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nivolumab

Phase 1

Non-Small Cell Lung Cancer | Small molecule | Oncology |AbbVie Inc.|Last Updated: Oct 23, 2019

Success Probability

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Market & Valuation

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Trial Design

RandomizedCONTROLLED
Total Trials1
Total Enrollment25

FDA Designations

No designations recorded

Clinical trial landscape

nivolumab · 1 trial · 1 indication

Phase 1 1
NCT02944396Study of Veliparib in Combination With Nivolumab and Platinum Doublet Chemotherapy in Participants With Metastatic or Advanced Non-Small Cell Lung Cancer (NSCLC)Non-Small Cell Lung Cancer
COMPLETED25 Analytics
PHASE1COMPLETED
Study of Veliparib in Combination With Nivolumab and Platinum Doublet Chemotherapy in Participants With Metastatic or Advanced Non-Small Cell Lung Cancer (NSCLC)
Non-Small Cell Lung CancerUnlock trial analytics

Study Endpoints

Primary Endpoints

Progression-free survival (PFS)
Up to approximately 3.5 years

PFS is defined as the number of days from the date of randomization to the date of earliest disease progression (radiographic progression per RECIST version 1.1 or clinical disease progression) or death. If the participant does not experience disease progression or death, then the data will be censored at the date of the last disease assessment.

Recommended Phase 2 dose (RPTD) of veliparib (ABT-888) in combination with nivolumab and platinum doublet chemotherapy in participants with metastatic or advanced Non-Small Cell Lung Cancer (NSCLC).
Up to 6 weeks

Secondary Endpoints

Tmax for pemetrexed
Up to approximately 3 weeks
AUC for nivolumab
Up to approximately 3.5 years
Overall Survival (OS)
Up to approximately 3.5 years
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Study Design & Arms

AllocationRANDOMIZED
MaskingNONE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Veliparib and nivolumab with platinum doublet chemotherapyEXPERIMENTALVeliparib and nivolumab in combination with platinum doublet chemotherapy (carboplatin/paclitaxel or carboplatin/pemetrexed)
Veliparib with platinum doublet chemotherapyEXPERIMENTALVeliparib in combination with platinum doublet chemotherapy (carboplatin/paclitaxel or carboplatin/pemetrexed)

Interventions

NameTypeDescription
pemetrexedDRUGintravenous; administered on Day 1 via infusion in a 21-day cycle
nivolumabDRUGintravenous; administered on Day 1 via infusion in a 21-day cycle
paclitaxelDRUGintravenous; administered on Day 1 via infusion in a 21-day cycle
veliparibDRUGoral capsule; varying doses administered on Days -2 to 5 in a 21-day cycle
carboplatinDRUGintravenous; administered on Day 1 via infusion in a 21-day cycle
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Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites6

Inclusion Criteria: * Participant must have a life expectancy greater than 12 weeks, * Participant must have cytologically or histologically confirmed Non-small Cell Lung Cancer (NSCLC). * Participant must have metastatic or advanced NSCLC (Stage IIIB or IV) that is not amenable to surgical resecti...

Countries:United States
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Competitive Landscape -Non-Small Cell Lung Cancer 391 trials

Frequently asked questions about nivolumab

What is nivolumab used for in Non-Small Cell Lung Cancer?

Nivolumab is an investigational antibody being studied for use in Non-Small Cell Lung Cancer (NSCLC). In a completed Phase 1 trial, it was evaluated in combination with veliparib and platinum doublet chemotherapy in participants with metastatic or advanced NSCLC. The trial enrolled 25 participants in the United States.

What does nivolumab target?

Nivolumab is a monoclonal antibody, indicated by its -mab suffix. It is being studied in Non-Small Cell Lung Cancer, where it is combined with veliparib and platinum doublet chemotherapy. The specific molecular target is not disclosed in the available trial information.

Who makes nivolumab?

Nivolumab is being developed by AbbVie Inc., a biopharmaceutical company traded under the ticker ABBV. The drug is currently in Phase 1 clinical development for Non-Small Cell Lung Cancer.

What phase is nivolumab in?

Nivolumab is in Phase 1 clinical development. It is an investigational drug, not yet approved, and has completed one Phase 1 trial. The completed trial studied nivolumab in combination with veliparib and platinum doublet chemotherapy for Non-Small Cell Lung Cancer.

What clinical trials is nivolumab in?

Nivolumab has one completed clinical trial, NCT02944396, titled "Study of Veliparib in Combination With Nivolumab and Platinum Doublet Chemotherapy in Participants With Metastatic or Advanced Non-Small Cell Lung Cancer (NSCLC)." This Phase 1 trial enrolled 25 participants in the United States and is now completed.

Is nivolumab the same as any other drug?

Nivolumab is not reported to have any alternative names. It is a distinct investigational monoclonal antibody being developed by AbbVie Inc. for Non-Small Cell Lung Cancer. No other names for this drug have been disclosed in the available information.