Window Studies in Glioblastoma: A Phase I Trial Investigating Neoadjuvant Ipilimumab in Newly Diagnosed Glioblastoma

Plain English Summary

A Study Assessing if it is Safe and Possible to Treat Brain Cancer Patients With Immunotherapy Before They Receive the Standard Treatment. is a Phase 1 clinical trial sponsored by University College, London studying Glioblastoma, Gliosarcoma, Adult, Glioblastoma - Category. This trial tests if a new immunotherapy drug, ipilimumab, is safe to give to patients with newly diagnosed brain cancer (glioblastoma) before their standard treatment. It is for adults (18+) with newly diagnosed glioblastoma who are well enough to receive this treatment. Participants will receive up to two cycles of ipilimumab before surgery and standard treatments like radiation and chemotherapy. Currently, standard treatments for glioblastoma are surgery, radiation, and chemotherapy; this trial explores adding immunotherapy beforehand. The trial aims to enroll 16 participants.

Official Summary

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.

Who Can Participate

Here is what you need to know about eligibility for this trial. Adults aged 18 and older with a confirmed diagnosis of glioblastoma. Patients must be well enough to undergo treatment, with good organ and bone marrow function. Individuals with known cancer spread outside the brain or certain autoimmune conditions may not be eligible. Patients currently on high doses of steroids or other immune-suppressing medications might not qualify. This trial is studying Glioblastoma, Gliosarcoma, Adult, Glioblastoma - Category, so participants generally need a confirmed diagnosis. The trial is currently accepting new participants.

What They're Measuring

The primary outcomes measure how safe the new treatment is by tracking side effects and how well patients are doing overall at 12 months, and whether the treatment can be successfully given before sta The specific primary outcome measures are: Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability] (From trial registration to 3 months post ipilimumab administration); Overall Survival at 12 months post trial registration (From trial registration to 1 year post treatment); Feasibility of neoadjuvant ipilimumab (Upon the final patient completing treatment); Best overall objective response rate (Through study completion, an average of 14 months). These endpoints are how researchers determine whether the treatment is effective and will form the basis of any future regulatory submissions.

About This Phase

This trial is in Phase 1, the first major stage of clinical testing. Phase 1 trials typically involve 20-100 participants and focus on safety, dosage levels, and side effects. The primary goal is not to test whether the treatment works but to establish that it is safe enough for further testing. About 70% of Phase 1 drugs advance to Phase 2. If successful, the treatment will proceed to Phase 2 efficacy testing.

Why This Trial Matters

This trial matters because glioblastoma is a very aggressive brain cancer with limited treatment options, and this study explores a new approach using immunotherapy before surgery to potentially impro This research targets Glioblastoma, Gliosarcoma, Adult, Glioblastoma - Category, where improved treatment options are needed.

Investor Insight

This early-phase trial investigating a novel neoadjuvant immunotherapy for glioblastoma signals potential innovation in a challenging oncology market, with success potentially paving the way for large Phase 1 trials have approximately a 10% chance of eventually gaining FDA approval.

Is This Trial Right for Me?

Ask your doctor about the potential benefits and risks of receiving ipilimumab before your standard treatment. Understand that participation involves receiving the study drug before surgery and standard therapies, with regular check-ups and tests. Be prepared for potential side effects and the need to adhere strictly to the trial schedule. This trial is currently recruiting participants. The trial is being conducted at 1 site. Always discuss clinical trial participation with your healthcare provider before making any decisions. This information is for educational purposes only and is not medical advice.

AI-generated analysis for educational purposes only. This is not medical advice. Discuss clinical trial participation with your doctor. Data sourced from ClinicalTrials.gov.

Study Design

• Study Type: INTERVENTIONAL
• Allocation: NA
• Model: SINGLE_GROUP
• Masking: NONE
• Enrollment: 16 participants

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.

Primary Outcomes

• Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability] (From trial registration to 3 months post ipilimumab administration)
• Overall Survival at 12 months post trial registration (From trial registration to 1 year post treatment)
• Feasibility of neoadjuvant ipilimumab (Upon the final patient completing treatment)
• Best overall objective response rate (Through study completion, an average of 14 months)

Secondary Outcomes

• Overall survival at 24 months (From date of registration up to 104 weeks)
• Progression Free Survival (From date of registration up to date of progression)
• Surgical Complications (During surgery)
• Treatment Compliance (Through treatment completion, an average of 42 days)
• Changes in Eastern Cooperative Oncology Group performance status (From baseline to end of 12 month follow up)

Full Eligibility 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 Locations

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

Frequently Asked Questions

Related Conditions

• Glioblastoma
• Brain Cancer
• Gliosarcoma
• Brain Tumors
• Oncology
• Immunotherapy
• Neoadjuvant Therapy
• Phase I Clinical Trials
• Cancer Research
• Targeted Therapy

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