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Trial registered on ANZCTR
Registration number
ACTRN12625000197437p
Ethics application status
Not yet submitted
Date submitted
24/01/2025
Date registered
20/02/2025
Date last updated
20/02/2025
Date data sharing statement initially provided
20/02/2025
Type of registration
Prospectively registered
Titles & IDs
Public title
Immunotherapy in Perineural Spread of Cutaneous Squamous Cell Carcinoma - IPERCS
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Scientific title
A single arm, phase II trial of Cemiplimab in Head and Neck Cutaneous Squamous Cell Carcinoma with Large Nerve Perineural Spread
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Secondary ID [1]
313805
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NIL Known
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Skin Cancer
336441
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Cutaneous Squamous Cell Carcinoma
336442
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Condition category
Condition code
Cancer
332961
332961
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0
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Other cancer types
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Cancer
332962
332962
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0
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Head and neck
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Single arm, nonrandomised
Cemiplimab intravenous 350mg every three weeks for 8 cycles.
Patients will attend the day oncology unit at their treating institution for administration of Cemiplimab 350mg every 3 weeks for a period of 24 weeks. Patient will be monitored as per industry standards and guidelines.
Patients will be assessed for response via medical imaging. The mode of medical imaging to be used in this study is Computer Tomography (CT), Positron Emission Tomography (PET/CT
and Magnetic Resonance Imaging (MRI) with contrast.
These modes of imaging require a contrast dye which is administered intravenously.
The amount of contrast needed can vary dependant on patient weight, but approximately 30-120ml of contrast is needed.
A CT scan can take up to 30 mins to perform
An MRI can take up to 30 mins to perform
All imaging is performed by a qualified radiologist at the patient's treating institution. Imaging scans are required at screening, 6 weeks and 12 weeks during the treatment phase.
Imaging is required every 3 months during for follow up phase until disease progression, withdrawal of consent of death.
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Intervention code [1]
330393
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Treatment: Drugs
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Comparator / control treatment
No control group
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Control group
Uncontrolled
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Outcomes
Primary outcome [1]
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To estimate the efficacy of Cemiplimab in patients with large nerve perineural spread from cSCC, as assessed by landmark progression free survival (PFS)
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Assessment method [1]
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Response will be measured by the treating clinician via clinical assessment, pathological reviews and radiological imaging using PET Scans, CT Scans and MRI scans.
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Timepoint [1]
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Every available time point and as a change from baseline. Timepoints: Baseline, Week 6 and Week 12. Post-intervention commencement and every 3 months following completion of Cemiplimab for a maximum of three years until disease progression, withdrawal of consent or death.
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Secondary outcome [1]
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Disease Control Rate (DCR) as per Modified RANO criteria
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Assessment method [1]
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MRI scans
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Timepoint [1]
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Every available time point and as a change from baseline Baseline, week 6, week 12 and week 24 then every three months post intervention dose until disease progression, withdrawal of consent or death.
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Secondary outcome [2]
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To estimate the overall response rate (ORR) as per Modified RANO criteria
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Assessment method [2]
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Radiological assessment using MRI/CT imaging Baseline, week 6, week 12 and week 24 then every three months post intervention dose until disease progression, withdrawal of consent or death.
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Timepoint [2]
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Baseline, week 6, week 12 and week 24 then every three months post intervention dose until disease progression, withdrawal of consent or death.
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Eligibility
Key inclusion criteria
1. Histologically confirmed history of cutaneous cell carcinoma (cSCC)
2. Large Nerve-Perineural Spread (LN-PNS) defined as clinical and /or radiologic involvement of named nerves (UICC 2015 )
3. Stage III-IV cSCC as defined by AJCC8th edition
4. Measurable LN-PNS on baseline MRI
5. Absence of distant metastatic disease on baseline imaging
6. ECOG performance status 0-1
7. Participants must have adequate organ function as defined below:
Laboratory Value
Haematological
Absolute neutrophil count (ANC): equal to 1500 cells/µL without granulocyte colony-stimulating factor (G- CSF) support within 2 weeks prior to the first dose of study treatment
Platelets: equal to 100 000/µL
Haemoglobin: equal to 9 g/dL or equal to 5.6 mmol/L. Participants are eligible if levels are reached after blood transfusion.
Renal: a Measured or calculated creatinine clearance (GFR can also be used in place of creatinine or CrCl) equal to1.5 × ULN OR equal to 45 mL/min for participants with creatinine levels
greater than 1.5 × institutional ULN
Hepatic: bTotal bilirubin equal to 1.5 × ULN OR direct bilirubin equal to ULN for participants with total bilirubin levels greater than 1.5 × ULN
AST: (SGOT) and ALT
(SGPT) equal to 2.5 × ULN
Coagulation: international normalized ratio (INR)
OR PT and aPTT equal to 1.5 × ULN unless participant is receiving anticoagulant therapy as long as prothrombin time (PT) or activated partial thromboplastin time (aPTT) is within therapeutic range of intended use of anticoagulants
a. Creatinine clearance should be calculated per institutional standard.
b. For participants with Gilbert's disease, total bilirubin may be greater than 1.5 × ULN; however, direct bilirubin must be normal.
c. Partial thromboplastin time (PTT) may be performed if the local laboratory is unable to perform aPTT.
