AzTrials
AzTrials

Renal Cell CarcinomaPhase 2UNISoNNCT03177239

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

A Phase 2 study testing Nivolumab and Ipilimumab in people with Renal Cell Carcinoma and Papillary Renal Cell Carcinoma Type 1, run by Australian and New Zealand Urogenital and Prostate Cancer Trials Group at 19 sites in Australia.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Nivolumab and Ipilimumab
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
85 participants
Where
19 sitesAustralia
Study dates
19 Oct 2017to 31 Dec 2022
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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:
  • Papillary renal cell carcinoma (type 1)
  • Papillary renal cell carcinoma (type 2)
  • Other: including chromophobe renal cell carcinoma, pure sarcomatoid renal cell carcinoma, Xp11 translocation (TFE3+ IHC) carcinoma, other renal carcinoma NOS
  • Be ≥18 years of age on the day of signing informed consent
  • At least 1 target lesion according to RECIST v1.1.
Show all 23Show fewer
  • 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):
  • Haemoglobin ≥ 90g/L
  • Platelets ≥ 100x109/L
  • Neutrophil count ≥ 1.5x109/L
  • Adequate liver function (should be performed within 14 days prior to registration and with values within the ranges specified below):
  • Bilirubin ≤ 1.5 x upper limit of normal (ULN) except for participants with known Gilbert's syndrome who can have total bilirubin < 3.0 mg/dL
  • AST or ALT ≤ 3.0 x ULN (or ≤ 5.0x ULN in the presence of liver metastases)
  • Adequate renal function (should be performed within 14 days prior to registration and with values within the ranges specified below):
  • Creatinine ≤ 1.5x ULN OR
  • Creatinine clearance (CrCl) ≥ 30mL/min (use Cockcroft-Gault Formula)
  • 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.
  • Female participants of childbearing potential should be willing to use two methods of birth control or be surgically sterile, or abstain from heterosexual activity for the course of the study through to 5 months after the last dose of study medication. Participants of childbearing potential are those who have not been surgically sterilized or have not been free from menses for > 1 year.
  • Male participants should agree to use an adequate method of contraception starting with the first dose of study therapy through to 7 months after the last dose of study therapy.
  • Able to provide a formalin-fixed paraffin embedded (FFPE) tumour block, representative of the participant's primary or metastatic disease (preferred), which must be forwarded to the Centre for Biostatistics and Clinical Trials (BaCT) within 10 working days post registration
  • Willing and able to start treatment within 14 days of registration, and to comply with all study requirements, including the timing and/or nature of the required treatment and assessments
  • Has provided signed, written informed consent.

Who cannot join

  • 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.
Show all 19Show fewer
  • 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
  • Active infection requiring systemic therapy within 14 days before registration.
  • Receipt of live attenuated vaccination within 30 days of registration.
  • Life expectancy of less than 3 months.
  • Prior systemic therapy, surgery or radiation therapy within 4 weeks before registration.
  • Note: If the participant has undergone major surgery, they must have recovered adequately before registration. Prior treatments with radiation therapy in the adjuvant and/or metastatic setting is permitted provided that therapy and is completed at least 14 days prior to the first dose of study drug and all treatment related adverse events are < Grade 1 at the time of registration.
  • History of another active malignancy within the previous 5 years, except for locally curable cancers that have been apparently cured, such as low-grade thyroid carcinoma, prostate cancer not requiring treatment (Gleason grade ≤ 6), basal or squamous cell skin cancer, superficial bladder cancer, melanoma in situ or carcinoma in situ of the prostate, cervix, or breast. Participants who have been free of other malignancies for ≥ 5 years prior to registration are eligible for this study.
  • Positive test for hepatitis B virus surface antigen (HBVsAg) or antibodies to hepatitis C virus ribonucleic acid (HCV antibody) indicating acute or chronic infection.
  • A history of other significant infection, including HIV. HIV testing is not mandatory unless clinically indicated.
  • Participants should be excluded if they have a history of allergy to study drug components, or a history of severe hypersensitivity reaction to any monoclonal antibody.
  • Serious medical or psychiatric conditions that might limit the ability of the patient to comply with the protocol
  • Female patient is pregnant or lactating.

