Delving into the Latest Updates on Nivolumab with Synapse

Overview

Basic Info

Drug Type

Monoclonal antibody

Synonyms

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

+ [16]

Target

PD-1

Action

inhibitors

Mechanism

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

Therapeutic Areas

NeoplasmsImmune System DiseasesDigestive System Disorders+ [13]

Active Indication

Microsatellite instability-high Rectal CancerPD-L1 positive Non-Small Cell Lung CancerMetastatic hepatocellular carcinoma+ [471]

Inactive Indication

Acidemia, IsovalericAcquired Immunodeficiency SyndromeAcute bilineal leukemia+ [143]

Originator Organization

Ono Pharmaceutical Co., Ltd.

Bristol Myers Squibb Co.

Active Organization

Bristol-Myers Squibb (China) Investment Co. Ltd.

Bristol Myers Squibb Co.

Ono Pharmaceutical Co., Ltd.

+ [26]

Inactive Organization

Nektar Therapeutics

Bolt Biotherapeutics, Inc.

Regeneron Pharmaceuticals, Inc.

+ [16]

License Organization

Nektar Therapeutics

NeoImmuneTech, Inc.

Vedanta Biosciences, Inc.

+ [19]

Drug Highest PhaseApproved

First Approval Date

Japan (04 Jul 2014),

Esophageal CarcinomaMelanoma

RegulationPriority Review (United States), Breakthrough Therapy (United States), Accelerated Approval (United States), Orphan Drug (United States), Priority Review (China), Breakthrough Therapy (China), Conditional marketing approval (China), Orphan Drug (Japan), Priority Review (Australia), Fast Track (United States)

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Structure/Sequence

Sequence Code 93681H

Source: *****

Sequence Code 93684L

Source: *****

This phase III trial compares the effect of adding live biotherapy, MO-03, to standard of care (SOC) immunotherapy, including ipilimumab, nivolumab, axitinib, pembrolizumab, cabozantinib, and lenvatinib, to SOC immunotherapy alone in treating patients with clear cell renal cell cancer that may have spread from where it first started (primary site) to nearby tissue, lymph nodes, or distant parts of the body (advanced) or that has spread from where it first started to other places in the body (metastatic). Studies have shown that gut health (the gut microbiome) may impact the effectiveness of immunotherapy. The microbiome includes all of the bacteria and organisms naturally found in the digestive tract. MO-03, a type of biotherapy, contains material from living organisms that may help keep the digestive tract healthy and may help to increase the effect of immunotherapy. Immunotherapy with monoclonal antibodies, such as ipilimumab, nivolumab, pembrolizumab, may help the body's immune system attack the tumor, and may interfere with the ability of tumor cells to grow and spread. Axitinib, cabozantinib, and lenvatinib are a type of angiogenesis inhibitor and tyrosine kinase inhibitor (TKI) that block certain proteins which may help keep tumor cells from growing and may also help prevent the growth of new blood vessels that tumors need to grow. Adding MO-03 to SOC immunotherapy may be more effective than SOC immunotherapy alone in treating patients with advanced or metastatic clear cell renal cell cancer.

Start Date10 Jun 2026

Sponsor / Collaborator

SWOG

[+1]

NCT07176975

/ Not yet recruitingPhase 1

Phase I Open-label, Dose Escalation and Expansion Trial of BI 1831169 in Combination With an Anti-PD1 mAb in Japanese Patients With Advanced/Metastatic Solid Tumours

This study is open to Japanese adults with different types of advanced cancer (solid tumors). People can join the study if their cancer has spread, and previous treatments were not successful or no treatments exist.
The purpose of this study is to find the highest dose of a medicine called BI 1831169 that people can tolerate when taken together with an anti-PD1 antibody. The anti-PD1 antibody is already used to treat different cancers. Participants receive BI 1831169 together with an anti-PD1 antibody, which is given as an infusion into a vein for up to 1 year.
Participants visit the study site regularly. The number of site visits vary based on the study part and treatment response. Some visits include an overnight stay. The doctors regularly check the participants' health and monitor the tumors. The doctors also take note of any health problems that could have been caused by the study treatment.

