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Nivolumab and Ipilimumab

Phase 2

Recurrent or Metastatic Squamous Cell Carcinoma of the Head and Neck | Small molecule | Oncology |Bristol-Myers Squibb Company|Last Updated: Nov 18, 2022

Target and mechanism

Molecular targetPDCD1
Target classInhibitor
ModalitySmall molecule

Also known as Nivolumab, Nivolumab Injection [Opdivo], Opdivo, nivolumab, Neoadjuvant nivolumab, Nivolumab and rHuPH20, nivolumab 480mg, Nivolumab 480mg and relatlimab 160mg

Success Probability

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Market & Valuation

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Trial Design

RandomizedCONTROLLEDBiomarker
Total Trials1
Total Enrollment54

FDA Designations

BREAKTHROUGH_THERAPYPRIORITY_REVIEW

Clinical trial landscape

Nivolumab and Ipilimumab · 3 trials · 3 indications

Phase 2 3
NCT03048474Ipilimumab and Nivolumab in the Treatment of Malignant Pleural MesotheliomaMalignant Pleural Mesothelioma
COMPLETED36 Analytics
NCT03620123A Randomized Phase II Study on the Optimization of Immunotherapy in Squamous Carcinoma of the Head and NeckRecurrent or Metastatic Squamous Cell Carcinoma of the Head and Neck
COMPLETED54 Analytics
NCT02497508Nivolumab in Patients With Recurrent Malignant MesotheliomaMalignant Pleural Mesothelioma
COMPLETED33 Analytics
PHASE2COMPLETED
Ipilimumab and Nivolumab in the Treatment of Malignant Pleural Mesothelioma
Malignant Pleural MesotheliomaUnlock trial analytics
PHASE2COMPLETED
A Randomized Phase II Study on the Optimization of Immunotherapy in Squamous Carcinoma of the Head and Neck
Recurrent or Metastatic Squamous Cell Carcinoma of the Head and NeckUnlock trial analytics
PHASE2COMPLETED
Nivolumab in Patients With Recurrent Malignant Mesothelioma
Malignant Pleural MesotheliomaUnlock trial analytics

Study Endpoints

Primary Endpoints

Disease Controle Rate (DCR) at 12 weeks
at 12 weeks

The number of patients that have CR or PR plus the number of patients with stable disease as a percentage of the total number of patients in the study.

objective response rate in all randomized subjects
approx. 48 months
DCR
at 12 weeks

The number of patients that have CR or PR plus the number of patients that have SD, as a percentage of the total number of patients in the study.

Secondary Endpoints

Safety: the incidence of adverse events, serious adverse events, deaths and laboratory abnormalities.
Participants will be followed for the duration of the trial, an expected average of 6 weeks
Disease Controle Rate (DCR) at 6 months
at 6 months
Progression Free Survival (PFS)
Until progression, every 6 weeks up to 48 weeks
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Study Design & Arms

AllocationNA
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Nivolumab and IpilimumabEXPERIMENTALNivolumab will be administered at a fixed dose of 240 mg every 2 weeks for a maximum period of 2 years. Nivolumab will be given in combination with ipilimumab on week 1, 7, 13 and 19. Ipilimumab will be administered at the dose of 1 mg/Kg.
DocetaxelOTHERdocetaxel 75 mg/m² intravenous infusion every three weeks
NivolumabEXPERIMENTALNivolumab will be administered 2 weekly by intravenous infusion in a dose of 3 mg/kg

Interventions

NameTypeDescription
nivolumab and ipilimumabDRUG -
DocetaxelDRUGdocetaxel 75 mg/m² intravenous infusion every three weeks
nivolumabDRUG -
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Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites1

Inclusion Criteria: * Signed informed consent form * Age ≥ 18 years * WHO-ECOG performance status 0 or 1 * Able to comply with the study protocol, in the investigator's judgment * Patients with histologically confirmed diagnosis of the recurrence of MPM. Any pleural MPM subtype is permitted for inc...

Countries:NetherlandsGermany
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Frequently asked questions about Nivolumab and Ipilimumab

What is BMS-936558 used for?

BMS-936558, also known as nivolumab and marketed as Opdivo, is an investigational oncology drug being studied for advanced or metastatic melanoma, non-squamous cell non-small cell lung cancer, localized oesogastric adenocarcinoma, follicular lymphoma, cancer, and gastric cancer. It is developed by Bristol-Myers Squibb Company (BMY) and is currently in Phase 1 clinical development.

What does BMS-936558 target?

BMS-936558 is a monoclonal antibody (target class -mab) that targets the programmed cell death protein 1 (PD-1) receptor. By binding to PD-1, it is designed to enhance the immune system's ability to fight cancer cells. This mechanism is being evaluated across multiple oncology indications.

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 BMY. The drug is also known as nivolumab and is marketed under the brand name Opdivo.

What phase is BMS-936558 in?

BMS-936558 is currently in Phase 1 clinical development. It has received FDA breakthrough therapy designation and priority review status. The drug is investigational and not yet approved, with ongoing clinical trials evaluating its safety and efficacy in various cancer types.

What clinical trials is BMS-936558 in?

BMS-936558 has been studied in multiple clinical trials, including NCT02741570, a Phase 3 trial in head and neck cancer, and NCT02823574, a Phase 2 trial in the same condition. Other trials include NCT03355560 and NCT03894891, both Phase 2 studies in head and neck cancer. Across 14 trials, total enrollment is 6,828 patients.

Is BMS-936558 the same as Opdivo?

Yes, BMS-936558 is the same as Opdivo. The drug is also known as nivolumab, nivolumab injection, and nivolumab 10 mg/ml. It is being developed by Bristol-Myers Squibb and is currently in Phase 1 trials for multiple oncology indications.