ClinicaliQ Trial Snapshot
- A Study Assessing if it is Safe and Possible to Treat Brain Cancer Patients With Immunotherapy Before They Receive the Standard Treatment. — Recruiting • Phase I • Oncology • NCT07134842.
- What is being tested: Neoadjuvant ipilimumab (an immune checkpoint inhibitor) administered before standard surgical treatment in newly diagnosed glioblastoma patients, evaluating both safety and feasibility of this sequencing approach.
- Patient eligibility overview: Adults with newly diagnosed glioblastoma who are candidates for surgery, with adequate organ function and performance status, excluding those with prior brain cancer treatment or significant comorbidities that would contraindicate immunotherapy.
Use This Page For
- Quick orientation before opening the registry record.
- Checking recruitment status, phase and sponsor at a glance.
- Connecting this trial to nearby guidelines, Drug Science and education.
What This Trial Is Studying
WinGlio is a phase I study investigating neoadjuvant (before surgery) ipilimumab ( a type of immunotherapy drug) in patients with newly diagnosed glioblastoma (a form of brain cancer). Participants will receive up to 2 cycles of ipilimumab prior to the standard of care treatments for this patient group which can include debulking surgery and chemoradiation. The aim of giving the ipilimumab to the participants is to see if it is safe to treat patients with this condition with ipilimumab and also to see if the drug helps to reduce or…
Eligibility Snapshot
- : 1. Radiologically or histologically confirmed, newly diagnosed de-novo supratentorial glioblastoma (including gliosarcoma) 2. Age ≥18 years 3. Eastern Cooperative Oncology Group (ECOG) performance status of 0-1 (see appendix 3) 4. Clinically fit for, and appropriate to receive, neoadjuvant ipilimumab followed by standard of care treatment, based on investigator and MDT judgement 5. Adequate organ and bone marrow function: * Hb ≥9 g/dL * Neutrophils ≥1.5 x 109/L * Platelets ≥100 x 109/L * Lymphocyte count ≥1.0 x 109/L 6. Adequate renal function: • Creatinine clearance of ≥ 50mL/min calculated by Cockroft-Gault equation 7. Adequate liver function: * Bilirubin ≤ 1.5 x ULN (except for patients with known Gilbert's Syndrome who may have total bilirubin ≤ 3 x ULN) * Aspartate or alanine transferase (AST or ALT) ≤ 2.5 x ULN 8. Life expectancy of greater than 12 weeks 9. Willing to comply with the contraceptive requirements of the trial (see section 6.3.5) 10. Willing and able to comply with scheduled visits, treatment plan, laboratory tests and other study procedures 11. Written informed consent
Use the source registry for the full inclusion and exclusion criteria before discussing referral or enrolment.