Start Date01 Jun 2026

Sponsor / Collaborator

Boehringer Ingelheim GmbH

100 Clinical Results associated with Nivolumab

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100 Translational Medicine associated with Nivolumab

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100 Patents (Medical) associated with Nivolumab

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10,717

Literatures (Medical) associated with Nivolumab

31 Dec 2026·PLATELETS

Immune thrombocytopenia triggered by dostarlimab in a patient with endometrial carcinoma: first reported case

Article

Author: Pazmiño-Zambrano, M. Belén ; García-Jaén, Pablo ; González-Porras, José Ramón ; Bastida, José María ; Reguera-Puertas, Pablo ; Fernández-Sánchez, Adolfo ; Puerta-Vázquez, Carlos

Immune checkpoint inhibitors (ICIs) have transformed the treatment landscape for various malignancies, but they are associated with a range of immunerelated adverse events, including rare hematological complications. Immune thrombocytopenia (ITP) has been reported with other antiPD1 agents such as nivolumab and pembrolizumab, but to date, no cases have been described with dostarlimab. We report the first case of ITP in a patient receiving dostarlimab for relapsed endometrial carcinoma. A 55yearold woman developed severe thrombocytopenia (3 × 10⁹/L) accompanied by rectal bleeding, resulting in a lifethreatening condition. Secondary causes were excluded, and bone marrow findings supported a diagnosis of ITP. Initial treatment with highdose corticosteroids and intravenous immunoglobulin achieved only a partial response, while sustained platelet recovery was obtained with the addition of romiplostim. The patient remained on dostarlimab following hematological recovery without further episodes of ITP. This case highlights a potentially lifethreatening adverse effect of a widely used immunotherapy and underscores the importance of early recognition and timely escalation of treatment in ICIinduced ITP.

01 Sep 2026·Value in Health Regional Issues

Cost Savings in Oncology Chemotherapy: The Role of Vial Sharing in Centralized Preparation

Article

Author: Jalil, Mariam Abdel ; El-Dahiyat, Faris ; Almomani, Alaa ; Ballout, Mohammad ; Abu-Farha, Rana K ; Allan, Aya ; Hammour, Khawla Abu

OBJECTIVES:

The objective of this study was to find out how much money can be saved by introducing a vial sharing program in a Jordanian tertiary hospital's centralized intravenous admixture service.

METHODS:

From March 2023 to September 2025, 1662 prescriptions for 24 intravenous anticancer medications were part of this quasi-experimental study. Efficiency of a centralized vial share program and a conventional dispersed preparation technique were compared. Time efficiency, drug waste minimization, and total cost saving (JD) were some of the outcomes that were measured.

RESULTS:

A total of 309 patients were enrolled in the study and followed for 28 months and had 1662 prescription orders for 24 chemotherapy drugs. Median age was 58 years, and most patients were females (54.7%). The most common diagnoses were lymphoma (10.0%), breast cancer (9.1%), and acute myeloid leukemia (6.8%). Most patients (99%) had insurance. Doxorubicin (291 prescriptions, 17.5%), vincristine (234 prescriptions, 14.1%), and rituximab (210 prescriptions, 12.6%) were the highest prescribed medications. Implementation of a vial-sharing system resulted in cost savings of 39.6%, amounting to JD 254 743.28 (USD 359 188.02). Nivolumab caused most cost savings per prescription, followed by trastuzumab, whereas vincristine and fluorouracil saved very minimal amounts per prescription. Based on total savings, Rituximab led the list with JD 83 211.31 (USD 117 327.94).

CONCLUSIONS:

Vial sharing as part of a centralized preparation model has significantly decreased the cost and drug wastage in oncology care. It provides a viable method to increase resource efficiency in cancer care, especially within institutions that have limited healthcare budgets.

01 May 2026·INTERNATIONAL JOURNAL OF CANCER

Real‐world efficacy and toxicity of ipilimumab and nivolumab as a first‐line treatment for advanced renal cell carcinoma according to IMDC risk criteria—A multi‐center retrospective analysis on behalf of the GUARDIANS group

Article

Author: Christopher Gossler ; Marit Ahrens ; Can D. Aydogdu ; Jozefina Casuscelli ; Julie Steinestel ; Stephanie Neuberger ; Linus Materna ; Katrin Schlack ; Timo Egenolf ; Florian Kirchhoff ; Philipp Ivanyi ; Richard Cathomas ; Berna C. Özdemir ; Pia Paffenholz ; Hendrik Dinkel ; Ramona Stelmach ; Matteo Silberg ; Marc Rehlinghaus ; Viktor Grünwald ; Thomas Hilser ; Stefanie Zschäbitz ; Arne Strauss

Abstract:

