CLINICAL TRIALS CURRENTLY RECRUITING PATIENTS
Melanoma Trials
MelDx trial – Autoantibodies for the early detection of melanoma
Brief summary:
The MelDx blood test aims to identify a combination of autoantibodies (including ZBTB7B, PRKCH, TP53, PCTK1, PQBP1, UBE2V1, IRF4, MAPK8_tv2, MSN and TPM1 and potentially other refined combinations of these or new antibodies) in the blood of patients with suspicious lesions thought be a melanoma.
This is a prospective trial aimed to confirm the efficacy, sensitivity and specificity of the melanoma diagnostic test, MelDx, in collaboration with GPs, Skin Check specialists, dermatologists and plastic surgeons.
In this trial,
• blood will be collected from 1000 participants with suspected melanoma via routine venepuncture prior to the collection of the routine biopsy of the lesion for diagnosis.
• The result of the blood test will be compared with that from the biopsy and statistical analyses of the diagnostic accuracy of the MelDx test will be determined.
We propose that a blood test based on a diagnostic autoantibody signature (as described in Zaenker et al. 2018) from patient sera can be used in conjunction with current melanoma diagnostic techniques, to improve the early diagnosis and diagnostic certainty of melanoma to ultimately decrease the mortality rate of patients.
Hypothesis
Autoantibody positivity in sera using the MelDx test will correspond with histological diagnosis of melanoma via biopsy.
Primary Aim
To validate a combination of autoantibodies that provide diagnostic accuracy of 80% or greater in early stage melanoma.
Secondary Aim
To evaluate whether a history of skin cancers affects the test results.
To evaluate the specificity of MelDx for melanoma relative to other skin cancers, other cancers and autoimmune diseases.
Principal investigator
Dr Pauline Zaenker
Building 17, level 2, PO Box 2
School of Medical and Health Sciences
Edith Cowan University
270 Joondalup Drive
Joondalup, WA, 6027
Heads Up Clinical Research Study (Atopic dermatitis study)
Phase IIIb multicentre, randomised, double-blind, double-dummy, active controlled study comparing efficacy and safety of upadacitinib (JAK-1 inhibitor) versus dupilumab for the treatment of adult individuals with moderate to severe AD who are candidates for systemic therapy. (Abbvie sponsored)
Study Design
Approximately 650 eligible individuals will be randomised to receive daily oral doses of upadacitinib or subcutaneous injections of dupilumab every other week. Both treatment groups will receive a matching placebo of the comparator drug. It is expected the site in Perth will recruit up to 10 patients.
The study is expected to last for just over 9 months comprising a 35 day screening period, 24 week treatment period and a follow-up visit 12 weeks after the last injection. Trial may be extended for patients who respond.
Key eligibility criteria for study
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Aged 18-75 years old at the time of screening
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Active moderate to severe AD defined by Eczema Area and Severity Index(EASI), Investigator Global Assessment(IGA) of moderate or severe, body surface area(BSA) of >10% and pruritus
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Candidate for systemic therapy or have recently (within 6 months) required systemic therapy for AD
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No prior exposure to any JAK inhibitor or prior exposure to dupilumab
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No use of strong cytochrome P450 inhibitors or CYP3A inducers
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No other active skin diseases or skin infections requiring systemic treatment that would interfere with assessment of AD lesions
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Female patients cannot be pregnant, breastfeeding or considering pregnancy during the study or for approximately 12 weeks after the last injection
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No malignancy for the last 5 years except for treated non-melanoma skin cancers or localised carcinoma in situ of the cervix
Referral of patients to study coordinator at Burswood Dermatology:
Pam Clements, Mob: 0402 786 811, email: pamyclements@hotmail.com
Psoriasis study
Linear Clinical Research Ltd.
“A Phase I, Randomized, Vehicle-Controlled, Double-Blind (Sponsor Open) Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of Single and Repeat Topical Administration of BOS-475 in Healthy Subjects and Patients with Psoriasis.
The objectives of the study are to evaluate the safety and tolerability of topical administration of BOS-475 to patients with stable plaque psoriasis (≥ 6 months). Subjects will be required to attend clinic visits at Linear Clinical Research for study assessments.
