Nivolumab
- Generic Name
- Nivolumab
- Brand Names
- Opdivo, Opdualag
- Drug Type
- Biotech
- CAS Number
- 946414-94-4
- Unique Ingredient Identifier
- 31YO63LBSN
- Background
Nivolumab is a fully human IgG4 antibody targeting the immune checkpoint programmed death receptor-1 (PD-1). This antibody was produced entirely in mice and grafted onto human kappa and IgG4 Fc region with the mutation S228P for additional stability and reduced variability. It was developed by Bristol Myers Squibb.
Nivolumab was granted FDA approval on 22 December 2014.
- Indication
Nivolumab is indicated to treat unresectable or metastatic melanoma, melanoma as adjuvant treatment, resectable or metastatic non-small cell lung cancer, small cell lung cancer, advanced renal cell carcinoma, classical Hodgkin lymphoma, squamous cell carcinoma of the head and neck, urothelial carcinoma, microsatellite instability-high or mismatch repair deficient metastatic colorectal cancer, hepatocellular carcinoma, and esophageal cancer. The indication for classical Hodgkin lymphoma, microsatellite instability-high or mismatch repair deficient metastatic colorectal cancer, and hepatocellular carcinoma were approved under accelerated approval based on the overall response rate. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials.
Nivolumab is also approved for the treatment of HER2-negative advanced or metastatic gastric, gastroesophageal junction, or esophageal adenocarcinoma when used in combination with a fluoropyrimidine- and platinum-containing chemotherapy regimen.
In combination with relatlimab, nivolumab is indicated for the treatment of patients ≥12 years old with unresectable or metastatic melanoma.
- Associated Conditions
- Advanced Esophageal Adenocarcinoma, Advanced Gastric Adenocarcinoma, Advanced Gastric Carcinoma, Advanced Gastroesophageal Junction Adenocarcinoma, Advanced Renal Cell Carcinoma, Classical Hodgkin's Lymphoma, Completely resected Stage IIB melanoma, Completely resected Stage III melanoma, Completely resected Stage IV melanoma, Hepatocellular Carcinoma, Locally Advanced Hepatocellular Carcinoma, Locally Advanced Non-Small Cell Lung Cancer, Melanoma, Metastatic Colorectal Cancer (CRC), Metastatic Esophageal Adenocarcinoma, Metastatic Esophageal Squamous Cell Carcinoma, Metastatic Gastric Adenocarcinoma, Metastatic Gastric Cancers, Metastatic Gastroesophageal Junction Adenocarcinoma, Metastatic Hepatocellular Carcinoma, Metastatic Melanoma, Metastatic Non-Small Cell Lung Cancer, Metastatic Renal Cell Carcinoma ( mRCC), Metastatic Squamous Cell Carcinoma of the Head and Neck (HNSCC), Metastatic Urothelial Carcinoma (UC), Mismatch Repair-deficient (dMMR) Metastatic Colorectal Cancer (CRC), Muscle-invasive Urothelial Carcinoma, Poor Risk Advanced Renal Cell Cancer, Recurrent Non-small Cell Lung Cancer, Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma, Relapsed or Refractory Classical Hodgkin's Lymphoma, Resectable Non-small Cell Lung Cancer, Stage IIB Melanoma, Stage IIC Melanoma, Unresectable Esophageal Squamous Cell Carcinoma, Unresectable Locally Advanced Urothelial Cancer, Unresectable Melanoma, Urothelial Carcinoma, Completely resected Stage IIC melanoma, Intermediate risk Advanced Renal Cell Cancer, Locally advanced Urothelial Carcinoma, Metastatic Microsatellite Instability High Colorectal Cancer, Metastatic Mismatch Repair Deficient Colorectal Cancer, Metastatic gastroesphageal juntion adenocarcinoma, Recurrent Squamous Cell Carcinoma of the Head and Neck (SCCHN), Relapsed Classical Hodgkin's Lymphoma, Residual Esophageal Cancer, Residual Gastroesophageal Junction Cancer, Unresectable Malignant Pleural Mesothelioma (MPM), Unresectable advanced, recurrent or metastatic oesophageal squamous cell carcinoma, Unresectable, advanced Esophageal Squamous Cell Carcinoma (ESCC), Unresectable, metastatic Esophageal Squamous Cell Carcinoma (ESCC), Unresectable, recurrent Esophageal Squamous Cell Carcinoma (ESCC)
- Associated Therapies
- Complete Surgical Resection, Neoadjuvant Therapies
An Expanded Access Program for VO (RP1) in Combination With Nivolumab in Patients With Advanced Melanoma
- Conditions
- Advanced Melanoma
- First Posted Date
- 2024-09-19
- Last Posted Date
- 2025-03-19
- Lead Sponsor
- Replimune Inc.
- Registration Number
- NCT06590480
A Randomized, Phase 2/3 Study to Investigate the Efficacy and Safety of RP2 in Combination With Nivolumab in Immune Checkpoint Inhibitor-Naïve Adult Patients With Metastatic Uveal Melanoma
- Conditions
- Metastatic Uveal Melanoma
- Interventions
- First Posted Date
- 2024-09-03
- Last Posted Date
- 2025-04-16
- Lead Sponsor
- Replimune Inc.