Ipilimumab and nivolumab are recommended as first‐line therapy for patients with metastatic or advanced renal cell carcinoma (aRCC) and International Metastatic RCC Database Consortium (IMDC) intermediate or poor risk. We retrospectively evaluated efficacy and safety in a multi‐center real‐world cohort with 356 patients initiating ipilimumab and nivolumab from 17 centers in Germany and Switzerland. Median age was 64 years, most patients were male (69.1%) and had clear cell histology (74.1%). IMDC risk was intermediate in 61.8% and poor in 28.7%. About 37.1% of cases did not meet the inclusion criteria for the CheckMate 214 pivotal study (e.g., poor Eastern Cooperative Oncology Group [Performance Status Scale] [ECOG] status, comorbidities, brain metastases, and impaired renal function). After a median follow‐up of 17.5 months, complete response was seen in 8.7%, partial response in 28.7% of patients. Median progression‐free survival (PFS) was 8 (95% confidence interval [CI] 5.4–10.6) and median overall survival (OS) 39 months (95% CI 27.5–50.5). Subgroup analysis of patients with non‐clear cell histology showed a shorter PFS and OS. Other negative predictors were poor ECOG, fewer induction cycles, ineligibility to pivotal study, and hepatic metastases. Adverse events occurred in 76.4% of patients (35.4% ≥ grade 3). High‐dose corticosteroids were applied in 27.3% of cases. Cabozantinib was most frequently administered (63.4%) as subsequent therapy and showed superior OS and PFS compared to other second‐line options. Our data support ipilimumab and nivolumab as a first‐line treatment of aRCC with robust efficacy and safety. Patient selection was less restrictive in our clinical practice and may explain differences to CheckMate 214 trial.

2,202

News (Medical) associated with Nivolumab

15 Apr 2026

·www.businesswire.com

Enodia Therapeutics Appoints Dr. Yvonne McGrath as Chief Scientific Officer to Accelerate Upstream Targeted Protein Degradation Platform

