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Last update 21 Feb 2025

Nivolumab

Last update 21 Feb 2025

Overview

R&D Status

Clinical Result

Translational Medicine

Overview

Basic Info

Drug Type

Monoclonal antibody

Synonyms

Nivolumab (Genetical Recombination), Nivolumab (genetical recombination) (JAN), Nivolumab (USAN/INN)

+ [14]

Target

PD-1

Mechanism

PD-1 inhibitors(Programmed cell death protein 1 inhibitors)

Therapeutic Areas

NeoplasmsImmune System DiseasesDigestive System Disorders+ [13]

Active Indication

Skin NeoplasmsMesothelioma, MalignantResectable Lung Non-Small Cell Carcinoma+ [498]

Inactive Indication

Acidemia, IsovalericAcquired Immunodeficiency SyndromeAcute lymphoblastic leukemia recurrent+ [96]

Originator Organization

Ono Pharmaceutical Co., Ltd.

Bristol Myers Squibb Co.

Active Organization

Bristol Myers Squibb Co.

National Cancer Institute

Ono Pharmaceutical Co., Ltd.

+ [26]

Inactive Organization

Transgene SA

Navire Pharma, Inc.Startup

The University of Texas Southwestern Medical Center

+ [11]

Drug Highest PhaseApproved

First Approval Date

JP (04 Jul 2014),

Esophageal CarcinomaMelanoma

RegulationPriority Review (US), Breakthrough Therapy (US), Fast Track (US), Accelerated Approval (US), Orphan Drug (US), Priority Review (CN), Breakthrough Therapy (CN), Priority Review (AU), Conditional marketing approval (CN), Orphan Drug (JP)

Structure/Sequence

Sequence Code 93681H

Source: *****

Sequence Code 93684L

Source: *****

1,831

Clinical Trials associated with Nivolumab

NCT06794229

/ Not yet recruitingPhase 2IIT

A Phase II, Open-label, Single-arm Study of NEoadjuvant Zanzalintinib (XL092) Plus NivoLumab in Patients with LOcally Advanced And/or InopeRable ClEar Cell Renal Cell Carcinoma with or Without Non-measurable Metastasis (EXPLORE-RCC)

All subjects will receive zanzalintinib 100mg orally (PO) once daily plus nivolumab standard of care dosing (i.e., 240mg IV every 2 weeks or 480mg IV every 4 weeks) for a total of 12 weeks, followed by restaging scan/evaluation for surgical operability and an adaptive approach that includes (1) surgical resection if the participant is eligible for surgery (Cohort A), (2) up to 48 weeks total (from Cycle 1 Day 1) of zanzalintinib plus nivolumab if the participant has partial response or stable disease but remains inoperable (Cohort B1), or (3) stopping protocol mandated treatment to receive standard of care systemic therapy and continue follow up per protocol if the participant has disease progression (Cohort B2).

Start Date01 Nov 2025

Sponsor / Collaborator

Hoosier Cancer Research Network

[+2]

NCT06047015

/ Not yet recruitingPhase 1/2IIT

Immune Response to Irreversible Electroporation (NanoKnife ®) and a Checkpoint Inhibitor With or Without CpG Oligodeoxynucleotides for the Treatment of Stage IV Colorectal Cancer

The goal of this pilot clinical trial is to learn about the combination of immune boosting drugs and irreversible electroporation (IRE) in patients with colon cancer that has spread to the liver (metastasis). The main questions it aims to answer are:
1. to document the rate of complications associated with combining IRE with immune boosting drugs.
2. After one liver metastasis is treated with IRE and immune boosting drugs, what is the change in the size of the non-IRE-treated liver metastases?
3. What is the immune response (measured in a blood sample) when IRE is combined with one or two types of immune boosting drugs?

Start Date01 Jul 2025

Sponsor / Collaborator

University of Saskatchewan

NCT06816927

/ Not yet recruitingPhase 2IIT

A Multi-Center, Randomized, Phase 2 Trial of Glioblastoma Immunotherapy Advancement With Nivolumab and Relatlimab (GIANT)

GIANT is an open-label, multi-center, randomized, perioperative (neoadjuvant followed by adjuvant), phase 2 trial with a safety lead-in phase to investigate the feasibility, safety and tolerability, and establish the biological activity of nivolumab with or without relatlimab in patients with isocitrate dehydrogenase (IDH) wildtype newly diagnosed glioblastoma (ndGBM).

Start Date01 Jun 2025

Sponsor / Collaborator

Duke University

100 Clinical Results associated with Nivolumab

100 Translational Medicine associated with Nivolumab

100 Patents (Medical) associated with Nivolumab

10,667

Literatures (Medical) associated with Nivolumab

31 Dec 2025·Human Vaccines & Immunotherapeutics

State of the art of adjuvant immunotherapy in urothelial cancer: New developments and upcoming changes

Review

Author: Marchetti, Andrea ; Mollica, Veronica ; Mottaran, Angelo ; Piazza, Pietro ; Rosellini, Matteo ; Danielli, Linda ; Ricci, Costantino ; Schiavina, Riccardo ; Tassinari, Elisa ; Massari, Francesco ; Santoni, Matteo

In recent years, several clinical trials focused on the potential role of immune-checkpoint inhibitors (ICIs) in the adjuvant treatment of muscle-invasive urothelial cancer (UC). Heretofore, only the anti-programmed death protein 1 (anti-PD1) nivolumab received European Medical Agency (EMA) approval for cisplatin-unfit patients. In our work, we deeply analyzed the results of the three pivotal studies in view of the rapidly evolving therapeutic advanced UC's scenario. Furthermore, there are several ongoing research to investigate ICIs and other emerging immune agents in this setting; results are awaited. Additionally, current efforts have been made to assess the role of these agents in earlier disease settings, particularly in high-risk non-muscle-invasive bladder cancer (NMIBC). In our review, we analyzed the potential role of predictive and/or prognostic biomarkers that may improve patient selection and treatment efficacy. To conclude, we highlighted the upcoming changes that could redefine the standard of care for patients with early-stage UC.

