NCT03525925 is a Phase 1 clinical trial of Ibrutinib in Metastatic Malignant Solid Neoplasm, sponsored by Ohio State University Comprehensive Cancer Center.

Who is sponsoring NCT03525925?

NCT03525925 is sponsored by Ohio State University Comprehensive Cancer Center.

What drugs are being tested in NCT03525925?

Interventions in NCT03525925: Ibrutinib, Laboratory Biomarker Analysis, Nivolumab.

What condition does NCT03525925 study?

NCT03525925 studies Metastatic Malignant Solid Neoplasm.

Is NCT03525925 still recruiting?

NCT03525925 is currently completed. Last updated 18 March 2024.

Last reviewed 2024-03-18 · How we verify

NCT03525925

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

Ibrutinib and Nivolumab in Treating Participants With Metastatic Solid Tumors

Completed Phase 1 Last updated 18 March 2024

What this trial tests

Phase 1 trial testing Ibrutinib in Metastatic Malignant Solid Neoplasm in 16 participants. Completed in 31 July 2022.

Timeline

18 July 2018

Primary endpoint
20 February 2020

31 July 2022

Quick facts

Lead sponsor	Ohio State University Comprehensive Cancer Center
Phase	Phase 1
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	16
Start date	18 July 2018
Primary completion	20 February 2020
Estimated completion	31 July 2022
Sites	1 location across United States

Drugs / interventions tested

Ibrutinib (ibrutinib) — full drug profile →
Laboratory Biomarker Analysis — full drug profile →
Nivolumab (nivolumab) — full drug profile →

Conditions studied

Metastatic Malignant Solid Neoplasm — all drugs for Metastatic Malignant Solid Neoplasm →

Sponsor

Ohio State University Comprehensive Cancer Center

Who can join

Eligibility, any sex, with Metastatic Malignant Solid Neoplasm. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

This phase I trial studies how well ibrutinib and nivolumab work in treating participants with solid tumors that have spread to other places in the body. Ibrutinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Monoclonal antibodies, such as nivolumab, may interfere with the ability of tumor cells to grow and spread. Giving ibrutinib and nivolumab may work better in treating participants with solid tumors.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

Myeloid-derived suppressor cells as immunosuppressive regulators and therapeutic targets in cancer.
Li K, Shi H, Zhang B, Ou X, et al · · 2021 · cited 687× · PMID 34620838 · DOI 10.1038/s41392-021-00670-9
Immunosuppressive cells in cancer: mechanisms and potential therapeutic targets.
Tie Y, Tang F, Wei YQ, Wei XW. · · 2022 · cited 386× · PMID 35585567 · DOI 10.1186/s13045-022-01282-8
Understanding the immunosuppressive microenvironment of glioma: mechanistic insights and clinical perspectives.
Lin H, Liu C, Hu A, Zhang D, et al · · 2024 · cited 232× · PMID 38720342 · DOI 10.1186/s13045-024-01544-7
Pre-metastatic niche: formation, characteristics and therapeutic implication.
Wang Y, Jia J, Wang F, Fang Y, et al · · 2024 · cited 143× · PMID 39317708 · DOI 10.1038/s41392-024-01937-7
Friend or Foe? Recent Strategies to Target Myeloid Cells in Cancer.
Chaib M, Chauhan SC, Makowski L. · · 2020 · cited 53× · PMID 32509781 · DOI 10.3389/fcell.2020.00351
Metabolic Regulation of Myeloid-Derived Suppressor Cell Function in Cancer.
Wang Y, Jia A, Bi Y, Wang Y, et al · · 2020 · cited 46× · PMID 32325683 · DOI 10.3390/cells9041011
The emerging role of myeloid-derived suppressor cells in radiotherapy.
Kang C, Jeong SY, Song SY, Choi EK. · · 2020 · cited 46× · PMID 32229803 · DOI 10.3857/roj.2019.00640
Granulocytic Myeloid-Derived Suppressor Cells as Negative Regulators of Anticancer Immunity.
Kramer ED, Abrams SI. · · 2020 · cited 42× · PMID 32983128 · DOI 10.3389/fimmu.2020.01963

Verify or expand the search:

Other trials of Ibrutinib

Trials testing the same drug.

NCT07377578 — A Study of Rocbrutinib Versus Investigator's Choice of BTK Inhibitors in Patients With Relapsed or Refractory Mantle Cel · Phase 3 · recruiting
NCT07052695 — Mosunetuzumab for CLL MRD Clearance · Phase 1, PHASE2 · recruiting
NCT06649812 — Testing the Effectiveness of a Combination Targeted Therapy (ViPOR) for Patients With Relapsed and/or Refractory Aggress · Phase 2 · recruiting
NCT07169565 — Ibrutinib Followed by BR (Bendamustine and Rituximab) as a Time-Limited Therapy for Waldenström Macroglobulinemia · Phase 1 · not yet recruiting
NCT06357676 — Glofitamab Plus Ibrutinib With Obinutuzumab for the Treatment of Patients With Mantle Cell Lymphoma, IGNITE MCL Trial · Phase 1, PHASE2 · recruiting

Other recruiting trials for Metastatic Malignant Solid Neoplasm

Currently open trials in the same condition.

NCT07137416 — Testing the Safety of the Combination of Anti-Cancer Drugs CX-5461 (Pidnarulex) and Trastuzumab Deruxtecan (T-DXd) for H · Phase 1 · recruiting
NCT07336238 — Group Retreat Psilocybin Therapy for the Treatment of Anxiety and Depression in Patients With Metastatic Solid Tumors or · Phase 2 · recruiting
NCT06911008 — MTI-301 for the Treatment of Metastatic or Unresectable and Refractory Solid Cancers · Phase 1 · recruiting
NCT07189195 — TR-002 for the Treatment of Advanced, Unresectable or Metastatic Solid Tumors and Unresectable or Metastatic, Refractory · Phase 1 · recruiting
NCT06942104 — Imaging of Solid Tumors Using 18F-TRX · Phase 1 · recruiting

Other Ohio State University Comprehensive Cancer Center trials

Trials by the same sponsor.

NCT06816979 — Lumbar Punctures for the Detection of ctDNA in the Cerebrospinal Fluid of Patients With Stage III and IV Non-Small Cell · NA · not yet recruiting
NCT07529483 — Endoscopic Ultrasound-Guided Chemoablation for the Treatment of Pancreatic Cysts · Phase 2 · not yet recruiting
NCT07455513 — A Novel Tobacco Cessation Resource for Smokers With a Diagnosed or Suspected Thoracic Cancer · NA · not yet recruiting
NCT07217990 — Neoadjuvant Complete Response Customized Treatment Approach for Definitive Management of Breast Cancer · Phase 1, PHASE2 · not yet recruiting
NCT07503925 — THRIVE Study: Understanding How Oral Nicotine Pouches Affect Public Health · Phase 4 · not yet recruiting

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT03525925 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 9 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Ohio State University Comprehensive Cancer Center
Last refreshed: 18 March 2024

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03525925.

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