PARIS--(BUSINESS WIRE)--Enodia Therapeutics, a biotechnology company developing small-molecule therapies targeting a unique form of protein degradation at the point of synthesis, appointed Yvonne McGrath, Ph.D. as Chief Scientific Officer. With over 25 years of experience in biopharma drug development and life sciences, Dr. McGrath will help optimize Enodia’s proprietary platform, which is designed to discover and develop small-molecule therapies that enable the selective degradation of proteins upstream, effectively destroying disease-driving proteins at the point of synthesis. "Yvonne joins Enodia to help translate our scientific vision into meaningful clinical progress. Her insights will be instrumental in sharpening our translational strategy and accelerating our timelines," said Yves Ribeill, CEO of Enodia Therapeutics. “Yvonne joins Enodia to help translate our scientific vision into meaningful clinical progress,” said Yves Ribeill, Chief Executive Officer of Enodia Therapeutics. “She brings a wealth of translational experience across the industry, spanning multiple drug modalities and indications. With firsthand experience advancing novel drug candidates into the clinic, her insights will be instrumental in sharpening our translational strategy and accelerating our timelines, as we progress our small molecules designed to halt pathological proteins at the source.” Prior to joining Enodia, Dr. McGrath served as Chief Scientific Officer of iTeos Therapeutics, where she led a team of discovery scientists and provided translational leadership to advance immuno-oncology therapies into clinical development. Previously, she was Chief Scientific Officer and a board member of Complix N.V., providing R&D strategy for novel protein therapeutics and biologics in oncology. Dr. McGrath also held multiple leadership roles at Immunocore, including Head of Development and Head of Preclinical Development and CMC, leading research through clinical development of a pioneering therapy now approved as Kimmtrak for the treatment of uveal melanoma. She holds a Ph.D. in Immunology from the University of Wales College of Medicine. “Enodia’s differentiated platform integrates multiple state-of-the-art approaches, including machine learning and proteomics, to engineer drug candidates for selective Sec61 modulation,” said Dr. McGrath. “Joining at this critical juncture in the company’s growth, I’m excited by what the team is building and look forward to working with Yves Ribeill and the rest of the world-class team at Enodia to accelerate the development of life-saving therapies for patients with limited treatment options.” Enodia is also supported by a Scientific Advisory Board (SAB) comprising leading experts who help guide and shape the company's scientific strategy. Together, the SAB provides deep expertise across Sec61 biology, immunology and drug development. Members of the SAB include: Caroline Demangel, Ph.D. is President of the SAB & Co-Founder of Enodia. She is a Professor at the Institut Pasteur, where she leads the Immunobiology and Therapy Research Unit, focusing on pathogen-mediated immunomodulation. Her studies using mycolactone revealed a critical role for the Sec61 translocon in immune and cancer cell biology and highlighted the potential of Sec61 inhibition for targeted protein degradation. Michaela Müller-Trutwin, Ph.D. is Professor at Institut Pasteur, Head of the HIV, Inflammation and Viral Persistences Unit, Deputy Director of Scientific Assessment at Institut Pasteur, and the Chair of the Coordinated Action on HIV Science for the French Agency of HIV, Hepatitis and Emerging Infectious Diseases. Her research contributed to the discovery of distinct HIV and SIV groups and subtypes, the identification of the mechanisms of HIV pathogenesis and the understanding of the role of cellular innate immunity in the control of HIV and SARS-CoV-2 Stephen High, Ph.D. is an Emeritus Professor of Biochemistry at the University of Manchester with over 30 years of experience in the cellular production of membrane proteins. Inspired by his postdoctoral work in Bernhard Dobberstein’s group, he dedicated his career to studying the machinery and mechanisms that enable membrane and secretory protein biogenesis at the endoplasmic reticulum. Alan Korman, Ph.D. is Chief Scientific Officer at BlueSphere Bio and has significantly contributed to the field of cancer therapy research over the last 30 years, including directing the preclinical development of Yervoy and Opdivo and their combination. Dr. Korman has held several high-level positions at leading biopharma companies, including SVP, Human Immunology at Vir Biotechnology and VP, Immuno-Oncology at Bristol-Myers Squibb. Bernard Malissen, Ph.D. is Emeritus CNRS Research Director at Centre d'Immunologie de Marseille Luminy (CIML, Marseille, France) and Centre for Immunophenomics (CIPHE, Marseille, France). He pioneered the use of gene transfer approaches to dissect the function of molecules involved in T cell function. Dr. Malissen is Co-founder and Chief Scientific Officer of JC Discovery. Eunyong Park, Ph.D. is Associate Professor, Department of Molecular and Cell Biology at University of California, Berkeley. Dr. Park’s research is focused on the molecular mechanisms of protein targeting and the transport of polypeptides across organelle membranes. Utilizing structural and biochemical technologies, including cryo-electron microscopy, Dr. Park and his research team have made significant advances in the understanding of protein translocases, such as Sec61, and their pathogenic role in disease pathways. About Enodia Therapeutics Enodia Therapeutics is a biotechnology company focused on developing best-in-class small-molecule therapies that enable the degradation of disease-driving proteins at the point of synthesis, before they have a damaging effect. Rooted in pioneering research from the Institut Pasteur and built by Argobio, Enodia, through its Sec61 platform, is advancing a pipeline initially focused on inflammation, immunology and oncology, with additional opportunities in virology.

Executive Change

15 Apr 2026

·www.biospace.com

Arbutus Receives U.S. FDA Fast Track Designation for Imdusiran for the Treatment of Chronic Hepatitis B