31 Dec 2025·Human Vaccines & Immunotherapeutics

PD-1/PD-L1 inhibitors related adverse events: A bibliometric analysis from 2014 to 2024

Article

Author: Chang, Lei ; Lu, Wenping ; Zhang, Dongni ; Mei, Heting ; Zhuo, Zhili ; Cui, Yongjia ; Yu, Zongliang ; Song, Qingya

Programmed cell death-1 (PD-1) inhibitors and programmed cell death ligand 1 (PD-L1) inhibitors are considered effective alternatives for the primary treatment of recurrent metastatic cancers. However, they can induce various adverse events affecting multiple organ systems, potentially diminishing patients' quality of life, and even leading to treatment interruptions. Adverse events related to PD-1/PD-L1 inhibitors differ from those associated with CTLA-4 inhibitors and are more commonly observed in the treatment of solid tumors. This study aimed to address the knowledge gap regarding adverse events related to PD-1/PD-L1 inhibitors. A visual bibliometric network was constructed using VOSviewer, CiteSpace, R software, and the Web of Science Core Collection (WoSCC) to quantitatively analyze this research field. Future research directions were also explored. The USA ranked first in publication count and total citations. Over time, publication types transitioned from case reports to clinical trials. Research on for nivolumab was the most prevalent. The spectrum of cancers treated by PD-1/PD-L1 inhibitors expanded beyond melanoma and lung cancer to include renal cell carcinoma, esophageal cancer, and others. Common adverse events included pneumonitis, myasthenia gravis, and vitiligo. There was a significant increase in multi-phase clinical trials and studies related to biomarkers. This study offers valuable insights for potential collaborators and institutions, highlighting trends in the study of adverse events related to PD-1/PD-L1 inhibitors. The management of these adverse events has become more refined and standardized. Biomarker research and multi-phase clinical trials are likely to be key areas of focus in future studies.

31 Dec 2025·OncoImmunology

Circulating cytokine associations with clinical outcomes in melanoma patients treated with combination nivolumab plus ipilimumab

Article

Author: Baginska, Joanna ; Rodig, Scott J. ; Hodi, F. Stephen ; Severgnini, Mariano ; Manuszak, Claire ; Brennick, Ryan ; Chen, Jiajia ; Weirather, Jason L. ; Manos, Michael ; Ranasinghe, Srinika ; Liu, David ; Huang, Amy Y. ; Holovatska, Marta ; Hathaway, Emma ; Nazzaro, Matthew ; Giobbie-Hurder, Anita ; Tarantino, Giuseppe ; Russell, Janice D. ; Pfaff, Kathleen L.

Nivolumab plus ipilimumab (aCTLA-4/aPD-1) combination therapy has significantly improved clinical outcomes in patients with metastatic melanoma, with 50%-60% of patients responding to treatment, but predictors of response are poorly characterized. We hypothesized that circulating cytokines and peripheral white blood cells may predict response to therapy and evaluated 15 cytokines and complete blood counts (CBC with differentials) from 89 patients with advanced melanoma treated with combination therapy from three points in time: pre-treatment, one month and approximately three months after starting therapy. Clinical endpoints evaluated included durable clinical benefit (DCB), progression-free survival (PFS), and overall survival (OS). A parsimonious predictive model was developed to identify cytokines predictors of response to combination therapy. In this study, we found that pre-treatment, patients with DCB had higher IL-23, lower CXCL6, and lower IL-10 levels. Lower NLR one month after starting therapy predicted better PFS and OS, primarily driven by an increase in absolute lymphocytes. A multivariate model demonstrated that baseline CXCL6, IL-10, IL-23 were independent predictors of therapy response, and the combined model has reached an area under the curve (AUC) of 0.79 in prediction of response to combination therapy. Our study identified baseline CXCL6, IL-23, and IL-10 as predictors of response to aCTLA4/aPD1 combination therapy among patients with metastatic melanoma. This study also provides a framework for identifying patients who are likely to respond to combination ICB, as well as a subset of patients with high risk of developing resistance and are thus in need of alternative therapeutic options, such as clinical trials.

