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AzTrials

Clear Cell Metastatic Renal Cell CarcinomaPhase 2BIONIKKNCT02960906

A BIOmarker Driven Trial With Nivolumab and Ipilimumab or VEGFR tKi in Naïve Metastatic Kidney Cancer

A Phase 2 study testing Nivolumab, Ipilimumab and Pazopanib in people with Clear Cell Metastatic Renal Cell Carcinoma, run by Association Pour La Recherche des Thérapeutiques Innovantes en Cancérologie at 16 sites in France.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

Disease and Stage: naïve metastatic kidney cancer. A multicenter, randomized, a Phase 2 BIOmarker driven trial with Nivolumab and Ipilimumab or VEGFR tKi in naïve metastatic Kidney cancer Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Nivolumab, Ipilimumab and Pazopanib
Could I receive a placebo?
No, everyone receives an active treatment
How many people
200 participants
Where
16 sitesFrance
Study dates
31 May 2017to 15 Feb 2021
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

  • Histological confirmation of RCC with a clear-cell component. Patients with TFE3 or TFEB translocation proven by cytogenetic analysis or by fluorescence in situ hybridization (FISH) are eligible.
  • Metastatic (American Joint Committee on Cancer [AJCC] Stage IV) RCC
  • No prior systemic therapy for mRCC
  • Eastern Cooperative Oncology Group (ECOG) performance status (PS) of ≤2
  • Measurable disease as per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1
  • Frozen tumor samples (primary tumor and/or metastasis biopsies) must be available and received by the central laboratory (Cordelier Research Center) to determine molecular groups. (Note: fine needle aspiration [FNA] and bone metastases samples are not acceptable for submission).
  • Molecular group has to be determined prior to randomization.
  • Formalin-fixed, paraffin-embedded (FFPE) tumor tissue available for biomarker (gene expression and immunohistochemistry (IHC)) analysis.

