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Last update 28 Feb 2026

Nivolumab

Last update 28 Feb 2026

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)

+ [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+ [491]

Inactive Indication

Acidemia, IsovalericAcquired Immunodeficiency SyndromeAcute bilineal leukemia+ [145]

Originator Organization

Ono Pharmaceutical Co., Ltd.

Bristol Myers Squibb Co.

Active Organization

Bayer AG

Bristol Myers Squibb Co.

National Cancer Institute

+ [31]

Inactive Organization

Bristol-Myers Squibb GmbH & Co. KGaA

AbbVie, Inc.

Vedanta Biosciences, Inc.

+ [14]

License Organization

Nektar Therapeutics

NeoImmuneTech, Inc.

Vedanta Biosciences, Inc.

+ [19]

Drug Highest PhaseApproved

First Approval Date

Japan (04 Jul 2014),

Esophageal CarcinomaMelanoma

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

Structure/Sequence

Sequence Code 93681H

Source: *****

Sequence Code 93684L

Source: *****

1,944

Clinical Trials associated with Nivolumab

NCT07401875

/ Not yet recruitingPhase 1IIT

A Phase 1b Study of HC-7366, an Agonist of ISR With Immunotherapy in Kidney Cancer (SHARK)

To find out if the combination of HC-7366 and nivolumab (with or without ipilimumab) can help to control ccRCC. The

Start Date28 Jul 2026

Sponsor / Collaborator

The University of Texas MD Anderson Cancer Center

[+1]

NCT07383441

/ Not yet recruitingPhase 3IIT

Phase III Double Blinded Trial of Immune-Based Therapy With a Live Biotherapeutic MO-03 or Placebo for Frontline Therapy of Advanced Clear Cell Renal Cell Carcinoma [BioFront Trial]

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]

NCT07420439

/ Not yet recruitingPhase 2IIT

Phase II Trial Assessing 1st Line and 2nd Line Treatment in Patients With Advanced Non-Small Cell Lung Carcinoma and Interstitial Lung Disease

Lung cancer is a leading cause of cancer-related death worldwide. Interstitial Lung Diseases are closely associated with lung cancer either as complications or comorbidities to be considered for treatment.
Recently, a survey concerning the management of lung cancer in patients with ILDs was conducted by the Interstitial Lung Diseases and Thoracic Oncology Assemblies of the European Respiratory Society. Out of 494 practitioners, mostly pulmonologists, this survey showed that the majority of metastatic patients with pulmonary fibrosis would not be treated (69%), but that 25% and 31% of clinicians would offer chemotherapy or immunotherapy, respectively.
The systemic therapy is not clearly codified. There is a risk of worsening of ILDs with most of the treatments used in lung cancer including surgery, radiation therapy or certain systemic therapies. The Japanese Society of Pneumology has recently published proposals for care. However, the Asian population is unique in its incidence of ILDs and the frequency of drug toxicities and these recommendations may not be relevant for other populations. Thus, data are still needed to validate carboplatin and weekly paclitaxel as the best regimen for first-line treatment of NSCLC patients with ILD in a caucasian population.
In 2nd line setting, immune checkpoint blocker (ICB) in monotherapy or associated with chemotherapy has become an essential part of the therapeutic arsenal in advanced NSCLC. Several agents have been shown to be superior to docetaxel, following platinum-based chemotherapy failure, and have resulted in several marketing authorizations for PD-1 inhibitors (nivolumab, pembrolizumab) and PD-L1 inhibitors (atezolizumab).
We now have the long-term benefits of using ICBs as second-line therapy. Survival at 5 years is 10% higher than that obtained with docetaxel alone.
The safety profile is well known in particular with a risk of pulmonary toxicity. It should be noted that in most trials, patients with ILDs were not included. Therefore, we do not have trial data from these pivotal trials in patients with concomitant ILD.
Two prospective studies are available on the use of nivolumab in the second-line setting in patients with idiopathic ILDs. The first, in an Asian population, included 6 patients. It showed an interesting response rate of 50% without grade III or IV pulmonary toxicity or worsening of at 12 weeks.
Following this, the same team proposed a multicenter phase 2 study. Included patients had mild ILDs (VCf >80%) and were treated with nivolumab in 2nd line. The primary objective was PFS at 6 months. 18 patients were treated. 3 patients developed toxicity leading to discontinuation of nivolumab including 2 patients with grade 2 pneumonitis. PFS at 6 months was 56%, response rate was 39% and disease control achieved for 72% of patients.
In a recent prospective study in Asia, atezolizumab was administered to patients with moderate IPF and advanced NSCLC. The study was stopped prematurely due to a high incidence of inflammatory pneumonitis.
Thus, data are still needed to assess the safety of ICB in NSCLC patients with ILD in second line setting.

