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OpenTrials
Completed

NCT Number: NCT03335540

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

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.

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Key information

Conditions

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Local Institution - 0001, Chicago, Illinois, United States

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Nivolumab

Biological

Specified dose on specified day

Other names: BMS-936558

Relatlimab

Biological

Specified dose on specified day

Other names: BMS-986016

Cabiralizumab

Biological

Specified dose on specified day

Other names: BMS-986227, FPA008

Ipilimumab

Biological

Specified dose on specified day

Other names: BMS-734016

IDO1 Inhibitor

Drug

Specified dose on specified day

Other names: BMS-986205

radiation therapy

Radiation

Specified dose on specified day

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Bristol-Myers Squibb

Industry

Registry information

Official study title

ADaptiVe Biomarker Trial That InformS Evolution of Therapy

Acronym: ADVISE

Important dates

Study start
2018
Primary completion
2021
Study completion
2021
First posted
Nov 7, 2017
Registry last updated
Sep 26, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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