UNISoN

Trial Title:

UNISoN: anzUp Nivo -> Ipi + Nivo Sequential Non-clear cell

Proposed phase II sequential cohort trial of single agent Nivolumab, then combination Ipilimumab + Nivolumab in Metastatic or unresectable non-clear cell renal cell carcinoma

Trial Acronym:

UNISoN

Protocol Number:

ANZUP 1602

Trial Design:

Single-arm, multicentre, phase 2 trial

ANZ Study Chairs:

Dr Craig Gedye

ANZ Coordinating Centre:

Centre for Biostatistics and Clinical Trials

Trial Coordinator:

Laura Galletta

Trial Email:

Contact.Bact@petermac.org 

Patient Population:

Adults with m-n-ccRCC. Key eligibility criteria include target lesion(s) according to RECIST 1.1, good performance status (ECOG 0-2), no history of significant autoimmune disease, tumour sample available (previously resected or fresh biopsy) and no previous treatment with immunotherapy.  

Intervention:

1st stage, nivolumab 240mg IV q2w, until prohibitive toxicity, death, disease progression or 12 months of treatment. If disease progresses on nivolumab alone, and patient PS remains good (0-2), patient may enter 2nd stage; nivolumab 240mg IV q2w + ipilimumab 1mg/kg q3w x 4 cycles, then continue nivolumab until prohibitive toxicity, death, disease progression or 12 months total nivolumab treatment. Treatment beyond 12 months or beyond late progression with discussion with Study PI and sponsor.

Primary Outcome:

1. Objective tumour response rate (OTRR = CR or PR, RECIST 1.1) of nivolumab in m-n-ccRCC

2. Objective tumour response rate (OTRR = CR or PR, RECIST 1.1) of ipilimumab + nivolumab in patients with m-n-ccRCC refractory to nivolumab alone

Secondary Outcomes:

3. Progression-free survival at 6 months (PFS6m, proportion alive and progression-free at 6 months according to RECIST 1.1)
4. OTRR and disease control rate (CR, PR, or SD at 6 months) according to irRC.
5. Frequency and severity of adverse events (CTCAE v4.03), particularly selected immune-related adverse events (IRAE)
6. Frequency of treatment modifications and discontinuation due to toxicity

Status:

Active and recruiting

Sites Recruiting:

NSW
  • Calvary Mater Newcastle
  • Northern Cancer Institute
  • St George Hospital
VIC
  • Box Hill Hospital
SA
  • Adelaide Hospital/ Ashford Cancer Centre Research
QLD
  • Royal Brisbane and Women's Hospital

Further sites will be listed here as they open
Further Information: Click Here
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