Who cannot join

  • Any untreated CNS metastases. Patients with CNS metastases will be eligible if they are: asymptomatic, without significant oedema, not on corticosteroids, not eligible for radiation therapy/surgery or have already received radiation therapy.
  • Prior systemic treatment with vascular endothelial growth factor (VEGF) or VEGF receptor-targeted therapy (including, but not limited to, sunitinib, pazopanib, axitinib, tivozanib, and bevacizumab) except in an adjuvant setting with a free interval of more than 1 year.
  • Prior treatment with an anti-programmed cell death protein 1 (PD-1), anti-programmed death-ligand 1 (PD-L1), anti-PD-L2, anti-CD137, or anti-cytotoxic T-lymphocyte-associated protein 4 (CTLA-4) antibody, or any other antibody or drug specifically targeting T-cell co-stimulation or checkpoint pathways.
  • Any active or recent history of a known or suspected autoimmune disease or recent history of a syndrome that required systemic corticosteroids (>10 mg daily prednisone equivalent) or immunosuppressive medications except for syndromes which would not be expected to recur in the absence of an external trigger. Subjects with vitiligo or type 1 diabetes mellitus or residual hypothyroidism due to autoimmune thyroiditis only requiring hormone replacement are permitted to enroll.
  • Any condition requiring systemic treatment with corticosteroids (>10 mg daily prednisone equivalents) or other immunosuppressive medications within 14 days prior to first dose of study drug. Inhaled steroids and adrenal replacement steroid doses >10 mg daily prednisone equivalents are permitted in the absence of active autoimmune disease.
  • Uncontrolled adrenal insufficiency.
Show all 37Show fewer
  • Ongoing symptomatic cardiac dysrhythmias, uncontrolled atrial fibrillation, or prolongation of the Fridericia corrected QT (QTcF) interval defined as >450 msec for males and >470 msec for females, where QTcF = QT / 3√RR.
  • Poorly controlled hypertension (defined as systolic blood pressure (SBP) of >150 mmHg or diastolic blood pressure (DBP) of >90 mmHg), despite antihypertensive therapy.
  • History of any of the following cardiovascular conditions within 12 months of enrollment: cardiac angioplasty or stenting, myocardial infarction, unstable angina, coronary artery by-pass graft surgery, symptomatic peripheral vascular disease, class III or IV congestive heart failure, as defined by the New York Heart Association.
  • History of cerebrovascular accident including transient ischemic attack within the past 12 months.
  • History of deep vein thrombosis (DVT) unless adequately treated with low molecular weight heparin.
  • History of pulmonary embolism within the past 6 months unless stable, asymptomatic, and treated with low molecular weight heparin for at least 6 weeks.
  • Known history of COPD (of any stage).
  • Known history of uveitis or complaint of double vision.
  • History of abdominal fistula, gastrointestinal perforation, or intra-abdominal abscess within the past 6 months.
  • Serious, non-healing wound or ulcer.
  • Evidence of active bleeding or bleeding susceptibility; or medically significant hemorrhage within prior 30 days.
  • Any requirement for anti-coagulation, except for low molecular weight heparin.
  • Prior malignancy active within the previous 3 years except for locally curable cancers that have been apparently cured, such as basal or squamous cell skin cancer, superficial bladder cancer, or carcinoma in situ of the prostate, cervix, or breast.
  • Known history of testing positive for human immunodeficiency virus (HIV) or known acquired immunodeficiency syndrome (AIDS).
  • Any positive test for hepatitis B or hepatitis C virus indicating acute or chronic infection.
  • Known medical condition (e.g., a condition associated with diarrhea or acute diverticulitis) that, in the Investigator's opinion, would increase the risk associated with study participation or study drug administration, or interfere with the interpretation of safety results.
  • Known history of hyperesthesia, hypoesthesia, paresthesia, dysesthesia, peripheral motor neuropathy, peripheral sensory, neuropathy, and polyneuropathy.
  • Major surgery (e.g., nephrectomy) less than 35 days prior to the first dose of study drug.
  • Focal radiation therapy less than 14 days prior to the first dose of study drug.
  • Receiving concomitant CYP3A4 inducers or strong CYP3A4 inhibitors
  • Impairment of gastrointestinal function or gastrointestinal disease that may significantly alter the absorption of cabozantinib (e.g., malabsorptive disorder, ulcerative disease, uncontrolled nausea, vomiting, diarrhea, or small bowel resection).
  • Any of the following laboratory test findings:
  • WBC <2,000/mm3
  • Hemoglobin ≤9.0 g/dL
  • Neutrophils <1,500/mm3
  • Platelets <100,000/mm3
  • AST or ALT >3 x ULN (>5 x ULN if liver metastases are present)
  • Lipase and amylase > 1.5 ULN
  • Total Bilirubin >1.5 x ULN (except subjects with Gilbert Syndrome, who can have total bilirubin <3.0 mg/dL)
  • Serum creatinine >1.5 x ULN or creatinine clearance <40 mL/min (measured or calculated by Cockroft-Gault formula)
  • Proteinuria: patients with ≥2+ protein on urine dipstick at baseline must undergo a 24-hour urine collection for protein then if > 1.0 g of protein patient will not be included.

Trial locations and contacts

16 sites in 1 country.

16 sites in 1 country

France16 sites

  • Hôpital Saint André, CHU de Bordeaux

    Bordeaux, 33075

  • Centre Francois Baclesse

    Caen, 14000

  • CHU Henri-Mondor

    Créteil, 94000

  • Centre OSCAR LAMBRET LILLE

    Lille, 59000

  • Institut Paoli Calmettes (IPC)

    Marseille, 13009

  • Centre Antoine Lacassagne

    Nice, 06100

  • Institut de Cancérologie du Gard - CHU Caremeau

    Nîmes, 30029

  • Institut Mutualiste Montsouris

    Paris, 75014

  • Hôpital Européen Georges Pompidou

    Paris, 75015

  • Hôpital Cochin

    Paris, 75679

  • Centre Hospitalier Lyon Sud - Institut de Cancérologie des Hospices Civils de Lyon (IC-HCL)

    Pierre-Bénite, 69310

  • Centre Eugene Marquis

    Rennes, 35042

  • Hôpitaux universitaires de Strasbourg

    Strasbourg, 67000

  • Hopital Foch

    Suresnes, 92151

  • Institut Claudius Regaud

    Toulouse, 31059

  • CHU Bretonneau

    Tours, 37000

Other trials in France

About this study

Official title: A Phase 2 BIOmarker Driven Trial With Nivolumab and Ipilimumab or VEGFR tKi in Naïve Metastatic Kidney Cancer

Disease and Stage: naïve metastatic kidney cancer.

