Renal Adjuvant Multiple Arm Randomised Trial (RAMPART)

ISRCTN	ISRCTN53348826
DOI	https://doi.org/10.1186/ISRCTN53348826
EudraCT/CTIS number	2017-002329-39
ClinicalTrials.gov number	NCT03288532
Secondary identifying numbers	RE06

Submission date: 22/09/2017
Registration date: 02/10/2017
Last edited: 21/09/2021

Recruitment status: No longer recruiting
Overall study status: Ongoing
Condition category: Cancer

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

Plain English Summary

https://www.cancerresearchuk.org/about-cancer/find-a-clinical-trial/a-trial-looking-at-durvalumab-and-tremelimumab-for-kidney-cancer-rampart#undefined (added 13/08/2020)

Background and study aims
Renal cell carcinoma is a type of kidney cancer that starts from the kidneys. It is the 8th most common cancer in the UK and an increase of new cases of 2% has been seen in the last 20 years. About half of the new cases of kidney cancer are among people aged 70 and over. Patients whose disease has not spread outside the kidneys typically have surgery to remove a part or all of their kidney (called a partial or radical nephrectomy). After surgery, patients are seen by their doctor with regular check-ups to look for signs of the cancer coming back or spreading to other parts of the body. This is generally called ‘active monitoring’ or ‘active surveillance’. Unfortunately, it is estimated that the cancer will return in 30-40% of the patients who have undergone surgery. Many studies have been carried out to find if a new treatment after surgery might slow the cancer coming back or prevent it from coming back altogether. However, to date no treatment is available. Immunotherapy is a type of cancer treatment that ‘wakes up’ the patient’s own immune system so it can fight the cancer. New drugs which act in this way have worked well in patients with skin cancer (melanoma), lung cancer and in patients witch kidney cancer that has spread outside the kidney. This study is looking at two new immunotherapy treatments. The aim is to find out whether taking one drug (durvalumab) or a combination of two drugs (durvalumab and tremelimumab) for one year can prevent or delay kidney cancer from coming back compared to the current standard of care (active monitoring after surgery). Durvalumab is currently being tested (alone or in combination with other drugs) in many types of cancer. Tremelimumab is also being tested in different types of cancer.

Who can participate?
Patients aged 18 and over with renal cell carcinoma

What does the study involve?
Participants are randomly allocated to one of three groups. Group A is actively monitored for 1 year after nephrectomy. Group B is treated with durvalumab (1500 mg) administered 4 weekly for 1 year (13 cycles maximum) by intravenous infusion (into a vein). Group C is treated with durvalumab administered as per group B (13 cycles maximum) and tremelimumab on day 1 and week 4 visits (2 cycles) by intravenous infusion. The treatment duration is 1 year maximum. Once treatment is completed, participants are seen at week 52, then 3 monthly up to the end of year 3, 6-monthly up to year 5 and annually thereafter.

What are the possible benefits and risks of participating?
If positive, the results of the study will change the current standard of care for the treatment of kidney cancer after surgery. Like all drugs, these treatments have side effects and participants have regular blood tests and scans and appointments with their study doctor and nurse.

Where is the study run from?
Participating centres are being confirmed, list of centres to be updated in due course (Australia, France, UK and USA)

When is the study starting and how long is it expected to run for?
December 2017 to December 2037

Who is funding the study?
1. Kidney Cancer UK
2. AstraZeneca (UK)
3. Medical Research Council (UK)

Who is the main contact?
1. Mr Ben Smith
mrcctu.rampart@ucl.ac.uk
2. Ms Hanna Bryant (updated 17/07/2020, previously: Dr Francesca Schiavone)
mrcctu.rampart@ucl.ac.uk

Study website

Contact information

Mr Ben Smith
Public

MRC Clinical Trials Unit at UCL
90 High Holborn, 2nd floor
London
WC1V 6LJ
United Kingdom