Fast Track designation has the potential to facilitate development and accelerate FDA review of imdusiran WARMINSTER, Pa., April 15, 2026 (GLOBE NEWSWIRE) -- Arbutus Biopharma Corporation (Nasdaq: ABUS) (“Arbutus” or the “Company”), a clinical-stage biopharmaceutical company focused on infectious disease, today announced that the U.S. Food and Drug Administration (“FDA”) has granted Fast Track designation for imdusiran for the treatment of chronic hepatitis B (“cHBV”). “We are excited about the potential of imdusiran, which in trials has achieved functional cure for 10 chronic hepatitis B patients to date and allowed many others to live medication-free, to address significant unmet medical need,” said Lindsay Androski, President and CEO of Arbutus. “The FDA grant of Fast Track designation validates imdusiran as an important drug candidate, and we look forward to working collaboratively and closely with the FDA during the remaining stages of the development process.” The FDA’s Fast Track program is designed to facilitate the development and expedite the review of investigational therapies to treat serious conditions with unmet medical need. A drug granted Fast Track designation may be eligible for several benefits, including earlier and more frequent meetings and communications with the FDA and, if relevant criteria are met, the potential for Accelerated Approval, Priority Review or Rolling Review of a Biologics License Application or New Drug Application. About Imdusiran (AB-729) Imdusiran is an RNAi therapeutic specifically designed to reduce all hepatitis B viral proteins and antigens, including hepatitis B surface antigen (“HBsAg”), which is thought to be a key prerequisite to enable reawakening of a patient’s immune system to control the virus. Imdusiran targets hepatocytes using Arbutus’ novel covalently conjugated N-Acetylgalactosamine delivery technology enabling subcutaneous delivery. In Arbutus’ Phase 2a clinical trials, eight patients with cHBV achieved functional cure following treatment with imdusiran and nucleos(t)ide analogue (“NA”) therapy in combination with either pegylated interferon alfa-2a or low dose nivolumab plus an immunotherapeutic, with six out of the eight patients continuing to sustain functional cure for over two years. An additional 41 patients across the Company’s Phase 2a clinical trials were able to remain off NA therapy for at least 48 weeks during their Phase 2a clinical trials following treatment with imdusiran. Two additional patients who discontinued NA therapy in their Phase 2a clinical trials have now achieved functional cure during their participation in long-term follow-up. Functional cure is defined as sustained HBsAg seroclearance and hepatitis B virus deoxyribonucleic acid (“HBV DNA”) less than the lower limit of quantification after 24 weeks off treatment, with or without anti-hepatitis B surface antibodies. Clinical data generated thus far has shown imdusiran to be generally safe and well-tolerated, while also providing meaningful reductions in HBsAg and HBV DNA. About HBV Hepatitis B is a potentially life-threatening liver infection caused by hepatitis B virus (“HBV”). HBV can cause chronic infection which leads to a higher risk of death from cirrhosis and liver cancer. cHBV infection represents a significant unmet medical need. The World Health Organization estimates that over 250 million people worldwide suffer from cHBV infection, while other estimates indicate that approximately 2 million people in the United States suffer from cHBV infection. Approximately 1.1 million people die every year from complications related to cHBV infection despite the availability of effective vaccines and current treatment options. About Arbutus Arbutus Biopharma Corporation (Nasdaq: ABUS) is a clinical-stage biopharmaceutical company focused on infectious disease. The Company is currently developing imdusiran (AB-729) and an oral PD-L1 inhibitor (AB-101) for the treatment of cHBV infection. The Company is also consulting closely with and supporting its exclusive licensee, Genevant Sciences, to protect and defend its intellectual property, which is the subject of an on-going lawsuit against Pfizer/BioNTech for use of Arbutus’ patented LNP technology in their COVID-19 vaccines. For more information, visit . Forward-Looking Statements and Information This press release contains forward-looking statements within the meaning of the Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934, and forward-looking information within the meaning of Canadian securities laws (collectively, forward-looking statements). Forward-looking statements in this press release include statements about: the potential to lead to a functional cure for HBV and/or the discontinuation of HBV therapies after treatment with Arbutus’ product candidates; the durability of clinical benefits from Arbutus’ product candidates; the potential for Arbutus’ product candidates to achieve success in clinical trials; the potential for regulatory approval of Arbutus’ product candidates; and Arbutus’ pipeline and development plans for its cHBV programs. With respect to the forward-looking statements contained in this press release, Arbutus has made numerous assumptions regarding, among other things: the effectiveness and timeliness of clinical trials, and the usefulness of the data; the continued demand for Arbutus’ assets; and the stability of economic and market conditions. While Arbutus considers these assumptions to be reasonable, these assumptions are inherently subject to significant business, economic, competitive, market and social uncertainties and contingencies. Additionally, there are known and unknown risk factors which could cause Arbutus’ actual results, performance or achievements to be materially different from any future results, performance or achievements expressed or implied by the forward-looking statements contained herein. Known risk factors include, among others: ongoing and anticipated clinical trials may be more costly or take longer to complete than anticipated, and may never be initiated or completed, or may not generate results that warrant future development of the tested product candidate; Arbutus may elect to change its strategy regarding its product candidates and clinical development activities; Arbutus may not receive the necessary regulatory approvals for the clinical development of Arbutus’ product candidates; economic and market conditions may worsen; market shifts may require a change in strategic focus; Arbutus’ workforce reduction and plans to reduce its net cash burn may not materially extend the cash runway and may create a distraction or uncertainty that may adversely affect its operating results, business, or investor perceptions; and risks related to the sufficiency of Arbutus’ cash resources for its foreseeable and unforeseeable operating expenses and capital expenditures. A more complete discussion of the risks and uncertainties facing Arbutus appears in Arbutus’ Annual Report on Form 10-K, Arbutus’ Quarterly Reports on Form 10-Q and Arbutus’ continuous and periodic disclosure filings, which are available at and at . All forward-looking statements herein are qualified in their entirety by this cautionary statement, and Arbutus disclaims any obligation to revise or update any such forward-looking statements or to publicly announce the result of any revisions to any of the forward-looking statements contained herein to reflect future results, events or developments, except as required by law. CONTACT: Arbutus Biopharma Corporation / ir@arbutusbio.com

