ADaptiVe Biomarker Trial That InformS Evolution of Therapy
Overview
- Phase
- Phase 1
- Intervention
- Nivolumab
- Conditions
- Advanced Cancer
- Sponsor
- Bristol-Myers Squibb
- Enrollment
- 20
- Locations
- 4
- Primary Endpoint
- Number of participants with qualified tumor biopsy specimen at baseline
- Status
- Completed
- Last Updated
- 3 years ago
Overview
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.
Investigators
Eligibility Criteria
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
Arms & Interventions
Arm B
Combination therapy determined by biomarker assessment
Intervention: Nivolumab
Arm B
Combination therapy determined by biomarker assessment
Intervention: Relatlimab
Arm C
Combination therapy determined by biomarker assessment
Intervention: Nivolumab
Arm C
Combination therapy determined by biomarker assessment
Intervention: Cabiralizumab
Arm D
Combination therapy determined by biomarker assessment
Intervention: Nivolumab
Arm D
Combination therapy determined by biomarker assessment
Intervention: Ipilimumab
Arm F
Combination therapy determined by biomarker assessment
Intervention: Nivolumab
Arm F
Combination therapy determined by biomarker assessment
Intervention: IDO1 Inhibitor
Arm G
Combination therapy determined by biomarker assessment
Intervention: Nivolumab
Arm G
Combination therapy determined by biomarker assessment
Intervention: Radiation Therapy
Outcomes
Primary Outcomes
Number of participants with qualified tumor biopsy specimen at baseline
Time Frame: Up to 28 days
An adequate quality tumor biopsy providing sufficient information prior to choosing a combination immunotherapy/Stereotactic Body Radiation Therapy (SBRT)
Secondary Outcomes
- 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 Serious Adverse Events (SAEs)(Up to 4 years)
- Number of Adverse Events(AEs) leadind to discontinutaion(up to 4 years)
- Number of Adverse Events (AEs)(Up to 4 years)
- Number of Laboratory Abnormalities(Up to 4 years)
- Number of Deaths(up to 4 years)