Phone	+44 (0)207 670 4743
Email	mrcctu.rampart@ucl.ac.uk

Ms Hanna Bryant
Public

MRC Clinical Trials Unit at UCL
90 High Holborn, 2nd floor
London
WC1V 6LJ
United Kingdom

Phone	+44 (0)207 670 4683
Email	mrcctu.rampart@ucl.ac.uk

Study information

Study design	Multi-centre multi-arm multi-stage unblinded randomised controlled platform trial
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Hospital
Study type	Treatment
Participant information sheet	Not available in web format, please use the contact details to request a patient information sheet
Scientific title	An international investigator-led phase III multi-arm multi-stage multi-centre randomised controlled platform trial of adjuvant therapy in patients with resected primary renal cell carcinoma (RCC) at high or intermediate risk of relapse
Study acronym	RAMPART
Study hypothesis	Durvalumab is able to prevent tumour relapse by the inhibition of the programmed cell death 1 (PD-1)/ programmed death ligand 1 (PD-L1) pathway, which plays a critical role in tumour immune evasion. Combination treatment with anti-CTLA4 agent tremelimumab increases immune response and anti-tumour activity.
Ethics approval(s)	Approved 07/01/2018, London Riverside Ethics Committee (Level 3 Block B, Whitefriars, Lewins Mead, Bristol BS1 2NT; +44 (0)207 1048340, riverside.rec@hra.nhs.uk), ref 17/LO/1875
Condition	Resected primary renal cell carcinoma
Intervention	The trial will initially open with 3 research arms. The allocation ratio will be 3:2:2 with patients assigned centrally through block randomisation with a small number of clinically important stratification factors. Arm A: The control arm is active monitoring after nephrectomy (observation through radiological means) for 1 year Arm B: Durvalumab (1500 mg) administered 4 weekly for 1 year (13 cycles maximum) via intravenous infusion Arm C: Durvalumab (1500 mg) administered as per arm B (13 cycles maximum) and tremelimumab (75 mg) on day 1 and week 4 visits (2 cycles) via intravenous infusion The treatment duration is 1 year maximum. Once treatment is completed, patients will be seen at week 52, then 3 monthly up to the end of year 3, 6-monthly up to year 5 and annually thereafter.
Intervention type	Drug
Pharmaceutical study type(s)
Phase	Phase III
Drug / device / biological / vaccine name(s)	Durvalumab, tremelimumab
Primary outcome measure	1. Disease Free Survival (DFS) will be assessed via radiological assessments through CT scans. DFS is defined as the interval from randomisation to first evidence of local recurrence, new primary RCC, distant metastases or death from any cause, whichever occurs first. All CT scans received will be further assessed by an independent review panel to ensure that progression has been reported correctly. Primary analysis for DFS will be carried out when: Arm C vs Arm A 276 control arm events (approx 6.25 years) have occurred Arm B vs Arm A 416 control arm events (approx 10.75 years) have occurred DFS Interim analysis will be carried out at the following timepoints: Arm B vs Arm A Interim analysis 1 (overwhelming and lack-of-benefit) when 197 control arm events have occurred (approx 4.75 years) Interim analysis 2 (overwhelming and lack-of-benefit) when 277 control arm events have occurred (approx 6.25 years) Interim analysis 3 (overwhelming benefit) when 332 control arm events have occurred (approx 8 years) Arm C vs Arm A: Interim analysis 1 (overwhelming benefit and lack-of-benefit) when 198 control arm events have occurred (approx 4.75 years) 2. Overall Survival (OS) is another co-primary endpoint. OS is defined as all cause mortality, the time from randomisation to death from any cause (including RCC). For UK sites, survival status will also be collected against national mortality registers. Comparison of overall survival for Arm B vs Arm A will be carried out at approximately 20.5 years after trial commencement (triggered by 344 control arm OS events). For Arm C vs Arm A, overall survival will be assessed at approximately 13.25 years after trial commences (triggered by 238 control arm OS events)
Secondary outcome measures	Assessment of all secondary outcomes will take place at each follow-up visit at week 52, then 3 monthly up to the end of year 3, 6-monthly up to year 5 and annually thereafter. 1. Metastasis-free survival (MFS), defined as the interval from randomisation to first evidence of metastasis or death from RCC, measured via radiological means (CT scan with contrast) 2. RCC-specific survival time, defined as the time from randomisation to death from RCC, reported on trial-specific CRF 3. Quality of life, measured using quality of life questionnaires (EQ-5D and QLQ-C30 CRFs) at baseline, week 16, month 15, month 36 visits and at progression (if progression occurs before month 36) 4. Toxicity, reported on trial-specific CRF 5. Patient preferences for adjuvant immunotherapy information collected through the optional PAIR questionnaire completed at baseline, at the week 12 visit and the month 15 visit, or approximately 3 months after the last treatment visit if patient stops treatment early Secondary outcome measures will be assessed after the primary analysis and therefore will be confirmed at a later date
Overall study start date	01/12/2017
Overall study end date	01/12/2037