A multicenter, randomized, a Phase 2 BIOmarker driven trial with Nivolumab and Ipilimumab or VEGFR tKi in naïve metastatic Kidney cancer

Read the detailed description

Research Hypothesis: Molecular groups of ccrcc will define patients who will respond to nivolumab alone, nivolumab combined with ipilimumab, or VEGFR-TKI (sunitinib or pazopanib) in subjects with previously untreated metastatic renal cell carcinoma (mRCC).

Conditions:

  • Advanced or metastatic RCC: previously untreated in metastatic setting.
  • Frozen tumor samples available for molecular group determination.
  • Determination of molecular subgroup prior to randomization.

Product(s):

  • ARM A: nivolumab alone administered IV over 60 minutes at 240 mg every 2 weeks (molecular group 1 and 4).
  • ARM B : Nivolumab administered IV over 60 minutes at 3 mg/kg combined with ipilimumab administered IV over 30 minutes at 1 mg/kg every 3 weeks for 4 doses followed by nivolumab administered IV over 60 minutes at 240 mg every 2 weeks starting from the Cycle 7 possibility to switch from nivolumab 240 mg every 2 weeks to 480 mg every 4 weeks according to the Investigator's preference (Arm A and B),
  • ARM C: TKI (molecular group 2 and 3), pazopanib or sunitinib according to investigator's choice until disease progression, unacceptable toxicity or other reasons specified in the protocol.

Biological assessments:

Molecular groups (1 to 4) will be determined for all patients from frozen tumor tissue samples or from fresh tumor samples immediately stored in "RNA later" medium.

Further exploratory biological assessments will be performed in order to define predictive biomarkers of response to N+I, N alone or TKI (sunitinib or pazopanib) by analyzing tumor specimens and blood samples:

  • To assess gene expression of immune population markers in the primary tumor as well as in the metastases before beginning treatment, and at progression if safely achievable.
  • Gene expression analysis will be performed from frozen and FFPE tumor tissue in order to compare the two methods.
  • To assess the density and phenotype of selected immune populations (CD8, CD3/CD20, PD-1, TIM-3, LAG3, FoxP3) as well as the phenotype of tumor cells (PD-L1, PD-L2) by immunohistochemistry (IHC) in the primary tumor and metastases, before treatment initiation and at progression if safely achievable.
  • To assess the functional status of peripheral blood lymphocytes (PBL) by flow cytometry, before treatment initiation, during treatment, and at progression.
  • To quantify plasmatic angiogenesis-related (i.e. VEGF-A, VEGF-C its soluble receptors VEGFR-1 and 2 and co-receptors neuropilin 1 and 2, angiopoietins, SDF-1, PDGFs…)) and endothelial cell-derived molecules (i.e. endoglin, VE-cadherin) before treatment initiation, during treatment, and at progression.
  • To correlate plasmatic angiogenesis-related molecules with tumor vascularization studied by immunofluorescence (IF) and a multi-spectral analyzer (Vectra technology) on tumor tissue.
  • To investigate a predictive role of the response of CXCL7 and sCD146 to TKI, nivolumab and/or nivolumab+ipilimumab.
  • To determine whether the mutation and methylation analysis of circulating tumor DNA can be used as predictive biomarker of response, resistance to treatment or progression.
  • Identify genetic and epigenetic alterations associated with either response or resistance to immune checkpoint inhibitors and tyrosine kinase inhibitors
  • Evaluate association between immune cells composing tumor microenvironment and response and/or resistance to immune checkpoint inhibitors or tyrosine kinase inhibitors
  • Evaluate additional genetic and epigenetic tumor alterations at resistance/progression or after resection of residual mass.

Statistical Considerations:

An adaptative design will be used to ensure that conclusions can be made with a limited number of patients in each molecular group, which is the major constraint of the study.

Sample Size: Approximately 150 patients are planned to be treated. Given an expected failure rate of molecular grouping of less than 20%, 150-200 patients must be included.

Being tested
Nivolumab, Ipilimumab, Pazopanib, Sunitinib
Medical subject headings
Clear-cell metastatic renal cell carcinoma

What participants receive

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

  • NivolumabDrug

    Also called BMS-936558, Opdivo

    For Arms 1A and 4A:

    Nivolumab alone administered IV over 60 minutes at 240 mg every 2 weeks until disease progression, unacceptable toxicity or other reasons specified in the protocol.