15 Apr 2026

·www.biospace.com

BioTesserae Conducts Milestone First in Dog Studies with Proprietary PD-1 Single Domain Antibody

CORVALLIS, Ore. & MEDFORD, Mass.--(BUSINESS WIRE)--BioTesserae Inc. (BTC), a biotechnology company focused on innovative veterinary therapeutics, in collaboration with Sunflower Therapeutics PBC, a public benefit corporation transforming global access to protein manufacturing capacity for diverse applications, today announced that BTC-001 was well tolerated in healthy dogs following a single ascending dose study. BTC-001 is a single domain antibody (SdA) that recognizes the immune checkpoint inhibitor PD-1 and is part of BioTesserae’s growing portfolio of biologic drugs for the treatment of cancer in companion animals. Cancer is one of the leading causes of death for all dog breeds in the U.S. and treatment options are limited. BioTesserae’s innovative approach leverages the success of human cancer therapies such as Opdivo and Keytruda. BTC-001 is simpler than typical oncology biologic drugs making it conducive to streamlined manufacturing, and allowing for more flexible treatment options for pet owners and veterinarians. BioTesserae is working in collaboration with Sunflower Therapeutics PBC to develop novel product compositions, formulations, and manufacturing methods for BTC-001 using Sunflower’s yeast-based biomanufacturing platform. “This study addresses two key milestones for BioTesserae. First, we demonstrated that the proprietary single domain antibody to PD-1 (BTC-001) is well tolerated in dogs following a single dose up to three times the anticipated therapeutic dose. Second, we accomplished the synthesis, purification, concentration, and release of the single domain antibody in yeast at pilot scale,” said Dr. Patrick Iversen, CEO of BioTesserae Inc. “Through the completion of this study, we have shown how our engineered yeast host and a product optimization approach centered on manufacturability-by-design can enable the production of novel high-quality protein-based veterinary therapies in meaningful quantities for clinical and commercial development,” said Dr. Laura Crowell Orella, Director of R&D at Sunflower Therapeutics. “In partnership with BioTesserae, we are achieving significant milestones in the development of affordable solutions for canine cancer.” About BioTesserae BioTesserae is an emerging biotechnology company dedicated to accelerating access to cutting-edge immune therapies, helping pet owners safely extend the length and quality of life of their animal companions. We develop single domain antibody-based immunotherapies intended for canine cancer treatment. The company's platform utilizes single-domain antibody fragments to modulate the canine immune system and specifically target malignant cells, enabling the veterinary healthcare market to access precision biological treatments that improve clinical outcomes and survival rates for dogs suffering from various oncological conditions. About Sunflower Therapeutics Sunflower Therapeutics is a unique biotech with a mission to transform bioeconomies worldwide by creating accessible solutions for protein product development and commercial manufacturing. Using our core technologies – an efficient host, data-driven methods and Contract Research Organization (CRO) services for process development, and continuous biomanufacturing equipment – our team aims to democratize bioprocessing. Contacts BioTesserae Inc. Biotesserae.com Sunflower Therapeutics PBC info@sunflowertx.com

