Renal Adjuvant MultiPle Arm Randomised Trial (RAMPART)

STATUS

Recruiting
End date

Dec 1, 2034
participants needed

1750
sponsor

University College, London

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Updated on 14 February 2022

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ct scan

platelet count

cancer

corticosteroids

systemic therapy

serum pregnancy test

carcinoma

metastasis

neutrophil count

tremelimumab

nephrectomy

Summary

RATIONALE: The current global standard of care after nephrectomy for localised RCC therefore remains active monitoring (i.e., observation by clinical and radiological means). 30-40% patients with initially localised RCC develop metastatic disease following nephrectomy. Need for adjuvant therapy is most marked in the high risk population where outcomes are predictably poor. However, the risk of recurrence in patients who are of intermediate risk of recurrence is not insignificant. Unfortunately, despite showing efficacy in advanced RCC, the results in the adjuvant setting, so far, are inconclusive.

AIM: RAMPART is a phase III Multi-Arm Multi-Stage randomised controlled platform trial, initiated with three arms. The trial is assessing if durvalumab monotherapy or the combination of durvalumab and tremelimumab can improve Disease Free Survival (DFS) or Overall Survival (OS) compared to the current global standard-of-care (active monitoring). At the start of recruitment, patients with Leibovich scores 3 to 11 will be eligible for randomisation. Accrual of intermediate risk patients (Leibovich scores 3 5) will stop after 3 years or when intermediate risk patients contribute 25% of the total accrual target, whichever is earlier. Recruitment of patients with Leibovich scores 6 to 11 will continue until the accrual target is reached.

Details

Condition	Renal Cell Carcinoma
Treatment	tremelimumab, durvalumab
Clinical Study Identifier	NCT03288532
Sponsor	University College, London
Last Modified on	14 February 2022

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Eligibility		Yes	No	Not Sure
Inclusion Criteria
	Patients with Grade 2 neuropathy will be evaluated on a case-by-case basis after consultation with the Study Physician
	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
	History of another primary malignancy except for
	Malignancy treated with curative intent and with no known active disease 5 years before the first dose of IP and of low potential risk for recurrence
	Adequately treated non-melanoma skin cancer or lentigo maligna without evidence of disease
	Adequately treated carcinoma in situ without evidence of disease
	History of leptomeningeal carcinomatosis
	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
	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
	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
	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
	Patients with vitiligo or alopecia
	Patients with hypothyroidism (e.g., following Hashimoto syndrome) stable on hormone replacement
	Any chronic skin condition that does not require systemic therapy
	Patients without active disease in the last 5 years may be included but only after consultation with the RAMPART Trial Management Team
	Patients with coeliac disease controlled by diet alone
	A history of immunodeficiency syndrome. Please consult the MRC CTU at UCL on an individual basis if there is any uncertainty
	History of allogeneic organ transplant
	Uncontrolled intercurrent illness including, but not limited to
	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)
	Symptomatic congestive heart failure
	Uncontrolled hypertension
	Unstable angina pectoris
	Uncontrolled cardiac arrhythmia
	Active peptic ulcer disease or gastritis
	Active bleeding diatheses
	Psychiatric illness or social situations that would limit compliance with study requirements or compromise the ability of the subject to give written informed consent
	Active infection including
	Tuberculosis (clinical evaluation that includes clinical history, physical examination and radiographic findings, and TB testing in line with local practice)
	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
	Hepatitis C
	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
	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
	Pregnant or breastfeeding patients
	Any condition that, in the opinion of the investigator, would interfere with evaluation of study treatment or interpretation of patient safety or study results
	Known allergy or hypersensitivity to durvalumab or tremelimumab, or any of their excipients
	Previous investigational medicinal product assignment in the present study
	Clinically significant pneumonitis or fibrosis
Exclusion Criteria
	Previous diagnosis of RCC
	Metastatic or macroscopic residual disease
	Patients with positive resection margins after partial nephrectomy
	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
	Prior anticancer treatment (other than nephrectomy) for RCC

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Study Definition

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Renal Adjuvant MultiPle Arm Randomised Trial (RAMPART)