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A Study Assessing if it is Safe and Possible to Treat Brain Cancer Patients With Immunotherapy Before They Receive the Standard Treatment.

Study Purpose

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 control the patient's disease.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Interventional
Eligible Ages 18 Years and Over
Gender All
More Inclusion & Exclusion Criteria

Inclusion Criteria:

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.

Exclusion Criteria:

1. Known extracranial metastatic or leptomeningeal disease. 2. Prior treatment for glioblastoma other than a biopsy or limited resection leaving residual disease. 3. Dexamethasone dose >3mg daily (or equivalent) at the time of starting study treatment. 4. Antibiotics received within 30 days prior to starting study treatment, except for prophylactic antibiotics given with surgery. 5. Intratumoural or peritumoural haemorrhage deemed significant by the treating clinician. 6. Active autoimmune disease apart from: 1. Skin conditions such as psoriasis, vitiligo or alopecia not requiring systemic treatment. 2. Type 1 diabetes or thyroid disease, controlled on medication. 7. Any evidence of severe or uncontrolled diseases (e.g. unstable or uncompensated respiratory, cardiac, hepatic or renal disease) 8. Known hypersensitivity to ipilimumab or any of its excipients. 9. Past medical history of interstitial lung disease, idiopathic pulmonary fibrosis, drug-induced interstitial disease which required steroid treatment or any evidence of clinically active interstitial lung disease. 10. Any condition requiring systemic treatment with corticosteroids (>10mg prednisolone daily or equivalent) or other immunosuppressive medications within 14 days prior to starting study treatment. Inhaled or topical steroids, and adrenal replacement steroid doses > 10mg daily prednisolone or equivalent are permitted in the absence of active autoimmune disease. 11. Treatment with any other investigational agent within 28 days or 5 half lives of the investigational agent (whichever is longer) prior to starting ipilimumab treatment. 12. History of previous cancer within 5 years, with the exception of adequately treated cone-biopsied in situ carcinoma of the cervix uteri and non-melanoma skin lesions. 13. Positive serology for Hepatitis B defined as a positive test for HepB surface antigen (HBsAg). Note: patients who are HepB core antibody (HBcAb) positive will only be eligible for the study if the HepB virus deocyribonucleic acid (DNA) test is negative and patients are willing to undergo monthly monitoring for HBV reactivation. 14. Positive serology for Hepatitis C defined as a positive test for HCV antibody. 15. Diagnosis of prior immunodeficiency or organ-transplant requiring immunosuppressive therapy or known HIV or acquired immunodeficiency syndrome (AIDS)-related illness. 16. History or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the study, interfere with the subject's participation for the full duration of the study, or is not in the best interest of the subject to participate, in the opinion of the treating investigator. 17. Women who are pregnant or breast feeding

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT07134842
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

Phase 1
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

University College, London
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

Paul Mulholland, MBBS, PhD
Principal Investigator Affiliation University College, London
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Other
Overall Status Recruiting
Countries United Kingdom
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Glioblastoma, Gliosarcoma, Adult, Glioblastoma - Category
Arms & Interventions

Arms

Experimental: Interventional

All patients will be treated with up to two cycles of ipilimumab prior to their standard treatment. Each cycle will last 21 days.

Interventions

Biological: - Ipilimumab (3 mg/kg)

All participants will be treated with ipilimumab (3mg/kg) for up to 2 cycles. Each cycle will last 21 days with participants receiving ipilimumab on the 1st day of the cycle.

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

International Sites

University College London Hospital, London 2643743, Greater London, United Kingdom

Status

Recruiting

Address

University College London Hospital

London 2643743, Greater London, NW1 2PG

Site Contact

Hasina Mangal

[email protected]

020 3447 2929

Nearest Location

Site Contact

Hasina Mangal

[email protected]

020 3447 2929


Resources

  • Patient and Caregiver Survey
  • Clinical Trial Endpoints
  • Research Resources
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The content provided on clinical trials is for informational purposes only and is not a substitute for medical consultation with your healthcare provider. We do not recommend or endorse any specific study and you are advised to discuss the information shown with your healthcare provider. While we believe the information presented on this website to be accurate at the time of writing, we do not guarantee that its contents are correct, complete, or applicable to any particular individual situation. We strongly encourage individuals to seek out appropriate medical advice and treatment from their physicians. We cannot guarantee the availability of any clinical trial listed and will not be responsible if you are considered ineligible to participate in a given clinical trial. We are also not liable for any injury arising as a result of participation.

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