1,831

News (Medical) associated with Nivolumab

18 hours ago

·synapse.patsnap.com

Overview of the Development Progress of PARP-7 Drug Target

PARP7 functions by catalyzing the transfer of a single ADP-ribose unit onto substrates, altering their functionality. As a negative regulator of nucleic acid sensing in tumor cells, inhibiting PARP7 has demonstrated remarkable effects in restoring the response of nucleic acids to the type I interferon (IFN) signaling pathway in tumor models. This restoration of signaling not only directly inhibits cell proliferation but also activates the immune system, contributing to tumor regression. The preclinical proof-of-concept (POC) and the confirmed druggability of this pathway further enhance the attractiveness of PARP7 as a therapeutic target. Among the pioneers in recognizing the pharmaceutical potential of PARP7 inhibitors is AZ, a leading company in this field. Understanding and targeting PARP7 can open new avenues for effective cancer treatments. According to the statistics from Synapse, there are currently 20 drugs targeting PARP7 in the developmental stage, covering indications in 8 disease areas. The competition among 19 research institutions in this field is intense. Small molecules are the predominant type of drugs being developed, with a high number of 216 patents and 191 scientific publications. These numbers highlight the research intensity and potential value of PARP7-targeted drugs. With a significant number of ongoing developments, it is evident that PARP7 is a promising drug target with considerable interest in the scientific community and industry. Exploring the therapeutic potential of PARP7 inhibition could lead to innovative treatments across various disease domains. If you are looking for effective drugs targeting PARP7, the ongoing research and development efforts offer promising prospects. PARP7 Competitive LandscapeWhen conducting a search for PARP7 in Synapse, it is evident that numerous domestic companies in China have actively participated in the development of PARP7 inhibitors. Some of these companies include Jacobio、Novostar、Haisco、Shandong Lufa、Chongqing Pharscin、WuXi AppTec、Inventisbio、Hangzhou Yingchuang, among others. Notably, Ribon's RBN-2397 has progressed to Phase 1/2 clinical trials, Jasco has submitted a clinical application for JAB-26766, and Novostar has initiated preclinical research on two PARP-7 inhibitors, NSP-5020 and NSP-5033. Key Drug: RBN2397RBN-2397 is a drug developed by Ribon Therapeutics. It was discovered through high-throughput screening (HTS) as a potential compound and further optimized based on its interaction with the key binding pocket region of nicotinamide adenine dinucleotide (NAD+). By inhibiting PARP7 in tumor cells, RBN-2397 directly suppresses cell proliferation and restores type I interferon signaling, thereby activating innate or adaptive anti-tumor immune responses. Currently, RBN-2397 is in the dose escalation phase, involving 50 patients. Dose regimens and relative bioavailability have been evaluated through administration ranging from 25 mg to 500 mg twice daily (BID). The most common tumor types enrolled in the study were breast cancer (n=8), lung cancer (n=7), and colorectal cancer (n=5). The recommended phase 2 dose (RP2D) is 200 mg BID, administered continuously with oral tablets. In the dose expansion phase, 53 patients have been enrolled, including small cell lung cancer (22 cases), head and neck squamous cell carcinoma (17 cases), and hormone receptor-positive breast cancer (14 cases). RBN-2397 has demonstrated good tolerability at the RP2D and exhibited both biological and anti-tumor activities based on the observed exposure. Phase 1 clinical protocol of RBN2397The development of RBN-2397 represents a significant advancement in the field of PARP7 inhibitors. Its promising pharmacological profile and potential efficacy in various tumor types make it a subject of great interest among researchers, healthcare professionals, and the pharmaceutical industry. By targeting PARP7, RBN-2397 holds the potential to offer a novel therapeutic approach in cancer treatment and has the possibility to address unmet medical needs in patients. Staying informed about the ongoing clinical trials and updates related to RBN-2397 is crucial for researchers, medical practitioners, and stakeholders in the field. This information can aid in identifying potential collaborations, investment opportunities, and the future market landscape. As the development of RBN-2397 progresses, continued monitoring of its efficacy and safety profiles will contribute to the advancement of precision medicine and personalized treatment strategies for cancer patients. RBN-2397 demonstrates excellent safety and tolerability, as evidenced by the following observations. Only five patients (4.9%) experienced treatment-related acute lung injury, and treatment was discontinued due to adverse events in 28 patients (27.2%) and 12 patients (11.7%), respectively. Compared to approved PARP1/2 inhibitors, RBN-2397 exhibits a lower incidence of hematological toxicity. Overall, RBN-2397 shows good tolerability, with most adverse events being mild to moderate. Preliminary evidence of anti-tumor activity has been observed during dose escalation and expansion cohort studies. In the dose escalation phase, one patient with hormone receptor-positive breast cancer achieved partial response (PR), and 13 patients had disease stabilization (SD) with a clinical benefit duration exceeding four months. In the dose expansion phase, one patient with head and neck squamous cell carcinoma (HNSCC) achieved a response, and four patients had disease stabilization with a clinical benefit duration exceeding four months. Baseline biopsies across all evaluations revealed expression of PARP7, with higher expression levels observed in tumor cells compared to stromal cells. Increased expression of CD8+ T cells and/or granzyme B was observed in expanded cohort patients across multiple tumor types, indicating the induction of adaptive immune responses following RBN-2397 treatment. RBN-2397 can activate the tumor-specific IFN pathway and enhance immune cell infiltration into the tumor site, providing evidence for the induction of adaptive immune responses. These data validate the role of PARP7 as a novel target for anti-cancer therapy and confirm the mechanism of action of RBN-2397. These results support the ongoing clinical trials investigating the combination of RBN-2397 with pembrolizumab (NCT05127590) and nivolumab (jRCT2031210373). References 1.https://www.futuremarketinsights.com/reports/parp-inhibitors-market. 2. Heike Keilhack, et al. PARP7 negatively regulates the type I interferon response in cancer cells and its inhibition triggers antitumor immunity. https://doi-org.libproxy1.nus.edu.sg/10.1016/j.ccell.2021.06.018. 3.Melissa Johnson, et al. First-in-Class First-in-Human Phase 1 Trial of RBN-2397 in Patients with Advanced Solid Tumors Validates PARP7 as a Novel Anticancer Therapeutic Target.2023,ESMO,TAT. 4.Yun genxu, et al. Discovery of the Potent and Highly Selective PARP7 Inhibitor as a Novel Immunotherapeutic Agent for Tumors.J. Med. Chem. 2023, 66, 473−490. 5.Oriana Tabarrini, et al. Medicinal Chemistry Perspective on Targeting Mono-ADPRibosylating PARPs with Small Molecules.J. Med. Chem. 2022, 65, 7532−7560. The content above comes from the network. if any infringement, please contact us to modify.

