NCT04195139 (NUTMEG) is a Phase 2 clinical trial of Nivolumab in Glioblastoma Multiforme, sponsored by University of Sydney.

Who is sponsoring NCT04195139?

NCT04195139 is sponsored by University of Sydney.

What drugs are being tested in NCT04195139?

Interventions in NCT04195139: Nivolumab, Temozolomide.

What condition does NCT04195139 study?

NCT04195139 studies Glioblastoma Multiforme.

Is NCT04195139 still recruiting?

NCT04195139 is currently active, enrolled. Last updated 11 December 2024.

Last reviewed 2024-12-11 · How we verify

NCT04195139: NUTMEG

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

Nivolumab and Temozolomide Versus Temozolomide Alone in Newly Diagnosed Elderly Patients With GBM

Active, enrolled Phase 2 Last updated 11 December 2024

What this trial tests

Phase 2 trial testing Nivolumab in Glioblastoma Multiforme in 103 participants. Participants enrolled and being followed up; not accepting new ones.

Timeline

22 February 2018

Primary endpoint
28 June 2024

31 December 2025

Quick facts

Lead sponsor	University of Sydney
Phase	Phase 2
Status	Active, enrolled
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	103
Start date	22 February 2018
Primary completion	28 June 2024
Estimated completion	31 December 2025
Sites	20 locations across United States, Australia

Drugs / interventions tested

Nivolumab (nivolumab) — full drug profile →
Temozolomide (temozolomide) — full drug profile →

Conditions studied

Glioblastoma Multiforme — all drugs for Glioblastoma Multiforme →

Sponsor

University of Sydney

Who can join

65 and older, any sex, with Glioblastoma Multiforme. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

This study aims to investigate effect of Nivolumab and Temozolomide vs Temozolomide alone on overall survival in newly diagnosed elderly patients with glioblastoma. Who is it for? You may be eligible to join this study if you are aged 65 years or above, with newly diagnosed histologically confirmed GBM (WHO grade IV glioma including gliosarcoma) following surgery. The study aims to evaluate whether the combination of adjuvant nivolumab with temozolomide improves overall survival outcomes for this patient population. The outcome of the study will help determine the most effective treatment for patients with glioblastoma in the future.

Publications & conference data

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

Immunotherapy: a promising approach for glioma treatment.
Yasinjan F, Xing Y, Geng H, Guo R, et al · · 2023 · cited 156× · PMID 37744349 · DOI 10.3389/fimmu.2023.1255611
Glioblastoma at the crossroads: current understanding and future therapeutic horizons.
Singh S, Dey D, Barik D, Mohapatra I, et al · · 2025 · cited 91× · PMID 40628732 · DOI 10.1038/s41392-025-02299-4
Pathogenetic Features and Current Management of Glioblastoma.
Nguyen HM, Guz-Montgomery K, Lowe DB, Saha D. · · 2021 · cited 42× · PMID 33670551 · DOI 10.3390/cancers13040856
Immunotherapeutic Strategies for the Treatment of Glioblastoma: Current Challenges and Future Perspectives.
Salvato I, Marchini A. · · 2024 · cited 32× · PMID 38610954 · DOI 10.3390/cancers16071276
Immunotherapy for Glioblastoma: Current State, Challenges, and Future Perspectives.
Yang M, Oh IY, Mahanty A, Jin WL, et al · · 2020 · cited 31× · PMID 32824974 · DOI 10.3390/cancers12092334
Looking for the Holy Grail-Drug Candidates for Glioblastoma Multiforme Chemotherapy.
Pająk B. · · 2022 · cited 21× · PMID 35625738 · DOI 10.3390/biomedicines10051001
Advanced Age in Humans and Mouse Models of Glioblastoma Show Decreased Survival from Extratumoral Influence.
Johnson M, Bell A, Lauing KL, Ladomersky E, et al · · 2023 · cited 20× · PMID 37725593 · DOI 10.1158/1078-0432.ccr-23-0834
Exploiting Radiation Therapy to Restore Immune Reactivity of Glioblastoma.
De Martino M, Padilla O, Daviaud C, Wu CC, et al · · 2021 · cited 18× · PMID 34094969 · DOI 10.3389/fonc.2021.671044

Verify or expand the search:

Other trials of Nivolumab

Trials testing the same drug.

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NCT07383441 — Adding Biotherapy or Placebo to Standard Treatment for Advanced Kidney Cancer · Phase 3 · not yet recruiting
NCT07420439 — Treatment in Patients With Advanced Non-Small Cell Lung Carcinoma and Interstitial Lung Disease · Phase 2 · not yet recruiting
NCT07510334 — VSV-IFNβ-NIS With Ipilimumab and Nivolumab for the Treatment of Advanced or Metastatic Clear Cell Renal Cell Carcinoma · Phase 2 · not yet recruiting

Other recruiting trials for Glioblastoma Multiforme

Currently open trials in the same condition.

NCT06466031 — Application of FET-PET in Fusion With MRI in the Treatment of Glioblastoma Multiforme [TYR-GLIO] · NA · recruiting
NCT06333899 — Lorlatinib for Newly-Diagnosed High-Grade Glioma With ROS or ALK Fusion · EARLY_PHASE1 · recruiting
NCT05956821 — Treatment of Relapsed/Refractory Intracranial Glioma in Patients Under 22 Years of Age · Phase 1, PHASE2 · recruiting
NCT06496971 — A Prospective Pivotal Study to Evaluate the Efficacy and Safety of Avastin® Bevacizumab (BEV) With or Without Microbubbl · Phase 3 · recruiting
NCT06329570 — Safety and Efficacy of Bevacizumab in Combination With NaviFUS System for the Treatment of Recurrent Glioblastoma Multif · Phase 1, PHASE2 · recruiting

Other University of Sydney trials

Trials by the same sponsor.

NCT07173335 — Integrated Healthy Lifestyle and Pain Care for People With Musculoskeletal Conditions Living in Rural Areas. · NA · not yet recruiting
NCT06908486 — Cognitive Bias Modification for Interpretation (CBM-I) in People With Type 2 Diabetes and Persistent Pain · NA · recruiting
NCT06159660 — Ventilation Using Radiographic Examination: Functional Lung Imaging Techniques for the Reduction of Toxicity in Function · not yet recruiting
NCT05568381 — Sleep Disturbance in MCI: A Study of a Cognitive Behavioural Therapy Digital Intervention · NA · completed
NCT05184790 — LEARN: Learning Environment for Artificial Intelligence in Radiotherapy New Technology · 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 NCT04195139 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 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 University of Sydney
Last refreshed: 11 December 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/NCT04195139.

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