Is NCT06816927 recruiting in Houston, TX?

Yes, NCT06816927 is currently recruiting participants at its Houston, TX location. This newly diagnosed glioblastoma clinical trial is actively enrolling qualified participants.

How do I join the newly diagnosed glioblastoma clinical trial in Houston?

To join this clinical trial in Houston, complete the eligibility form on this page. A study coordinator will contact you to discuss next steps and determine if you qualify.

Is participation in this Houston clinical trial free?

Yes, all study-related care is provided at no cost to qualified participants. Many studies also offer compensation for time and travel expenses.

Newly Diagnosed Glioblastoma Clinical Trial in Houston, TX

About This Newly Diagnosed Glioblastoma Study in Houston

GIANT is an open-label, multi-center, randomized, perioperative (neoadjuvant followed by adjuvant), phase 2 trial with a safety lead-in phase to investigate the feasibility, safety and tolerability, and establish the biological activity of nivolumab with or without relatlimab in patients with isocitrate dehydrogenase (IDH) wildtype newly diagnosed glioblastoma (ndGBM).

Sponsor: Duke University

Who Can Participate

Inclusion Criteria

Signed informed consent approved by the IRB

Adults ≥ 18 years of age

Patients with either:

A newly suspected diagnosis of GBM based on MRI

A previous diagnosis of GBM and who have not received prior RT or systemic therapy for their brain tumor

Patients who in the opinion of the treating neurosurgeon require resection

Patient is willing to undergo planned surgical procedures

Patient agrees to make biospecimens that will be prospectively collected (after date of consent) available for research

Patients who have undergone a diagnostic biopsy or open surgical procedure prior to enrolling in this study:

If adequate archival tissue, defined as at least 3 blocks, is readily available, there is clear documentation of its availability, and the patient must consents to provide that tissue, the patient does not need to undergo another biopsy prior to, or on study, in order to be eligible for this trial

If archival tissue is sufficient as described above, patient must have either residual enhancing disease requiring resection, or molecularly confirmed GBM with a clear clinical indication for additional resection, as determined by the country PI (or delegate) and the designated trial surgeon.

If archival tissue is insufficient, or if the patient previously underwent a needle biopsy and there is no clear documentation of tissue availability, and the patient wishes to enroll, the patient must agree to undergo a repeat biopsy as part of this study prior to Screening.

Hematological function as follows:

Absolute neutrophil count ≥ 1.5 x 109/L

Platelet count ≥ 100 x 109/L

Haemoglobin \> 90 g/L

Prothrombin time (PT) or partial thromboplastin time (PTT) \< 1.5 x upper limit of normal (ULN)

Renal function as follows: • Serum creatinine ≤ 1.5 x ULN or calculated creatinine clearance ≥ 40 ml/min using the Cockcroft-Gault formula (Appendix 1)

Hepatic function as follows:

Total bilirubin ≤ 1.5 x ULN (Exception: Patient has known or suspected Gilbert's Syndrome for which additional lab testing of direct and/or indirect bilirubin supports this diagnosis. In these instances, a total bilirubin of ≤ 3.0 x ULN is acceptable)

Alkaline phosphatase (ALP) ≤ 2.5 x ULN

Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 2.5 x ULN

Serum albumin ≥ 25 g/L

Eastern Co-operative Oncology Group (ECOG) performance status of 0-1 (Appendix 2)

Life expectancy of at least 12 months

Negative human immunodeficiency virus (HIV) test at Screening

Negative hepatitis B surface antigen (HbsAg) test at Screening or positive test followed by a negative hepatitis B virus (HBV) DNA test at Screening

Negative hepatitis C antibody (anti-HCV) test at Screening or positive test followed by a negative HCV RNA test at Screening

Able to undergo brain MRI with and without contrast

People of childbearing potential must agree to use a highly effective contraceptive method (with a failure rate of \< 1%) during study treatment and for at least 6 months following the last dose of study drug and agree not to donate eggs (ova, oocytes) for the purpose of reproduction for the same time period. Acceptable methods of contraception are:

Combined estrogen and progestin containing hormonal contraception associated with inhibition of ovulation given orally, intravaginally, or transdermally

Progestin-only hormonal contraception associated with inhibition of ovulation given orally, by injection, or by implant

Intrauterine device: Intrauterine hormone-releasing system

Bilateral tubal occlusion

Vasectomised partner

Sexual abstinence: Considered a highly effective method only if defined as refraining from heterosexual intercourse during an entire period of risk associated with the study treatment. The reliability of sexual abstinence needs will be evaluated in relation to the duration of the study and to the usual lifestyle of the patient Note: People are considered post-menopausal and not of childbearing potential if they have had 12 months of natural (spontaneous) amenorrhea with an appropriate clinical profile (e.g. age appropriate history of vasomotor symptoms) or have had surgical bilateral oophorectomy (with or without hysterectomy), total hysterectomy or tubal ligation at least 6 weeks ago. In the case of oophorectomy alone, only when the reproductive status of the person has been confirmed by follow-up hormone level assessment are they considered not of childbearing potential.

