Phase II Sequential Treatment Trial of Single Agent Nivolumab, Then Combination Ipilimumab + Nivo… (NCT03177239) | Clinical Trial Compass
UnknownPhase 2
Phase II Sequential Treatment Trial of Single Agent Nivolumab, Then Combination Ipilimumab + Nivolumab in Metastatic or Unresectable Non-Clear Cell Renal Cell Carcinoma (ANZUP1602)
Australia85 participantsStarted 2017-10-19
Plain-language summary
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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Histologically confirmed unresectable, locally advanced (defined as disease not amenable to curative surgery or radiation therapy) or metastatic nccRCC (both treatment-naïve or those treated with a VEGFR TKI or another systemic medical therapy). Non-clear cell histology including:
. Be ≥18 years of age on the day of signing informed consent
. At least 1 target lesion according to RECIST v1.1.
. Eastern Cooperative Oncology Group (ECOG) performance status of 0-1
. Adequate bone marrow function (should be performed within 14 days prior to registration and with values within the ranges specified below):
. Adequate liver function (should be performed within 14 days prior to registration and with values within the ranges specified below):
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
The objective tumour response rate, as assessed by RECIST1.1
Timeframe: Through study completion, on average 5 years.
Trial details
NCT IDNCT03177239
SponsorAustralian and New Zealand Urogenital and Prostate Cancer Trials Group
. Adequate renal function (should be performed within 14 days prior to registration and with values within the ranges specified below):
. Female participants of childbearing potential should have a negative urine or serum pregnancy within 24 hours prior to registering the patient. If the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required.
Exclusion criteria
. Urothelial or transitional cell carcinoma of the renal pelvis or ureter
. Predominant clear cell renal cell carcinoma. A minority of clear cell histology (\<50%) is acceptable, but there must be \>50% non-clear cell histology predominant.
. Participation in a study of an investigational agent within 30 days of registration.
. Prior treatment with nivolumab, ipilimumab, or with any other anti-PD-1, anti-PD-L1, Anti-PD-L2, anti-CTLA-4 antibody or any other antibody or drug specifically targeting T cell co-stimulation or immune checkpoint pathways (NB Participant is eligible for Part 2 of the study if they took nivolumab monotherapy in Part 1 of the study).
. Active autoimmune disease that has required systemic treatment in the past 2 years (i.e. with use of disease modifying agents, corticosteroids or immunosuppressive drugs). Replacement therapy (e.g., thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency, etc.) is not considered a form of systemic treatment.
. Any condition requiring systemic treatment with either corticosteroids (\>10mg daily prednisone or equivalent dose of alternative corticosteroid) or other immunosuppressive medications within 14 days of registration. Intranasal, inhaled or topical steroids are permitted in the absence of active autoimmune disease. Participants are permitted to enrol if they have vitiligo, type I diabetes mellitus, residual hypothyroidism due to autoimmune condition only requiring hormone replacement, psoriasis not requiring systemic treatment, or conditions not expected to recur in the absence of an external trigger.
. Untreated brain or leptomeningeal metastases or current clinical or radiological progression of known brain metastases or requirement for steroid therapy for brain metastases. Participants with treated brain metastases are eligible if they have been stable and off steroids for ≥ 3 weeks.
. Prior allogeneic organ transplant, inflammatory bowel disease, pneumonitis, tuberculosis, or primary immunodeficiency