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CompletedNCT03335540ADVISEUpdated Sep 26, 2022

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

A Phase 1 interventional study of Nivolumab and Relatlimab in Advanced Cancer, sponsored by Bristol-Myers Squibb. Completed at 4 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2022-09-26.

Sponsored by Bristol-Myers Squibb · Phase 1, Interventional, and Treatment

Phase
Phase 1
Study type
Interventional
Enrollment
20
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Advanced Cancer
03

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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

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

04

Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
20 participants (actual)

Study arms

  • Experimental
    Arm B

    Combination therapy determined by biomarker assessment

    Biological: Nivolumab · Biological: Relatlimab

  • Experimental
    Arm C

    Combination therapy determined by biomarker assessment

    Biological: Nivolumab · Biological: Cabiralizumab

  • Experimental
    Arm D

    Combination therapy determined by biomarker assessment

    Biological: Nivolumab · Biological: Ipilimumab

  • Experimental
    Arm F

    Combination therapy determined by biomarker assessment

    Biological: Nivolumab · Drug: IDO1 Inhibitor

  • Experimental
    Arm G

    Combination therapy determined by biomarker assessment

    Biological: Nivolumab · Radiation: Radiation Therapy

Interventions

  • BiologicalNivolumab

    Specified dose on specified day

    Also known as: BMS-936558

  • BiologicalRelatlimab

    Specified dose on specified day

    Also known as: BMS-986016

  • BiologicalCabiralizumab

    Specified dose on specified day

    Also known as: BMS-986227, FPA008

  • BiologicalIpilimumab

    Specified dose on specified day

    Also known as: BMS-734016

  • DrugIDO1 Inhibitor

    Specified dose on specified day

    Also known as: BMS-986205

  • RadiationRadiation Therapy

    Specified dose on specified day

05

What researchers measure

Primary outcomes

  1. Number of participants with qualified tumor biopsy specimen at baseline

    An adequate quality tumor biopsy providing sufficient information prior to choosing a combination immunotherapy/Stereotactic Body Radiation Therapy (SBRT)

    Time frame: Up to 28 days

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

    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

    Time frame: Up to 4 years

  6. Number of Adverse Events(AEs) leadind to discontinutaion

    Number of Adverse Events leadind to discontinutaion

    Time frame: up to 4 years

  7. Number of Deaths

    Time frame: up to 4 years

06

Study locations

4 sites
  • Local Institution - 0001
    Chicago, Illinois 60637, United States
  • University of Chicago
    Chicago, Illinois 60637, United States
  • Local Institution - 0002
    Baltimore, Maryland 21287, United States
  • Local Institution - 0003
    Pittsburgh, Pennsylvania 15232, United States
07

References and documents

08

Registry details

Key details

Study ID
NCT03335540
Lead sponsor
Bristol-Myers Squibb
Responsible party
Sponsor
First posted
Nov 7, 2017
Start date
May 7, 2018
Primary completion
Mar 31, 2021
Completion
Aug 25, 2021
Last update
Sep 26, 2022

Study contacts

Bristol-Myers Squibb
study director · Bristol-Myers Squibb

Oversight

Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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