100 Deals associated with Nivolumab

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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
Microsatellite instability-high Rectal Cancer	Japan	Ono Pharmaceutical Co., Ltd.	25 Aug 2025
PD-L1 positive Non-Small Cell Lung Cancer	China	Bristol-Myers Squibb Pharma EEIG	22 Jul 2025
Metastatic hepatocellular carcinoma	Australia	Bristol-Myers Squibb Australia Pty Ltd.	26 Jun 2025
Malignant neoplasm of gastro-oesophageal junction	European Union	Bristol-Myers Squibb Pharma EEIG	17 Mar 2025
Malignant neoplasm of gastro-oesophageal junction	Iceland	Bristol-Myers Squibb Pharma EEIG	17 Mar 2025
Malignant neoplasm of gastro-oesophageal junction	Liechtenstein	Bristol-Myers Squibb Pharma EEIG	17 Mar 2025
Malignant neoplasm of gastro-oesophageal junction	Norway	Bristol-Myers Squibb Pharma EEIG	17 Mar 2025
Advanced Hepatocellular Carcinoma	European Union	Bristol Myers Squibb Co.	08 Mar 2025
Advanced Hepatocellular Carcinoma	Iceland	Bristol Myers Squibb Co.	08 Mar 2025
Advanced Hepatocellular Carcinoma	Liechtenstein	Bristol Myers Squibb Co.	08 Mar 2025
Advanced Hepatocellular Carcinoma	Norway	Bristol Myers Squibb Co.	08 Mar 2025
Unresectable Hepatocellular Carcinoma	European Union	Bristol Myers Squibb Co.	08 Mar 2025
Unresectable Hepatocellular Carcinoma	Iceland	Bristol Myers Squibb Co.	08 Mar 2025
Unresectable Hepatocellular Carcinoma	Liechtenstein	Bristol Myers Squibb Co.	08 Mar 2025
Unresectable Hepatocellular Carcinoma	Norway	Bristol Myers Squibb Co.	08 Mar 2025
Carcinoma	Japan	Ono Pharmaceutical Co., Ltd.	09 Feb 2024
Mesothelioma, Malignant	Japan	Ono Pharmaceutical Co., Ltd.	24 Nov 2023
Resectable Lung Non-Small Cell Carcinoma	European Union	Bristol-Myers Squibb Pharma EEIG	14 Jul 2023
Resectable Lung Non-Small Cell Carcinoma	Iceland	Bristol-Myers Squibb Pharma EEIG	14 Jul 2023
Resectable Lung Non-Small Cell Carcinoma	Liechtenstein	Bristol-Myers Squibb Pharma EEIG	14 Jul 2023

Developing

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Mismatch repair-deficient Colonic Cancer	NDA/BLA	China	Bristol-Myers Squibb (China) Investment Co. Ltd.	18 Apr 2024
Mismatch repair-deficient Rectal Cancer	NDA/BLA	China	Bristol-Myers Squibb (China) Investment Co. Ltd.	18 Apr 2024
Advanced Gastric Adenocarcinoma	Phase 3	United States	National Cancer Institute	24 Jun 2024
Advanced Gastroesophageal Junction Adenocarcinoma	Phase 3	United States	National Cancer Institute	24 Jun 2024
Metastatic gastric adenocarcinoma	Phase 3	United States	National Cancer Institute	24 Jun 2024
stomach adenocarcinoma	Phase 3	United States	National Cancer Institute	24 Jun 2024
Mediastinal large B-cell lymphoma	Phase 3	United States	National Cancer Institute	05 Oct 2021
Mediastinal large B-cell lymphoma	Phase 3	Australia	National Cancer Institute	05 Oct 2021
Mediastinal large B-cell lymphoma	Phase 3	Canada	National Cancer Institute	05 Oct 2021
Refractory Cancer	Phase 3	United States	Bayer AG	01 Jun 2021

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Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