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	Both
Target number of participants	1,750
Participant inclusion criteria	Current inclusion criteria as of 17/07/2020: 1. Histologically proven RCC (all cell types of RCC are eligible, except for pure oncocytoma, collecting duct, medullary and transitional cell cancer [TCC]); no evidence of residual macroscopic disease on post-operative CT scan after resection of RCC. Patients with treated bilateral synchronous RCCs are eligible 2. At the start of recruitment patients with Leibovich score 3-11 will be eligible for randomisation . MRC CTU at UCL will monitor accrual and stop recruiting intermediate risk patients (Leibovich Score 3-5) after three years or when intermediate risk patients contribute 25% of the total accrual target, whichever is earlier. Recruitment of patients with Leibovich Score 6-11 will continue until the accrual target is reached 3. Patients should have had surgery at least 28 days but no more than 91 days prior to their randomisation date 4. Post-operative scans should be performed within 28 days prior to randomisation 5. Patients with microscopically positive resection margins after radical nephrectomy at the nephrectomy bed, renal vein or inferior vena cava are eligible provided the post-operative CT scan shows no evidence of residual macroscopic disease 6. WHO Performance Status 0 or 1 7. Patient has archival FFPE pathology tissue available, and agrees to provide at least one sample (FFPE tumour block from nephrectomy, or a minimum of 10 unstained slides), as well as a baseline EDTA blood sample for future translational research (this is separate to providing consent for TransRAMPART) 8. Adequate normal organ and marrow function 8.1. Haemoglobin ≥ 9.0g/dl (transfusions will be allowed within 2 weeks prior to randomisation in order to achieve the entry criteria) 8.2. Absolute neutrophil count (ANC) ≥ 1.5 x 109/l (≥ 1,500 per mm3) 8.3. Platelet count ≥ 100 x 10^9 (≥ 100,000 per mm3) 8.4. Bilirubin ≤ 1.5 x ULN (This will not apply to subjects with confirmed Gilbert’s syndrome (i.e., persistent or recurrent hyperbilirubinemia that is predominantly unconjugated in the absence of haemolysis or hepatic pathology), who will be allowed only in consultation with their physician) 8.5. AST/ALT ≤2.5 x ULN 8.6. Calculated Creatinine Clearance level >40mL/min by Cockcroft Gault formula (using actual body weight) 9. 12-lead ECG on which QTcF must be <450 ms. In case of clinically significant ECG abnormalities, including a QTcF value ≥ 450 ms, two additional 12-lead ECGs should be obtained over a brief period (e.g., 30 minutes) to confirm the finding. Patients are only eligible if a QTcF of < 450ms is confirmed 10. Subjects must be ≥ 18 y of age 11. Written informed consent obtained from the patient 12. Both men and women enrolled in this trial must be in agreement with trial policy on contraception (Section 5.8.4) during the treatment phase of the study and 6 months afterwards. Egg donation, sperm donation and breastfeeding must be avoided 13. Evidence of post-menopausal status or negative serum HCG pregnancy test for female pre-menopausal patients. Women will be considered post-menopausal if they have been amenorrhoeic for 12 months without an alternative medical cause. The following age-specific requirements apply: 13.1. Women < 50 y of age will be considered post-menopausal if they have been amenorrhoeic for 12 months or more following cessation of exogenous hormonal treatments and if they have luteinising hormone and follicle-stimulating hormone levels in the post-menopausal range for the institution or underwent surgical sterilisation (bilateral oophorectomy or hysterectomy) 13.2. Women ≥ 50 y of age will be considered post-menopausal if they have been amenorrhoeic for 12 months or more following cessation of all exogenous hormonal treatments, had radiation-induced menopause with last menses > 1 y ago, had chemotherapy-induced menopause with last menses > 1 y ago, or underwent surgical sterilisation (bilateral oophorectomy, bilateral salpingectomy, or hysterectomy) _____ Previous inclusion criteria: 1. Histologically proven RCC (all cell types of RCC are eligible, except for pure oncocytoma, collecting duct, medullary and transitional cell cancer [TCC]); no evidence of residual macroscopic disease on post-operative CT scan after resection of