Evidence map›Paper›PMID 34538402›Full record

Trial reportContemporary clinical trials2021

RAMPART: A phase III multi-arm multi-stage trial of adjuvant checkpoint inhibitors in patients with resected primary renal cell carcinoma (RCC) at high or intermediate risk of relapse.

Bhavna Oza, Eleni Frangou, Ben Smith, Hanna Bryant, Rick Kaplan, Babak Choodari-Oskooei, Tom Powles, Grant D Stewart, Laurence Albiges, Axel Bex and 17 more

Registry-linked trialOpen access · hybridAbstract readClinical Trial, Phase IIIRandomized Controlled TrialAdaptive Clinical Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Contemporary clinical trials, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT03288532 (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), which is not on this map. Cited by 33 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
33citing papers in PubMed, 1 pooled it
6.6field-weighted citation impact, top 2% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT03288532 phase3recruitingnot on this map

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

TypeinterventionalSponsorUniversity College, LondonRan2018 to 2034Enrolled1,750ConditionsRenal Cell CarcinomaArmsDurvalumab, Tremelimumab
3 · Its place in the literature

Who cites it

33 citing papers in PubMed, 1 synthesis or guideline pooled it, 59 citations in OpenAlex.

  1. Pooled it
  2. Trial
  3. Review
  4. Review
  5. Review
  6. Article
  7. Review
  8. Review
  9. Review
  10. Advances in Adjuvant Therapy for Renal Cell Carcinoma: Perspectives on Risk Stratification and Treatment Outcomes.International journal of urology : official journal of the Japanese Urological Association · 2025
    Review
  11. Review
  12. Perioperative therapies for metastatic renal cell carcinoma.Journal of cancer metastasis and treatment · 2025
    Article
  13. Article
  14. Review
  15. Role of theBiomedicines · 2024
    Article
  16. Turning the tide: pembrolizumab's triumph in adjuvant RCC therapy.Medical oncology (Northwood, London, England) · 2024
    Review
  17. Review
  18. Article
  19. Bibliometric analysis of renal cell carcinoma with venous tumor thrombus.International journal of medical sciences · 2024
    Article
  20. Review
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

27 authors at 14 institutions in 5 countries.

Bhavna OzaMRC Clinical Trials Unit at UCL, Institute of Clinical Trials & Methodology, 2nd Floor 90 High Holborn, London WC1V 6LJ, UK. Electronic address: b.oza@ucl.ac.uk.
Eleni FrangouMRC Clinical Trials Unit at UCL, Institute of Clinical Trials & Methodology, 2nd Floor 90 High Holborn, London WC1V 6LJ, UK.
Ben SmithMRC Clinical Trials Unit at UCL, Institute of Clinical Trials & Methodology, 2nd Floor 90 High Holborn, London WC1V 6LJ, UK.
Hanna BryantMRC Clinical Trials Unit at UCL, Institute of Clinical Trials & Methodology, 2nd Floor 90 High Holborn, London WC1V 6LJ, UK.
Rick KaplanMRC Clinical Trials Unit at UCL, Institute of Clinical Trials & Methodology, 2nd Floor 90 High Holborn, London WC1V 6LJ, UK.
Babak Choodari-OskooeiMRC Clinical Trials Unit at UCL, Institute of Clinical Trials & Methodology, 2nd Floor 90 High Holborn, London WC1V 6LJ, UK.
Tom PowlesSt Bartholomew's Hospital, W Smithfield, London EC1A 7B, UK.
Grant D StewartDepartment of Surgery, University of Cambridge, Cambridge Biomedical Campus, Cambridge CB2 0QQ, UK.
Laurence AlbigesInstitut Gustave Roussy, 114 Rue Edouard Vaillant, 94805 Villejuif, France.
Axel BexRoyal Free London NHS Foundation Trust UCL Division of Surgery and Interventional Science, Pond Street, London NW3 2QG; Netherlands Cancer Institute, Amsterdam, the Netherlands.
Toni K ChoueiriDana-Farber Cancer Institute, 450 Brookline Ave, Boston, MA 02215, United States.
Ian D DavisMonash University Eastern Health Clinical School, Level 2, 5 Arnold Street, Box Hill, VIC 3128, Australia; Department of Medical Oncology, Eastern Health, Melbourne, Australia; ANZUP Cancer Trials Group, Sydney, Australia.
Tim EisenDepartment of Oncology, Cambridge University Hospitals NHS Foundation Trust, Addenbrooke's Hospital, Cambridge Biomedical Campus Hill's Road, Cambridge CB2 0QQ, UK.
Alison FieldingMRC Clinical Trials Unit at UCL, Institute of Clinical Trials & Methodology, 2nd Floor 90 High Holborn, London WC1V 6LJ, UK.
David HarrisonUniversity of St Andrews, North Haugh, St Andrews KY16 9TF, UK.
Anita McWhirterRoyal Marsden Hospital, 203 Fulham Rd, Chelsea, London SW3 6JJ, UK.
Salena MulhereMRC Clinical Trials Unit at UCL, Institute of Clinical Trials & Methodology, 2nd Floor 90 High Holborn, London WC1V 6LJ, UK.
Paul NathanMount Vernon Cancer Centre, Rickmansworth Rd, Northwood HA6 2RN, UK.
Brian RiniCleveland Clinic, 9500 Euclid Avenue, Cleveland, OH, United States.
Alastair RitchieMRC Clinical Trials Unit at UCL, Institute of Clinical Trials & Methodology, 2nd Floor 90 High Holborn, London WC1V 6LJ, UK.
Sarah ScovellSt Bartholomew's Hospital, W Smithfield, London EC1A 7B, UK.
Clare ShakeshaftMRC Clinical Trials Unit at UCL, Institute of Clinical Trials & Methodology, 2nd Floor 90 High Holborn, London WC1V 6LJ, UK.
Martin R StocklerANZUP Cancer Trials Group, Sydney, Australia; NHMRC Clinical Trials Centre, University of Sydney, Camperdown, NSW 2006, Australia.
Nat ThorogoodMRC Clinical Trials Unit at UCL, Institute of Clinical Trials & Methodology, 2nd Floor 90 High Holborn, London WC1V 6LJ, UK.
Mahesh K B ParmarMRC Clinical Trials Unit at UCL, Institute of Clinical Trials & Methodology, 2nd Floor 90 High Holborn, London WC1V 6LJ, UK.
James LarkinRoyal Marsden Hospital, 203 Fulham Rd, Chelsea, London SW3 6JJ, UK.
Angela MeadeMRC Clinical Trials Unit at UCL, Institute of Clinical Trials & Methodology, 2nd Floor 90 High Holborn, London WC1V 6LJ, UK.
University College London · GBMRC Clinical Trials Unit at UCL · GBRoyal Marsden NHS Foundation Trust · GBSt Bartholomew's Hospital · GBCambridge University Hospitals NHS Foundation Trust · GBCleveland Clinic · USDana-Farber Cancer Institute · USInstitut Gustave Roussy · FRMonash University · AUMount Vernon Cancer Centre · GBNational Health and Medical Research Council · AUOncode Institute · NLUniversity of Cambridge · GBUniversity of St Andrews · GB

