NCT04817254

Association of Peripheral Blood Immunologic Response to Therapeutic Response to Adjuvant Treatment With Immune Checkpoint Inhibition (ICI) in Patients With Newly Diagnosed Glioblastoma or Gliosarcoma

Completed Phase 2 Last updated 17 April 2026

What this trial tests

Phase 2 trial testing TMZ in Glioblastoma in 47 participants. Completed in 20 March 2026.

Timeline

8 December 2021

Primary endpoint
20 March 2026

20 March 2026

Quick facts

Lead sponsor	National Cancer Institute (NCI)
Phase	Phase 2
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	47
Start date	8 December 2021
Primary completion	20 March 2026
Estimated completion	20 March 2026
Sites	1 location across United States

Drugs / interventions tested

• TMZ — full drug profile →
• ipilimumab 3mg/kg — full drug profile →
• Nivolumab (nivolumab) — full drug profile →
• ipilimumab 1mg/kg — full drug profile →

Conditions studied

• Glioblastoma — all drugs for Glioblastoma →
• Gliosarcoma — all drugs for Gliosarcoma →
• Malignant Glioma — all drugs for Malignant Glioma →

Sponsor

National Cancer Institute (NCI)

Who can join

18 and older, any sex, with Glioblastoma or Gliosarcoma. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Background:

Glioblastoma (GBM) is a type of malignant glioma. These cancers are nearly always fatal. People who develop these cancers get aggressive treatments. But the tumors almost always recur. Researchers want to study people with newly diagnosed disease to learn more.

Objective:

To study people with newly diagnosed GBM or gliosarcoma to look at the changes in immune cells in the blood of those who take ipilimumab and nivolumab, along with temozolomide.

Eligibility:

Adults ages 18 and older with newly diagnosed GBM or gliosarcoma, who have had surgical removal of their tumor and have completed standard initial chemotherapy and radiation therapy.

Design:

Participants will be screened with the following:

Medical record review

Medical history

Physical exam

Tests to assess their nervous system and their ability to do typical activities

Blood tests

Tumor assessment. For this, they will have magnetic resonance imaging (MRI). They may get a contrast dye through an intravenous (IV) catheter. The MRI scanner makes noise. They will get earplugs.

Electrocardiogram. It measures heart rate and rhythm. They will lie still. Sticky pads will be placed on their chest, arms, and legs.

Screening tests will be repeated during the study.

Treatment will be given in cycles. Each cycle lasts 4 weeks. Participants will get nivolumab and ipilimumab via IV. They will take temozolomide by mouth. They will keep a pill diary.

Participants will fill out surveys about their symptoms.

Participants will have follow-up visits about 60 days and 100 days after treatment ends. Then they will be contacted every 6 months for the rest of their life.

Publications & conference data

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

1. 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
2. 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
3. T cell exhaustion in malignant gliomas.
   Watowich MB, Gilbert MR, Larion M. · · 2023 · cited 84× · PMID 36681605 · DOI 10.1016/j.trecan.2022.12.008
4. Translational landscape of glioblastoma immunotherapy for physicians: guiding clinical practice with basic scientific evidence.
   Kreatsoulas D, Bolyard C, Wu BX, Cam H, et al · · 2022 · cited 53× · PMID 35690784 · DOI 10.1186/s13045-022-01298-0
5. Signaling pathways in brain tumors and therapeutic interventions.
   Li S, Wang C, Chen J, Lan Y, et al · · 2023 · cited 51× · PMID 36596785 · DOI 10.1038/s41392-022-01260-z
6. Dosing Regimens of Immune Checkpoint Inhibitors: Attempts at Lower Dose, Less Frequency, Shorter Course.
   Jiang M, Hu Y, Lin G, Chen C. · · 2022 · cited 36× · PMID 35795044 · DOI 10.3389/fonc.2022.906251
7. 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
8. Immune checkpoint inhibitors for glioblastoma: emerging science, clinical advances, and future directions.
   Badani A, Ozair A, Khasraw M, Woodworth GF, et al · · 2025 · cited 12× · PMID 39570554 · DOI 10.1007/s11060-024-04881-2