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NCT03177239: UNISoN

Phase II Sequential Treatment Trial of Single Agent Nivolumab, Then Combination Ipilimumab + Nivolumab in Metastatic or Unresectable Non-Clear Cell Renal Cell Carcinoma (ANZUP1602)

Status unknown Phase 2 Last updated 16 February 2022
What this trial tests

Phase 2 trial testing Nivolumab in Renal Cell Carcinoma in 85 participants. Status unknown.

Timeline
19 October 2017
Primary endpoint
31 December 2021
31 December 2022

Quick facts

Lead sponsorAustralian and New Zealand Urogenital and Prostate Cancer Trials Group
PhasePhase 2
StatusStatus unknown
Study typeINTERVENTIONAL
Allocationna
Designsingle group
Maskingnone
Primary purposetreatment
Enrollment85
Start date19 October 2017
Primary completion31 December 2021
Estimated completion31 December 2022
Sites19 locations across Australia

Drugs / interventions tested

Conditions studied

Sponsor

Australian and New Zealand Urogenital and Prostate Cancer Trials Group — full company profile →

Who can join

18 and older, any sex, with Renal Cell Carcinoma or Papillary Renal Cell Carcinoma Type 1. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

This study aims to evaluate the safety, tolerability and effectiveness of new treatments for kidney cancer called Nivolumab and Ipilimumab. The study is in two parts; in the first instance patients receive nivolumab alone. If this treatment is not effective patients may move onto the second part of the trial, where they receive nivolumab + ipilimumab. There is no placebo. The reason to offer one treatment alone, followed by two treatments together is that it is thought that the double treatment may have more side-effects, but also may be effective in people in whom the single first treatment (nivolumab alone) has not helped. Nivolumab and ipilimumab are experimental treatments. This means that they are not an approved treatment for non-clear cell kidney cancer in Australia. The purpose of this study is to test the effectiveness, safety, and tolerability of Nivolumab (also known as Opdivo or BMS-936558) and Ipilumumab (also known as MDX-010 or Yervoy). Nivolumab and ipilimumab are antibodies (a type of human protein) that are being tested to see if they will allow the body's immune system to work against tumour cells. The immune system is the body's defence against cancer, bacteria and viruses. The effectiveness of nivolumab and ipilimumab in cancer of the kidney will be assessed by measuring the size of patient tumours via CT scans. Nivolumab and ipilimumab have been used alone or in combination in many other cancers, and are licenced for use in other cancers like advanced melanoma and bladder cancer in Australia. They have not been tested in people with non-clear cell kidney cancer. About 85 participants with non-clear cell kidney cancer are expected to participate in this study, from Australia and New Zealand. This research study has been initiated by Dr. Craig Gedye, is being conducted in collaboration with the Centre for Biostatistics and Clinical Trials (BaCT) and sponsored in Australia by the Australian and New Zealand Urogenital and Prostate (ANZUP) Cancer Trials Group Pty Ltd. Bristol Myers Squibb (BMS) is supplying the study drugs and grant funding for this research.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

  1. Immunotherapy in Renal Cell Carcinoma: The Future Is Now.
    Deleuze A, Saout J, Dugay F, Peyronnet B, et al · · 2020 · cited 178× · PMID 32260578 · DOI 10.3390/ijms21072532
  2. Targeting the PD-1/PD-L1 Pathway in Renal Cell Carcinoma.
    Kammerer-Jacquet SF, Deleuze A, Saout J, Mathieu R, et al · · 2019 · cited 64× · PMID 30987368 · DOI 10.3390/ijms20071692
  3. A Review of Papillary Renal Cell Carcinoma and MET Inhibitors.
    Rhoades Smith KE, Bilen MA. · · 2019 · cited 45× · PMID 31867475 · DOI 10.3233/kca-190058
  4. Current Status in Rechallenge of Immunotherapy.
    Hu H, Wang K, Jia R, Zeng ZX, et al · · 2023 · cited 35× · PMID 37215995 · DOI 10.7150/ijbs.82776
  5. Unclassified renal cell carcinoma: diagnostic difficulties and treatment modalities.
    Sirohi D, Smith SC, Agarwal N, Maughan BL. · · 2018 · cited 29× · PMID 30510921 · DOI 10.2147/rru.s154932
  6. MiTF/TFE Translocation Renal Cell Carcinomas: From Clinical Entities to Molecular Insights.
    Simonaggio A, Ambrosetti D, Verkarre V, Auvray M, et al · · 2022 · cited 22× · PMID 35886994 · DOI 10.3390/ijms23147649
  7. Immune Checkpoint Inhibition in Advanced Non-Clear Cell Renal Cell Carcinoma: Leveraging Success from Clear Cell Histology into New Opportunities.
    Zarrabi K, Walzer E, Zibelman M. · · 2021 · cited 22× · PMID 34359554 · DOI 10.3390/cancers13153652
  8. The Molecular Characteristics of Non-Clear Cell Renal Cell Carcinoma: What's the Story Morning Glory?
    Marchetti A, Rosellini M, Mollica V, Rizzo A, et al · · 2021 · cited 21× · PMID 34207825 · DOI 10.3390/ijms22126237

Verify or expand the search:

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Data sources for this page

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03177239.

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