Inclusion Criteria
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Male or female participants with mild to moderate psoriasis 18 to 65 years of age
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Females must be of Non-Childbearing Potential (either Surgically Sterile or Postmenopausal)
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Body Mass Index (BMI) between 18 – 35 kg/m2
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Must have a diagnosis of stable plaque psoriasis for ≥ 6 months
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At least 1 psoriasis plaque located on the trunk or extremities (excluding knees and elbows) that is at least 5cm2 in size at Screening and Day 1 with a TPSS >5 and induration subscore >2
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Must have Body Surface Area involvement of psoriasis lesions between 2% and 15% (excluding face, scalp, palms, soles, nails, and intertriginous areas)
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Must be willing to refrain from using any topical treatments
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Participants must be non heavy smokers (smoke less than 25 cigarettes per day) or former heavy smoker who has stopped smoking within 1 month of screening
For further information, please contact:
Dr Shashi Aggarwal
M: +61 (0) 432 605 618
EMail: saggarwal@linear.org.au
Pemphigus Clinical Trial
Study: Principa Biopharma Protocol No.: PRN1008-012
A Randomized, Double-Blind, Placebo-Controlled, Multicenter Trial to Evaluate the
Efficacy and Safety of Oral BTK Inhibitor PRN1008 in Moderate to Severe Pemphigus
Re: Currently Recruiting Clinical Trial
We are currently recruiting for a clinical trial with an investigational oral treatment for pemphigus vulgaris or pemphigus foliaceus. We are seeking your support in identifying and directing any of your interested patients to contact our clinic.
Eligible participants will:
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Be male or female, aged 18 to 80 years old with moderate to severe, newly diagnosed or relapsing pemphigus vulgaris or pemphigus foliaceus.
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Have a body mass index (BMI) > 17.5.
There is no cost to participate. Qualified participants will have regular visits with study doctors who specialize in treating pemphigus. Participation will last approximately 68 weeks and involve about 20 visits to the study research site.
For more information about this clinical trial, please visit https://www.australanclinicaltrials.gov.au/ or visit www.ResearchTrials.org (under the “Fremantle Dermatology” location).
If any of your patients are interested in participating in this clinical trial, please have them contact:
Ron Pensini ron@fremantledermatology.com.au
Other Melanoma Trials
The adjuvant landscape for early stage melanoma is rapidly evolving with a number of systemic therapy options being currently available in form of clinical trials or compassionate access scheme.
Stage III melanoma:
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Keynote-942 Phase II study: This best option now is the trial below that got activated at SJOG Subiaco today under my supervision. It involves free access to standard immunotherapy with pembrolizumab (not approved by PBS yet) as well as 2:1 randomisation to additional personalised cancer vaccine where patient tumour is sent to the US where through a novel technology, patient tumour specific cancer neo-antigens are identified and an mRNA vaccine developed against it. Each patient randomised to the additional personalised cancer vaccine arm will have a patient tumour specific vaccine different than any other patient. Patients would start standard immunotherapy for 2 x cycles while the personalised cancer vaccine is developed in US (takes about 6 weeks) and delivered to Perth for IM injection to be given every 3 weeks x 9 cycles.
See video link below for a short 4min clip to explain how all this works. You will find it interesting and informative.
This trial is for Stage IIIC/D, resected stage IV or (stage IIIB patients who have relapsed within 3months and re-resected, this will be a minority), irrespective of BRAF status. Its open for private patients but I am trying to get SJOG to agree to entertain a certain number of public patients as well. There are only 3 x sites across Australia and 14 in US. No European centres. Mark Lee and Mark Hanikeri's patients that I am seeing tomorrow will be the first few patients across the world to consent.
An Efficacy Study of Adjuvant Treatment With the Personalized Cancer Vaccine mRNA-4157 and Pembrolizumab in Patients With High-Risk Melanoma (KEYNOTE-942)
https://www.youtube.com/watch?v=zM97kg7atWw&feature=youtu.be
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BMS compassionate access scheme: this is for Stage IIIB/C/D and resected stage IV patients, irrespective of BRAF status.
