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

September 23, 2022 updated by: Bristol-Myers Squibb

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

20

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Illinois
      • Chicago, Illinois, United States, 60637
        • University of Chicago
      • Chicago, Illinois, United States, 60637
        • Local Institution - 0001
    • Maryland
      • Baltimore, Maryland, United States, 21287
        • Local Institution - 0002
    • Pennsylvania
      • Pittsburgh, Pennsylvania, United States, 15232
        • Local Institution - 0003

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Arm B
Combination therapy determined by biomarker assessment
Biological: Nivolumab
Specified dose on specified day
Other Names:
  • BMS-936558
Biological: Relatlimab
Specified dose on specified day
Other Names:
  • BMS-986016
Experimental: Arm C
Combination therapy determined by biomarker assessment
Biological: Nivolumab
Specified dose on specified day
Other Names:
  • BMS-936558
Biological: Cabiralizumab
Specified dose on specified day
Other Names:
  • FPA008
  • BMS-986227
Experimental: Arm D
Combination therapy determined by biomarker assessment
Biological: Ipilimumab
Specified dose on specified day
Other Names:
  • BMS-734016
Biological: Nivolumab
Specified dose on specified day
Other Names:
  • BMS-936558
Experimental: Arm F
Combination therapy determined by biomarker assessment
Biological: Nivolumab
Specified dose on specified day
Other Names:
  • BMS-936558
Drug: IDO1 Inhibitor
Specified dose on specified day
Other Names:
  • BMS-986205
Experimental: Arm G
Combination therapy determined by biomarker assessment
Biological: Nivolumab
Specified dose on specified day
Other Names:
  • BMS-936558
Radiation: Radiation Therapy
Specified dose on specified day

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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)
Up to 28 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percent of change from baseline in histopathologic features
Time Frame: Up to 4 years
Up to 4 years
Percent of change from baseline in biomarker expression patterns
Time Frame: Up to 4 years
Up to 4 years
Number of Adverse Events (AEs)
Time Frame: Up to 4 years
Up to 4 years
Number of Serious Adverse Events (SAEs)
Time Frame: Up to 4 years
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
Up to 4 years
Number of Adverse Events(AEs) leadind to discontinutaion
Time Frame: up to 4 years
Number of Adverse Events leadind to discontinutaion
up to 4 years
Number of Deaths
Time Frame: up to 4 years
up to 4 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Bristol-Myers Squibb

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 7, 2018

Primary Completion (Actual)

March 31, 2021

Study Completion (Actual)

August 25, 2021

Study Registration Dates

First Submitted

November 6, 2017

First Submitted That Met QC Criteria

November 6, 2017

First Posted (Actual)

November 7, 2017

Study Record Updates

Last Update Posted (Actual)

September 26, 2022

Last Update Submitted That Met QC Criteria

September 23, 2022

Last Verified

September 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CA028-001

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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