    For Arms 1B, 2B, 3B and 4B:

    Nivolumab administered IV over 60 minutes at 3 mg/kg combined with ipilimumab administered IV over 30 minutes at 1 mg/kg every 3 weeks for 4 doses followed by nivolumab administered IV over 60 minutes at 240 mg every 2 weeks until disease progression, unacceptable toxicity or other reasons specified in the protocol.

    Starting from the Cycle 7 possibility to switch from nivolumab 240 mg every 2 weeks to 480 mg every 4 weeks according to the Investigator's preference.

  • IpilimumabDrug

    Also called YERVOY, BMS-734016

    For Arms 1B, 2B, 3B and 4B:

    Ipilimumab administered IV over 30 minutes at 1 mg/kg every 3 weeks combined with Nivolumab administered IV over 60 minutes at 3 mg/kg for 4 doses until disease progression, unacceptable toxicity or other reasons specified in the protocol.

  • PazopanibDrug

    Also called Votrient

    For Arms 2C and 3C (TKI pazopanib or sunitinib):

    Pazopanib 800 mg orally QD until disease progression, unacceptable toxicity or other reasons specified in the protocol

  • SunitinibDrug

    Also called Sutent

    For Arms 2C and 3C (TKI pazopanib or sunitinib):

    Sunitinib 50 mg orally QD until disease progression, unacceptable toxicity or other reasons specified in the protocol

Study groups in NCT02960906
Study groupRoleWhat they receive
ccRCC molecular subgroup 1: 1AExperimentalccRCC molecular subgroup 1 -> randomisation: subjects with ccRCC1 treated with nivolumab 240mg IV every 2 weeks until disease progression, unacceptable toxicity or other reasons specified in the protocol. Starting from the Cycle 7 possibility to switch from nivolumab 240 mg every 2 weeks to 480 mg every 4 weeks according to the Investigator's preference.
Receives: Drug: Nivolumab
ccRCC molecular subgroup 1: 1BExperimentalccRCC molecular subgroup 1 -> randomisation: subjects with ccRCC1 treated with nivolumab 3 mg/kg IV combined with ipilimumab 1 mg/kg IV every 3 weeks for 4 doses then nivolumab 240mg IV every 2 weeks until disease progression, unacceptable toxicity or other reasons specified in the protocol. Starting from the Cycle 7 possibility to switch from nivolumab 240 mg every 2 weeks to 480 mg every 4 weeks according to the Investigator's preference.
Receives: Drug: Nivolumab; Drug: Ipilimumab
ccRCC molecular subgroup 4: 4AExperimentalccRCC molecular subgroup 4 -> randomisation: subjects with ccRCC1 treated with nivolumab 240mg IV every 2 weeks until disease progression, unacceptable toxicity or other reasons specified in the protocol. Starting from the Cycle 7 possibility to switch from nivolumab 240 mg every 2 weeks to 480 mg every 4 weeks according to the Investigator's preference.
Receives: Drug: Nivolumab
ccRCC molecular subgroup 4: 4BExperimentalccRCC molecular subgroup 4 -> randomisation: subjects with ccRCC1 treated with nivolumab 3 mg/kg IV combined with ipilimumab 1 mg/kg IV every 3 weeks for 4 doses then nivolumab 240mg IV every 2 weeks until disease progression, unacceptable toxicity or other reasons specified in the protocol. Starting from the Cycle 7 possibility to switch from nivolumab 240 mg every 2 weeks to 480 mg every 4 weeks according to the Investigator's preference.
Receives: Drug: Nivolumab; Drug: Ipilimumab
ccRCC molecular subgroup 2: 2CExperimentalccRCC molecular subgroup 2 -> randomisation: TKI (sunitinib 50mg daily or Pazopanib 800mg daily) according to investigator's choice until disease progression, unacceptable toxicity or other reasons specified in the protocol.
Receives: Drug: Pazopanib; Drug: Sunitinib
ccRCC molecular subgroup 2: 2BExperimentalccRCC molecular subgroup 2 -> randomisation: subjects with ccRCC1 treated with nivolumab 3 mg/kg IV combined with ipilimumab 1 mg/kg IV every 3 weeks for 4 doses then nivolumab 240mg IV every 2 weeks until disease progression, unacceptable toxicity or other reasons specified in the protocol. Starting from the Cycle 7 possibility to switch from nivolumab 240 mg every 2 weeks to 480 mg every 4 weeks according to the Investigator's preference.
Receives: Drug: Nivolumab; Drug: Ipilimumab
ccRCC molecular subgroup 3: 3BExperimentalccRCC molecular subgroup 3 -> randomisation: subjects with ccRCC1 treated with nivolumab 3 mg/kg IV combined with ipilimumab 1 mg/kg IV every 3 weeks for 4 doses then nivolumab 240mg IV every 2 weeks until disease progression, unacceptable toxicity or other reasons specified in the protocol. Starting from the Cycle 7 possibility to switch from nivolumab 240 mg every 2 weeks to 480 mg every 4 weeks according to the Investigator's preference.
Receives: Drug: Nivolumab; Drug: Ipilimumab
ccRCC molecular subgroup 3: 3CExperimentalccRCC molecular subgroup 3 -> randomisation: TKI (sunitinib 50mg daily or Pazopanib 800mg daily) according to investigator's choice until disease progression, unacceptable toxicity or other reasons specified in the protocol.
Receives: Drug: Pazopanib; Drug: Sunitinib