Sexually active patients that are able to produce a sperm, must use a condom during intercourse and must agree to refrain from sperm donation, from registration on the study until 3 months after the last dose of treatment

People of childbearing potential must have a negative highly sensitive serum pregnancy test (minimum sensitivity 25 IU/L or equivalent units of human chorionic gonadotropin) at the time of screening and within 48 hours of starting the study drug(s)

Ability to adhere to the study visit schedule and all protocol requirements

Exclusion Criteria

Tumors where a gross total resection is not considered feasible by the treating neurosurgeon

Tumor involves cerebellum, brainstem, or deep basal ganglia

Patients who require urgent resection for mass effect, cerebral edema, or hydrocephalus in the opinion of the treating neurosurgeon

Patients with contraindications to MRI or unwilling to undergo MRI

History of CNS bleeding as defined by stroke within 6 months prior to registration

Contraindication to surgery

Treatment with immunosuppressive medications Note: Low-dose corticosteroids (≤ 2 mg/day dexamethasone or equivalent) for tumor-associated edema is permitted. Patients who require corticosteroids \> 2mg/day dexamethasone (or equivalent) for acute emergencies during the screening window will be eligible, if the corticosteroid dosing reduces to ≤ 2 mg/day dexamethasone (or equivalent) at least one day prior to the initial trial-mandated biopsy.

Active autoimmune disease or immune deficiency including, but not limited to, myasthenia gravis, myositis, autoimmune hepatitis, systemic lupus erythematosus, rheumatoid arthritis, inflammatory bowel disease, antiphospholipid antibody syndrome, Wegener granulomatosis, Sjögren syndrome, Guillain-Barré syndrome, or multiple sclerosis

Active tuberculosis

Patient has had a previous SARS-CoV-2 infection either suspected or confirmed within 4 weeks prior to screening. Acute symptoms must have resolved and based on treating physician's assessment, there are no sequelae that would place the patient at a higher risk of receiving trial treatment

Evidence of acute intracranial/intra-tumoral hemorrhage, which requires urgent intervention

Severe infection within 4 weeks prior to registration

Treatment with a live, attenuated vaccine within 4 weeks prior to registration, or anticipation of need for such a vaccine during study or within 5 months after final dose of nivolumab and relatlimab

Patients with prior, unrelated malignancy requiring current active treatment with the exception of cervical carcinoma in situ and adequately treated basal cell or squamous cell carcinoma of the skin or other malignancies with no evidence of disease for 2 years or more

Major surgical procedure, other than for diagnosis, within 4 weeks prior to registration

History of idiopathic pulmonary fibrosis, organising pneumonia (e.g., bronchiolitis obliterans), drug-induced pneumonitis, or idiopathic pneumonitis, or evidence of active pneumonitis Note: History of radiation pneumonitis in the radiation field (fibrosis) is permitted

Patient is pregnant or breastfeeding/chestfeeding

Prior allogeneic stem cell or solid organ transplantation

Known allergy or sensitivity nivolumab, relatlimab, temozolomide or their excipients

Patient has any kind of disorder that, in the opinion of the site PI, may compromise the ability of the patient to give written informed consent and/or to comply with all required study procedures

Patients with a history of myocarditis

Patient has troponin T (TnT) or I (TnI) \> 2 × ULN Note: Patients with TnT or TnI levels between \> 1 × to 2 × ULN will be eligible if repeat levels within 24 hours are ≤ 1 × ULN. If TnT or TnI levels are between \> 1 × to 2 × ULN within 24 hours, the patient must be evaluated by a cardiologist. When repeat levels within 24 hours are not available, a repeat test should be conducted as soon as possible. If TnT or TnI repeat levels beyond 24 hours are \< 2 × ULN, the patient must be evaluated by a cardiologist. After cardiologist evaluation, the patient may be eligible if the site PI assesses a favorable benefit/risk

Left ventricular ejection fraction (LVEF) \< 50% by either echocardiogram (ECHO) or multigated acquisition (MUGA) scan within 6 months prior to registration

History or evidence of any other clinically significant disorder, condition, or disease (with the exception of those outlined above) that, in the opinion of the site PI would pose a risk to patient safety or interfere with the study evaluation, procedures or completion

Not sure if you qualify? Submit your interest and a study coordinator will help determine your eligibility.

Frequently Asked Questions

Q:Is this study available in Houston?

Yes, this clinical trial (NCT06816927) has an active research site in Houston, TX that is currently enrolling participants.

Q:Is it safe to participate?

Clinical trials follow strict safety guidelines and ethical standards. This study has been reviewed and approved, and participants are closely monitored by medical professionals. You can withdraw at any time.

Q:Will I be compensated?

Many clinical trials offer compensation for your time and travel expenses. Specific compensation details will be discussed during the screening process. All study-related medical care is provided at no cost.

Q:Can I leave the trial if I change my mind?

Absolutely. Participation is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty.

Still have questions? Our study coordinators are here to help.

Newly Diagnosed Glioblastoma Treatment Options in Houston, TX

If you're searching for newly diagnosed glioblastoma treatment options in Houston, TX, this clinical trial (NCT06816927) may be an excellent opportunity. Clinical trials provide access to cutting-edge treatments that aren't yet available to the general public, often at no cost to participants.

Our Houston research site is actively enrolling participants for this phase 2 clinical trial. You'll receive care from experienced newly diagnosed glioblastoma specialists who are at the forefront of medical research. All study-related care, including examinations, treatments, and monitoring, is provided at no cost to qualified participants.

Looking for more options? Browse all newly diagnosed glioblastoma clinical trials near you to find additional studies recruiting in your area.

Newly Diagnosed Glioblastoma Clinical Trial in Houston, TX

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