An Adaptive Study to Match Patients With Solid Tumors to Various Immunotherapy Combinations Based Upon a Broad Biomarker Assessment
ADVISE
ADaptiVe Biomarker Trial That InformS Evolution of Therapy
1 other identifier
interventional
20
1 country
4
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_1
Started May 2018
Typical duration for phase_1
4 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 6, 2017
CompletedFirst Posted
Study publicly available on registry
November 7, 2017
CompletedStudy Start
First participant enrolled
May 7, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 31, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
August 25, 2021
CompletedSeptember 26, 2022
September 1, 2022
2.9 years
November 6, 2017
September 23, 2022
Conditions
Outcome Measures
Primary Outcomes (1)
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 Outcomes (7)
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
Up to 4 years
- +2 more secondary outcomes
Study Arms (5)
Arm B
EXPERIMENTALCombination therapy determined by biomarker assessment
Arm C
EXPERIMENTALCombination therapy determined by biomarker assessment
Arm D
EXPERIMENTALCombination therapy determined by biomarker assessment
Arm F
EXPERIMENTALCombination therapy determined by biomarker assessment
Arm G
EXPERIMENTALCombination therapy determined by biomarker assessment
Interventions
Specified dose on specified day
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (4)
Local Institution - 0001
Chicago, Illinois, 60637, United States
University of Chicago
Chicago, Illinois, 60637, United States
Local Institution - 0002
Baltimore, Maryland, 21287, United States
Local Institution - 0003
Pittsburgh, Pennsylvania, 15232, United States
Related Publications (1)
Luke JJ, Bever K, Hodi FS, Taube J, Massey A, Yao D, Neely J, Tam R, Lee G, Gupta A, Dutta S, Szabo P, Bao R, Reilly T. Rationale and feasibility of a rapid integral biomarker program that informs immune-oncology clinical trials: the ADVISE trial. J Immunother Cancer. 2025 May 19;13(5):e011170. doi: 10.1136/jitc-2024-011170.
PMID: 40389374DERIVED
Related Links
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Bristol-Myers Squibb
Bristol-Myers Squibb
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 6, 2017
First Posted
November 7, 2017
Study Start
May 7, 2018
Primary Completion
March 31, 2021
Study Completion
August 25, 2021
Last Updated
September 26, 2022
Record last verified: 2022-09