8. Participants must have a life expectancy of greater than 6 months
9. Be at least 18 years of age
10. Female participants of childbearing potential must have a negative urine or serum pregnancy test within 72 hrs prior to receiving the first dose of medication
11. Female participants of childbearing potential must agree to use a highly effective method of contraception during the treatment period and for at least 120 days after the last dose.
12. The participant or legal representative must be willing and able to sign to provide written informed consent.
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
1. Participant with distant metastatic cSCC
2. Participants with any prior allogeneic solid organ or hematopoietic stem cell transplantations are excluded.
3. Participant has received prior therapy with an anti-PD-1, anti-PD-L1, or anti-PD-L2 agent or with an agent directed to another stimulatory or co-inhibitory T-cell receptor (eg, CTLA-4, OX-40, CD137).
4. Participant has received prior systemic anti-cancer therapy including investigational agents for cSCC.
5. Participant has received prior radiotherapy to the target lesion.
6. Participant has a contraindication to MRI
7. Participant is currently participating in or has participated in a trial of an investigational agent or has used an investigational device within 4 weeks prior to the first dose of trial treatment.
8. Ongoing or recent (within 5 years) evidence of significant autoimmune disease that required treatment with systemic immunosuppressive treatments (eg, with use of disease-modifying agents, anticoagulants, corticosteroids or immunosuppressive drugs)., which may suggest risk for immune-related adverse events (irAEs) or has a diagnosis of immunodeficiency disorders (such as organ transplantation or hematologic malignancies associated with immune suppression).
9. Participant has a diagnosis of immunodeficiency or is receiving systemic steroid therapy (in dosing exceeding 10 mg daily of prednisone equivalent) or any other form of immunosuppressive therapy within 7 days prior to the first dose of trial drug.
10. Has uncontrolled infection with human immunodeficiency virus, hepatitis B, or hepatitis C infection; or has a diagnosis of immunodeficiency
a. Patients with known HIV infection who have controlled infection (undetectable viral load (HIV RNA PCR) and CD4 count above 350 either spontaneously or on a stable antiviral regimen) are permitted.
b. Patients with hepatitis B (HBsAg+) who have controlled infection (serum hepatitis B virus DNA PCR that is below the limit of detection and receiving anti-viral therapy for hepatitis B) are permitted. Patients must remain on anti-viral therapy for at least 6 months beyond the last dose of investigational study drug.
c. Patients who are hepatitis C virus antibody positive (HCV Ab+) who have controlled infection (undetectable HCV RNA by PCR either spontaneously or in response to a successful prior course of anti-HCV therapy) may be enrolled into the study.
11. Participant has a diagnosis and/or has been treated for additional malignancy within the past 3 years prior to allocation.
12. Participant has a history of (non-infectious) pneumonitis that required steroids or has current pneumonitis.
13. Participant has a history or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the trial, interfere with the participant's participation for the full duration of the trial, or is not in the best interest of the participant to participate, in the opinion of the treating investigator.
14. Participant has a known psychiatric or substance abuse disorder that would interfere with the participant’s ability to cooperate with the requirements of the trial.
15. Participant is pregnant or breastfeeding or expecting to conceive or father children within the projected duration of the trial, starting with the screening visit through 120 days after the last dose of trial treatment.
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Non-randomised trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Single group
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Other design features
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Phase
Phase 2
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Type of endpoint/s
Efficacy
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Statistical methods / analysis
The estimate of the landmark PFS along with its 95% CI.