What is being measured

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

  1. ORR evaluation according to molecular groups (ccRCC1 to 4) and assigned treatment

    ORR evaluation according to molecular groups (ccRCC1 to 4) and assigned treatment (nivolumab monotherapy, nivolumab combined with ipilimumab, or TKI: sunitinib or pazopanib), based on Investigator assessments.

    Measured: 54 months

Secondary outcomes (14)

  1. Progression-free survival (PFS)

    progression-free survival (PFS) in subjects with previously untreated mRCC according to molecular groups and assigned treatment, based on Investigator radiological assessments.

    Measured: 54 months

  2. Overall Survival

    To evaluate OS in subjects with previously untreated mRCC according to molecular groups and assigned treatment.

    Measured: 54 months

  3. Objective response rate at 22 weeks

    To evaluate objective response rate at 22 weeks as a surrogate of other endpoints according to molecular groups and assigned treatment.

    Measured: at 22 weeks

  4. Duration of treatment (DOT)

    To evaluate the duration of treatment (DOT) of nivolumab combined with ipilimumab or nivolumab alone or cabozantinib in subjects with previously untreated mRCC according to their molecular subgroup (1\&4 vs 2\&3).

    Measured: 54 months

  5. Duration of response (DOR)

    To evaluate the duration of response (DOR) of nivolumab combined with ipilimumab or nivolumab alone or cabozantinib in subjects with previously untreated mRCC according to their molecular subgroup (1\&4 vs 2\&3).

    Measured: 54 months

  6. Number of Participants With Treatment-Related Adverse Events

    To estimate the incidence of AEs associated with nivolumab combined with ipilimumab or nivolumab alone or cabozantinib in all treated subjects with previously untreated mRCC.

    Measured: 54 months

  7. Gene expression of immune population markers

    To assess gene expression of immune population markers in the primary tumor as well as in the metastases before beginning treatment, and at progression if safely achievable.populations (CD3, CD8...) and regulatory markers (PD-1, LAG-3…) within the primary tumor, and metastases whenever possible, using frozen and FFPE tumor tissue.

    Measured: at baseline at progression (36 months maximum)

  8. Gene expression levels obtained from FFPE

    Gene expression levels obtained from FFPE tumor tissue (exploratory method) will be compared to those obtained with frozen tumor tissue (standard method).

    Measured: at the end of the study (36 months)

  9. Functional status of peripheral blood lymphocytes (PBL)

    To assess the functional status of peripheral blood lymphocytes (PBL) by flow cytometry, before treatment initiation, during treatment, and at progression.

    Measured: at baseline, at cycle 2 and at progression (36 months maximum)

  10. Association between non-immune tissue and circulating biomarkers and outcomes

    To explore the association between non-immune tissue and circulating biomarkers and outcomes (ORR, ORR at 22 weeks, OS and PFS).