RCC. Patients with treated bilateral synchronous RCCs are eligible 2. At the start of recruitment patients with Leibovich score 3-11 will be eligible for randomisation. MRC CTU at UCL will monitor accrual and stop recruiting intermediate risk patients (Leibovich Score 3-5) after three years or when intermediate risk patients contribute 25% of the total accrual target, whichever is earlier. Recruitment of patients with Leibovich Score 6 11 will continue until the accrual target is reached 3. Patients should have had surgery at least 28 days but no more than 91 days prior to randomisation date 4. Post-operative scans should be performed within 28 days prior to randomisation 5. WHO Performance Status 0 or 1 6. Patient has archival FFPE pathology tissue (FFPE tumour block from nephrectomy, or a minimum of 10 unstained slides) available as well as a baseline EDTA blood sample and agrees to provide a sample for future biomarker testing 7. Adequate normal organ and marrow function: 7.1. Haemoglobin ≥9.0g/dL (transfusions will be allowed within 2 weeks prior to randomisation in order to achieve the entry criteria). 7.2. Absolute neutrophil count (ANC) ≥1.5 x 109/L (≥1500 per mm3) 7.3. Platelet count ≥100 x 109 (≥100,000 per mm3) 7.4. Bilirubin ≤1.5 x ULN (This will not apply to subjects with confirmed Gilbert’s syndrome (i.e., persistent or recurrent hyperbilirubinemia that is predominantly unconjugated in the absence of haemolysis or hepatic pathology), who will be allowed only in consultation with their physician) 7.5. AST/ALT ≤2.5 x ULN. 7.6. Calculated Creatinine Clearance level >40mL/min by Cockcroft Gault formula (using actual body weight) 8. 12-lead ECG on which QTcF must be <470 ms. In case of clinically significant ECG abnormalities, including a QTcF value >470 ms, two additional 12-lead ECGs should be obtained over a brief period (e.g., 30 minutes) to confirm the finding 9. Current weight ≥ 40kg 10. Subjects must be ≥18 years of age 11. Written informed consent obtained from the patient 12. Both men and women enrolled in this trial must be in agreement with trial policy on contraception during the treatment phase of the study and for 9 months afterwards. Egg donation, sperm donation and breastfeeding must be avoided 13. Evidence of post-menopausal status or negative urinary or serum pregnancy test for female pre menopausal patients. Women will be considered post-menopausal if they have been amenorrhoeic for 12 months without an alternative medical cause. The following age specific requirements apply: 13.1. Women <50 years of age will be considered post-menopausal if they have been amenorrhoeic for 12 months or more following cessation of exogenous hormonal treatments and if they have luteinising hormone and follicle-stimulating hormone levels in the post-menopausal range for the institution or underwent surgical sterilisation (bilateral oophorectomy or hysterectomy) 13.2. Women ≥50 years of age will be considered post-menopausal if they have been amenorrhoeic for 12 months or more following cessation of all exogenous hormonal treatments, had radiation-induced menopause with last menses >1 year ago, had chemotherapy induced menopause with last menses >1 year ago, or underwent surgical sterilisation (bilateral oophorectomy, bilateral salpingectomy, or hysterectomy)
Participant exclusion criteria	Current exclusion criteria as of 17/07/2020: 1. Previous diagnosis of RCC 2. Metastatic or macroscopic residual disease 3. Patients with positive resection margins after partial nephrectomy 4. Patients with a single pulmonary nodule ≥ 5mm diameter are not eligible unless the nodule has had a definite benign diagnosis. Patients with multiple small, less than 5 mm nodules may be eligible if nodules have been shown to be radiologically stable for at least 8 weeks. 