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
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
An Open-label, Uncontrolled Study of ONO-4578 and ONO-4538 in Combination With Standard-of-care Modified FOLFIRINOX (mFFX) or Gemcitabine Plus Nab-paclitaxel (GnP) Therapy as First-line Treatment in Patients With Metastatic Pancreatic Cancer
- Conditions
- Metastatic Pancreatic Cancer
- Interventions
- First Posted Date
- 2024-08-05
- Last Posted Date
- 2025-02-06
- Lead Sponsor
- Ono Pharmaceutical Co. Ltd
- Target Recruit Count
- 46
- Registration Number
- NCT06538207
- Locations
- 🇯🇵
National Cancer Center Hospital East, Kashiwa-shi, Chiba, Japan
🇯🇵Kanagawa Cancer Center, Yokohama-shi, Kanagawa, Japan
🇯🇵Seirei Hamamatsu General Hospital, Hamamatsu-shi, Shizuoka, Japan
Study of ONO-7914 Alone and in Combination With ONO-4538 in Patients With Solid Tumors
- First Posted Date
- 2024-08-02
- Last Posted Date
- 2025-02-21
- Lead Sponsor
- Ono Pharmaceutical Co. Ltd
- Target Recruit Count
- 204
- Registration Number
- NCT06535009
- Locations
- 🇯🇵
Cancer Institute Hospital of JFCR, Koto-ku, Tokyo, Japan
A Study to Evaluate the Efficacy and Safety of Autogene Cevumeran With Nivolumab Versus Nivolumab Alone in Participants With High-Risk Muscle-Invasive Urothelial Carcinoma (MIUC)
- Conditions
- Muscle Invasive Urothelial Carcinoma
- Interventions
- First Posted Date
- 2024-08-02
- Last Posted Date
- 2025-04-29
- Lead Sponsor
- Hoffmann-La Roche
- Target Recruit Count
- 362
- Registration Number
- NCT06534983
- Locations
- 🇩🇪
Uniklinik-Eppendorf, Hamburg, Germany
🇩🇪Uniklinikum Heidelberg, Heidelberg, Germany
🇩🇪Marien Hospital Herne, Herne, Germany
CD8 PET Imaging in Metastatic Solid Tumours
- Conditions
- Locally Advanced Solid Tumor
- Interventions
- Radiation: 89Zr-Df-crefmirlimab PET scanOther: zirconium Zr 89 crefmirlimab berdoxam
- First Posted Date
- 2024-08-02
- Last Posted Date
- 2025-03-30
- Lead Sponsor
- University Medical Center Groningen
- Target Recruit Count
- 30
- Registration Number
- NCT06534190
- Locations
- 🇳🇱
VUMC, Amsterdam, Netherlands
🇪🇸Vall d'Hebron Institute of Oncology (VHIO) / Vall d'Hebron Institute Research (VHIR), Barcelona, Spain
🇳🇱University Medical Center Groningen, Groningen, Netherlands
An Open-label, Uncontrolled Study of ONO-7913 and ONO-4538 in Combination With Modified FOLFIRINOX Therapy, the Standard of Care, as First-line Treatment in Patients With Metastatic Pancreatic Cancer
- Conditions
- Metastatic Pancreatic Cancer
- Interventions
- First Posted Date
- 2024-08-01
- Last Posted Date
- 2024-11-14
- Lead Sponsor
- Ono Pharmaceutical Co. Ltd
- Target Recruit Count
- 32
- Registration Number
- NCT06532344
- Locations
- 🇯🇵
National Cancer Center Hospital, Chuo Ku, Japan
🇯🇵Kanagawa Cancer Center, Yokohama-shi, Kanagawa, Japan
🇯🇵National Cancer Center Hospital East, Kashiwa-shi, Chiba, Japan
ERectile Dysfunctions, gOnadotoxicity and Sexual Health Assessment in Men With Lung Cancer
- Conditions
- Hypogonadism, MaleNSCLC Stage IVSex DisorderErectile Dysfunction
- Interventions
- First Posted Date
- 2024-08-01
- Last Posted Date
- 2024-08-09
- Target Recruit Count
- 80
- Registration Number
- NCT06532149
- Locations
- 🇮🇹
Fondazione Policlinico Gemelli IRCCS, Rome, Italy
A PhaseⅠStudy of ONO-7475 in Combination With ONO-4538 and Gemcitabine Plus Nab-paclitaxel (GnP), the Standard of Care, and ONO-7475 in Combination With GnP in Patients With Pancreatic Cancer
- Conditions
- Metastatic Pancreatic Cancer
- Interventions
- First Posted Date
- 2024-08-01
- Last Posted Date
- 2025-04-18
- Lead Sponsor
- Ono Pharmaceutical Co. Ltd
- Target Recruit Count
- 87
- Registration Number
- NCT06532331
- Locations
- 🇯🇵
Aichi Cancer Center, Nagoya-shi, Aichi, Japan
🇯🇵National Cancer Center Hospital East, Kashiwa-shi, Chiba, Japan
🇯🇵Kanazawa University Hospital, Kanazawa-shi, Ishikawa, Japan
Nivolumab in Multiple Myeloma Patients After Idecabtagene Vicleucel
- First Posted Date
- 2024-07-26
- Last Posted Date
- 2025-03-13
- Lead Sponsor
- Wake Forest University Health Sciences
- Target Recruit Count
- 50
- Registration Number
- NCT06523621
- Locations
- 🇺🇸
Levine Cancer Institute, Charlotte, North Carolina, United States
🇺🇸Atrium Health Wake Forest Baptist Comprehensive Cancer Center, Winston-Salem, North Carolina, United States
A Pilot Study Investigating Upfront Adaptive Immunotherapy Approach in Children, Adolescent and Young Adult (CAYA) Patients With Replication-Repair Deficient (RRD) High-Grade Gliomas (HGG)
- Conditions
- High Grade GliomaReplication Repair Deficient
- Interventions
- Radiation: Radiation
- First Posted Date
- 2024-07-25
- Last Posted Date
- 2025-05-15
- Lead Sponsor
- Daniel Morgenstern
- Target Recruit Count
- 20
- Registration Number
- NCT06519682
- Locations
- 🇨🇦
Hospital for Sick Children, Toronto, Ontario, Canada
Drug Development Updates
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