    Measured: 36 months maximum

  11. Mutation and methylation analysis of circulating tumor DNA

    The initial rate of ctDNA and its evolution will be correlated to the clinical evolution of patients and progression-free survival.

    Measured: 36 months maximum

  12. Genetic and epigenetic alterations

    To identify genetic and epigenetic alterations associated with either response or resistance to immune checkpoint inhibitors and tyrosine kinase inhibitors.

    Measured: 36 months maximum

  13. association between immune cells composing tumor microenvironment and response and/or resistance

    To evaluate the association between immune cells composing tumor microenvironment and response and/or resistance to immune checkpoint inhibitors or tyrosine kinase inhibitors.

    Measured: 36 months maximum

  14. additional genetic and epigenetic tumor alterations

    To evaluate additional genetic and epigenetic tumor alterations at resistance/progression or after resection of residual mass.

    Measured: 36 months maximum

Timeline

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

  1. First posted10 Nov 2016 (estimated)
  2. Study start31 May 2017
  3. Primary completion15 Feb 2021
  4. Study completion15 Feb 2021

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
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
200 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02960906
Sponsor's protocol ID
BIONIKK
Acronym
BIONIKK
Status last verified
Apr 2021
First submitted
18 Aug 2016
Last updated
26 Apr 2021
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Davidson G, Helleux A, Vano YA, Lindner V, Fattori A, Cerciat M, Elaidi RT, Verkarre V, Sun CM, Chevreau C, Bennamoun M, Lang H, Tricard T, Fridman WH, Sautes-Fridman C, Su X, Plassard D, Keime C, Thibault-Carpentier C, Barthelemy P, Oudard SM, Davidson I, Malouf GG. Mesenchymal-like Tumor Cells and Myofibroblastic Cancer-Associated Fibroblasts Are Associated with Progression and Immunotherapy Response of Clear Cell Renal Cell Carcinoma. Cancer Res. 2023 Sep 1;83(17):2952-2969. doi: 10.1158/0008-5472.CAN-22-3034.

    PubMed 37335139

  • Vano YA, Elaidi R, Bennamoun M, Chevreau C, Borchiellini D, Pannier D, Maillet D, Gross-Goupil M, Tournigand C, Laguerre B, Barthelemy P, Coquan E, Gravis G, Houede N, Cancel M, Huillard O, Beuzeboc P, Fournier L, Mejean A, Cathelineau X, Doumerc N, Paparel P, Bernhard JC, de la Taille A, Bensalah K, Tricard T, Waeckel T, Pignot G, Braychenko E, Caruso S, Sun CM, Verkarre V, Lacroix G, Moreira M, Meylan M, Bougouin A, Phan L, Thibault-Carpentier C, Zucman-Rossi J, Fridman WH, Sautes-Fridman C, Oudard S. Nivolumab, nivolumab-ipilimumab, and VEGFR-tyrosine kinase inhibitors as first-line treatment for metastatic clear-cell renal cell carcinoma (BIONIKK): a biomarker-driven, open-label, non-comparative, randomised, phase 2 trial. Lancet Oncol. 2022 May;23(5):612-624. doi: 10.1016/S1470-2045(22)00128-0. Epub 2022 Apr 4.

    PubMed 35390339

  • Epaillard N, Simonaggio A, Elaidi R, Azzouz F, Braychenko E, Thibault C, Sun CM, Moreira M, Oudard S, Vano YA. BIONIKK: A phase 2 biomarker driven trial with nivolumab and ipilimumab or VEGFR tyrosine kinase inhibitor (TKI) in naive metastatic kidney cancer. Bull Cancer. 2020 Jun;107(5S):eS22-eS27. doi: 10.1016/S0007-4551(20)30283-6.

    PubMed 32620212

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Nivolumab, Ipilimumab and Pazopanib in people with Clear Cell Metastatic Renal Cell Carcinoma, run by Association Pour La Recherche des Thérapeutiques Innovantes en Cancérologie at 16 sites in France.

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 8 inclusion and 37 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: finished, as of the sponsor's last update on 26 Apr 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 16 sites in France. 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

ORR evaluation according to molecular groups (ccRCC1 to 4) and assigned treatment (time frame: 54 months). 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 NCT02960906, which also lists 3 linked publications.

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 26 Apr 2021.

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