5. Prior anticancer treatment (other than nephrectomy) for RCC 6. Any unresolved toxicity NCI CTCAE Grade ≥ 2 from previous anticancer therapy with the exception of alopecia, vitiligo, and the laboratory values defined in the inclusion criteria: 6.1. Patients with Grade ≥ 2 neuropathy will be evaluated on a case-by-case basis after consultation with the Study Physician 6.2. Patients with irreversible toxicity not reasonably expected to be exacerbated by treatment with durvalumab or tremelimumab may be included only after consultation with the Study Physician 7. History of another primary malignancy except for: 7.1. Malignancy treated with curative intent and with no known active disease ≥ 5 y before the first dose of IP and of low potential risk for recurrence 7.2. Adequately treated non-melanoma skin cancer or lentigo maligna without evidence of disease 7.3. Adequately treated carcinoma in situ without evidence of disease 8. History of leptomeningeal carcinomatosis 9. Concurrent enrolment in another clinical study, unless it is an observational (non-interventional) clinical study or during the follow-up period of an interventional study 10. Major surgical procedure (as defined by the Investigator) within 28 days prior to the start of treatment. Local surgery of isolated lesions for palliative intent is acceptable 11. Current or prior use of immunosuppressive medication within 14 days before the first dose of durvalumab or tremelimumab, with the exceptions of intranasal and inhaled corticosteroids or systemic corticosteroids at physiological doses, which are not to exceed 10 mg/day of prednisone, or an equivalent corticosteroid 12. Active or prior documented autoimmune or inflammatory disorders (including inflammatory bowel disease [e.g., colitis or Crohn's disease], diverticulitis [with the exception of diverticulitis], systemic lupus erythematosus, Sarcoidosis syndrome, or Wegener syndrome [granulomatosis with polyangiitis, Graves' disease, rheumatoid arthritis, hypophysitis, uveitis, etc]). The following are exceptions to this criterion: 12.1. Patients with vitiligo or alopecia 12.2. Patients with hypothyroidism (e.g., following Hashimoto syndrome) stable on hormone replacement 12.3. Any chronic skin condition that does not require systemic therapy 12.4. Patients without active disease in the last 5 years may be included but only after consultation with the RAMPART Trial Management Team 12.5. Patients with coeliac disease controlled by diet alone 13. A history of immunodeficiency syndrome. Please consult the MRC CTU at UCL on an individual basis if there is any uncertainty 14. History of allogeneic organ transplant 15. Uncontrolled intercurrent illness including, but not limited to: 15.1. Ongoing or active infection of any kind (patients who are exhibiting symptoms consistent with COVID-19, or who have tested positive, should not be randomised into the study until they are asymptomatic and at least 14 days after a positive test) 15.2. Symptomatic congestive heart failure 15.3. Uncontrolled hypertension 15.4. Unstable angina pectoris 15.5. Uncontrolled cardiac arrhythmia 15.6. Active peptic ulcer disease or gastritis 15.7. Active bleeding diatheses 15.8. Psychiatric illness or social situations that would limit compliance with study requirements or compromise the ability of the subject to give written informed consent 16. Active infection including: 16.1. Tuberculosis (clinical evaluation that includes clinical history, physical examination and radiographic findings, and TB testing in line with local practice) 16.2. Hepatitis B (known positive HBV surface antigen (HBsAg) result). Patients with a past or resolved HBV infection (defined as the presence of hepatitis B core antibody [anti-HBc] and absence of HBsAg) are eligible 16.3. Hepatitis C 16.4. Human immunodeficiency virus (positive HIV 1/2 antibodies). Note: Patients positive for hepatitis C (HCV) antibody are eligible only if polymerase chain reaction is negative for HCV RNA 17. Receipt of live attenuated vaccine within 30 days prior to the start of treatment. Note: Patients, if enrolled, should not receive live vaccine while receiving investigational medicinal product and up to 30 days after the last dose of investigational medicinal product 18. Pregnant or breastfeeding patients 19. Any condition that, in the opinion of the investigator, would interfere with evaluation of study treatment or interpretation of patient safety or study results 20. Known allergy or hypersensitivity to durvalumab or tremelimumab, or any of their excipients 21. Previous investigational medicinal product assignment in the present study 22. Clinically significant pneumonitis or fibrosis _____ Previous exclusion criteria: 1. Previous diagnosis of RCC 2. Metastatic or macroscopic residual disease 3. Patients with a single pulmonary nodule ≥5mm diameter are not eligible unless the nodule has had a definite benign diagnosis. Patients with multiple small, less than 5 mm nodules may be eligible if nodules have been shown to be radiologically stable for at least 8 weeks 4. Prior anticancer treatment (other than nephrectomy) for RCC 5. Any unresolved toxicity NCI CTCAE Grade ≥2 from previous anticancer therapy with the exception of alopecia, vitiligo, and the laboratory values defined in the inclusion criteria: 5.1. Patients with Grade ≥2 neuropathy will be evaluated on a case-by-case basis after consultation with the Study Physician. 