nivolumab

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Associated Genetic Biomarkers

Associated Diseases

Overview

Generic Name(s):

nivolumab

Trade Name(s):

Opdivo

NCI Definition [1]:

A fully human immunoglobulin (Ig) G4 monoclonal antibody directed against the negative immunoregulatory human cell surface receptor programmed death-1 (PD-1,PCD-1,) with immune checkpoint inhibitory and antineoplastic activities. Nivolumab binds to and blocks the activation of PD-1, an Ig superfamily transmembrane protein, by its ligands programmed cell death ligand 1 (PD-L1), overexpressed on certain cancer cells, and programmed cell death ligand 2 (PD-L2), which is primarily expressed on APCs. This results in the activation of T-cells and cell-mediated immune responses against tumor cells or pathogens. Activated PD-1 negatively regulates T-cell activation and and plays a key role in in tumor evasion from host immunity.

Biomarker-Directed Therapies

Nivolumab can be used in the treatment of colorectal carcinoma, non-small cell lung carcinoma, and endometrial adenocarcinoma. Deficient DNA Mismatch Repair (dMMR), MLH1 Deficient Expression, and MSH2 Deficient Expression are the most frequent biomarker inclusion criteria for use of nivolumab [2].

Colorectal Carcinoma +

Disease is predicted to be sensitive to nivolumab: -

Biomarker Criteria:

Sample must match all of the following:

MSI-High/dMMR

Clinical Setting(s): Metastatic (FDA, NCCN)

Note: Approved for patients 12 years and older with microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) metastatic colorectal cancer that has progressed following treatment with a uoropyrimidine, oxaliplatin, and irinotecan.

Biomarker Criteria: Sample must match all of the following: MSI-High/dMMR	Clinical Setting(s): Metastatic (FDA, NCCN)
	Note: Approved for patients 12 years and older with microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) metastatic colorectal cancer that has progressed following treatment with a uoropyrimidine, oxaliplatin, and irinotecan.

Endometrial Adenocarcinoma +

Clinical Trials

View Clinical Trials for nivolumab

Nivolumab has been investigated in 745 clinical trials, of which 644 are open and 101 are closed. Of the trials investigating nivolumab, 14 are early phase 1 (12 open), 165 are phase 1 (134 open), 157 are phase 1/phase 2 (133 open), 339 are phase 2 (297 open), 10 are phase 2/phase 3 (10 open), 56 are phase 3 (54 open), 1 is phase 4 (1 open), and 3 are no phase specified (3 open).

Microsatellite Stable (MSS), HER2 Negative, and MLH1 Deficient Expression are the most frequent biomarker inclusion criteria for nivolumab clinical trials.

Melanoma, non-small cell lung carcinoma, and malignant solid tumor are the most common diseases being investigated in nivolumab clinical trials [2].

Top Biomarker Inclusion Criteria for Open Clinical Trials Investigating Nivolumab

Top Biomarker Inclusion Criteria for Closed Clinical Trials Investigating Nivolumab

This graph displays the 20 most frequently occurring biomarkers curated on clinical trials investigating nivolumab and the cancer types associated with these biomarkers. These numbers are derived from a set of 5,956 clinical trials for which biomarker status defines treatment.

Drug Details

Synonyms [2]:

bms-936558, mdx-1106, ono-4538, Opdivo, nivolumab (substance), opdivo injection, anti-pd-1 human monoclonal antibody mdx-1106, nivolumab, nivo, nivolumab, nivolumab (product)

Drug Categories [2]:

Anti-PD-1 antibodies, Immunotherapies, Therapeutic antibodies

Drug Target(s) [2]:

PDCD1

NCIT ID [1]:

C68814

SNOMED ID [1]:

R-FC17E

References

1. National Cancer Institute. NCI Thesaurus Version 18.11d. https://ncit.nci.nih.gov/ncitbrowser/. [2018-07-30] [2018-08-02].

2. All assertions and clinical trial landscape data are curated from primary sources. You can read more about the curation process here.

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