Phase 2 Brain Cancer Trial, Recruiting NCT06069726 Sponsor: Duke University Condition: Brain Cancer
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Phase 2 Brain Cancer Trial, Recruiting

NCT06069726
Recruiting Phase 2

Who may be able to join

AI generated eligibility summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI

Who might be able to join this trial:

  • You are 18 years of age or older
  • You have been diagnosed with a specific type of brain tumour called glioblastoma (GBM, IDH-wildtype), confirmed by a tissue test
  • Your brain tumour has come back for the first or second time after you received radiation therapy and a chemotherapy drug called temozolomide (TMZ)
  • Tissue samples from your original tumour diagnosis are available for testing
  • Your blood counts and organ function (kidneys, liver, and blood clotting) are within acceptable ranges, as measured by blood tests (confirm with trial site)
  • You are well enough to carry out most daily activities, as measured by a standard health scale called the Karnofsky Performance Status (confirm with trial site)
  • You are not able to become pregnant, or you agree to use an approved and reliable form of contraception during the trial and for 5 months after your last dose of treatment
  • You are able to read, understand, and sign a consent form agreeing to take part in the study
  • You have tested negative for HIV, or if positive, your HIV is well controlled with medication, with a CD4 count above 200 and an undetectable viral load
  • You have tested negative for active Hepatitis B infection (based on specific blood tests)
  • You have tested negative for active Hepatitis C infection (based on specific blood tests)

Who may not be able to join:

  • You are currently pregnant, breastfeeding, or planning to become pregnant during the trial or within 5 months of your last dose of treatment
  • You have previously received any form of immunotherapy treatment
  • You received a drug called bevacizumab within 4 weeks before your biopsy
  • You have taken immune-suppressing medications (such as steroids above a low dose, or certain other drugs) within the past 2 weeks, or are expected to need them during the trial — with some exceptions for certain low-dose or short-term uses (confirm with trial site)
  • You have had a severe allergic reaction to certain types of laboratory-made antibody treatments in the past
  • You have a known allergy to any ingredient in the study drug (atezolizumab), including products derived from Chinese hamster ovary cells
  • You have an active autoimmune disease or immune deficiency — though some conditions such as well-controlled thyroid problems, Type 1 diabetes on insulin, or mild skin conditions may still be eligible (confirm with trial site)
  • It has been fewer than 12 weeks since you finished radiation therapy, unless your tumour is clearly growing (confirm with trial site)
  • You have a medical reason that makes surgery unsafe for you
  • You have had a significant heart problem, heart attack, or stroke within the past 3 months, or you have an unstable heart condition
  • You have had major surgery (not including a diagnostic biopsy) within the past 4 weeks, or are expected to need major surgery during the trial
  • You have had another cancer diagnosed within the past 12 months, with some exceptions for certain low-risk or well-treated cancers (confirm with trial site)
  • You had a serious infection within the past 4 weeks, or currently have an active infection
  • You have received a live vaccine within the past 4 weeks, or expect to need one during the trial or within 5 months of your last dose
  • You have taken part in another experimental treatment study within the past 28 days
  • You have previously received certain types of immunotherapy drugs, including checkpoint inhibitor treatments (such as anti-PD-1, anti-PD-L1, or anti-CTLA-4 therapies)
  • You have uncontrolled fluid build-up around your lungs, heart, or abdomen that needs to be drained frequently (more than once a month)
  • You have uncontrolled high calcium levels in your blood
  • You currently have active tuberculosis (TB)
  • You have a history of certain lung conditions, such as pulmonary fibrosis or drug-related lung inflammation, or you currently have active lung inflammation
  • You have been on antibiotic treatment (not just preventative antibiotics) within the past 2 weeks
  • You have previously had a stem cell transplant or an organ transplant from another person

Important: Always verify eligibility with the trial site directly before applying.

Based on publicly available eligibility criteria from ClinicalTrials.gov. Verify directly with the trial site before acting. This is not medical advice.

This is a simplified plain English summary of the eligibility criteria. Full criteria are set by the trial investigators and may include additional requirements not shown here. Never self-exclude from a trial based on this summary. Contact the trial site directly to confirm your eligibility.
Last synced 5 July 2026
Phase 2: approximately ~30% of drugs entering this phase reach regulatory approval, based on published industry-wide historical data. This is not specific to this trial.
Phase success rates shown are historical industry-wide averages based on published data. They are not a prediction for this specific trial or your individual situation.

Contact this trial

Principal Investigator: Mustafa Khasraw, MD, Duke University

Phone: 919 684 5301

Contact details sourced from ClinicalTrials.gov. Verify directly with the trial site before attending.

GP referral letter

Print a one-page summary to share with your doctor.

Trial details

Status
Recruiting
Phase
Phase 2
Sponsor
Registry
ClinicalTrials.gov
Start date
21 March 2024
Est. completion
1 January 2028

Where this trial is recruiting

🇺🇸 United States

Primary endpoints

Median survival within the low and high TMB groups; Median survival within the low and high TMB groups and their respective matched historical control group

Can't join this trial?

Expanded access pathways

If this trial is not available to you, other access pathways may exist. In Australia, the TGA Special Access Scheme allows access to unapproved therapeutic goods for individual patients.

TGA Special Access Scheme information

Find other recruiting trials on ClinicalTrials.gov

Data last synced from ClinicalTrials.gov: 5 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.

Trial recruitment status can change without notice between our nightly data updates. Always contact the trial site directly to confirm current recruitment status before making any decisions or travel arrangements.

View original record on ClinicalTrials.gov