An Investigational Immuno-therapy Study of Experimental Medication BMS-986156, Given by Itself or in Combination With Nivolumab in Patients With Solid Cancers or Cancers That Have Spread.

Study at a glance

From the registry record, last updated by the sponsor on 6 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title

A Phase 1/2a Dose Escalation and Cohort Expansion Study for Safety, Tolerability, and Efficacy of BMS-986156 Administered Alone and in Combination With Nivolumab (BMS-936558, Anti PD-1 Monoclonal Antibody) in Advanced Solid Tumors

ClinicalTrials.gov ID

NCT02598960

Acronym / sponsor ID

CA009-002

Conditions

Solid Tumors

Phase

Phase 1/2

Study type

Interventional

Recruitment status

Completed

Enrolment

295 participants (actual)

Lead sponsor

Bristol-Myers SquibbIndustry (pharma, biotech, devices)

Study start

14 Oct 2015 (actual)

Primary completion

16 Dec 2019 (actual)

Study completion

16 Dec 2019 (actual)

First posted

6 Nov 2015 (estimated)

Results

Posted 6 Mar 2023

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose

Treatment

Allocation

Non-randomised

Intervention model

Parallel groups

Masking

None (open label)

Number of arms

5

Who may qualify

Ages

18 years and older

Sex

All

Healthy volunteers

Not accepted

Age groups

Adult, Older adult

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Primary outcome

1. Number of Participants With All Cause Adverse Events (AEs), Serious Adverse Events, AEs Leading to Discontinuation and Deaths

   Time frame: From first treatment to 100 days post last dose. Approximately 29 months

   Number of participants with all cause adverse events (AEs), serious adverse events (SAEs), adverse events leading to discontinuation, and number of participant deaths. AEs and laboratory values will be graded according to the NCI CTCAE version 4.03.

2. Number of Participants With Laboratory Abnormalities in Specific Thyroid Tests

   Time frame: From first treatment to 100 days post last dose. Approximately 29 months

   Number of Participants with laboratory abnormalities in specific thyroid tests. TSH = Thyroid stimulating hormone ULN = Upper limit number LLN = Lower limit number

3. Number of Participants With Laboratory Abnormalities in Specific Liver Tests

   Time frame: From first treatment to 100 days post last dose. Approximately 29 months

   Number of Participants with laboratory abnormalities in specific liver tests. ALT = alanine aminotransferase AST = aspartate aminotransferase ALP = alkaline phosphatase

Results and safety

Loading the posted results from ClinicalTrials.gov…

Research links

• Official record on ClinicalTrials.govLast updated by the sponsor 6 Mar 2023.
• Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
• Derived from this study: PubMed 36863094Wang R, Baxi V, Li Z, Locke D, Hedvat C, Sun Y, Walsh AM, Shao X, Basavanhally T, Greenawalt DM, Patah P, Novosiadly R. Pharmacodynamic activity of BMS-986156, a glucocorticoid-induced TNF receptor-related protein agonist, alone or in combination with nivolumab in patients with advanced solid tumors. ESMO Open. 2023 Apr;8(2):100784. doi: 10.1016/j.esmoop.2023.100784. Epub 2023 Feb 28.
• Derived from this study: PubMed 31697308Heinhuis KM, Carlino M, Joerger M, Di Nicola M, Meniawy T, Rottey S, Moreno V, Gazzah A, Delord JP, Paz-Ares L, Britschgi C, Schilder RJ, O'Byrne K, Curigliano G, Romano E, Patah P, Wang R, Liu Y, Bajaj G, Siu LL. Safety, Tolerability, and Potential Clinical Activity of a Glucocorticoid-Induced TNF Receptor-Related Protein Agonist Alone or in Combination With Nivolumab for Patients With Advanced Solid Tumors: A Phase 1/2a Dose-Escalation and Cohort-Expansion Clinical Trial. JAMA Oncol. 2020 Jan 1;6(1):100-107. doi: 10.1001/jamaoncol.2019.3848.
• BMS Clinical Trial InformationLink provided by the sponsor.
• BMS Clinical Trial Patient RecruitingLink provided by the sponsor.
• Investigator Inquiry FormLink provided by the sponsor.
• FDA Safety Alerts and RecallsLink provided by the sponsor.

Related trials for Solid Tumors

• RecruitingPhase 1/2

  Study of INBRX-106 and INBRX-106 in Combination With Pembrolizumab (Keytruda®) in Subjects With Locally Advanced or Metastatic Solid Tumors (Hexavalent OX40 Agonist)

  Solid Tumor, Non-Small Cell Lung Cancer

• Active, not recruitingPhase 1

  A Study to Assess Safety, Tolerability, and Pharmacokinetics of ABSK043 in Patients With Advanced Solid Tumor

  Neoplasms

• Active, not recruitingPhase 3

  A Safety and Efficacy Extension Study of Pertuzumab in Patients With Solid Tumors Previously Enrolled in a Hoffmann-La Roche-Sponsored Pertuzumab Clinical Trial

  Solid Tumors

• RecruitingPhase 1

  IL-12 Genetically Engineered Myeloid Cells in Participants With Relapsed, Refractory Solid Tumors

  Relapsed Solid Tumor Malignancies, Refractory Solid Tumor Malignancies

• RecruitingObservational study

  Immune Checkpoint Inhibitor Toxicity Risk Prediction in Solid Tumors

  Malignant Solid Neoplasm

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

27 sites in 10 countries: see every site and its status.