Advanced CancerPhase 1ADVISENCT03335540
An Adaptive Study to Match Patients With Solid Tumors to Various Immunotherapy Combinations Based Upon a Broad Biomarker Assessment
A Phase 1 study testing Nivolumab, Relatlimab and Cabiralizumab in people with Advanced Cancer, run by Bristol-Myers Squibb at 4 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Advanced Cancer
- What is being tested?
- Nivolumab, Relatlimab and Cabiralizumab
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 4 sitesUnited States
- Study dates
- 7 May 2018to 25 Aug 2021
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
4 sites in 1 country.
United States4 sites
Local Institution - 0002
Baltimore, Maryland, 21287
Local Institution - 0001
Chicago, Illinois, 60637
University of Chicago
Chicago, Illinois, 60637
Local Institution - 0003
Pittsburgh, Pennsylvania, 15232
About this study
Official title: ADaptiVe Biomarker Trial That InformS Evolution of Therapy
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.
- Conditions
- Advanced Cancer
- Being tested
- Nivolumab, Relatlimab, Cabiralizumab, Ipilimumab, IDO1 Inhibitor
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NivolumabBiological
Also called BMS-936558
Specified dose on specified day
RelatlimabBiological
Also called BMS-986016
Specified dose on specified day
CabiralizumabBiological
Also called BMS-986227, FPA008
Specified dose on specified day
IpilimumabBiological
Also called BMS-734016
Specified dose on specified day
IDO1 InhibitorDrug
Also called BMS-986205
Specified dose on specified day
Radiation TherapyRadiation
Specified dose on specified day
| Study group | Role | What they receive |
|---|---|---|
| Arm B | Experimental | Combination therapy determined by biomarker assessment Receives: Biological: Nivolumab; Biological: Relatlimab |
| Arm C | Experimental | Combination therapy determined by biomarker assessment Receives: Biological: Nivolumab; Biological: Cabiralizumab |
| Arm D | Experimental | Combination therapy determined by biomarker assessment Receives: Biological: Nivolumab; Biological: Ipilimumab |
| Arm F | Experimental | Combination therapy determined by biomarker assessment Receives: Biological: Nivolumab; Drug: IDO1 Inhibitor |
| Arm G | Experimental | Combination therapy determined by biomarker assessment Receives: Biological: Nivolumab; Radiation: Radiation Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: Up to 28 days
Secondary outcomes (7)
Percent of change from baseline in histopathologic features
Measured: Up to 4 years
Percent of change from baseline in biomarker expression patterns
Measured: Up to 4 years
Number of Adverse Events (AEs)
Measured: Up to 4 years
Number of Serious Adverse Events (SAEs)
Measured: 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
Measured: Up to 4 years
Number of Adverse Events(AEs) leadind to discontinutaion
Number of Adverse Events leadind to discontinutaion
Measured: up to 4 years
Number of Deaths
Measured: up to 4 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Nov 2017
- Study start7 May 2018
- Primary completion31 Mar 2021
- Study completion25 Aug 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Advanced CancerStudies of the same condition, open and under way.
- More trials run by Bristol-Myers SquibbThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bristol-Myers Squibb
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Bristol-Myers Squibb, Study director, Bristol-Myers Squibb
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03335540
- Sponsor's protocol ID
- CA028-001
- Acronym
- ADVISE
- Status last verified
- Sep 2022
- First submitted
- 6 Nov 2017
- Last updated
- 26 Sep 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Publications
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.
PubMed 40389374
Study at a glance
From the registry record, last updated by the sponsor on 26 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- ADaptiVe Biomarker Trial That InformS Evolution of Therapy
- ClinicalTrials.gov ID
- NCT03335540
- Acronym / sponsor ID
- ADVISE / CA028-001
- Conditions
- Advanced Cancer
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Bristol-Myers SquibbIndustry (pharma, biotech, devices)
- Study start
- 7 May 2018 (actual)
- Primary completion
- 31 Mar 2021 (actual)
- Study completion
- 25 Aug 2021 (actual)
- First posted
- 7 Nov 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Arm B | Experimental | Biological: Nivolumab, Biological: RelatlimabCombination therapy determined by biomarker assessment |
| Arm C | Experimental | Biological: Nivolumab, Biological: CabiralizumabCombination therapy determined by biomarker assessment |
| Arm D | Experimental | Biological: Nivolumab, Biological: IpilimumabCombination therapy determined by biomarker assessment |
| Arm F | Experimental | Biological: Nivolumab, Drug: IDO1 InhibitorCombination therapy determined by biomarker assessment |
| Arm G | Experimental | Biological: Nivolumab, Radiation: Radiation TherapyCombination therapy determined by biomarker assessment |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| NivolumabAlso: BMS-936558Specified dose on specified day | Biological | Arm B, Arm C, Arm D, Arm F, Arm G |
| RelatlimabAlso: BMS-986016Specified dose on specified day | Biological | Arm B |
| CabiralizumabAlso: BMS-986227, FPA008Specified dose on specified day | Biological | Arm C |
| IpilimumabAlso: BMS-734016Specified dose on specified day | Biological | Arm D |
| IDO1 InhibitorAlso: BMS-986205Specified dose on specified day | Drug | Arm F |
| Radiation TherapySpecified dose on specified day | Radiation | Arm G |
Primary outcome
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)
7 secondary outcomes
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
Number of Adverse Events(AEs) leadind to discontinutaion
Time frame: up to 4 years
Number of Deaths
Time frame: up to 4 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Sep 2022.
- Derived from this study: PubMed 40389374Luke 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.
- BMS Clinical Trial InformationLink provided by the sponsor.
- BMS Clinical Trial Patient RecruitingLink provided by the sponsor.
- FDA Safety Alerts and RecallsLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Bristol-Myers Squibb study director
Bristol-Myers Squibb
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Nivolumab, Relatlimab and Cabiralizumab in people with Advanced Cancer, run by Bristol-Myers Squibb at 4 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Sep 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of participants with qualified tumor biopsy specimen at baseline (time frame: Up to 28 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03335540, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Sep 2022; AzTrials last refreshed its copy on 28 Oct 2026.