Start Date15 May 2026

Sponsor / Collaborator

Intergroupe Francophone Cancerologie Thoracique

100 Clinical Results associated with Nivolumab

100 Translational Medicine associated with Nivolumab

100 Patents (Medical) associated with Nivolumab

9,981

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 May 2026·PROTEIN EXPRESSION AND PURIFICATION

Detection of human PD-1 on T-cells using a fusion protein consisting of an anti-PD-1 single chain variable fragment linked to superfolder GFP

Article

Author: Sanford, David ; Bachovchin, William ; Bohm, Alex A ; Bullock, Peter A ; Shin, Jong

Monoclonal antibodies that disrupt the interaction between T-cell derived PD-1 and immunosuppressive ligands, such as PD-L1, have dramatically improved approaches to cancer therapy. One such antibody is termed Nivolumab (trade name Opdivo) that selectively targets PD-1. We previously described a Nivolumab-based anti-PD-1 single chain variable fragment (scFv), termed the anti-PD-1 double mutant (dm) scFv, that tightly binds to PD-1 and blocks the interaction between PD-1 expressed on T-cells and PD-L1 on CHO cells. Extending these experiments, we now report a fluorescent reporter formed by the fusion of the anti-PD-1dm with superfolder (sf) GFP. Immunofluorescence and flow cytometry studies established that the anti-PD-1dm-sfGFP fusion protein can be used to detect PD-1 on the surface of PD-1 expressing Jurkat cells. Furthermore, using a humanized mouse strain that expresses human PD-1 and PD-L1, we report that when combined with an anti-CD3 antibody, the anti-PD-1dm-sfGFP can be used to identify PD-1 expressing T-cells within mouse tumor biopsies. Thus, we have developed a reagent for the quantitative determination of activated T-cells in tumor biopsies. Finally, we report that an additional fluorescent probe for the detection of PD-1 in vivo can be generated by linking, via maleimide chemistry, a derivative of the anti-PD-1dm to the near-infrared dye IR800.

01 Apr 2026·UROLOGIC ONCOLOGY-SEMINARS AND ORIGINAL INVESTIGATIONS

Distinct pathways of disease progression with dual checkpoint blockade versus immunotargeted therapy in metastatic renal cell carcinoma

Article

Author: Zukov, Ruslan ; Abdrakhmanov, Ramil ; Kaidarova, Dilyara ; Baklanova, Olga ; Musaeva, Gunel ; Ongarbayev, Bakytzhan ; Tsimafeyeu, Ilya ; Petkau, Vladislav ; Chubenko, Vyacheslav ; Guliyev, Fuad

BACKGROUND:

Patterns of progression under immuno-oncology regimens in metastatic renal cell carcinoma (mRCC) remain poorly described. This study characterizes site-specific disease progression in patients receiving first-line dual immunotherapy or immunotargeted therapy.

METHODS:

This retrospective, observational cohort study included patients with clear-cell metastatic renal cell carcinoma treated between 2018 and 2024 with standard-dose regimens of nivolumab-ipilimumab (IO-IO) or pembrolizumab-axitinib and avelumab-axitinib combinations (IO-axitinib). The primary endpoint was the occurrence of new metastatic lesions at progression. Secondary endpoints included progression by >20% increase in target lesion size.

RESULTS:

Of 334 patients identified, 233 were evaluable for analysis. Radiographic progression occurred in 86.3% of IO-IO and 60% of IO-axitinib. Development of new metastatic lesions was more frequent with Nivo-Ipi (39.3% vs. 22.2%), most commonly involving the lungs and bones. In contrast, IO-axitinib combinations showed a greater propensity for progression through enlargement of pre-existing lesions (77.8% vs. 60.7%), accompanied by the emergence of new adrenal gland metastases. Across both treatment groups, lymph nodes emerged as the most frequent new site of disease progression.

CONCLUSIONS:

Nivo-Ipi was associated with more frequent development of new metastatic lesions, particularly in the lungs, bones, and lymph nodes, while axitinib-based combinations more often resulted in regrowth of existing disease with higher rates of adrenal involvement.

2,151

News (Medical) associated with Nivolumab

10 hours ago

·www.businesswire.com

Signatera™ MRD Data at ASCO GU Highlights Potential Utility Across GU Cancers, Including for Bladder Preservation