5.2. Patients with irreversible toxicity not reasonably expected to be exacerbated by treatment with durvalumab or tremelimumab may be included only after consultation with the Study Physician 6. Prior malignancy which in the opinion of the investigator has an estimated risk of recurrence in 5 years greater than 5% 7. History of leptomeningeal carcinomatosis 8. Concurrent enrolment in another clinical study, unless it is an observational (non interventional) clinical study or during the follow up period of an interventional study 9. Major surgical procedure (as defined by the Investigator) within 28 days prior to the start of treatment. Local surgery of isolated lesions for palliative intent is acceptable 10. Current or prior use of immunosuppressive medication within 14 days before the first dose of durvalumab or tremelimumab, with the exceptions of intranasal and inhaled corticosteroids or systemic corticosteroids at physiological doses, which are not to exceed 10 mg/day of prednisone, or an equivalent corticosteroid 11. Active or prior documented autoimmune or inflammatory disorders (including inflammatory bowel disease [e.g., colitis or Crohn's disease], diverticulitis [with the exception of diverticulosis], systemic lupus erythematosus, Sarcoidosis syndrome, or Wegener syndrome [granulomatosis with polyangiitis, Graves' disease, rheumatoid arthritis, hypophysitis, uveitis, etc]). The following are exceptions to this criterion: 11.1. Patients with vitiligo or alopecia 11.2. Patients with hypothyroidism (e.g., following Hashimoto syndrome) stable on hormone replacement 11.3. Any chronic skin condition that does not require systemic therapy 11.4. Patients without active disease in the last 5 years may be included but only after consultation with the RAMPART Trial Management Team 11.5. Patients with coeliac disease controlled by diet alone 12. A history of immunodeficiency syndrome. Please consult the MRC CTU at UCL on an individual basis if there is any uncertainty. 13. History of allogeneic organ transplant. 14. Uncontrolled intercurrent illness including, but not limited to: 14.1. Ongoing or active infection 14.2. Symptomatic congestive heart failure 14.3. Uncontrolled hypertension 14.4. Unstable angina pectoris 14.5. Uncontrolled cardiac arrhythmia 14.6. Active peptic ulcer disease or gastritis 14.7. Active bleeding diatheses 14.8. Psychiatric illness or social situations that would limit compliance with study requirements or compromise the ability of the subject to give written informed consent. 15. Active infection including: 15.1. Tuberculosis (clinical evaluation that includes clinical history, physical examination and radiographic findings, and TB testing in line with local practice) 15.2. Hepatitis B (known positive HBV surface antigen (HBsAg) result) 15.3. Hepatitis C 15.4. Human immunodeficiency virus (positive HIV 1/2 antibodies). Patients with a past or resolved HBV infection (defined as the presence of hepatitis B core antibody [anti HBc] and absence of HBsAg) are eligible Note: Patients positive for hepatitis C (HCV) antibody are eligible only if polymerase chain reaction is negative for HCV RNA 16. Receipt of live attenuated vaccine within 30 days prior to the start of treatment. Note: Patients, if enrolled, should not receive live vaccine while receiving investigational medicinal product and up to 30 days after the last dose of investigational medicinal product. 17. Pregnant or breastfeeding patients 18. Any condition that, in the opinion of the investigator, would interfere with evaluation of study treatment or interpretation of patient safety or study results 19. Known allergy or hypersensitivity to durvalumab or tremelimumab, or any of their excipients 20. Previous investigational medicinal product assignment in the present study
Recruitment start date	20/12/2017
Recruitment end date	30/03/2023

