 7. Time of maximum observed concentration (Tmax) [ Time Frame: Up to 4 years ]
  • 8. Area under the concentration-time curve from time zero to the time of the [ Time Frame: Up to 4 years ]
  • 9. Area under the concentration-time curve in 1 dosing interval [AUC(TAU)] [ Time Frame: Up to 4 years ]
  • 10. Trough observed serum concentration (Ctrough) [ Time Frame: Up to 4 years ]
  • 11. Total body clearance (CLT) [ Time Frame: Up to 4 years ]
  • 12. Ratio of an exposure measure at steady state to that after the first dose [exposure measure includes AUC[TAU] and Cmax (AI)] [ Time Frame: Up to 4 years ]
  • 13. Terminal serum half-life if data permit (T-HALF) [ Time Frame: Up to 4 years ]
  • 14. Observed concentration at the end of a dosing interval (Ctau) [ Time Frame: Up to 4 years ]

Eligibility Criteria

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

Criteria

For more information regarding Bristol-Myers Squibb Clinical Trial participation, please visit www.BMSStudyConnect.com Inclusion Criteria: - histologic or cytologic confirmation of a solid tumor that is advanced (metastatic, recurrent and/or unresectable) - Eastern Cooperative Oncology Group Performance Status of 0 or 1 - Participants must have received, and then progressed, relapsed, or been intolerant to at least 2 standard treatment regimens with proven survival benefit in the advanced or metastatic setting according to tumor type, if such a therapy exists - Advanced stage cutaneous melanoma who have received standard therapies with proven survival benefit including prior immunotherapy with an anti-programmed cell death 1 (anti-PD-1) or anti-programmed death ligand 1 (anti-PD-L1) (For Part 2A) - Non-small cell lung cancer (NSCLC) (adenocarcinoma or squamous cell carcinoma) who have received standard therapies with proven survival benefit including prior immunotherapy with an anti-PD-1 or anti-PD-L1 (For Part 2B) - Women must agree to follow methods of contraception, if applicable Exclusion Criteria: - Participants with primary CNS malignancies, or tumors with CNS metastases as the only site of disease, will be excluded - Cytotoxic agents, unless at least 4 weeks have elapsed from last dose of prior anti-cancer therapy and initiation of study therapy - Prior anti-cancer treatments such as chemotherapy, radiotherapy, hormonal, or immunotherapy (including anti-PD-1/PD-L1) are permitted Other protocol defined inclusion/exclusion criteria could apply

Contacts and Locations

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 #

Locations

United States, Colorado
Local Institution
Aurora

United States, Georgia
Northside Hospital
Atlanta

United States, Massachusetts
Dana-Farber Cancer Institute
Boston

United States, Nevada
Local Institution
Las Vegas

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

United States, New Jersey
Rutgers Cancer Institute of New Jersey
New Brunswick

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

United States, New York
Memorial Sloan Kettering Nassau
New York

United States, Pennsylvania
University Of Pennsylvania
Philadelphia

United States, Pennsylvania
UPMC Cancer Center
Pittsburgh

United States, South Dakota
Sanford Clinical Research
Sioux Falls

Argentina, Buenos Aires
Local Institution
Ciudad Autónoma De Buenos Aires

Argentina, Cordoba
Local Institution
Rio Cuarto

Argentina, Distrito Federal
Local Institution
Buenos Aires

Argentina, Distrito Federal
Local Institution
Cuiudad Autonoma De Buenos Aires

Argentina
Local Institution
Caba

Argentina
Local Institution
Cordoba

Argentina
Local Institution
Cordoba

Australia, New South Wales
Local Institution
Westmead

Australia, New South Wales
Local Institution
Wollstonecraft

Australia, Western Australia
Local Institution
Murdoch

Belgium
Local Institution
Gent

Canada, Alberta
Local Institution
Edmonton

Canada, British Columbia
Local Institution
Vancouver

Canada, Ontario
Local Institution
Ottawa

Canada, Ontario
Local Institution
Toronto

Canada
Local Institution
Quebec

Chile, Metropolitana
Local Institution
Santiago

Chile, Metropolitana
Local Institution
Santiago

Chile, Valparaiso
Local Institution
Vina del Mar

Denmark
Local Institution
Copenhagen

Finland
Local Institution
Helsinki

France
Local Institution
Lyon Cedex 08

France
Local Institution
Toulouse Cedex 9

France
Local Institution
Villejuif

Germany
Universitaetsklinikum Carl Gustav Carus
Dresden

Germany
Universitatsklinik Essen
Essen

Israel
Local Institution
Haifa

Israel
Local Institution
Ramat Gan

Italy
Istituto Nazionale Tumori Fondazione Pascale
Napoli

Italy
Local Institution
Rozzano

Italy
Local Institution
Siena

Netherlands
Local Institution
Amsterdam

Netherlands
Local Institution
Nijmegen

Norway
Local Institution
Oslo

Poland
Local Institution
Warszawa

Romania
Local Institution
Cluj-Napoca

Romania
Local Institution
Craiova

Spain
H. Univ. Vall dHebron
Barcelona

Spain
Local Institution
Madrid

Spain
Local Institution
Madrid

Spain
Centro Integral Oncologico Clara Campal
Madrid

Spain
Local Institution
Malaga

Spain
Clinica Universidad de Navarra
Pamplona

Switzerland
University Hospital of Lausanne
Lausanne

Switzerland
University Hospital Zuerich
Zurich

Sponsors and Collaborators

Bristol-Myers Squibb

Investigators

Study Director: Bristol Myers Squibb Bristol-Myers Squibb

More Information

  • Responsible Party: Bristol-Myers Squibb
  • ClinicalTrials.gov Identifier: NCT03110107 History of Changes
  • Other Study ID Numbers: CA022-001, 2017-000597-11
  • First Posted: April 12, 2017 Key Record Dates
  • Last Update Posted: July 12, 2021
  • Last Verified: July 2021
  • Studies a U.S. FDA-regulated Drug Product: Yes
  • Studies a U.S. FDA-regulated Device Product: No