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At Bolder Science, we want your clinical trial search experience to be the best it can be. Complete the following prompts to easily find the trials you are interested in and see trials recruiting near you. You can adjust these selections in your dashboard after creating your account.

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Clinical Trials of Interest

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

  • Clinicaltrials.gov identifier

    NCT03335540

  • Recruitment Status

    Recruiting

  • First Posted

    November 7, 2017

  • Last update posted

    May 18, 2020

Study Description

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:Advanced Cancer
  • Intervention/Treatment: Biological: Nivolumab
    Biological: Relatlimab
    Biological: Cabiralizumab
    Biological: Ipilimumab
    Drug: IDO1 Inhibitor
    Radiation: Radiation Therapy
  • Phase: Phase 1

Detailed Description

N/A

Study Design

  • Study Type: Interventional
  • 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 2018
  • Estimated Primary Completion Date: March 2021
  • Estimated Study Completion Date: April 2022

Arms and interventions

Arm Intervention/treatment
Experimental: Arm B
Combination therapy determined by biomarker assessment
Biological: Nivolumab
Specified dose on specified day

Biological: Relatlimab
Specified dose on specified day
Experimental: Arm C
Combination therapy determined by biomarker assessment
Biological: Nivolumab
Specified dose on specified day

Biological: Cabiralizumab
Specified dose on specified day
Experimental: Arm D
Combination therapy determined by biomarker assessment
Biological: Nivolumab
Specified dose on specified day

Biological: Ipilimumab
Specified dose on specified day
Experimental: Arm F
Combination therapy determined by biomarker assessment
Biological: Nivolumab
Specified dose on specified day

Drug: IDO1 Inhibitor
Specified dose on specified day
Experimental: Arm G
Combination therapy determined by biomarker assessment
Biological: Nivolumab
Specified dose on specified day

Radiation: Radiation Therapy
Specified dose on specified day

Outcome Measures

  • 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

  • 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

Contacts

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

United States, Illinois
The University of Chicago Medicine
Chicago

United States, Illinois
University of Chicago
Chicago

United States, Maryland
Sidney Kimmel Can. Ctr
Baltimore

United States, Pennsylvania
Upmc Hillman Cancer Center
Pittsburgh

Sponsors and Collaborators

Bristol-Myers Squibb

Investigators

Study Director: Bristol-Myers Squibb Bristol-Myers Squibb

Principal Investigator: Jason J. Luke, MD, FACP The University of Pittsburgh Medical Center

More Information

  • Responsible Party: Bristol-Myers Squibb
  • ClinicalTrials.gov Identifier: NCT03335540 History of Changes
  • Other Study ID Numbers: CA028-001
  • First Posted: November 7, 2017 Key Record Dates
  • Last Update Posted: May 18, 2020
  • Last Verified: May 2020
  • Studies a U.S. FDA-regulated Drug Product: Yes
  • Studies a U.S. FDA-regulated Device Product: No