A Phase 1/2a Study of BMS-986178 Administered Alone or in Combination with Nivolumab and/or Ipilimumab in Subjects with Advanced Solid Tumors
- Conditions
- During the Dose Escalation phase the following tumor histologies permitted except primary CNS tumors
- Registration Number
- NL-OMON47099
- Lead Sponsor
- Bristol-Myers Squibb
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending
- Sex
- Not specified
- Target Recruitment
- 20
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
• 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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>Safety:<br /><br>The primary endpoint of this Phase I / IIa study's safety as measured using<br /><br>extensive medical assessment of adverse events (AEs), vital signs (blood<br /><br>pressure etc), ECGs, physical examination, and clinical significant laboratory<br /><br>abnormalities. Side effects are continuously monitored during the investigation<br /><br>and 100 days after the last treatment. Reported side effects will be further<br /><br>analysed significance and clinical importance. </p><br>
- Secondary Outcome Measures
Name Time Method