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

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT03251924
• Date of registration: 15/08/2017
• Prospective Registration: Yes
• Primary sponsor: Bristol-Myers Squibb
• Public title: 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
• Scientific 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
• Date of first enrolment: August 31, 2017
• Target sample size: 234
• Recruitment status: Active, not recruiting
• URL: https://clinicaltrials.gov/show/NCT03251924
• Study type: Interventional
• Study design: Allocation: Non-Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: None (Open Label).
• Phase: Phase 1/Phase 2

Countries of recruitment

Canada, Spain, Switzerland, United States

Contacts

• Name: Bristol-Myers Squibb
• Affiliation: Bristol-Myers Squibb

Key inclusion & exclusion criteria

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



Age minimum: 18 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Cancer

Malignancy

Neoplasm

Tumors

Intervention(s)

Drug: BMS-986226

Biological: Ipilimumab

Biological: Nivolumab

Biological: Tetanus Vaccine

Primary Outcome(s)

Incidence of AE resulting in death [Time Frame: Approximately 2 years]

Incidence of serious adverse events (SAE) [Time Frame: Approximately 2 years]

Incidence of adverse events (AE) [Time Frame: Approximately 2 years]

Incidence of AE due to discontinuation [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]

Secondary Outcome(s)

Time of maximum observed plasma concentration (Tmax) [Time Frame: Approximately 2 years]

Median Duration of Response (mDOR) measured by Kaplan-Meier method [Time Frame: Approximately 2 years]

Objective response rate (ORR) measure by Clopper-Pearson method [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]

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]

Progression Free Survival (PFS) measured by Kaplan-Meier method [Time Frame: At 24 weeks]

Area under the concentration-time curve in 1 dosing interval [AUC(TAU)] [Time Frame: Approximately 2 years]

Maximum observed plasma concentration (Cmax) [Time Frame: Approximately 2 years]

Secondary ID(s)

2017-000238-73

CA021-002

Source(s) of Monetary Support

Please refer to primary and secondary sponsors