An Adaptive Study to Match Patients With Solid Tumors to Various Immunotherapy Combinations Based Upon a Broad Biomarker Assessment

Study Overview
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Brief Summary
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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.

Official Title
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ADaptiVe Biomarker Trial That InformS Evolution of Therapy

Conditions
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Advanced Cancer

Intervention / Treatment
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* Biological: Nivolumab
* Biological: Relatlimab
* Biological: Cabiralizumab
* Biological: Ipilimumab
* Drug: IDO1 Inhibitor
* Radiation: Radiation Therapy


Participation Criteria
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Eligibility Criteria
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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/exclusion criteria could apply

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Arm B<br>Combination therapy determined by biomarker assessment | Biological: Nivolumab<br>* Specified dose on specified day<br>* Other names: BMS-936558;Biological: Relatlimab<br>* Specified dose on specified day<br>* Other names: BMS-986016;|
| Experimental: Arm C<br>Combination therapy determined by biomarker assessment | Biological: Nivolumab<br>* Specified dose on specified day<br>* Other names: BMS-936558;Biological: Cabiralizumab<br>* Specified dose on specified day<br>* Other names: FPA008;|
| Experimental: Arm D<br>Combination therapy determined by biomarker assessment | Biological: Nivolumab<br>* Specified dose on specified day<br>* Other names: BMS-936558;Biological: Ipilimumab<br>* Specified dose on specified day<br>* Other names: BMS-734016;|
| Experimental: Arm F<br>Combination therapy determined by biomarker assessment | Biological: Nivolumab<br>* Specified dose on specified day<br>* Other names: BMS-936558;Drug: IDO1 Inhibitor<br>* Specified dose on specified day<br>* Other names: BMS-986205;|
| Experimental: Arm G<br>Combination therapy determined by biomarker assessment | Biological: Nivolumab<br>* Specified dose on specified day<br>* Other names: BMS-936558;Radiation: Radiation Therapy<br>* Specified dose on specified day<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of participants with qualified tumor biopsy specimen at baseline | An adequate quality tumor biopsy providing sufficient information prior to choosing a combination immunotherapy/Stereotactic Body Radiation Therapy (SBRT) | Up to 28 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percent of change from baseline in histopathologic features |  | Up to 4 years | 
| 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 | 
| Number of Laboratory Abnormalities | 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 | Up to 4 years | 
| Number of Adverse Events(AEs) leadind to discontinutaion | Number of Adverse Events leadind to discontinutaion | up to 4 years | 
| Number of Deaths |  | up to 4 years |