21 Feb 2025

·pmlive.com

BMS shares overall survival results for Opdivo in phase 3 lung cancer trial

Bristol Myers Squibb (BMS) has shared positive overall survival (OS) results from a late-stage study of its Opdivo (nivolumab) combination in non-small cell lung cancer (NSCLC). The phase 3 CheckMate-816 study has been evaluating the drug alongside platinum-doublet chemotherapy as a neoadjuvant treatment for adults with resectable cases of the disease. The final analysis of the trial demonstrated a statistically significant and clinically meaningful improvement in the key secondary endpoint of OS for Opdivo-treated patients compared to those receiving neoadjuvant chemotherapy alone. The safety profile of the Opdivo combination was also found to be consistent with previously reported studies, with no new safety signals observed. The results come after CheckMate-816 showed statistical significance in the primary endpoints of event-free survival and pathological complete response, which supported the US approval of Opdivo in this indication in March 2022. “This is the first and only phase 3 study of a neoadjuvant-only immuno-oncology therapy to show a statistically significant [OS] benefit in patients with resectable NSCLC,” said Dana Walker, vice president, global programme lead, late development, oncology, BMS. “The final analysis of OS in the CheckMate-816 study underscores the potential of Opdivo in combination with chemotherapy to provide a meaningful survival benefit for patients with resectable NSCLC,” Walker said. More than 200,000 people are diagnosed with lung cancer in the US every year, with NSCLC accounting for up to 85% of cases. Opdivo is a programmed death-1 immune checkpoint inhibitor designed to use the body’s own immune system to help restore anti-tumour immune response. Beyonds its NSCLC indications, the drug holds approvals to treat certain cases of melanoma, pleural mesothelioma, renal cell carcinoma, classical Hodgkin lymphoma, squamous cell carcinoma of the head and neck, and colorectal cancer, among other cancer types. The latest results come less than two months after an injectable form of Opdivo was approved by the US Food and Drug Administration for most previously approved adult, solid tumour intravenous (IV) Opdivo indications. It is hoped that the subcutaneous formulation will be more convenient for patients, reducing the steps required for preparation and offering an average administration time of three to five minutes compared to 30 minutes for the drug’s IV form.

Clinical ResultPhase 3ImmunotherapyDrug Approval

20 Feb 2025

·pipelinereview.com

Bristol Myers Squibb Announces Opdivo® Plus Chemotherapy as the First and Only Neoadjuvant-Only Immuno-Oncology Therapy to Demonstrate Statistically Significant and Clinically Meaningful Overall Survival in Resectable Non-Small Cell Lung Cancer

