NCT02960906 (BIONIKK) is a Phase 2 clinical trial of Nivolumab in Clear Cell Metastatic Renal Cell Carcinoma, sponsored by Association Pour La Recherche des Thérapeutiques Innovantes en Cancérologie.

What drugs are being tested in NCT02960906?

Interventions in NCT02960906: Nivolumab, Ipilimumab, Pazopanib, Sunitinib.

What condition does NCT02960906 study?

NCT02960906 studies Clear Cell Metastatic Renal Cell Carcinoma.

Is NCT02960906 still recruiting?

NCT02960906 is currently completed. Last updated 26 April 2021.

Last reviewed 2021-04-26 · How we verify

NCT02960906: BIONIKK

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

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

Completed Phase 2 Last updated 26 April 2021

What this trial tests

Phase 2 trial testing Nivolumab in Clear Cell Metastatic Renal Cell Carcinoma in 200 participants. Completed in 15 February 2021.

Timeline

31 May 2017

Primary endpoint
15 February 2021

15 February 2021

Quick facts

Lead sponsor	Association Pour La Recherche des Thérapeutiques Innovantes en Cancérologie
Phase	Phase 2
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	200
Start date	31 May 2017
Primary completion	15 February 2021
Estimated completion	15 February 2021
Sites	16 locations across France

Drugs / interventions tested

Nivolumab (nivolumab) — full drug profile →
Ipilimumab — full drug profile →
Pazopanib — full drug profile →
Sunitinib (sunitinib) — full drug profile →

Conditions studied

Clear Cell Metastatic Renal Cell Carcinoma — all drugs for Clear Cell Metastatic Renal Cell Carcinoma →

Sponsor

Association Pour La Recherche des Thérapeutiques Innovantes en Cancérologie

Who can join

18 and older, any sex, with Clear Cell Metastatic Renal Cell Carcinoma. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

Immunotherapy in Renal Cell Carcinoma: The Future Is Now.
Deleuze A, Saout J, Dugay F, Peyronnet B, et al · · 2020 · cited 178× · PMID 32260578 · DOI 10.3390/ijms21072532
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.
Vano YA, Elaidi R, Bennamoun M, Chevreau C, et al · · 2022 · cited 105× · PMID 35390339 · DOI 10.1016/s1470-2045(22)00128-0
Mesenchymal-like Tumor Cells and Myofibroblastic Cancer-Associated Fibroblasts Are Associated with Progression and Immunotherapy Response of Clear Cell Renal Cell Carcinoma.
Davidson G, Helleux A, Vano YA, Lindner V, et al · · 2023 · cited 74× · PMID 37335139 · DOI 10.1158/0008-5472.can-22-3034
Targeting the PD-1/PD-L1 Pathway in Renal Cell Carcinoma.
Kammerer-Jacquet SF, Deleuze A, Saout J, Mathieu R, et al · · 2019 · cited 64× · PMID 30987368 · DOI 10.3390/ijms20071692
Tumor Microenvironment Features as Predictive Biomarkers of Response to Immune Checkpoint Inhibitors (ICI) in Metastatic Clear Cell Renal Cell Carcinoma (mccRCC).
Simonaggio A, Epaillard N, Pobel C, Moreira M, et al · · 2021 · cited 52× · PMID 33435262 · DOI 10.3390/cancers13020231
Variation in neutrophil to lymphocyte ratio (NLR) as predictor of outcomes in metastatic renal cell carcinoma (mRCC) and non-small cell lung cancer (mNSCLC) patients treated with nivolumab.
Simonaggio A, Elaidi R, Fournier L, Fabre E, et al · · 2020 · cited 51× · PMID 32561968 · DOI 10.1007/s00262-020-02637-1
Drug-Induced Hypertension Caused by Multikinase Inhibitors (Sorafenib, Sunitinib, Lenvatinib and Axitinib) in Renal Cell Carcinoma Treatment.
Bæk Møller N, Budolfsen C, Grimm D, Krüger M, et al · · 2019 · cited 43× · PMID 31547602 · DOI 10.3390/ijms20194712
Molecular Classification of Renal Cell Carcinoma and Its Implication in Future Clinical Practice.
Casuscelli J, Vano YA, Fridman WH, Hsieh JJ. · · 2017 · cited 40× · PMID 30334000 · DOI 10.3233/kca-170008

Verify or expand the search:

Other trials of Nivolumab

Trials testing the same drug.

NCT07572123 — Evaluating the Addition of Maintenance Immunotherapy Compared to the Usual Treatment of Chemotherapy and Autologous Stem · Phase 2, PHASE3 · not yet recruiting
NCT07444619 — A Phase I Study of Pazopanib in Combination With Trabectedin, Ipilimumab and Nivolumab (TraPIN) in Pediatric and Young A · Phase 1 · not yet recruiting
NCT07383441 — Adding Biotherapy or Placebo to Standard Treatment for Advanced Kidney Cancer · Phase 3 · not yet recruiting
NCT07420439 — Treatment in Patients With Advanced Non-Small Cell Lung Carcinoma and Interstitial Lung Disease · Phase 2 · not yet recruiting
NCT07510334 — VSV-IFNβ-NIS With Ipilimumab and Nivolumab for the Treatment of Advanced or Metastatic Clear Cell Renal Cell Carcinoma · Phase 2 · not yet recruiting

Other Association Pour La Recherche des Thérapeutiques Innovantes en Cancérologie trials

Trials by the same sponsor.

NCT02961257 — Trial Evaluating the Safety of 2 Schedules of Cabazitaxel in Elderly Men With mCRPC Previously Treated With a Docetaxel · Phase 3 · completed
NCT01828736 — Efficacy of Combination of Trastuzumab to Gemcitabine - Platinum Advanced or Metastatic Urothelial Carcinoma · Phase 2 · completed

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT02960906 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Association Pour La Recherche des Thérapeutiques Innovantes en Cancérologie
Last refreshed: 26 April 2021

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT02960906.

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