An Investigational Immuno-therapy Study to Assess the Safety, Tolerability and Effectiveness of Anti-LAG-3 With and Without Anti-PD-1 in the Treatment of Solid Tumors
- Conditions
- eoplasms by Site
- Registration Number
- JPRN-jRCT2080223834
- Lead Sponsor
- Bristol-Myers Squibb K.K.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- completed
- Sex
- All
- Target Recruitment
- 1000
For Dose escalation: subjects with cervical, ovarian, bladder and colorectal cancer (CRC), head and neck, gastric and hepatocellular cancer naive to immuno-oncology agents; 1st line melanoma and 1st line/2nd line NSCLC; Renal Cell Carcinoma naive to IO; 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 or without anti-CTLA-4.
For Dose Expansion: all of the above in escalation except for cervical, ovarian, and CRC
Progressed, or been intolerant to, at least one standard treatment regimen, except for subjects in 1st line cohorts.
ECOG performance status of 0 or 1
At least 1 lesion with measurable disease at baseline
Availability of an existing tumor biopsy sample (and consent to allow pre-treatment tumor biopsy)
Primary central nervous system (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 safety<br>Proportion of subjects with Adverse Events (AEs) Grade 3 or higher per CTCAE v4<br>Proportion of subjects with Serious Adverse Events (SAEs) Grade 3 or higher per CTCAE v4 <br>Proportion of Deaths <br>Proportion of subjects with laboratory abnormalities<br>Objective response rate (ORR)<br>Disease control rate (DCR) <br>Duration of response (DOR) <br>Proportion of participants with AEs meeting acute safety criteria
- Secondary Outcome Measures
Name Time Method