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New treatment option for Malignant Primary Gliomas
Official title 5G-EMERALD: Amivantamab in Malignant Brain Tumours
ClinicalTrials.gov ID: NCT06632236
What this study is testing
What is Amivantamab?
Amivantamab is an investigational medicine, given as an once-weekly infusion into a vein, being studied as a potential treatment for malignant primary gliomas.
Also referred to as JNJ-61186372.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- The purpose of this clinical trial is to evaluate the safety and tolerability of amivantamab and to determine the preliminary antitumour activity of amivantamab administered at the recommended Phase 2 dose (RP2D). In the Phase 1b of this study a biomarker defined arm will be opened, initially in the relapsed GMB setting, enrolling 12 patients.
- Phase 1: an early, usually small safety study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 16 and older
You may be able to join if
- for Phase 1b:
- Patients with histologically confirmed advanced WHO Stage IV glioblastoma (per fourth edition 2016). Per the new 2021 fifth edition of WHO...
- Glioblastoma, IDH-wildtype Grade 4
- Astrocytoma, IDH-mutant, Grade 4 (lower Grade 2/3 are not included)
- Diffuse hemispheric glioma, H3 G34 mutant Grade 4
You likely can't join if
- 16 years or over.
- Life expectancy of at least 12 weeks.
- World Health Organisation (WHO) performance status of 0-1.
- Neurologically stable (e.g., without a progression of neurological symptoms or requiring escalating doses of systemic steroid therapy within the last...
- Written (signed or dated) informed consent and be capable of co-operating with treatment and follow up.
- Haematological and biochemical indices within the ranges shown below. These measurements must be performed within one week prior to the first dose of...
See the full eligibility criteria
Who can join
- for Phase 1b:
- Patients with histologically confirmed advanced WHO Stage IV glioblastoma (per fourth edition 2016). Per the new 2021 fifth edition of WHO Classification of Tumours of the Central Nervous System, this will include:
- Glioblastoma, IDH-wildtype Grade 4
- Astrocytoma, IDH-mutant, Grade 4 (lower Grade 2/3 are not included)
- Diffuse hemispheric glioma, H3 G34 mutant Grade 4
- Patients for Phase 1 will need to have consented to the Minderoo Precision Brain Tumour Programme and have available whole genome, and transcriptome data available.
- Patients for the relapsed cohorts will be eligible at first relapse following completion of optimal surgery, and Stupp based adjuvant chemo-radiotherapy (or equivalent). They will need to have measurable disease per...
- Patients for the front line minimal residual disease (MRD) cohort will be eligible following completion of optimal surgery and Stupp based adjuvant chemoradiotherapy as long as they meet all other inclusion/
What rules you out
- 16 years or over.
- Life expectancy of at least 12 weeks.
- World Health Organisation (WHO) performance status of 0-1.
- Neurologically stable (e.g., without a progression of neurological symptoms or requiring escalating doses of systemic steroid therapy within the last week).
- Written (signed or dated) informed consent and be capable of co-operating with treatment and follow up.
- Haematological and biochemical indices within the ranges shown below. These measurements must be performed within one week prior to the first dose of either IMP: Haemoglobin (Hb): ≥ 10.0 g/dL Absolute neutrophil count...
- Female patients with reproductive potential must have a negative serum, or urine, pregnancy test at screening and within 72 hours of the first dose of study treatment and must agree to further serum or urine pregnancy...
- A participant must be either of the following: a. not of childbearing potential, b. of child-bearing potential and practicing true abstinence during the entire period of the study, including up to 6 months after the...
- A participant must agree not to donate eggs (ova, oocytes) for the purposes of assisted reproduction during the study and for 6 months after receiving the last dose of study treatment.
- A participant must wear a condom when engaging in any activity that allows for passage of ejaculate to another person during the study and for 6 months after receiving the last dose of study treatment. A participant who...
- A participant must agree not to donate sperm for the purpose of reproduction during the study and for a minimum of 6 months after receiving the last dose of study treatment.
- A participant must be willing and able to adhere to the lifestyle restrictions specified in this protocol. Exclusion Criteria for Phase 1b:
- Receipt of treatment before the first dose of study drug (Cycle 1 Day 1) within an interval shorter than the following, as applicable:
- Cytotoxic chemotherapy during the prior 2 weeks or 6 weeks for nitrosoureas
- Bevacizumab during the prior 6 weeks
- Five half-lives of any small molecule investigational or licensed medicinal product.
- Prior immune checkpoint inhibitor therapy or vaccine therapy is not permitted. Prior EGFR-targeting therapy is not permitted. Prior use of any other immune-modulatory investigational agent must be discussed with sponsor...
- Ongoing Grade 2 or greater toxicities from pre-existing conditions or from previous treatments.
