Phase II Sequential Treatment Trial of Single Agent Nivolumab, Then Combination Ipilimumab + Nivolumab in Metastatic or Unresectable Non-Clear Cell Renal Cell Carcinoma (ANZUP1602) (UNISoN)
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|ClinicalTrials.gov Identifier: NCT03177239|
Recruitment Status : Recruiting
First Posted : June 6, 2017
Last Update Posted : June 29, 2018
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.
|Condition or disease||Intervention/treatment||Phase|
|Renal Cell Carcinoma Papillary Renal Cell Carcinoma Type 1 Papillary Renal Cell Carcinoma Type 2 Chromophobe Renal Cell Carcinoma Sarcomatoid Renal Cell Carcinoma Xp11 Translocation Carcinoma||Drug: Nivolumab Drug: Ipilimumab||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||85 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase II Sequential Treatment Trial of Single Agent Nivolumab, Then Combination Ipilimumab + Nivolumab in Metastatic or Unresectable Non-Clear Cell Renal Cell Carcinoma (ANZUP1602).|
|Actual Study Start Date :||October 19, 2017|
|Estimated Primary Completion Date :||December 2021|
|Estimated Study Completion Date :||December 2022|
Experimental: Nivolumab and Ipilimumab
Part 1: nivolumab 240mg IV q2w for a maximum of 12 months.
Part 2; nivolumab 240mg IV q3w in addition to ipilimumab 1mg/kg q3w x 4 cycles Then nivolumab 240mg q2w for a maximum of 12 months.
Dosage Form: Nivolumab BMS-936558-01 Solution for Injection Potency: 100 mg (10 mg/mL) Primary Packaging: 10 mL vial Appearance: Clear to opalescent colourless to pale yellow liquid. May contain particles.
Storage Condition: 2 to 8°C. Protect from light and freezing.
Other Name: Opdivo
Dosage Form: Ipilimumab Solution for Injection Potency: 200 mg (5 mg/mL) Primary Packaging: 40 mL vial Appearance: Clear, colourless to pale yellow liquid. May contain particles. Storage Condition: 2 to 8°C. Protect from light and freezing.
Other Name: Yervoy
- The objective tumour response rate, as assessed by RECIST1.1 [ Time Frame: Through study completion, on average 5 years. ]This is defined as the proportion of participants in the analysis set with a confirmed complete response (CR) or partial response (PR) divided by the number of participants in the analysis set.
- Duration of objective tumour response, as assessed by RECIST1.1 [ Time Frame: Through study completion, on average 5 years. ]Measured from the time measurement criteria are first met for CR/PR (whichever is first recorded) until the first date that progressive disease is objectively documented.
- Progression-free survival (PFS), as assessed by RECIST1.1 [ Time Frame: Through study completion, on average 5 years. ]For Part 1, PFS is defined as the interval from date of registration to the date of first evidence of disease progression or death, whichever occurs first. For Part 2, PFS is defined as the interval from date of progressive disease on nivolumab monotherapy until the date of first evidence of disease progression or death, whichever occurs first.
- Immune-related tumour response rate, as assessed by irRECIST. [ Time Frame: Through study completion, on average 5 years. ]Defined as the proportion of participants in the analysis set with an immune related complete response (irCR), or immune related partial response (irPR), divided by the number of participants in the analysis set.
- Immune-related disease control rate (irDCR6), as assessed by irRECIST. [ Time Frame: At 6 months during treatment. ]For Part 1, irDCR6 is defined as an assessment of CR or iPR or iSD according to modified irRECIST. For Part 2, irDCR6 is defined in the same way except that the extent of disease defining the baseline tumour burden is measured at the date of disease progression on nivolumab monotherapy.
- The number of patients alive at the end of the study, as assessed by date of death. [ Time Frame: Through study completion, on average 5 years. ]Overall survival (OS) is defined as the time between the date of registration to part 1 of the study and the date of death due to any cause.
- The number of patients with adverse events, particularly immune-related adverse events, that are related to study drug, as assessed and graded according to CTCAE v4.03. [ Time Frame: From time of patient registration, until 30 days after the last dose of treatment. ]
- The number of participants with permanent discontinuation of treatment or delays due to toxicity, as assessed and graded according to CTCAE v4.03. [ Time Frame: From time of patient registration, until 30 days after the last dose of treatment. ]
- The biomarkers of response and resistance to anti-cancer treatments, as assessed by gene expression arrays, cytokine arrays, multiplex immunohistochemistry and mass cytometry on tissue and blood samples. [ Time Frame: Through study completion, on average 5 years. ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03177239
|Contact: Craig Gedye, MBBS, FRACP||+61 2 4014 firstname.lastname@example.org|
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