PRINCETON, NJ, USA I February 19, 2025 I Bristol Myers Squibb (NYSE: BMY) today announced the final analysis of overall survival (OS) from the Phase 3 CheckMate -816 study, which evaluated Opdivo ® (nivolumab) in combination with platinum-doublet chemotherapy as a neoadjuvant treatment for adult patients with resectable (tumors ≥ 4 cm or node positive) non-small cell lung cancer (NSCLC). The results showed a statistically significant and clinically meaningful improvement in OS, a key secondary endpoint, compared to neoadjuvant chemotherapy alone. The results build on the previously reported primary endpoints of event-free survival (EFS) and pathological complete response (pCR), which also met statistical significance. The safety profile of Opdivo in combination with chemotherapy was consistent with previously reported studies, with no new safety signals observed. “The final analysis of overall survival in the CheckMate -816 study underscores the potential of Opdivo in combination with chemotherapy to provide a meaningful survival benefit for patients with resectable NSCLC,” said Dana Walker, M.D., M.S.C.E., vice president, global program lead, late development, oncology, Bristol Myers Squibb. “This is the first and only Phase 3 study of a neoadjuvant-only immuno-oncology therapy to show a statistically significant benefit in patients with resectable NSCLC. Opdivo -based therapies have shown improved efficacy in the neoadjuvant and perioperative treatment of patients with resectable NSCLC.” The company will conduct an analysis of the updated data and plans to provide a comprehensive update on the data in a future peer reviewed setting. About CheckMate -816 CheckMate -816 is a Phase 3 randomized, open label, multi-center trial evaluating Opdivo with chemotherapy compared to chemotherapy alone as neoadjuvant treatment in patients with resectable stage IB to IIIA non-small cell lung cancer (per the 7th edition American Joint Committee on Cancer/Union for International Cancer Control staging criteria), regardless of PD-L1 expression. For the primary analysis, 358 patients were randomized to receive either Opdivo 360 mg plus histology-based platinum doublet chemotherapy every three weeks for three cycles, or platinum doublet chemotherapy every three weeks for three cycles, followed by surgery. The primary endpoints of the trial are event-free survival and pathologic complete response. Secondary endpoints include overall survival, major pathologic response, and time to death or distant metastases. About Opdivo Opdivo is a programmed death-1 (PD-1) immune checkpoint inhibitor that is designed to uniquely harness the body’s own immune system to help restore anti-tumor immune response. By harnessing the body’s own immune system to fight cancer, Opdivo has become an important treatment option across multiple cancers. Opdivo ’s leading global development program is based on Bristol Myers Squibb’s scientific expertise in the field of Immuno-Oncology and includes a broad range of clinical trials across all phases, including Phase 3, in a variety of tumor types. To date, the Opdivo clinical development program has treated more than 35,000 patients. The Opdivo trials have contributed to gaining a deeper understanding of the potential role of biomarkers in patient care, particularly regarding how patients may benefit from Opdivo across the continuum of PD-L1 expression. In July 2014, Opdivo was the first PD-1 immune checkpoint inhibitor to receive regulatory approval anywhere in the world. Opdivo is currently approved in more than 65 countries, including the United States, the European Union, Japan and China. In October 2015, the Company’s Opdivo and Yervoy combination regimen was the first Immuno-Oncology combination to receive regulatory approval for the treatment of metastatic melanoma and is currently approved in more than 50 countries, including the United States and the European Union. INDICATIONS OPDIVO® (nivolumab), as a single agent, is indicated for the treatment of adult and pediatric patients 12 years and older with unresectable or metastatic melanoma. OPDIVO® (nivolumab), in combination with YERVOY® (ipilimumab), is indicated for the treatment of adult and pediatric patients 12 years and older with unresectable or metastatic melanoma. OPDIVO® is indicated for the adjuvant treatment of adult and pediatric patients 12 years and older with completely resected Stage IIB, Stage IIC, Stage III, or Stage IV melanoma. OPDIVO® (nivolumab), in combination with platinum-doublet chemotherapy, is indicated as neoadjuvant treatment of adult patients with resectable (tumors ≥4 cm or node positive) non-small cell lung cancer (NSCLC). OPDIVO® (nivolumab) in combination with platinum-doublet chemotherapy, is indicated for neoadjuvant treatment of adult patients with resectable (tumors ≥4 cm or node positive) non-small cell lung cancer (NSCLC) and no known epidermal growth factor receptor (EGFR) mutations or anaplastic lymphoma kinase (ALK) rearrangements, followed by single-agent OPDIVO® as adjuvant treatment after surgery. OPDIVO® (nivolumab), in combination with YERVOY® (ipilimumab), is indicated for the first-line treatment of adult patients with metastatic non-small cell lung cancer (NSCLC) whose tumors express PD-L1 (≥1%) as determined by an FDA-approved test, with no EGFR or ALK genomic tumor aberrations. OPDIVO® (nivolumab), in combination with YERVOY® (ipilimumab) and 2 cycles of platinum-doublet chemotherapy, is indicated for the first-line treatment of adult patients with metastatic or recurrent non-small cell lung cancer (NSCLC), with no EGFR or ALK genomic tumor aberrations. OPDIVO® (nivolumab) is indicated for the treatment of adult patients with metastatic non-small cell lung cancer (NSCLC) with progression on or after platinum-based chemotherapy. Patients with EGFR or ALK genomic tumor aberrations should have disease progression on FDA-approved therapy for these aberrations prior to receiving OPDIVO. OPDIVO® (nivolumab), in combination with YERVOY® (ipilimumab), is indicated for the first-line treatment of adult patients with unresectable malignant pleural mesothelioma (MPM). OPDIVO® (nivolumab), in combination with YERVOY® (ipilimumab), is indicated for the first-line treatment of adult patients with intermediate or poor risk advanced renal cell carcinoma (RCC). OPDIVO® (nivolumab), in combination with cabozantinib, is indicated for the first-line treatment of adult patients with advanced renal cell carcinoma (RCC). OPDIVO® (nivolumab) is indicated for the treatment of adult patients with advanced renal cell carcinoma (RCC) who have received prior anti-angiogenic therapy. OPDIVO® (nivolumab) is indicated for the treatment of adult patients with classical Hodgkin lymphoma (cHL) that has relapsed or progressed after autologous hematopoietic stem cell transplantation (HSCT) and brentuximab vedotin or after 3 or more lines of systemic therapy that includes autologous HSCT. This indication is approved under accelerated approval based on overall response rate. