Advanced Cancer
Conditions
Brief summary
The purpose of this study is to evaluate the treatment of solid tumors with various immunotherapy combinations. The treatment will be determined based upon a broad biomarker assessment.
Interventions
BIOLOGICALNivolumab
Specified dose on specified day
BIOLOGICALRelatlimab
Specified dose on specified day
BIOLOGICALCabiralizumab
Specified dose on specified day
BIOLOGICALIpilimumab
Specified dose on specified day
DRUGIDO1 Inhibitor
Specified dose on specified day
RADIATIONRadiation Therapy
Specified dose on specified day
Sponsors
Bristol-Myers Squibb
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Participants must have an ECOG performance status of less than or equal to 1 * Participants must have had prior therapy;Participants who have received adjuvant or neoadjuvant anti-PD(L)1 therapy andprogressed within 6 months of completing therapy will be considered IO refractory. * Participants must have at least 2 lesions with measurable disease as defined by RECIST Version 1.1
Exclusion criteria
* Participants with suspected, known, or progressive CNS metastases, have untreated CNS metastases, or have the CNS as the only site of disease * Participants with carcinomatous meningitis * Participants with other active malignancy requiring concurrent intervention Other protocol defined inclusion/
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of participants with qualified tumor biopsy specimen at baseline | Up to 28 days | An adequate quality tumor biopsy providing sufficient information prior to choosing a combination immunotherapy/Stereotactic Body Radiation Therapy (SBRT) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percent of change from baseline in biomarker expression patterns | Up to 4 years | — |
| Number of Adverse Events (AEs) | Up to 4 years | — |
| Number of Serious Adverse Events (SAEs) | Up to 4 years | — |
| Percent of change from baseline in histopathologic features | Up to 4 years | — |
| Number of Adverse Events(AEs) leadind to discontinutaion | up to 4 years | Number of Adverse Events leadind to discontinutaion |
| Number of Deaths | up to 4 years | — |
| Number of Laboratory Abnormalities | Up to 4 years | Any laboratory test result that is clinically significant or meets the definition of an SAE, requires the participant to have study treatment discontinued, or receive specific corrective therapy |
Countries
United States
Outcome results
None listed