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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03335540
Recruitment Status : Active, not recruiting
First Posted : November 7, 2017
Last Update Posted : April 13, 2022
Sponsor:
Information provided by (Responsible Party):
Bristol-Myers Squibb

Study Description
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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.

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 Design
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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
Arms and Interventions
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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:
  • BMS-986227
  • FPA008
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


Outcome Measures
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Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. Percent of change from baseline in histopathologic features [ Time Frame: Up to 4 years ]
  2. Percent of change from baseline in biomarker expression patterns [ Time Frame: Up to 4 years ]
  3. Number of Adverse Events (AEs) [ Time Frame: Up to 4 years ]
  4. Number of Serious Adverse Events (SAEs) [ Time Frame: Up to 4 years ]
  5. 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

  6. Number of Adverse Events(AEs) leadind to discontinutaion [ Time Frame: up to 4 years ]
    Number of Adverse Events leadind to discontinutaion

  7. Number of Deaths [ Time Frame: up to 4 years ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Contacts and Locations
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Information from the National Library of Medicine

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


Locations
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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
Sponsors and Collaborators
Bristol-Myers Squibb
Investigators
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Study Director: Bristol-Myers Squibb Bristol-Myers Squibb
More Information
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Additional Information:

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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

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Nivolumab
Ipilimumab
Linrodostat
Antineoplastic Agents, Immunological
 Antineoplastic Agents
Immune Checkpoint Inhibitors
Molecular Mechanisms of Pharmacological Action
Enzyme Inhibitors