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials. OPDIVO® (nivolumab) is indicated for the treatment of adult patients with recurrent or metastatic squamous cell carcinoma of the head and neck (SCCHN) with disease progression on or after platinum-based therapy. OPDIVO® (nivolumab) is indicated for the treatment of adult patients with locally advanced or metastatic urothelial carcinoma who have disease progression during or following platinum-containing chemotherapy or have disease progression within 12 months of neoadjuvant or adjuvant treatment with platinum-containing chemotherapy. OPDIVO® (nivolumab), as a single agent, is indicated for the adjuvant treatment of adult patients with urothelial carcinoma (UC) who are at high risk of recurrence after undergoing radical resection of UC. OPDIVO® (nivolumab), in combination with cisplatin and gemcitabine, is indicated as first-line treatment for adult patients with unresectable or metastatic urothelial carcinoma. OPDIVO® (nivolumab), as a single agent, is indicated for the treatment of adult and pediatric (12 years and older) patients with microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) metastatic colorectal cancer (CRC) that has progressed following treatment with a fluoropyrimidine, oxaliplatin, and irinotecan. This indication is approved under accelerated approval based on overall response rate and duration of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials. OPDIVO® (nivolumab), in combination with YERVOY® (ipilimumab), is indicated for the treatment of adult and pediatric patients 12 years and older with microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) metastatic colorectal cancer (CRC) that has progressed following treatment with a fluoropyrimidine, oxaliplatin, and irinotecan. This indication is approved under accelerated approval based on overall response rate and duration of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials. OPDIVO® (nivolumab), in combination with YERVOY® (ipilimumab), is indicated for the treatment of adult patients with hepatocellular carcinoma (HCC) who have been previously treated with sorafenib. This indication is approved under accelerated approval based on overall response rate and duration of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in the confirmatory trials. OPDIVO® (nivolumab) is indicated for the treatment of adult patients with unresectable advanced, recurrent or metastatic esophageal squamous cell carcinoma (ESCC) after prior fluoropyrimidine- and platinum-based chemotherapy. OPDIVO® (nivolumab) is indicated for the adjuvant treatment of completely resected esophageal or gastroesophageal junction cancer with residual pathologic disease in adult patients who have received neoadjuvant chemoradiotherapy (CRT). OPDIVO® (nivolumab), in combination with fluoropyrimidine- and platinum-containing chemotherapy, is indicated for the first-line treatment of adult patients with unresectable advanced or metastatic esophageal squamous cell carcinoma (ESCC). OPDIVO® (nivolumab), in combination with YERVOY® (ipilimumab), is indicated for the first-line treatment of adult patients with unresectable advanced or metastatic esophageal squamous cell carcinoma (ESCC). OPDIVO® (nivolumab), in combination with fluoropyrimidine- and platinum-containing chemotherapy, is indicated for the treatment of adult patients with advanced or metastatic gastric cancer, gastroesophageal junction cancer, and esophageal adenocarcinoma. Please see U.S. Full Prescribing Information for OPDIVO and YERVOY . Clinical Trials and Patient Populations Checkmate 227-previously untreated metastatic non-small cell lung cancer, in combination with YERVOY; Checkmate 9LA–previously untreated recurrent or metastatic non-small cell lung cancer in combination with YERVOY and 2 cycles of platinum-doublet chemotherapy by histology; Checkmate 649–previously untreated advanced or metastatic gastric cancer, gastroesophageal junction and esophageal adenocarcinoma; Checkmate 577–adjuvant treatment of esophageal or gastroesophageal junction cancer; Checkmate 238–adjuvant treatment of patients with completely resected Stage III or Stage IV melanoma; Checkmate 76K–adjuvant treatment of patients 12 years of age and older with completely resected Stage IIB or Stage IIC melanoma; Checkmate 274–adjuvant treatment of urothelial carcinoma; Checkmate 275–previously treated advanced or metastatic urothelial carcinoma; Checkmate 142–MSI-H or dMMR metastatic colorectal cancer, as a single agent or in combination with YERVOY; Checkmate 142–MSI-H or dMMR metastatic colorectal cancer, as a single agent or in combination with YERVOY; Attraction-3–esophageal squamous cell carcinoma; Checkmate 648-previously untreated, unresectable advanced recurrent or metastatic esophageal squamous cell carcinoma in combination with chemotherapy; Checkmate 648-previously untreated, unresectable advanced recurrent or metastatic esophageal squamous cell carcinoma combination with YERVOY; Checkmate 040–hepatocellular carcinoma, in combination with YERVOY; Checkmate 743–previously untreated unresectable malignant pleural mesothelioma, in combination with YERVOY; Checkmate 037–previously treated metastatic melanoma; Checkmate 066-previously untreated metastatic melanoma; Checkmate 067–previously untreated metastatic melanoma, as a single agent or in combination with YERVOY; Checkmate 017–second-line treatment of metastatic squamous non-small cell lung cancer; Checkmate 057–second-line treatment of metastatic non-squamous non-small cell lung cancer; Checkmate 816–neoadjuvant non-small cell lung cancer, in combination with platinum-doublet chemotherapy; Checkmate 77T–Neoadjuvant treatment with platinum-doublet chemotherapy for non-small cell lung cancer followed by single-agent OPDIVO as adjuvant treatment after surgery; Checkmate 901–Adult patients with unresectable or metastatic urothelial carcinoma; Checkmate 141–recurrent or metastatic squamous cell carcinoma of the head and neck; Checkmate 025–previously treated renal cell carcinoma; Checkmate 214–previously untreated renal cell carcinoma, in combination with YERVOY; Checkmate 9ER–previously untreated renal cell carcinoma, in combination with cabozantinib; Checkmate 205/039–classical Hodgkin lymphoma. Bristol Myers Squibb: Creating a Better Future for People with Cancer Bristol Myers Squibb is inspired by a single vision — transforming patients’ lives through science. The goal of the company’s cancer research is to deliver medicines that offer each patient a better, healthier life and to make cure a possibility. Building on a legacy across a broad range of cancers that have changed survival expectations for many, Bristol Myers Squibb researchers are exploring new frontiers in personalized medicine and, through innovative digital platforms, are turning data into insights that sharpen their focus. Deep understanding of causal human biology, cutting-edge capabilities and differentiated research programs uniquely position the company to approach cancer from every angle. Cancer can have a relentless grasp on many parts of a patient’s life, and Bristol Myers Squibb is committed to taking actions to address all aspects of care, from diagnosis to survivorship. As a leader in cancer care, Bristol Myers Squibb is working to empower all people with cancer to have a better future. About the Bristol Myers Squibb and Ono Pharmaceutical Collaboration In 2011, through a collaboration agreement with Ono Pharmaceutical Co., Bristol Myers Squibb expanded its territorial rights to develop and commercialize Opdivo globally, except in Japan, South Korea and Taiwan, where Ono had retained all rights to the compound at the time. On July 23, 2014, Ono and Bristol Myers Squibb further expanded the companies’ strategic collaboration agreement to jointly develop and commercialize multiple immunotherapies – as single agents and combination regimens – for patients with cancer in Japan, South Korea and Taiwan. About Bristol Myers Squibb Bristol Myers Squibb is a global biopharmaceutical company whose mission is to discover, develop and deliver innovative medicines that help patients prevail over serious diseases. For more information about Bristol Myers Squibb, visit us at BMS.com or follow us on LinkedIn , X , YouTube , Facebook and Instagram . SOURCE: Bristol Myers Squibb

