Renal Adjuvant MultiPle Arm Randomised Trial

  • STATUS
    Recruiting
  • End date
    Dec 1, 2034
  • participants needed
    1750
  • sponsor
    University College, London
Updated on 25 January 2021
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 Adenocarcinoma, Malignant neoplasm of kidney, Renal Cell Carcinoma, Kidney Cancer, Malignant Adenoma, Renal Cell Cancer, Renal Cancer, clear cell renal cell carcinoma
Treatment tremelimumab, durvalumab
Clinical Study IdentifierNCT03288532
SponsorUniversity College, London
Last Modified on25 January 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Is your age greater than or equal to 18 yrs?
Gender: Male or Female
Do you have any of these conditions: Renal Cell Cancer or Kidney Cancer or Malignant neoplasm of kidney or Malignant Adenoma or Renal Cancer or Adenocarcinoma or Renal Cell Carcinoma?
Do you have any of these conditions: Adenocarcinoma or Renal Cell Cancer or Malignant Adenoma or Renal Cell Carcinoma or Malignant neoplasm of kidney or Renal Cancer or clear cell renal c...?
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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