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Nivolumab

Phase 2

Carcinoma, Non-Small-Cell Lung | Small molecule | Oncology |Meridian Bioscience Inc|Last Updated: Feb 18, 2026

Success Probability

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Market & Valuation

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Trial Design

RandomizedACTIVE_CONTROLLEDDMCBiomarker
Total Trials1
Total Enrollment108

FDA Designations

No designations recorded

Clinical trial landscape

Nivolumab · 1 trial · 1 indication

Phase 2 1
NCT05715229Immune Profile Selection By Fraction of ctDNA in Patients With Advanced NSCLC Treated With ImmunotherapyCarcinoma, Non-Small-Cell Lung
RECRUITING108 Analytics
PHASE2RECRUITING
Immune Profile Selection By Fraction of ctDNA in Patients With Advanced NSCLC Treated With Immunotherapy
Carcinoma, Non-Small-Cell LungUnlock trial analytics

Study Endpoints

Primary Endpoints

Progression Free Survival (PFS)
Time from randomization to objective disease progression, or death from any cause, whichever first, up to 36 months

To compare progression free survival in patients with on-treatment-ctDNA guided therapy continuation or escalation by addition of platinum-doublet chemotherapy to therapy continuation with Nivolumab-Ipilimumab regardless of on-treatment-ctDNA results.

Secondary Endpoints

Progression Free Survival on Subsequent line of therapy (PFS2)
Duration of time from randomization to second objective disease progression, or death from any cause, whichever first, up to 36 months
Overall Survival
Duration of time from first treatment to time of death, up to 36 months
Objective Response Rate
Duration of time between the date of first treatment and the date of objectively documented progression per irRECIST or the date of initiation of palliative local therapy or the date of subsequent anti-cancer therapy, whichever occurs first, up to 36 mo
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Study Design & Arms

AllocationRANDOMIZED
MaskingNONE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Arm AACTIVE_COMPARATORArm A - Intervention arm (Immunotherapy and Chemotherapy) Nivolumab 360 mg/kg every 3 weeks Ipilimumab 1 mg/kg every 6 weeks Platinum- doublet Chemotherapy (Histology-based) 4 cycles depending on the investigator's discretion. Carboplatin dosed at AUC 5, and either Paclitaxel 175 mg/m2 for squamous or Pemetrexed 500 mg/m2 for non-squamous
Arm BOTHERArm B - control arm (Immunotherapy only) Nivolumab 360 mg/kg every 3 weeks Ipilimumab 1 mg/kg every 6 weeks

Interventions

NameTypeDescription
NivolumabDRUGImmunotherapy
IpilimumabDRUGImmunotherapy
CarboplatinDRUGChemotherapy
PaclitaxelDRUGChemotherapy
PemetrexedDRUGChemotherapy
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Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites3

Inclusion Criteria: 1. Eligible patients will have newly diagnosed, previously untreated histologically documented Stage IV NSCLC 2. Eligible patients will be required to have positive PD-L1 expression ≥1% by IHC using Dako 22C3 assay. 3. Patients will require a baseline Guardant360 CDx test prior ...

Countries:United States
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Frequently asked questions about Nivolumab

What is Nivolumab used for in Carcinoma, Non-Small-Cell Lung?

Nivolumab is being studied for the treatment of non-small-cell lung carcinoma. It is an investigational therapy currently in Phase 2 clinical development for this indication. The drug is being evaluated in a clinical trial that enrolls patients with advanced non-small-cell lung cancer.

What does Nivolumab target?

Nivolumab is a monoclonal antibody, classified as a -mab (antibody) modality. It is being investigated for its role in cancer immunotherapy, specifically in non-small-cell lung carcinoma. The drug is part of an active clinical trial studying immune profile selection in patients with advanced non-small-cell lung cancer.

Who is developing Nivolumab?

Nivolumab is being developed by Meridian Bioscience Inc, which trades under the ticker VIVO. The company is conducting a Phase 2 clinical trial for the drug in non-small-cell lung carcinoma. The trial is currently recruiting participants in the United States.

What phase is Nivolumab in?

Nivolumab is in Phase 2 clinical development for non-small-cell lung carcinoma. It is an investigational drug, meaning it has not been approved by regulatory authorities. The ongoing Phase 2 trial is actively recruiting patients with advanced non-small-cell lung cancer.

What clinical trials is Nivolumab in?

Nivolumab is being studied in a Phase 2 clinical trial with the identifier NCT05715229. The trial is titled "Immune Profile Selection By Fraction of ctDNA in Patients With Advanced NSCLC Treated With Immunotherapy." It is recruiting 108 participants in the United States and is actively enrolling patients aged 18 years and older.

Is Nivolumab the same as any other drug?

Nivolumab is a distinct drug candidate being developed by Meridian Bioscience Inc. It is a small molecule with a monoclonal antibody modality. No alternative names for this drug have been disclosed in the available information.