AACR2026	Not Applicable	Advanced Hepatocellular Carcinoma	55	Nivolumab + Ipilimumab	yudqcjjyzx(aexzqahaov) = dnmvicqzgr okrfbtveme (otvuakwzpy ) View more	Positive	22 Apr 2026
				placebo	yudqcjjyzx(aexzqahaov) = tznjkklqiy okrfbtveme (otvuakwzpy ) View more
NCT04457284 (AACR2026)	Phase 2	Metastatic Colorectal Carcinoma MSH2 \| MSI \| TMB	16	TMZ+CDDP+nivolumab	vfcjplthtu(ikgoxyejwz) = phkircxrxf rjnnwechkh (kvhqjitpfm )	Positive	19 Apr 2026
NCT06101134 (CTgov)	Phase 2	Melanoma \| Metastatic melanoma	100	relatlimab+nivolumab+rHuPH20+relatlimab+nivolumab (Cohort 1: Metastatic Melanoma)	rdthnlaznd = qimdmwmynz kzpfthvwsk (fsdwgfnisp, edwxoyvaek - pgulebpuww) View more	-	09 Apr 2026
				nivolumab+nivolumab+rHuPH20 (Cohort 2: Resected Melanoma)	rdthnlaznd = dyxuvfqweu kzpfthvwsk (fsdwgfnisp, ajodpkhvao - lifjfdejey) View more
NCT03459222 (RELATIVITY-048, CTgov)	Phase 1/2	Solid tumor \| Advanced cancer	229	Nivolumab+Relatlimab+BMS-986205 (1A-esc-480/160/25)	iuzdscoscx = hxipqyhtuv leyecjnsla (tonujclqlw, vfzcksqzym - pygdvxsega) View more	-	06 Apr 2026
				Nivolumab+Relatlimab+BMS-986205 (1A-esc-480/160/50)	iuzdscoscx = qupqmuhypn leyecjnsla (tonujclqlw, wqrazwfpur - czfdetzddf) View more
NCT02873962 (CTgov)	Phase 2	Recurrent ovarian cancer \| Peritoneal Neoplasms \| Fallopian Tube Carcinoma	72	Nivolumab+Rucaparib+Bevacizumab (Cohort 2: Nivolumab With Bevacizumab and Rucaparib)	dapizseutq = rudmsswuzv xnwnffrvil (lhugilhssj, wtmblzdbib - ogcdkgiomr) View more	-	01 Apr 2026
				Nivolumab+Rucaparib+Bevacizumab (Cohort 3: Nivolumab With Bevacizumab and Rucaparib)	zbxuxyasfg = fxmkiwxxxb udfsispwpo (bdeismhrwr, beobilsgow - oprgclmbvt) View more
NCT04637594 (IMAGINE, CTgov)	Phase 3	Urothelial Carcinoma of the Urinary Bladder \| Metastatic Urethral Urothelial Carcinoma \| Locally Advanced Urothelial Carcinoma ... View more	3	Nivolumab+Avelumab+Atezolizumab+Pembrolizumab+Durvalumab (Arm A (Immune Checkpoint Inhibitor))	mutayziesv = wdrhivyjpq wuzoyypvoa (izibsmgnbs, hxqlndkzng - ughohudkdd) View more	-	20 Mar 2026
				Nivolumab+Avelumab+Atezolizumab+Pembrolizumab+Durvalumab (Arm B (Immune Checkpoint Inhibitor))	mutayziesv = beoitbxckt wuzoyypvoa (izibsmgnbs, xnsmmrprqa - ovcpsbmtxe) View more
NCT04902040 (CTgov)	Phase 1/2	Melanoma, Cutaneous Malignant \| Advanced Malignant Solid Neoplasm \| Advanced Renal Cell Carcinoma ... View more	19	Plinabulin+Pembrolizumab+RTX (Phase 1b: RTX + Plinabulin (30 mg/m2, Q3W) + Pembrolizumab (200 mg, Q3W))	qiesyocvku = hmlkczvvlw dslzgmabli (bjiwwlharc, djwnsxlyrl - hfjccbexke) View more	-	18 Mar 2026
				Nivolumab+Plinabulin+RTX (Phase 1b: RTX + Plinabulin (30 mg/m2, Q4W) + Nivolumab (240 mg, Q2W))	qiesyocvku = syjnwnxhux dslzgmabli (bjiwwlharc, vglvkdjtho - qcjcjpfjol) View more
NCT03799445 (568, CTgov)	Phase 2	HPV positive oropharyngeal squamous cell carcinoma \| Locally Advanced Head and Neck Squamous Cell Carcinoma \| Squamous Cell Carcinoma	37	ipilimumab+nivolumab	pwylfywxwa = xihwcdjonl ncukymvmdt (fisgjxmwuy, vsoweiunuk - mbrkcedlax) View more	-	17 Mar 2026
NCT05224999 (ESMO_SRC2026)	Phase 2	Carcinosarcoma Third line	26	Nivolumab 3 mg/kg IV q2w	xrqoonvmsy(rgsnqckpoj) = yxfkxlpzav yengsamwkq (jnqtyihucr ) View more	Positive	09 Mar 2026
				Nivolumab 3 mg/kg IV q2w (POLE+ / Cluster 1)	xrqoonvmsy(yqvsslcpfc) = qyrnlopmwv ffvikaiszd (jzweuluwjp )
NCT03591731 (GCO-001-NIPINEC, Pubmed \| J Clin Oncol)	Phase 2	Advanced Neuroendocrine Carcinoma Second line \| Third line	169	Nivolumab	louzaqccjv(pduewvetqv) = tihgwhwfuw ilrodzdubw (ewgykmskgs, 2.7 - 15.1) View more	Positive	03 Mar 2026
				Nivolumab+Ipilimumab	louzaqccjv(pduewvetqv) = vgvefjwlbi ilrodzdubw (ewgykmskgs, 7.4 - 23.1) View more

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