Phase 3 Kidney Cancer Trial, RecruitingNCT03394365Sponsor: Pierre Fabre MedicamentCondition: Kidney Cancer
Printed from Voxsanity (voxsanity.com.au) — NCT03394365 — Data sourced from ClinicalTrials.gov. Verify directly with the trial site before attending. Not medical advice.
AI generated eligibility summary.
Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source.
How we use AI
Who might be able to join this trial:
People who have previously had a solid organ transplant (such as a kidney, liver, heart, lung, pancreas, or small bowel) or a bone marrow/stem cell transplant from a donor.
People who have been diagnosed with a condition called EBV-positive PTLD (a type of lymphoma linked to the Epstein-Barr virus after transplant), confirmed by a tissue biopsy.
People whose disease shows up on specific imaging scans (such as PET-CT or MRI) and meets the measurable disease requirements used in this trial.
People for whom a matched version of the study treatment (tabelecleucel) is available, as confirmed by the trial sponsor.
People whose PTLD did not respond to, or came back after, treatment with rituximab (alone or combined with chemotherapy).
People of any age, male or female.
People who are well enough to carry out some daily activities — this is measured using standard medical scoring tools based on age (confirm with trial site).
For stem cell transplant recipients only: people whose original condition (such as leukemia) that led to the transplant is currently in remission.
People whose blood counts and organ function meet the minimum levels required for the trial (confirm with trial site for specific values).
People (or their legal representative) who are willing and able to give written consent to participate.
Who may not be able to join:
People who currently have certain other types of lymphoma or blood cancers (such as Burkitt lymphoma, T-cell lymphoma, Hodgkin lymphoma, or others listed in the criteria) that require active treatment.
People taking high daily doses of steroids (above a certain threshold), or currently receiving methotrexate or a treatment called extracorporeal photopheresis.
People with PTLD that has spread to the brain or spinal cord that has not yet been treated, or where active chemotherapy or radiation to the brain/spine is still ongoing at the time of enrolment.
Stem cell transplant recipients who currently have moderate or severe graft-versus-host disease (a complication where donor cells attack the body).
People who have recently received certain immunotherapy drugs called checkpoint inhibitors (such as ipilimumab, pembrolizumab, or nivolumab) within a specific time window before enrolment.
Stem cell transplant recipients who currently have an active adenovirus infection in the blood.
People who currently need machines or medications to support their breathing or blood pressure.
People who received a specific type of immune-suppressing therapy (antithymocyte globulin or similar) within 4 weeks before enrolment.
People who received certain specialised T-cell or B-cell therapies related to EBV or transplant within 8 weeks before enrolment (confirm with trial site for specifics).
People who are pregnant or breastfeeding, or people of childbearing potential (male or female) who are unwilling to use a highly effective form of contraception during the trial.
People who would be unable to follow the procedures required by the study.
People with any other medical condition that the treating doctor believes could put them at risk or prevent them from completing the trial.
Important: Always verify eligibility with the trial site directly before applying.
Based on publicly available eligibility criteria from ClinicalTrials.gov. Verify directly with the trial site before acting. This is not medical advice.
This is a simplified plain English summary of the eligibility criteria. Full criteria are set by the trial investigators and may include additional requirements not shown here. Never self-exclude from a trial based on this summary. Contact the trial site directly to confirm your eligibility.
Last synced 12 July 2026
Phase 3: approximately ~65% of drugs entering this phase reach regulatory approval, based on published industry-wide historical data. This is not specific to this trial.
Phase success rates shown are historical industry-wide averages based on published data. They are not a prediction for this specific trial or your individual situation.
Contact this trial
Principal Investigator: Glen Lew, Pierre Fabre Laboratories
The Children's Hospital at Westmead (Pediatrics only), Westmead, New South Wales
2 9845 2185
Westmead Hospital (Adults only), Westmead, New South Wales
2 9845 6352
The Prince Charles Hospital (Adults only), Chermside, Queensland
Royal Adelaide Hospital (Adults only), Adelaide, South Australia
870740000
The Royal Children's Hospital Melbourne (Pediatrics only), Melbourne, Victoria
0393455522
Fiona Stanley Hospital (Adults only), Murdoch, Western Australia
(8) 6152 3788
Contact details sourced from ClinicalTrials.gov. Verify directly with the trial site before attending.
GP referral letter
Print a one-page summary to share with your doctor.