- Target Recruit Count
- 280
- Registration Number
- NCT06581406
- Locations
- 🇺🇸
Northwestern Memorial Hospital, Chicago, Illinois, United States
🇺🇸University Of Wisconsin Carbone Cancer Center - University Hospital, Madison, Wisconsin, United States
🇺🇸The West Clinic, PLLC dba West Cancer Center, Germantown, Tennessee, United States
Perioperative Immunotherapy for NSCLC (ECTOP-1030)
- Conditions
- Lung Cancer
- Interventions
- First Posted Date
- 2024-08-27
- Last Posted Date
- 2024-08-27
- Lead Sponsor
- Fudan University
- Target Recruit Count
- 200
- Registration Number
- NCT06572722
A Study to Compare the Efficacy of Nivolumab and Relatlimab Plus Chemotherapy vs Pembrolizumab Plus Chemotherapy for Stage IV/Recurrent Non-squamous Non-small Cell Lung Cancer With PD-L1 Expression ≥ 1%
- Conditions
- Non-small Cell Lung Cancer
- Interventions
- First Posted Date
- 2024-08-20
- Last Posted Date
- 2025-05-09
- Lead Sponsor
- Bristol-Myers Squibb
- Target Recruit Count
- 1000
- Registration Number
- NCT06561386
- Locations
- 🇮🇹
Local Institution - 0222, Ravenna, Italy
🇺🇸Local Institution - 0368, Tucson, Arizona, United States
🇺🇸Local Institution - 0112, Los Angeles, California, United States
Phase II Randomized, Placebo- Controlled Study of Intralesional Nivolumab for High-risk Oral Premalignant Lesions
- First Posted Date
- 2024-08-19
- Last Posted Date
- 2025-03-03
- Lead Sponsor
- M.D. Anderson Cancer Center
- Target Recruit Count
- 45
- Registration Number
- NCT06561087
- Locations
- 🇺🇸
MD Anderson Cancer Center, Houston, Texas, United States
Olanzapine Impact on First-line Immunotherapy for Advanced EGFR-negative NSCLC
- Conditions
- Non-Small Cell Lung Cancer
- Interventions
- First Posted Date
- 2024-08-15
- Last Posted Date
- 2024-08-15
- Lead Sponsor
- Second Affiliated Hospital of Nanchang University
- Target Recruit Count
- 156
- Registration Number
- NCT06554613
Study of ONO-4578 and XELOX/FOLFOX Plus Bevacizumab in Colorectal Cancer
- Conditions
- Colorectal Cancer
- Interventions
- First Posted Date
- 2024-08-09
- Last Posted Date
- 2024-08-09
- Lead Sponsor
- Ono Pharmaceutical Co. Ltd
- Target Recruit Count
- 40
- Registration Number
- NCT06547385
- Locations
- 🇯🇵
Cancer Institute Hospital of JFCR, Koto-Ku, Tokyo, Japan
🇯🇵Osaka Medical and Pharmaceutical University Hospital, Takatsuki-shi, Osaka, Japan
🇯🇵National Cancer Center Hospital East, Kashiwa-shi, Chiba, Japan
A Study of BMS-986484 Alone and Combination Therapy in Participants With Advanced Solid Tumors
- First Posted Date
- 2024-08-09
- Last Posted Date
- 2025-03-17
- Lead Sponsor
- Bristol-Myers Squibb
- Target Recruit Count
- 134
- Registration Number
- NCT06544655
- Locations
- 🇦🇺
St Vincent's Hospital, Darlinghurst, New South Wales, Australia
🇨🇦Princess Margaret Cancer Centre, Toronto, Ontario, Canada
🇺🇸Local Institution - 0003, Tucson, Arizona, United States
An Open-label, Uncontrolled Study of ONO-4578 and ONO-4538 in Combination With Standard-of-care Docetaxel and Ramucirumab as Second-line Therapy in Patients With Advanced or Recurrent Non-small Cell Lung Cancer
- Conditions
- Non-small Cell Lung Cancer
- Interventions
- First Posted Date
- 2024-08-07
- Last Posted Date
- 2024-08-07
- Lead Sponsor
- Ono Pharmaceutical Co. Ltd
- Target Recruit Count
- 42
- Registration Number
- NCT06542731
- Locations
- 🇯🇵
National Cancer Center Hospital, Chuo Ku, Tokyo, Japan
🇯🇵The Cancer Institute Hospital of JFCR, Koto-ku, Japan
🇯🇵Teikyo University Hospital, Itabashi-ku, Japan
The Study of ONO-7913, ONO-4538 and the Standard of Care as First-line Treatment in Patients Colorectal Cancer
- Conditions
- Unresectable Colorectal Cancer
- Interventions
- First Posted Date
- 2024-08-06
- Last Posted Date
- 2024-08-06
- Lead Sponsor
- Ono Pharmaceutical Co. Ltd
- Target Recruit Count
- 65
- Registration Number
- NCT06540261
- Locations
- 🇯🇵
Kanagawa Cancer Center, Yokohama, Kanagawa, Japan
🇯🇵Kurashiki Central Hospital, Kurashiki, Okayama, Japan
🇯🇵Saitama Medical University International Medical Center, Hidaka, Saitama, Japan
Drug Development Updates
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