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Nivolumab and rHuPH20

Phase 3

Clear Cell Renal Cell Carcinoma | Monoclonal antibody | Oncology |Bristol-Myers Squibb Company|Last Updated: Oct 9, 2025

Target and mechanism

Molecular targetPDCD1
Target classInhibitor
ModalityMonoclonal antibody

Also known as Nivolumab, Nivolumab Injection [Opdivo], nivolumab, Neoadjuvant nivolumab, Nivolumab -, nivolumab 480mg

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindACTIVE_CONTROLLEDDMC
Total Trials1
Total Enrollment681

FDA Designations

BREAKTHROUGH_THERAPYPRIORITY_REVIEW

Clinical trial landscape

Nivolumab and rHuPH20 · 1 trial · 1 indication

Phase 3 1
NCT04810078A Study of Subcutaneous Nivolumab Versus Intravenous Nivolumab in Participants With Previously Treated Clear Cell Renal Cell Carcinoma That is Advanced or Has SpreadClear Cell Renal Cell Carcinoma
ACTIVE NOT_RECRUITING681 Analytics
PHASE3ACTIVE NOT_RECRUITING
A Study of Subcutaneous Nivolumab Versus Intravenous Nivolumab in Participants With Previously Treated Clear Cell Renal Cell Carcinoma That is Advanced or Has Spread
Clear Cell Renal Cell CarcinomaUnlock trial analytics

Study Endpoints

Primary Endpoints

Time-averaged serum concentration over 28 days (Cavgd28)
Up to 28 days
Trough serum concentration at steady-state (Cminss)
Up to 4 months

Secondary Endpoints

Objective response rate (ORR) by Blinded Independent Central Review (BICR) with a minimum of 6 months follow-up
Up to 2 years 6 months
Trough serum concentration at day 28 (Cmind28)
At 28 days
Maximum serum concentration after the first dose (Cmax1)
Up to 7 days
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Study Design & Arms

AllocationRANDOMIZED
MaskingQUADRUPLE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Arm AEXPERIMENTAL -
Arm BACTIVE_COMPARATOR -
Arm CEXPERIMENTAL -
Arm DEXPERIMENTAL -

Interventions

NameTypeDescription
Nivolumab and rHuPH20BIOLOGICALSpecified dose on specified days
NivolumabBIOLOGICALSpecified dose on specified days
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Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites89

For more information regarding Bristol-Myers Squibb Clinical Trial participation, please visit www.BMSStudyConnect.com Inclusion Criteria: * Histological confirmation of renal cell carcinoma (RCC) with a clear cell component, including participants who may also have sarcomatoid features * Advanced...

Countries:United StatesArgentinaBrazilChileCzechiaFinlandFranceIrelandItalyMexicoNew ZealandPolandPortugalRomaniaRussiaSpainTurkey (Türkiye)
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Recent Changes (Last 90 Days)

LOWMay 26, 2026NCT04810078primaryCompletionDate: changed
LOWMay 24, 2026NCT04810078studyFirstPostDate: changed

Frequently asked questions about Nivolumab and rHuPH20

What is BMS-936558 used for?

BMS-936558, also known as nivolumab, is an investigational oncology drug being studied for brain cancer, advanced renal cell carcinoma, chronic myeloid leukemia, lymphoma, metastatic non-squamous non-small cell lung cancer, and neoplasms by site. It is developed by Bristol-Myers Squibb Company (BMY) and is currently in Phase 1 clinical development.

What does BMS-936558 target?

BMS-936558 targets PDCD1, also known as programmed cell death protein 1, and acts as an inhibitor of this target. By inhibiting PDCD1, the drug is designed to modulate immune responses in the treatment of various cancers, including non-small cell lung cancer and other solid tumors.

Who makes BMS-936558?

BMS-936558 is developed by Bristol-Myers Squibb Company, a biopharmaceutical company traded on the New York Stock Exchange under the ticker symbol BMY. The drug is also known as nivolumab and is being investigated for multiple oncology indications.

What phase is BMS-936558 in?

BMS-936558 is in Phase 1 clinical development. It has received FDA designations of Breakthrough Therapy and Priority Review. The drug is investigational and not yet approved, with 14 total clinical trials, 5 active and 9 completed, involving 6,828 participants.

What clinical trials is BMS-936558 in?

BMS-936558 is being studied in several clinical trials, including NCT01454102 (CheckMate 012) in non-small cell lung cancer, NCT02574078 in advanced NSCLC, NCT04123379 as neoadjuvant therapy for NSCLC or hepatocellular carcinoma, and NCT06946797 evaluating subcutaneous nivolumab with ipilimumab and chemotherapy in NSCLC.

Is BMS-936558 the same as nivolumab?

Yes, BMS-936558 is the same as nivolumab, which is also known as Nivolumab Injection [Opdivo]. Other names include Neoadjuvant nivolumab, Nivolumab 10 MG/ML, and Nivolumab 240 mg, among others. It is being developed by Bristol-Myers Squibb Company.