- Patients with carcinomatous meningitis, leptomeningeal spread of tumour, spread of tumour to the brain stem or spinal cord.
- Has evidence of recent intratumoural or peritumoural haemorrhage on baseline MRI. Patients with radiological findings that are stable on at least 2 consecutive MRI scans at least 3 weeks apart will be eligible.
- History of clinically relevant bleeding disorders, including significant gastrointestinal (GI) bleeding within last 6 months.
- Participant has active cardiovascular disease including, but not limited to:
- A medical history of deep venous thrombosis or pulmonary embolism within 1 month prior to first dose of study drug or any of the following within 6 months prior to first dose of study drug: myocardial infarction...
- Participant has a significant genetic predisposition to venous thromboembolic (VTE) events such as Factor V Leiden.
- Participant has a prior history of VTE and is not on appropriate therapeutic anticoagulation as per National Comprehensive Cancer Network (NCCN) or local guidelines.
- Uncontrolled (persistent) hypertension: systolic blood pressure \> 160 mm Hg; diastolic blood pressure \> 100 mm Hg.
- Congestive heart failure (CHF), defined as New York Heart Association (NYHA) class III-IV or hospitalization for CHF (any NYHA class) within 6 months of first dose of the study drug.
- Concurrent and clinically significant abnormalities on ECG at Screening, including a corrected QT interval (QTcF \> 460ms).
- History of malabsorption syndrome or other conditions that may interfere with enteral absorption. Patients with a history of or active inflammatory bowel disease (e.g., Crohn's disease or ulcerative colitis). Patients...
- Has urine protein \> 1g/24 hours. Participants with \> 1+ on urine dipstick testing will undergo 24-hour urine collection for quantitative assessment of proteinuria.
- Has significant lung disease including pneumonitis, interstitial lung disease (including drug-induced or radiation ILD/pneumonitis), idiopathic pulmonary fibrosis, cystic fibrosis, active tuberculosis, or history of...
- Participant is serologically positive for hepatitis B surface antigen (HbsAg), Note: participants with a prior history of hepatitis B virus (HBV) demonstrated by positive hepatitis B core antibody are eligible if they...
- Participant is serologically positive for hepatitis C antibody. Note: participants with a prior history of hepatitis C virus (HCV), who have completed antiviral treatment and have subsequently documented HCV RNA below...
- Participant has other clinically active infectious liver disease.
- Participant is positive for human immunodeficiency virus (HIV), with 1 or more of the following:
- Receiving antiretroviral therapy (ART) that may interfere with study treatment (consult sponsor for review of medication prior to enrolment).
- CD4 count \< 350 at screening
- AIDS-defining opportunistic infection within 6 months of start of screening
- Not agreeing to start ART and be on ART \> 4 weeks plus having HIV viral load \< 400 copies/mL at end of 4-week period (to ensure ART is tolerated and HIV controlled).
- Participant has an uncontrolled illness, including but not limited to:
- Uncontrolled diabetes
- Ongoing or active infection (includes infection requiring treatment with antimicrobial therapy [participants will be required to complete antibiotics 1 week prior to starting study treatment] or diagnosed or suspected...
- active bleeding diathesis
- Impaired oxygenation requiring continuous oxygen supplementation
- Psychiatric illness, social situation, or any other circumstances that would limit compliance with study requirements
- Any ophthalmologic condition that is clinically unstable
- Steroid requirement for neurological symptom control of \> 3mg Dexamethasone per day (patients will allowed to enrol if they have been on a stable dose of steroids of equivalent or less than 3mg Dexamethasone for at...
- Has received a live vaccine within 30 days of planned start of study therapy. Note: inactive vaccines including COVID vaccines are allowed prior to 1 week of Day 1 of Cycle 1).
- Concurrent or prior malignancy other than the disease under study. The following exceptions require consultation with the Chief Investigator:
- Non-muscle invasive bladder cancer (NMIBC) treated within the last 24 months that is considered completely cured.
- Skin cancer (non-melanoma or melanoma) treated within the last 24 months that is completely cured.
- Non-invasive cervical cancer treated within the last 24 months that is considered completely cured.
- Is a participant or plans to participate on another treatment clinical trial while taking part in this Phase 1 study. Participation in an observational trial would be acceptable.
- A participant has major surgery excluding placement of vascular access or tumour biopsy, or had significant traumatic injury within 4 weeks before first dose of study drug or minor surgery within 2 weeks, or will not...
- A participant has palliative radiotherapy within 1 week of the firs dose of study drug,
- Any other condition which in the investigator's opinion would not make the patient a good candidate for the clinical trial.
The study team makes the final eligibility decision.
Where it's taking place
- Cambridge, United Kingdom
- Sutton, United Kingdom
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 16 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Cambridge, United Kingdom; Sutton, United Kingdom. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.