An Adaptive Study to Match Patients With Solid Tumors to Various Immunotherapy Combinations Based Upon a Broad Biomarker Assessment (ADVISE)
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ClinicalTrials.gov Identifier: NCT03335540 |
Recruitment Status :
Active, not recruiting
First Posted : November 7, 2017
Last Update Posted : April 13, 2022
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Advanced Cancer | Biological: Nivolumab Biological: Relatlimab Biological: Cabiralizumab Biological: Ipilimumab Drug: IDO1 Inhibitor Radiation: Radiation Therapy | Phase 1 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 50 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | ADaptiVe Biomarker Trial That InformS Evolution of Therapy |
Actual Study Start Date : | May 7, 2018 |
Estimated Primary Completion Date : | April 16, 2024 |
Estimated Study Completion Date : | April 16, 2024 |
Arm | Intervention/treatment |
---|---|
Experimental: Arm B
Combination therapy determined by biomarker assessment
|
Biological: Nivolumab
Specified dose on specified day
Other Name: BMS-936558 Biological: Relatlimab Specified dose on specified day
Other Name: BMS-986016 |
Experimental: Arm C
Combination therapy determined by biomarker assessment
|
Biological: Nivolumab
Specified dose on specified day
Other Name: BMS-936558 Biological: Cabiralizumab Specified dose on specified day
Other Names:
|
Experimental: Arm D
Combination therapy determined by biomarker assessment
|
Biological: Nivolumab
Specified dose on specified day
Other Name: BMS-936558 Biological: Ipilimumab Specified dose on specified day
Other Name: BMS-734016 |
Experimental: Arm F
Combination therapy determined by biomarker assessment
|
Biological: Nivolumab
Specified dose on specified day
Other Name: BMS-936558 Drug: IDO1 Inhibitor Specified dose on specified day
Other Name: BMS-986205 |
Experimental: Arm G
Combination therapy determined by biomarker assessment
|
Biological: Nivolumab
Specified dose on specified day
Other Name: BMS-936558 Radiation: Radiation Therapy Specified dose on specified day |
- 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)
- Percent of change from baseline in histopathologic features [ Time Frame: Up to 4 years ]
- Percent of change from baseline in biomarker expression patterns [ Time Frame: Up to 4 years ]
- Number of Adverse Events (AEs) [ Time Frame: Up to 4 years ]
- Number of Serious Adverse Events (SAEs) [ Time Frame: Up to 4 years ]
- Number of Laboratory Abnormalities [ Time Frame: 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
- Number of Adverse Events(AEs) leadind to discontinutaion [ Time Frame: up to 4 years ]Number of Adverse Events leadind to discontinutaion
- Number of Deaths [ Time Frame: up to 4 years ]

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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts 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/exclusion criteria could apply

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03335540
United States, Illinois | |
The University of Chicago Medicine | |
Chicago, Illinois, United States, 60637 | |
University of Chicago | |
Chicago, Illinois, United States, 60637 | |
United States, Maryland | |
John Hopkins University | |
Baltimore, Maryland, United States, 21287 | |
United States, Pennsylvania | |
UPMC Hillman Cancer Center | |
Pittsburgh, Pennsylvania, United States, 15232 |
Study Director: | Bristol-Myers Squibb | Bristol-Myers Squibb |
Responsible Party: | Bristol-Myers Squibb |
ClinicalTrials.gov Identifier: | NCT03335540 |
Other Study ID Numbers: |
CA028-001 |
First Posted: | November 7, 2017 Key Record Dates |
Last Update Posted: | April 13, 2022 |
Last Verified: | March 2022 |
Studies a U.S. FDA-regulated Drug Product: | Yes |
Studies a U.S. FDA-regulated Device Product: | No |
Nivolumab Ipilimumab Linrodostat Antineoplastic Agents, Immunological |
Antineoplastic Agents Immune Checkpoint Inhibitors Molecular Mechanisms of Pharmacological Action Enzyme Inhibitors |