Locations

Countries of recruitment

Australia
England
France
Scotland
Spain
United Kingdom
Wales

Study participating centres

The Royal Marsden Hospital

Fulham Road
Chelsea
London
SW3 6JJ
United Kingdom

Aberdeen Royal Infirmary

Intensive Care Unit
Aberdeen
AB25 2ZN
United Kingdom

Addenbrooke's Hospital

Hills Road
Cambridge
CB2 0QQ
United Kingdom

Beatson West of Scotland Cancer Centre

1053 Great Western Road
Glasgow
G12 0YN
United Kingdom

Bristol Haematology and Oncology Centre

Horfield Road
Bristol
BS2 8ED
United Kingdom

Broomfield Hospital

Court Road
Chelmsford
CM1 7ET
United Kingdom

Castle Hill Hospital

Castle Road
Cottingham
HU16 5JQ
United Kingdom

Charing Cross Hospital

Imperial College Healthcare NHS Trust
Fulham Palace Rd
Hammersmith
London
W6 8RF
United Kingdom

Cheltenham General Hospital

Sandford Road
Cheltenham
GL53 7AN
United Kingdom

The Christie

Wilmslow Road
Manchester
M20 4BX
United Kingdom

Churchill Hospital

Oxford University Hospitals NHS Foundation Trust
Old Road
Headington
Oxford
OX3 7LE
United Kingdom