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Novartis compassionate access scheme: this is for Stage IIIB/C/D with BRAF mutation only. A separate individual patient request needs to be done to the Medical Advisor Novartis, for any stage IIIA patient and they will decide on a case by case basis.
Stage IIB/C melanoma:
For this cohort of patients, Keynote 716 study of Pembro vs placebo is open. It's a phase 3 study involving a placebo but pros even for placebo group are: close supervision by an International/local team in context of a phase 3 study, free access to Pembro if relapse in future and was receiving placebo, one can argue if patients do not participate in the trial, they are in placebo arm anyway.
If you are a clinician managing melanoma patients please do not hesitate to ring me on 0410 565 868 to discuss any suitable patients. You can email me, text or get your secretary to send me any path reports and I can advise accordingly. I see public patients at FSH and private ones at SJOG Subiaco as well as SJOG Murdoch if they are from South Perth Metro.
Thanks.
Best regards,
Adnan
Adnan Khattak I Clinical Professor/Medical Oncologist
Cancer Clinical Trials Lead
Raine Foundation Research Fellow
Cancer Centre, Level 1, Room B-L10073
11 Robin Warren Drive, Murdoch, WA 6150
Ph: +61 8 6152 6712 I Fax: +61 8 6152 0954
Clinical trial for Hidradenitis suppurativa (HS) and palmoplantar pustulosis (PPP)
Hidradenitis suppurativa (HS) and palmoplantar pustulosis (PPP) belong to the same group of skin conditions. Both diseases may cause lesions, redness, tenderness as well as painful lumps with HS or blisters with PPP.
These symptoms can be very uncomfortable and long-lasting, and you may have tried treatments that have not worked well in the past. This study is testing an investigational drug for these conditions.
Study volunteers can help us in this important research. Thank you for considering being a part of this trial.
Who can participate in this study?
To be eligible for this study, you must be:
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18 to 75 years of age
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Diagnosed with HS or PPP
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Able to give informed consent
This is not a complete list of study requirements. The study doctor will review the full requirements for this study with you.
How long will the study last?
If you are enrolled, you will be in this study for up to 28 weeks, including:
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Screening visit (4 weeks)
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Treatment period (15 weeks)
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Follow-up period (9 weeks)
What can I expect if I decide to participate?
If you are eligible, you will be enrolled in one of two treatment groups. One group will receive a certain dose of the study drug and the other group will receive a different dose of the study drug. Each group will enroll 10 participants with HS and 10 participants with PPP.
Every 21 days (Days 1, 22, 43, 64, and 85), you will receive CSL324 as an IV infusion. The IV infusion will last 60 minutes. You will be required to remain at the study site for at least 1 hour after the end of CSL324 administration so study staff can monitor you.
All participants will be asked if they consent to having photographs taken at certain visits throughout the study. HS photographs will be taken of HS lesions (if consented). PPP photographs will be taken of palms of hands and soles of feet (if consented).
Lab tests, a physical exam, and other assessments and questionnaires will be conducted at the in-clinic visits. Not all activities will occur at every visit.
What are my costs to take part in this trial?
You will not have to pay for the study drug CSL324, hospital stays, or any tests or procedures which are required only as a result of being in the study.
What risks are involved if I decide to participate?
There are possible risks involved with any clinical study. Your study doctor will review the risks with you, and you will be closely monitored throughout the study. There may be potential risks involved in taking this medication that have not been identified in the studies done so far.
What is a clinical trial?
A clinical trial is a scientific study in which participants are assigned to one or more investigational drugs to answer questions about the treatment to see if it works, works better than other treatments, and has side effects.
What is an investigational drug?
An investigational drug is a substance that is being tested in clinical trials. It has been approved by an ethics committee for testing in people and may or may not be approved by the government health agency for treatment for this condition.
Thank you for your interest in this study for hidradenitis suppurativa (HS) and palmoplantar pustulosis (PPP).
Principal Investigator
Clin. Assoc. Prof. KURT GEBAUER
229 HIGH STREET, FREMANTLE.
WESTERN AUSTRALIA. 6160
Ph. +61(08) 94304488