Counts, percentages and the corresponding 95% confidence intervals (CIs) of participants with AEs will be provided
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Recruitment
Recruitment status
Not yet recruiting
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Date of first participant enrolment
Anticipated
30/06/2025
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Actual
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Date of last participant enrolment
Anticipated
1/07/2025
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Actual
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Date of last data collection
Anticipated
31/12/2030
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Actual
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Sample size
Target
22
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
QLD
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Recruitment hospital [1]
27523
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Princess Alexandra Hospital - Woolloongabba
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Recruitment postcode(s) [1]
43636
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4102 - Woolloongabba
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Funding & Sponsors
Funding source category [1]
318272
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Commercial sector/Industry
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Name [1]
318272
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Regeneron Pharmaceuticals, Inc
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Address [1]
318272
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Country [1]
318272
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United States of America
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Primary sponsor type
Government body
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Name
Metro South Hospital and Health Services
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Address
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Country
Australia
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Secondary sponsor category [1]
320659
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None
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Name [1]
320659
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Address [1]
320659
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Country [1]
320659
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Ethics approval
Ethics application status
Not yet submitted
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Ethics committee name [1]
316912
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Metro South Human Research Ethics Committee
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Ethics committee address [1]
316912
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https://metrosouth.health.qld.gov.au/research/about-us/hrec
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Ethics committee country [1]
316912
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Australia
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Date submitted for ethics approval [1]
316912
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13/03/2025
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Approval date [1]
316912
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Ethics approval number [1]
316912
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Summary
Brief summary
This study is investigating whether an immunotherapy drug (Cemiplimab) is effective as a treatment for cutaneous squamous cell carcinoma (a skin cancer of the head and neck), particularly for patients who have had their cancer spread to large nerves within the head and neck area. Who is it for? You may be eligible for this study if you are aged 18 years or older, you have been diagnosed with stage 3-4 cutaneous squamous cell carcinoma (cSCC) and you also have been diagnosed with a spread of this cancer into large peripheral nerves (also known as large-nerve perineural spread). Study details There is only one treatment available as part of this study, all participants who choose to enrol will be offered the same immunotherapy treatment. Cemiplimab will be given to participants via an infusion into a vein, once every 3 weeks for up to 8 treatment cycles (approximately 6 months). Participants will need to attend their local hospital to receive this treatment and to undergo additional CT and MRI scans to review their nerves that may have been impacted by the cancer. Participants will be asked to undergo CT and MR imaging at the time that they enrol in the study, then at 6 weeks, 12 weeks and then at 12-weekly increments for a maximum of 5 years. It is hoped that this study will help us understand whether cemiplimab can shrink the tumour, in which patients this may be more likely to occur, and any side effects that may be experienced during this study. This may help to treat other patients with cSCC of the skin in future and reduce the impact of this type of cancer on the nearby nerves in the head and neck.
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Trial website
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Trial related presentations / publications
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Public notes
The following are not exclusionary: vitiligo; asthma; type 1 diabetes; hypothyroidism that required only hormone replacement; or psoriasis that does not require systemic treatment. Replacement therapy (eg, thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency) is not considered a form of systemic treatment and is allowed. Participants with cSCC of the skin that have undergone potentially curative therapy are not excluded if not related to current diagnosis Participants with basal cell carcinoma of the skin or carcinoma in situ (eg, breast carcinoma, cervical cancer or melanoma in situ) that can undergo potentially curative therapy are not excluded. Participants with low-risk early-stage prostate cancer, defined as below are not excluded: Stage T1c or T2a with a Gleason score equal to 6 and a prostate-specific antigen (PSA) (equal to 10 ng/ml) either treated with definitive intent or untreated in active surveillance that has been stable for the past year prior to trial allocation.
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Contacts
Principal investigator
Name
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A/Prof Rahul Ladwa
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Address
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Prinicess Alexandra Hospital, 199 Ipswich Rd, Woolloongabba, Qld, 4102
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Country
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Australia
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Phone
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+61 07 3176 3962
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Fax
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Email
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[email protected]
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Contact person for public queries
Name
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Kym Bessell
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Address
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Prinicess Alexandra Hospital, 199 Ipswich Rd, Woolloongabba, Qld, 4102
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Country
139411
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Australia
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Phone
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+61 07 3176 3962
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Fax
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Email
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[email protected]
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Contact person for scientific queries
Name
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Rahul Ladwa
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Address
139412
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Prinicess Alexandra Hospital, 199 Ipswich Rd, Woolloongabba, Qld, 4102
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Country
139412
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Australia
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Phone
139412
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+61 07 3176 2111
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Fax
139412
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Email
139412
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[email protected]
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Data sharing statement
Will the study consider sharing individual participant data?
Yes
Will there be any conditions when requesting access to individual participant data?
Persons/groups eligible to request access:
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On a case-by-case basis, at the discretion of the Primary Sponsor
Conditions for requesting access:
•
-
What individual participant data might be shared?
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Only relevant de-identified individual participant data collected during the trial may be used for statistical, translational research and publication purposes
What types of analyses could be done with individual participant data?
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PFS at 12 months: defined as the proportion of patients at 12 months without progression or death from first day of study treatment.
When can requests for individual participant data be made (start and end dates)?
From:
immediately following publication, no end date
To:
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Where can requests to access individual participant data be made, or data be obtained directly?
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Access to data is subject to approval by the Principal Investigator and or Sponsor.
Subject to approval by PI - email:
[email protected]
Are there extra considerations when requesting access to individual participant data?
No
What supporting documents are/will be available?
No Supporting Document Provided
Results publications and other study-related documents
Documents added manually
No documents have been uploaded by study researchers.
Documents added automatically
No additional documents have been identified.
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