Clinical ResultImmunotherapyPhase 3License out/inDrug Approval

100 Deals associated with Nivolumab

External Link

KEGG	Wiki	ATC	Drug Bank
D10316	Nivolumab	L01XC17	DB09035

R&D Status

Approved

10 top approved records.

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Indication	Country/Location	Organization	Date
Skin Neoplasms	JP	Ono Pharmaceutical Co., Ltd.	09 Feb 2024
Mesothelioma, Malignant	JP	Ono Pharmaceutical Co., Ltd.	24 Nov 2023
Resectable Lung Non-Small Cell Carcinoma	EU	Bristol-Myers Squibb Pharma EEIG	14 Jul 2023
Resectable Lung Non-Small Cell Carcinoma	IS	Bristol-Myers Squibb Pharma EEIG	14 Jul 2023
Resectable Lung Non-Small Cell Carcinoma	LI	Bristol-Myers Squibb Pharma EEIG	14 Jul 2023
Resectable Lung Non-Small Cell Carcinoma	NO	Bristol-Myers Squibb Pharma EEIG	14 Jul 2023
Urothelial Carcinoma of the Urinary Bladder	JP	Bristol Myers Squibb Co.	28 Mar 2022
Unknown Primary Neoplasms	JP	Bristol Myers Squibb Co.	24 Dec 2021
Unknown Primary Neoplasms	JP	Ono Pharmaceutical Co., Ltd.	24 Dec 2021
Gastrooesophageal junction cancer	US	Bristol Myers Squibb Co.	16 Apr 2021
Mesothelioma	JP	Bristol Myers Squibb Co.	21 Aug 2018
Small Cell Lung Cancer	US	Bristol Myers Squibb Co.	16 Aug 2018
Metastatic melanoma	AU	Bristol-Myers Squibb Australia Pty Ltd.	06 Jul 2018
Hepatocellular Carcinoma	US	Bristol Myers Squibb Co.	22 Sep 2017
Stomach Cancer	JP	Ono Pharmaceutical Co., Ltd.	22 Sep 2017
Stomach Cancer	JP	Bristol Myers Squibb Co.	22 Sep 2017
Colorectal Cancer	US	Bristol Myers Squibb Co.	31 Jul 2017
Head and Neck Neoplasms	JP	Ono Pharmaceutical Co., Ltd.	24 Mar 2017
Head and Neck Neoplasms	JP	Bristol Myers Squibb Co.	24 Mar 2017
Hodgkin's Lymphoma	US	Bristol Myers Squibb Co.	17 May 2016

Developing

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Advanced Hepatocellular Carcinoma	NDA/BLA	EU	Bristol Myers Squibb Co.	30 Jan 2025
Unresectable Hepatocellular Carcinoma	NDA/BLA	EU	Bristol Myers Squibb Co.	30 Jan 2025
Mismatch repair-deficient Colonic Cancer	NDA/BLA	CN	Bristol-Myers Squibb (China) Investment Co. Ltd.	18 Apr 2024
Mismatch repair-deficient Rectal Cancer	NDA/BLA	CN	Bristol-Myers Squibb (China) Investment Co. Ltd.	18 Apr 2024
Advanced Gastric Adenocarcinoma	Phase 3	US	National Cancer Institute	24 Jun 2024
Advanced Gastroesophageal Junction Adenocarcinoma	Phase 3	US	National Cancer Institute	24 Jun 2024
Metastatic gastric adenocarcinoma	Phase 3	US	National Cancer Institute	24 Jun 2024
stomach adenocarcinoma	Phase 3	US	National Cancer Institute	24 Jun 2024
HER2 negative Gastric Cancer	Phase 3	JP	Ono Pharmaceutical Co., Ltd.	05 Nov 2021
HER2 negative Gastric Cancer	Phase 3	KR	Ono Pharmaceutical Co., Ltd.	05 Nov 2021

Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


ASCO_GU2025 Manual	Not Applicable	Metastatic Renal Cell Carcinoma Maintenance \| First line	222	Four Doses of IPI + NIVO	acqfufbnoo(agerneyhbp) = yeputqjeja brpbhucnmo (pjauweuqub, 82 - 93) View more	Positive	13 Feb 2025
				Fewer Than Four Doses of IPI + NIVO	acqfufbnoo(agerneyhbp) = ulbhxxwjoi brpbhucnmo (pjauweuqub, 72 - 94) View more
NCT03172754 (phase I/II study of nivolumab and axitinib, ASCO_GU2025) Manual	Phase 1/2	Advanced Renal Cell Carcinoma	26	nivolumab + Axitinib	hgbepaxcii(xudgjtqneb) = rwiqeikxmd vlmmahmpnz (grpawjyqvz ) View more	Positive	13 Feb 2025
NCT05122546 (ASCO_GU2025) Manual	Phase 1	Metastatic Renal Cell Carcinoma	30	Cabozantinib (cabo) and nivolumab (nivo)nivolumab (nivo) with CBM588 (40mg PO QD and 480mg IV monthly, respectively; 80mg PO BID)	hrktuidoas(hqnkccqpui) = xlpfwhpzlp mzhrssapne (hlokopqsja ) View more	Positive	13 Feb 2025
				Cabozantinib (cabo) and nivolumab (nivo)nivolumab (nivo) without CBM588 (40mg PO QD and 480mg IV monthly, respectively))	hrktuidoas(hqnkccqpui) = fexjcnrtpp mzhrssapne (hlokopqsja ) View more
NCT04552223 (phase II study of nivolumab/relatlimab, CTgov)	Phase 2	Uveal Melanoma	27	Nivolumab+Relatlimab	lawhyjhcrr(sijnnsgslt) = icuhygdljw ieassgnffh (pculstkvxn, fvtaxoqpgf - hxlerfmibd) View more	-	13 Feb 2025
NCT02927769 (CheckMate 744, CTgov)	Phase 2	Relapsing classical Hodgkin lymphoma	72	Bv+nivolumab+bendamustine+brentuximab+brentuximab vedotin (Cohort 1: Relapsed/Refractory Classic Hodgkin Lymphoma - Low Risk Relapse)	yqvcsdpomx(tktkxjovlo) = nwyjzekjxy iecvxbjiie (aamojpvdvp, jocrsgxepe - debypbttls) View more	-	10 Feb 2025
				Bv+nivolumab+bendamustine+brentuximab+brentuximab vedotin (Cohort 2: Relapsed/Refractory Classic Hodgkin Lymphoma - Standard Risk Relapse)	tsimcjlsza(drmacoivus) = qixwxqnrhh znjoysmhzv (tbnplyncpd, xafnvhethj - nskmnplcme) View more
NCT04056910 (CTgov)	Phase 2	Advanced Malignant Solid Neoplasm \| IDH1-mutant Glioma	15	nivolumab	akkltfuhue(exuazmhcmw) = ijcpcejwjg qwbdbqiepe (nzqowupqul, htjzrwtwag - havialmhmb) View more	-	06 Feb 2025
NCT03161379 (CTgov)	Phase 2	Pancreatic adenocarcinoma	31	Stereotactic Body Radiation (SBRT)+Nivolumab+Cyclophosphamide+GVAX Pancreas Vaccine	jfqjjuefhj(jusesbhhtl) = yrmhilhcji cfmegpstds (tihykryfnf, jjlsbtztnw - qmlfkrsftz) View more	-	03 Feb 2025
NCT04197310 (CTgov)	Phase 2	Carcinoid Tumor \| Gastrointestinal Neoplasms	19	Nivolumab+Cabozantinib	zekrsxfmnw(cxnnbirjsp) = dwbnazxelj kuqignmvep (mlvzilvxqu, efkvwpkpcu - lzhkhfszbe) View more	-	31 Jan 2025
NCT03642067 (CTgov)	Phase 2	Microsatellite Stable Colorectal Carcinoma \| Adenocarcinoma of large intestine	59	Nivolumab+Relatlimab (Cohort A: Composite PD-L1/Mucin (CPM) Positive Colorectal Cancer)	dolppwjdta(krxgblgwzn) = crhgidzmph touqoosrdw (egtdqysigw, cuayykamvi - juhqjydjvz) View more	-	28 Jan 2025
				Nivolumab+Relatlimab (Cohort B: Composite PD-L1/Mucin (CPM) Negative Colorectal Cancer)	dolppwjdta(krxgblgwzn) = qhfllahkpk touqoosrdw (egtdqysigw, npfkzmdpfd - tytsplpovv) View more
NCT04008030 (CheckMate 8HW, ASCO_GI2025) Manual	Phase 3	Microsatellite instability-high colorectal cancer Second line \| First line MSI-High \| Deficient DNA Mismatch Repair (dMMR)	703	Nivolumab + ipilimumab	xkgffclaik(dtbwgsmrxy) = iaohllftqp poiteayloq (vnwcmxrpau, 53.8 - NE) Met View more	Superior	27 Jan 2025
				Nivolumab	xkgffclaik(dtbwgsmrxy) = dvtnuzbmtr poiteayloq (vnwcmxrpau, 22.1 - NE) Met View more

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