Trial locations and contacts

19 sites in 1 country.

19 sites in 1 country

Australia19 sites

  • Flinders Medical Centre

    Adelaide, South Australia, 5000

  • Ashford Cancer Centre

    Adelaide, South Australia, 5037

  • Border Medical Oncology

    Albury, New South Wales, 2460

  • Ballarat Oncology & Haematology Services

    Ballarat, Victoria, 3355

  • Sunshine Coast University Hospital

    Birtinya, Queensland, 4575

  • Box Hill Hospital - Eastern Health

    Box Hill, Victoria, 3128

  • Royal Brisbane & Women's Hospital

    Brisbane, Queensland, 4000

  • Campbelltown Hospital

    Campbelltown, New South Wales, 2560

  • Chris O'Brien Lifehouse

    Camperdown, New South Wales, 2050

  • Monash Medical Centre

    Clayton, Victoria, 3168

  • St Vincents Hospital

    Darlinghurst, New South Wales, 2010

  • Northern Cancer Institute

    Frenchs Forest, New South Wales, 2086

  • St. George Hospital

    Kogarah, New South Wales, 2217

  • Fiona Stanley Hospital

    Murdoch, Western Australia, 6150

  • Calvary Mater Newcastle

    Newcastle, New South Wales, 2298

  • Port Macquarie Base Hospital

    Port Macquarie, New South Wales, 2444

  • Prince of Wales Hospital

    Randwick, New South Wales, 2031

  • Tamworth Hospital - North West Cancer Centre

    Tamworth, New South Wales, 2340

  • Westmead Hospital

    Westmead, New South Wales, 2145

Other trials in Australia

About this study

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).

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.

Read more

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.

Being tested
Nivolumab, Ipilimumab
Medical subject headings
Carcinoma, Renal Cell

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • NivolumabDrug

    Also called Opdivo

    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.

  • IpilimumabDrug

    Also called Yervoy

    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.

Study groups in NCT03177239
Study groupRoleWhat they receive
Nivolumab and IpilimumabExperimentalPart 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.
Receives: Drug: Nivolumab; Drug: Ipilimumab

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. The objective tumour response rate, as assessed by RECIST1.1

    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.

    Measured: Through study completion, on average 5 years.

Secondary outcomes (7)

  1. Duration of objective tumour response, as assessed by RECIST1.1

    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.

    Measured: Through study completion, on average 5 years.

  2. Progression-free survival (PFS), as assessed by RECIST1.1

    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.

    Measured: Through study completion, on average 5 years.

  3. Immune-related tumour response rate, as assessed by irRECIST.

    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.

    Measured: Through study completion, on average 5 years.

  4. Immune-related disease control rate (irDCR6), as assessed by irRECIST.

    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.

    Measured: At 6 months during treatment.

  5. The number of patients alive at the end of the study, as assessed by date of death.

    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.

    Measured: Through study completion, on average 5 years.

  6. 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.

    Measured: From time of patient registration, until 30 days after the last dose of treatment.

  7. The number of participants with permanent discontinuation of treatment or delays due to toxicity, as assessed and graded according to CTCAE v4.03.

    Measured: From time of patient registration, until 30 days after the last dose of treatment.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted6 Jun 2017
  2. Study start19 Oct 2017
  3. Primary completion31 Dec 2021
  4. Study completion31 Dec 2022 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
85 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03177239
Sponsor's protocol ID
ANZUP 1602
Acronym
UNISoN
Status last verified
Feb 2022
First submitted
4 Jun 2017
Last updated
16 Feb 2022
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Nivolumab and Ipilimumab in people with Renal Cell Carcinoma and Papillary Renal Cell Carcinoma Type 1, run by Australian and New Zealand Urogenital and Prostate Cancer Trials Group at 19 sites in Australia.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 23 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 16 Feb 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 19 sites in Australia. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

The objective tumour response rate, as assessed by RECIST1.1 (time frame: Through study completion, on average 5 years.). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03177239.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Feb 2022.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in