A Dose Escalation and Combination Immunotherapy Study to Evaluate BMS-986226 Alone or in Combination With Nivolumab or Ipilimumab in Patients With Advanced Solid Tumors
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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. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT03251924 |
Recruitment Status :
Active, not recruiting
First Posted : August 16, 2017
Last Update Posted : September 10, 2020
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Cancer Tumors Neoplasm Malignancy | Drug: BMS-986226 Biological: Nivolumab Biological: Ipilimumab Biological: Tetanus Vaccine | Phase 1 Phase 2 |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 234 participants |
Allocation: | Non-Randomized |
Intervention Model: | Parallel Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | A Phase 1/2 Dose Escalation and Combination Cohort Study to Evaluate the Safety and Tolerability, Pharmacokinetics, and Efficacy of BMS-986226 Alone or in Combination With Nivolumab or Ipilimumab in Patients With Advanced Solid Tumors |
Actual Study Start Date : | August 31, 2017 |
Estimated Primary Completion Date : | October 4, 2022 |
Estimated Study Completion Date : | May 15, 2023 |

Arm | Intervention/treatment |
---|---|
Experimental: BMS-986226
administered intravenously
|
Drug: BMS-986226
specified dose on specified days Biological: Tetanus Vaccine specified dose on specified days |
Experimental: BMS-986226 and Nivolumab
administered intravenously
|
Drug: BMS-986226
specified dose on specified days Biological: Nivolumab specified dose on specified days
Other Names:
Biological: Tetanus Vaccine specified dose on specified days |
Experimental: BMS-986226 and Ipilimumab
administered intravenously
|
Drug: BMS-986226
specified dose on specified days Biological: Ipilimumab specified dose on specified days
Other Names:
Biological: Tetanus Vaccine specified dose on specified days |
- Incidence of adverse events (AE) [ Time Frame: Approximately 2 years ]
- Incidence of serious adverse events (SAE) [ Time Frame: Approximately 2 years ]
- Incidence of AE due to discontinuation [ Time Frame: Approximately 2 years ]
- Incidence of AE resulting in death [ Time Frame: Approximately 2 years ]
- Incidence of AEs meeting protocol defined dose-limiting toxicity (DLT) criteria [ Time Frame: Approximately 2 years ]
- Incidence of clinical laboratory test abnormalities graded according to common terminology criteria for adverse events (CTCAE) [ Time Frame: Approximately 2 years ]
- Objective response rate (ORR) measure by Clopper-Pearson method [ Time Frame: Approximately 2 years ]
- Median Duration of Response (mDOR) measured by Kaplan-Meier method [ Time Frame: Approximately 2 years ]
- Progression Free Survival (PFS) measured by Kaplan-Meier method [ Time Frame: At 24 weeks ]
- Maximum observed plasma concentration (Cmax) [ Time Frame: Approximately 2 years ]
- Time of maximum observed plasma concentration (Tmax) [ Time Frame: Approximately 2 years ]
- Area under the concentration-time curve from time 0 to the time of the last [AUC (0-T)] [ Time Frame: Approximately 2 years ]
- Area under the concentration-time curve in 1 dosing interval [AUC(TAU)] [ Time Frame: Approximately 2 years ]
- Incidence of anti-drug antibodies to BMS-986226 assessed by immunoassay [ Time Frame: Approximately 2 years ]
- Change from baseline in immunoassay for BMS-986226 [ Time Frame: Approximately 2 years ]

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 and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
For more information regarding Bristol-Myers Squibb Clinical Trial participation, please visit www.BMSStudyConnect.com
Inclusion Criteria:
- Advanced solid tumors
- Histological or cytological confirmation of a malignancy that is advanced (metastatic and/or unresectable) with measureable disease as defined by Response Evaluation Criteria In Solid Tumors (RECIST) v1.1 or PCWG3 (prostate only).
- At least 1 lesion accessible for biopsy in addition to the target lesion
- Participants must have received, and then progressed or been intolerant to, at least 1 standard treatment regimen
- Eastern Cooperative Oncology Group (ECOG) performance status ≤2
Exclusion Criteria:
- Participants with active central nervous system (CNS) metastases, untreated CNS metastases, or with the CNS as the only site of disease are excluded (controlled brain metastases will be allowed to enroll)
- Participants with carcinomatous meningitis
- Prior malignancy active within the previous 2 years except for locally curable cancers that have been apparently cured, such as basal or squamous cell skin cancer, superficial bladder cancer, or carcinoma in situ of the prostate, cervix, or breast
- Active, known, or suspected autoimmune disease
- Uncontrolled or significant cardiovascular disease
- Participants with known allergies to egg products, neomycin and tetanus toxoid.
- Prior adverse reaction to tetanus toxoid- containing vaccines.
Other protocol defined inclusion/exclusion criteria could apply

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): NCT03251924
United States, Massachusetts | |
Dana-Farber Cancer Institute | |
Boston, Massachusetts, United States, 02215 | |
United States, Missouri | |
Washington University School OF Medicine-Siteman Cancer Center | |
Saint Louis, Missouri, United States, 63110 | |
United States, New Jersey | |
John Theurer Cancer Center at Hackensack University Medical Center | |
Hackensack, New Jersey, United States, 07601 | |
United States, Pennsylvania | |
Fox Chase Cancer Center | |
Philadelphia, Pennsylvania, United States, 19111 | |
United States, Tennessee | |
Tennessee Oncology, PLLC | |
Nashville, Tennessee, United States, 37203 | |
Canada, Alberta | |
Local Institution | |
Edmonton, Alberta, Canada, T6G 1Z2 | |
Canada, Ontario | |
Juravinski Cancer Centre | |
Hamilton, Ontario, Canada, L8V 5C2 | |
Princess Margaret Cancer Centre | |
Toronto, Ontario, Canada, M5G 1Z5 | |
Spain | |
Local Institution | |
Madrid, Spain, 28040 | |
Local Institution | |
Madrid, Spain, 28050 | |
Switzerland | |
Kantonsspital Graubuenden | |
Chur, Switzerland, 7000 | |
Chu Vaudois Lausanne | |
Lausanne, Switzerland, 1011 | |
University Hospital Zuerich | |
Zuerich, Switzerland, 8091 |
Study Director: | Bristol-Myers Squibb | Bristol-Myers Squibb |
Responsible Party: | Bristol-Myers Squibb |
ClinicalTrials.gov Identifier: | NCT03251924 |
Other Study ID Numbers: |
CA021-002 2017-000238-73 ( EudraCT Number ) |
First Posted: | August 16, 2017 Key Record Dates |
Last Update Posted: | September 10, 2020 |
Last Verified: | September 2020 |
Studies a U.S. FDA-regulated Drug Product: | Yes |
Studies a U.S. FDA-regulated Device Product: | No |
Neoplasms Nivolumab Ipilimumab Antibodies Immunoglobulins |
Antibodies, Blocking Immunologic Factors Physiological Effects of Drugs Antineoplastic Agents, Immunological Antineoplastic Agents |