Voxsanity
Clinical trials and treatments, explained plainly · voxsanity.com.au
Date:
To: My Doctor
Re: Clinical trial enquiry
I am writing to enquire about the following clinical trial which may be relevant to my care:
Trial: NCT03394365
Sponsor: Pierre Fabre Medicament
Phase: Phase 3
Status: Recruiting
Condition: Kidney Cancer
Trial contact: (000) 000-0000
More information: https://clinicaltrials.gov/study/NCT03394365
Eligibility summary (AI generated)
Written by an AI model from ClinicalTrials.gov eligibility criteria and checked on a sample basis. Please confirm against the original criteria.
Who might be able to join this trial:
People who have previously had a solid organ transplant (such as a kidney, liver, heart, lung, pancreas, or small bowel) or a bone marrow/stem cell transplant from a donor.
People who have been diagnosed with a condition called EBV-positive PTLD (a type of lymphoma linked to the Epstein-Barr virus after transplant), confirmed by a tissue biopsy.
People whose disease shows up on specific imaging scans (such as PET-CT or MRI) and meets the measurable disease requirements used in this trial.
People for whom a matched version of the study treatment (tabelecleucel) is available, as confirmed by the trial sponsor.
People whose PTLD did not respond to, or came back after, treatment with rituximab (alone or combined with chemotherapy).
People of any age, male or female.
People who are well enough to carry out some daily activities — this is measured using standard medical scoring tools based on age (confirm with trial site).
For stem cell transplant recipients only: people whose original condition (such as leukemia) that led to the transplant is currently in remission.
People whose blood counts and organ function meet the minimum levels required for the trial (confirm with trial site for specific values).
People (or their legal representative) who are willing and able to give written consent to participate.
Who may not be able to join:
People who currently have certain other types of lymphoma or blood cancers (such as Burkitt lymphoma, T-cell lymphoma, Hodgkin lymphoma, or others listed in the criteria) that require active treatment.
People taking high daily doses of steroids (above a certain threshold), or currently receiving methotrexate or a treatment called extracorporeal photopheresis.
People with PTLD that has spread to the brain or spinal cord that has not yet been treated, or where active chemotherapy or radiation to the brain/spine is still ongoing at the time of enrolment.
Stem cell transplant recipients who currently have moderate or severe graft-versus-host disease (a complication where donor cells attack the body).
People who have recently received certain immunotherapy drugs called checkpoint inhibitors (such as ipilimumab, pembrolizumab, or nivolumab) within a specific time window before enrolment.
Stem cell transplant recipients who currently have an active adenovirus infection in the blood.
People who currently need machines or medications to support their breathing or blood pressure.
People who received a specific type of immune-suppressing therapy (antithymocyte globulin or similar) within 4 weeks before enrolment.
People who received certain specialised T-cell or B-cell therapies related to EBV or transplant within 8 weeks before enrolment (confirm with trial site for specifics).
People who are pregnant or breastfeeding, or people of childbearing potential (male or female) who are unwilling to use a highly effective form of contraception during the trial.
People who would be unable to follow the procedures required by the study.
People with any other medical condition that the treating doctor believes could put them at risk or prevent them from completing the trial.
Important: Always verify eligibility with the trial site directly before applying.
Access in Australia: A treatment being studied in a clinical trial is generally not yet listed on the PBS. Where a medicine is not approved or not available through a trial, the TGA Special Access Scheme may allow a doctor to access unapproved therapeutic goods for individual patients. See voxsanity.com.au/sas-navigator/ for a plain English explainer.
This information was sourced from ClinicalTrials.gov via Voxsanity (data last synced 12 July 2026). It is not medical advice. Please verify the trial's current status directly with the trial site before acting.
Trial details
Status
Recruiting
Phase
Phase 3
Sponsor
Pierre Fabre Medicament
Registry
ClinicalTrials.gov
Start date
29 December 2017
Est. completion
31 May 2030
Where this trial is recruiting
🇦🇺 Australia
🇦🇹 Austria
🇧🇪 Belgium
🇨🇦 Canada
🇫🇷 France
🇮🇹 Italy
🇪🇸 Spain
🇬🇧 United Kingdom
🇺🇸 United States
6 site(s) in Australia. Confirm current status and contact details directly with the trial site.
Primary endpoints
Objective Response Rate (ORR) in the Analysis Cohorts C-SOT, C-HCT, and Combined Population (C-SOT-R+C, C-SOT-R-Ci, and C-HCT) Who Received Commercial Product, or a Product Manufactured Using a Comparable PV
Can't join this trial?
Expanded access pathways
If this trial is not available to you, other access pathways may exist. In Australia, the TGA Special Access Scheme allows access to unapproved therapeutic goods for individual patients.
Data last synced from ClinicalTrials.gov: 12 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.
Trial recruitment status can change without notice between our nightly data updates. Always contact the trial site directly to confirm current recruitment status before making any decisions or travel arrangements.