Clatterbridge Cancer Centre

Clatterbridge Road
Bebington
Wirral
CH63 4JY
United Kingdom

Colchester General Hospital

Turner Road
Colchester
CO4 5JL
United Kingdom

Glan Clwyd Hospital

Rhuddlan Rd
Rhyl
LL18 5UJ
United Kingdom

Guy's Hospital

Great Maze Pond
London
SE1 9RT
United Kingdom

Leicester Royal Infirmary

Infirmary Square
Leicester
LE1 5WW
United Kingdom

Mount Vernon Hospital

Rickmansworth Road
Northwood
HA6 2RN
United Kingdom

Nottingham University Hospital

Hucknall Road
Nottingham
NG5 1PB
United Kingdom

Queen Alexandra Hospital

Southwick Hill Road
Cosham
PO6 3LY
United Kingdom

Raigmore Hospital

Old Perth Rd
Inverness
IV2 3UJ
United Kingdom

Royal Bournemouth Hospital

Castle Lane
Bournemouth
BH7 7DW
United Kingdom

Royal Free Hospital

Pond Street
London
NW3 2QG
United Kingdom

Royal Marsden Hospital

Downs Road
Sutton
SM2 5PT
United Kingdom

Scunthorpe General Hospital

Cliff Gardens
Scunthorpe
DN15 7BH
United Kingdom

Southend University Hospital

Prittlewell Chase
Southend-on-Sea
SS0 0RY
United Kingdom

South Tyneside District Hospital

Harton Ln
South Shields
NE34 0PL
United Kingdom

St Bart's Hospital

West Smithfield
London
EC1A 7BE
United Kingdom

St James University Hospital

Beckett Street
Leeds
LS9 7TF
United Kingdom

Sunderland Royal Hospital

Kayll Rd
Sunderland
SR4 7TP
United Kingdom

Torbay District Hospital

Lowes Bridge
Torquay
TQ2 7AA
United Kingdom

Velindre Cancer Centre

Velindre Road
Cardiff
CF14 2TL
United Kingdom

Western General Hospital

Crewe Road South
Edinburgh
EH4 2XU
United Kingdom

Weston Park Hospital

Whitham Road
Sheffield
S10 2SJ
United Kingdom

Ysbyty Gwynedd

Penrhosgarnedd
Bangor
LL57 2PW
United Kingdom

Sponsor information

University College London
University/education

Gower Street
London
WC1E 6BT
England
United Kingdom

Phone	+44 (0)20 7679 2000
Email	mrcctu.rampart@ucl.ac.uk
Website	https://www.ucl.ac.uk/
"ROR"	https://ror.org/02jx3x895

Funders

Funder type

Industry

Kidney Cancer UK

No information available

AstraZeneca
Government organisation / For-profit companies (industry)

Alternative name(s): AstraZeneca PLC, Pearl Therapeutics
Location: United Kingdom

Medical Research Council
Government organisation / National government

Alternative name(s): Medical Research Council (United Kingdom), UK Medical Research Council, MRC
Location: United Kingdom

Results and Publications

Intention to publish date	01/12/2038
Individual participant data (IPD) Intention to share	Yes
IPD sharing plan summary	Available on request
Publication and dissemination plan	The protocol and all patient-related documents will be made available on the trial website (https://www.rampart-trial.org/) once approved by ethics committee and regulatory authority. Planned publication in a high-impact peer reviewed journal; articles will be open access in line with UCL publication policy.
IPD sharing plan	The RAMPART Trial Management Team should be contacted in the first instance with any data release requests (mrcctu.rampart@ucl.ac.uk). Review of the request will be then escalated to the Trial Management Group and TSC for final approval. MRC CTU SOP on Data Sharing will be followed for the review and release process. Requests to release control arm data will be considered at any point during the trial but data release requests for the entire dataset (including treatment arms) will not be granted until the primary end-points have been reached and published. Consent will be obtained by patients prospectively and data release is subject to successful execution of the relevant contract.

Study outputs

Output type	Date created	Date added	Peer reviewed?	Patient-facing?
Protocol article	01/09/2021	21/09/2021	Yes	No
Protocol article	01/09/2021	21/09/2021	Yes	No
HRA research summary		28/06/2023	No	No

Editorial Notes

21/09/2021: Publication references added.
13/08/2020: Cancer Research UK summary link added to the plain English summary.
17/07/2020: The following changes were made to the trial record:
1. The ethics approval was added.
2. The inclusion criteria were changed.
3. The exclusion criteria were changed.
4. The recruitment country "USA" was removed and "Spain" was added.
5. The trial participating centres were added.
6. The study contact was changed.
7. The plain English summary was updated to reflect these changes.