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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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03335540
Recruitment Status : Recruiting
First Posted : November 7, 2017
Last Update Posted : October 23, 2019
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)
Estimated 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 : March 13, 2018
Estimated Primary Completion Date : April 15, 2020
Estimated Study Completion Date : April 16, 2022
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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Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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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

For more information regarding Bristol-Myers Squibb Clinical Trial participation, please visit www.BMSStudyConnect.com

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


Contacts
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Contact: Recruiting sites have contact information. Please contact the sites directly. If there is no contact information, please email: Clinical.Trials@bms.com
Contact: First line of the email MUST contain NCT # and Site #.

Locations
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United States, Illinois
The University of Chicago Medicine Active, not recruiting
Chicago, Illinois, United States, 60637
University of Chicago Recruiting
Chicago, Illinois, United States, 60637
United States, Maryland
Sidney Kimmel Can. Ctr Recruiting
Baltimore, Maryland, United States, 21231
Contact: Katherine Bever, Site 0002    410-502-5568      
United States, Pennsylvania
Upmc Hillman Cancer Center Recruiting
Pittsburgh, Pennsylvania, United States, 15232-1305
Contact: Jason Luke, Site 0003         
Sponsors and Collaborators
Bristol-Myers Squibb
Investigators
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Study Director: Bristol-Myers Squibb Bristol-Myers Squibb
Principal Investigator: Jason J. Luke, MD, FACP The University of Pittsburgh Medical Center
More Information
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Additional Information:
BMS Clinical Trial Information  This link exits the ClinicalTrials.gov site BMS Clinical Trial Patient Recruiting  This link exits the ClinicalTrials.gov site Investigator Inquiry Form  This link exits the ClinicalTrials.gov site FDA Safety Alerts and Recalls  This link exits the ClinicalTrials.gov site

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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: October 23, 2019
Last Verified: October 2019

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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
Antineoplastic Agents, Immunological
Antineoplastic Agents