A Phase 1/2a Dose Escalation and Cohort Expansion Study of the Safety, Tolerability, and Efficacy of Anti-LAG-3 Monoclonal Antibody (BMS-986016) Administered Alone and in Combination with Anti-PD-1 Monoclonal Antibody (Nivolumab, BMS-936558) in Advanced Solid Tumors

Phase 2

Recruiting

Conditions: Patients with Advanced Solid Tumors (see protocol for tumor types)
advanced solid tumors
cancer

Registration Number: NL-OMON54526

Lead Sponsor: Bristol-Myers Squibb

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Recruiting

Sex: Not specified

Target Recruitment: 26

Inclusion Criteria

-For Dose escalation: subjects with cervical, ovarian, bladder and CRC, head
and neck, gastric and hepatocellular cancer naive to immuno-oncology agents;
1st line melanoma and NSCLC; NSCLC progressing while on or after therapy with
anti-PD1/anti-PDL-1 and melanoma subjects progressed while-on or after
treatment with anti-PD1 or anti-PDL1 with/out anti-CTLA-4.
-For Dose Expansion: all of the above in escalation except for cervical,
ovarian bladder and CRC
-Progressed, or been intolerant to, at least one standard treatment regimen
-Received any number of prior treatment regimens
-ECOG performance status of 0 or 1
-At least 1 lesion with measurable disease at baseline
-Availability of an existing tumor biopsy sample (or consent to allow
pre-treatment tumor biopsy if sample not available

Exclusion Criteria

- Primary CNS tumors or solid tumors with CNS metastases as the only site of
active disease, - Autoimmune disease, - Encephalitis, meningitis, or
uncontrolled seizures in the year prior to informed consent, - Uncontrolled CNS
metastases

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Primary Endpoint:<br /><br><br /><br>The primary endpoint of this Phase 1/2a study is safety as measured by the rate<br /><br>of AEs, serious adverse events (SAEs), deaths, and laboratory abnormalities,<br /><br>assessed during treatment and for up to for 135 days after the last treatment.<br /><br>All subjects who receive at least one dose of BMS-986016 or nivolumab will be<br /><br>analyzed for safety.</p><br>

Secondary Outcome Measures