During the Dose Escalation phase the following tumor histologies permitted except primary CNS tumors
Conditions
Interventions
Group A, every two weeks, 24 weeks
Dose Level 1: 20 mg
Dose Level 2: 40 mg
Dose Level 3: 80 mg
Dose Level 4: 160 mg
Dose Level 5: 320 mg
Group B, every 2 weeks, 24 weeks. 3 dosage level BMS-986178 is
every 6 weeks for 4 cycles.
Patients in the safety cohort will r
Sponsors
Bristol-Myers Squibb
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: • Patients must have at least 1 standard treatment regimen in the advanced, recurrent or metastatic setting;• ECOG (Eastern Cooperative Oncology Group) 0-1;• Men and women 18 years old or older;• At least one measurable lesion at baseline by CT (computed tomography) or MRI (magnetic resonance imaging) as per RECIST (Response Evaluation Criteria In Solid Tumors) v1.1
Exclusion criteria
Exclusion criteria: • Known central nervous system metastases or central nervous system as the only source of disease;• Concomitant malignancies;• Active known or suspected autoimmune disease;• Uncontrolled or significant cardiovascular disease;• Major surgery less than 4 weeks before the start of the study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Safety: The primary endpoint of this Phase I / IIa study's safety as measured using extensive medical assessment of adverse events (AEs), vital signs (blood pressure etc), ECGs, physical examination, and clinical significant laboratory abnormalities. Side effects are continuously monitored during the investigation and 100 days after the last treatment. Reported side effects will be further analysed significance and clinical importance. | — |
Secondary
| Measure | Time frame |
|---|---|
| Efficacy: Anti-tumour activity is monitored by means of CT / MRI during screening and every 8 weeks until disease progression. When disease progression occurs, there is no need more scans to be performed unless there are by treated (by treatment after disease progression). In this case, every 12 weeks, scans are carried out to there again stops until disease progression or the treatment. Consideration will be given to overall survival, duration of response and progression-free survival at 24 weeks. pharmacokinetics: Selected PK parameters such as Cmax, Tmax, AUC () - t), AUC (TAU) will be determined in two cycles depending on the scheduling of mono- or combination therapy. Parameters such as Ctau, CLT, Css-avg, accumulation index (AI), and effective elimination half-life (THALFeff) will be assessed in the second cycle when intensive PK are collected. A separate listing, summary, and plot will be generated for Ctrough. immunogenicity: This consists of collection of serum samples to the development of specific antibodies (ADA's) in response to research tool (s) to evaluate BMS-986 178 and nivolumab or ipilimumab. Blood samples will be collected at several intervals. Exploratory biomarkers: Overall survival rate will be determined at a fixed time and the number of patients who are still alive at that time. Overall survival is defined as the time between the first dose and date of death from any cause. Analyses of biomarkers of samples obtained at baseline and during treatment from peripheral blood, serum and tumour biopsy to study markers of pharmacodynamics. Additional research is to investigate the hypothesis related to mechanisms, biomarkers for safety and biomarkers that predict what the response will be to treatment with BMS-986 178 as monotherapy or in combination with nivolumab and/ or ipilimumab. | — |
Countries
Netherlands
Outcome results
None listed