Funding

Cancer Research UK 28690Medical Research Council MC_UU_00004/01Medical Research Council MC_UU_00004/09Medical Research Council MC_UU_12023/29
6 · The paper itself

Abstract

background20-60% of patients with initially locally advanced Renal Cell Carcinoma (RCC) develop metastatic disease despite optimal surgical excision. Adjuvant strategies have been tested in RCC including cytokines, radiotherapy, hormones and oral tyrosine-kinase inhibitors (TKIs), with limited success. The predominant global standard-of-care after nephrectomy remains active monitoring. Immune checkpoint inhibitors (ICIs) are effective in the treatment of metastatic RCC; RAMPART will investigate these agents in the adjuvant setting. METHODS/

designRAMPART is an international, UK-led trial investigating the addition of ICIs after nephrectomy in patients with resected locally advanced RCC. RAMPART is a multi-arm multi-stage (MAMS) platform trial, upon which additional research questions may be addressed over time. The target population is patients with histologically proven resected locally advanced RCC (clear cell and non-clear cell histological subtypes), with no residual macroscopic disease, who are at high or intermediate risk of relapse (Leibovich score 3-11). Patients with fully resected synchronous ipsilateral adrenal metastases are included. Participants are randomly assigned (3,2:2) to Arm A - active monitoring (no placebo) for one year, Arm B - durvalumab (PD-L1 inhibitor) 4-weekly for one year; or Arm C - combination therapy with durvalumab 4-weekly for one year plus two doses of tremelimumab (CTLA-4 inhibitor) at day 1 of the first two 4-weekly cycles. The co-primary outcomes are disease-free-survival (DFS) and overall survival (OS). Secondary outcomes include safety, metastasis-free survival, RCC specific survival, quality of life, and patient and clinician preferences. Tumour tissue, plasma and urine are collected for molecular analysis (TransRAMPART).

trial registrationISRCTN #: ISRCTN53348826, NCT #: NCT03288532, EUDRACT #: 2017-002329-39, CTA #: 20363/0380/001-0001, MREC #: 17/LO/1875, ClinicalTrials.gov Identifier: NCT03288532, RAMPART grant number: MC_UU_12023/25, TransRAMPART grant number: A28690 Cancer Research UK, RAMPART Protocol version 5.0.

Indexed as

Carcinoma, Renal CellKidney NeoplasmsChronic DiseaseHumansQuality of LifeRecurrenceCheck-point inhibitorDurvalumabMAMSPlatform trialRAMPARTRenal cancerTremelimumab

Identifiers

PMID34538402
PMCPMC8520913
OpenAlexW3201135904

What OpenQuestion holds

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Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.