BridgeMD
New treatment option for Melanoma Stage Iv
Official title Anti-PD 1 Brain Collaboration + Radiotherapy Extension (ABC-X Study)
ClinicalTrials.gov ID: NCT03340129
What this study is testing
What is Ipilimumab?
Ipilimumab is an investigational medicine, given as an once-weekly pill taken by mouth, being studied as a potential treatment for melanoma stage iv.
Also referred to as Yervoy.
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
- This is a phase II, open label, randomised trial of ipilimumab and nivolumab with concurrent intracranial stereotactic radiotherapy versus ipilimumab and nivolumab alone in patients with asymptomatic, untreated melanoma brain metastases.
- Phase 2: a mid-size study of how well it works
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 120
You may be able to join if
- Female or male patients, ≥18 years of age.
- Signed, written, informed consent.
- AJCC Stage IV [any T, any N, M1d (0) or M1D(1)] histologically confirmed cutaneous, acral or mucosal unresectable melanoma or unknown primary...
- The BRAF mutation status must be available prior to randomisation.
- The treating clinician(s) should consider the intracranial disease amenable to stereotactic radiotherapy over whole brain radiotherapy. Patients for...
You likely can't join if
- Patients whose intracranial disease changes between the diagnostic MRI scan and the baseline / SRS planning MRI scan and who are no longer suitable...
- Melanoma brain metastasis greater than 40mm.
- Evidence of leptomeningeal disease, with the exception of pathological findings seen at a previous resection of brain disease, but with no evidence...
- History of, or current ocular melanoma (patients with mucosal and acral melanoma are eligible).
- Neurological symptoms from brain metastases present at baseline (resolved neurological symptoms, prior to enrolment, are permitted).
- Prior radiotherapy to the brain (surgery permitted).
See the full eligibility criteria
Who can join
- Female or male patients, ≥18 years of age.
- Signed, written, informed consent.
- AJCC Stage IV [any T, any N, M1d (0) or M1D(1)] histologically confirmed cutaneous, acral or mucosal unresectable melanoma or unknown primary melanoma and at least 1 radiological definitive brain metastasis that is ≥...
- The BRAF mutation status must be available prior to randomisation.
- The treating clinician(s) should consider the intracranial disease amenable to stereotactic radiotherapy over whole brain radiotherapy. Patients for whom there is a definite and immediate indication for radiotherapy...
- Brain metastases must be untreated with any modality of radiotherapy or systemic treatment. Previous surgery for melanoma brain metastases is permitted if it resulted in gross total resection and no radiotherapeutic...
- No prior systemic treatment for brain metastases is permitted unless given in the neoadjuvant or adjuvant settings for systemic drug the treatment for extracranial disease only. At the time of neoadjuvant or adjuvant...
- Asymptomatic from brain metastases at the time of study enrolment without corticosteroids, analgesia or any other treatment for the management of neurological symptoms (with the exception of antiepileptics prescribed...
- Eastern Cooperative Oncology Group (ECOG) Performance Status of 0-2.
- A life expectancy \> 30 days.
- Able to undergo MRI with Gadolinium contrast agent. CT of the brain is not an acceptable alternative should patients be unable to safely undergo a contrast MRI.
- Adequate haematological, hepatic and renal organ function as defined by:
- White cell count ≥ 2.0 × 10x9/L
- Neutrophil count ≥ 1.5 × 10x9/L
- Haemoglobin ≥ 90 g/L
- Platelet count ≥ 100 x 10x9/L
- Total bilirubin ≤ 1.5 x ULN
- Alanine transaminase ≤ 3.0 x ULN
- Aspartate aminotransferase ≤ 3.0 x ULN
- Serum creatinine ≤ 1.5 x the upper limit of normal (ULN). If serum creatinine is \> 1.5 x ULN, calculate creatinine clearance using standard Cockcroft-Gault formula. Creatinine clearance must be 40ml/min to be eligible.
- Women of childbearing potential (WOCBP) must have a negative serum pregnancy test within 7 days of the first dose of study treatment and agree to use effective contraception from 14 days prior to commencing study...
- Intrauterine device with a documented failure rate of less than 1% per year.
- Vasectomised partner who is sterile prior to the female partner patient's commencement of study treatment and is the sole sexual partner for that female.
- Combined (oestrogen and progestogen) hormonal contraception associated with inhibition of ovulation or progestogen only hormonal contraception associated with inhibition of ovulation. Women who are not of childbearing...
What rules you out
- Patients whose intracranial disease changes between the diagnostic MRI scan and the baseline / SRS planning MRI scan and who are no longer suitable for SRS and / or require a specific alternative treatment outside of...
- Melanoma brain metastasis greater than 40mm.
- Evidence of leptomeningeal disease, with the exception of pathological findings seen at a previous resection of brain disease, but with no evidence of leptomeningeal disease elsewhere at the time of resection or at...
- History of, or current ocular melanoma (patients with mucosal and acral melanoma are eligible).
- Neurological symptoms from brain metastases present at baseline (resolved neurological symptoms, prior to enrolment, are permitted).
- Prior radiotherapy to the brain (surgery permitted).
- Prior systemic drug therapy for melanoma, unless given in the neoadjuvant or adjuvant setting and completed 6 months before enrolment in this study.
- Patients with active, known or suspected autoimmune disease. Patients with the following are permitted to enrol:
- Vitiligo
- Type I diabetes mellitus
- Residual hypothyroidism due to an autoimmune condition only requiring hormone replacement
- Psoriasis not requiring systemic treatment
- Autoimmune conditions not expected to recur in the absence of an external trigger.
- Current systemic treatment with corticosteroids, or within 7 days of randomisation, with the exception of prednisone at non-immunosuppressive doses of ≤ 10 mg/day (or equivalent, e.g. e.g. prednisone 10mg =...
- Past treatment for non-neurological symptoms allowed, if this was ceased 7 days prior to randomisation
- Inhaled or intranasal corticosteroids (with minimal systemic absorption) may be continued if the patient is on a stable dose
- Non-absorbed intra-articular steroid injections. During the study, treatment with systemic corticosteroids is permitted during radiotherapy if the patient experiences radiation related symptoms but this should be...
- Any active infection requiring treatment.
- A history of interstitial lung disease.
- Any concurrent malignancy requiring any treatment or a history of another malignancy, unless the patient has been disease-free for 3 years.
- Serious or unstable pre-existing medical conditions or other conditions that could interfere with the patient's safety, consent, or compliance.
- Pregnant or breastfeeding females.
- Administration of any form of live vaccine within 30 days of starting the trial and during the trial. Administration of any other vaccine is cautionary within 30 days of starting the trial and for the duration of the...
- Hypersensitivy to study treatments.
The study team makes the final eligibility decision.
Where it's taking place
- Sydney, New South Wales, Australia
- Waratah, New South Wales, Australia
- Wollstonecraft, New South Wales, Australia
- Woolloongabba, Queensland, Australia
- Adelaide, South Australia, Australia
- East Melbourne, Victoria, Australia
- Melbourne, Victoria, Australia
- Perth, Western Australia, Australia
- Oslo, Oslo, Norway
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, 18 years to 120 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Sydney, New South Wales, Australia; Waratah, New South Wales, Australia; Wollstonecraft, New South Wales, Australia; Woolloongabba, Queensland, Australia; Adelaide, South Australia, Australia; East Melbourne, Victoria, Australia and 3 more location(s). 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.