AUSTIN, Texas--(BUSINESS WIRE)--Natera, Inc. (NASDAQ: NTRA), a global leader in cell-free DNA and precision medicine, today announced it will present new data in genitourinary malignancies at the American Society of Clinical Oncology Genitourinary Cancers Symposium (ASCO GU), taking place February 26-28, 2026. Across four oral presentations in muscle-invasive bladder cancer (MIBC), these data reinforce Signatera’s role in identifying patients who benefit from adjuvant immunotherapy, supporting response-adaptive bladder preservation strategies, and refining molecular residual disease (MRD) detection with plasma circulating tumor DNA (ctDNA) and urinary tumor DNA (utDNA). Bladder Preservation: INDIBLADE and RETAIN The INDIBLADE and RETAIN multicenter phase 2 trials demonstrate Signatera’s consistent performance in treatment response monitoring across diverse neoadjuvant regimens in MIBC, with 73-77% of patients demonstrating clearance of ctDNA following therapy and Signatera-negativity showing strong associations with positive outcomes, even with the bladder preserved. INDIBLADE, the findings of which will be published today in Nature Medicine, investigated induction with combination immune checkpoint inhibitors (ICI) followed by chemoradiotherapy as a bladder-sparing strategy in stage II/III MIBC patients. The results show that Signatera status post-ICI was associated with bladder-intact event-free survival (BI-EFS). Specifically, Signatera-negativity at baseline and post-neoadjuvant therapy was linked to an 88.6% and 91% estimated two-year BI-EFS, respectively. RETAIN evaluated a clinical response-adapted approach to identify patients for potential bladder-preservation following neoadjuvant therapy. The findings showed that post-treatment ctDNA clearance or negativity was associated with improved metastasis-free survival (MFS), and that Signatera-negative patients with no clinical or radiographic evidence of disease managed with active surveillance achieved MFS comparable to Signatera-negative patients undergoing cystectomy. In contrast, persistent Signatera-positivity was associated with poor outcomes. Perioperative Care: NIAGARA This phase 3 randomized perioperative study includes the first-ever presentation of utDNA data with clinical correlation. The combination of utDNA and ctDNA status post-neoadjuvant therapy and pre-cystectomy identified the group with the highest 24-month EFS. utDNA-positivity pre-cystectomy was more strongly associated with residual non-invasive disease vs ctDNA-positivity was more strongly associated with residual invasive disease. These data suggest that the combined assessment of utDNA and ctDNA can provide complementary risk stratification benchmarked against pathologic staging, enabling comprehensive identification of residual disease. “As treatment options expand in perioperative and bladder preservation settings, we need tools that help us determine who truly requires additional therapy and who may safely avoid it,” said Michiel van der Heijden, M.D., Ph.D., Netherlands Cancer Institute, principal investigator of INDIBLADE and presenting author of the NIAGARA study. “The data presented at ASCO GU demonstrate that MRD assessment with Signatera has strong correlations with outcomes and the potential to inform these critical treatment decisions.” “Following our milestone PMA submission to the FDA based on IMvigor011, these compelling data presentations reflect our commitment to transforming care across the spectrum of genitourinary malignancies,” said Minetta Liu, M.D., chief medical officer of oncology and early cancer detection at Natera. “The new data suggests a particularly important opportunity for Signatera to optimize clinical decisions around bladder preservation, a major opening to improve patient quality of life.” The full list of presentations at ASCO GU includes: February 27, 8:10 AM PT | Abstract #633 (Oral Presentation) Presenter: Joaquim Bellmunt, M.D. Circulating tumor (ct)DNA-guided adjuvant atezolizumab (atezo) in muscle-invasive bladder cancer (MIBC): Exploratory analysis of ctDNA dynamics in the IMvigor011 trial February 27, 8:10 AM PT | Abstract #632 (Oral Presentation) Presenter: Pooja Ghatalia, M.D. Circulating tumor DNA (ctDNA) to guide response-adapted bladder preservation in muscle invasive bladder cancer (MIBC): Integrated analysis of the RETAIN trials February 27, 11:30 AM PT | Abstract #797 Presenter: Can Aydogdu, M.D. Integrating genomic profiling and circulating tumor DNA monitoring to optimize surveillance strategies in muscle-invasive bladder cancer February 27, 11:30 AM PT | Abstract #831 Presenter: Can Aydogdu, M.D. Association of ctDNA status with upstaging, pathologic outcomes, and genomic alterations in high-risk NMIBC February 27, 2:30 PM PT | Abstract #637 (Oral Presentation) Presenter: Jan-Jaap J. Mellema, M.D. Induction ipilimumab plus nivolumab followed by consolidating chemoradiotherapy as bladder-sparing treatment in stage II/III urothelial carcinoma of the bladder: The phase 2 INDIBLADE trial February 27, 4:00 PM PT | Abstract #636 (Oral Presentation) Presenter: Michiel van der Heijden, M.D., Ph.D. Urinary tumor DNA (utDNA) and circulating tumor DNA (ctDNA) in patients (pts) with muscle-invasive bladder cancer (MIBC) who received perioperative durvalumab (D) in NIAGARA February 28, 7:00 AM PT | Abstract #532 Presenter: Shuchi Gulati, M.D., M.Sc. Association of pre-operative circulating tumor DNA (ctDNA) status with clinicopathologic characteristics in patients (pts) with localized renal cell carcinoma (RCC) February 28, 7:00 AM PT | Abstract #620 Presenter: Dalia Kaakour, M.D., MPH Use of circulating tumor DNA (ctDNA) in the detection of residual disease and recurrence for patients with testicular cancer February 27, 11:30 AM PT | Abstract #860 Presenter: Lingbin Meng, M.D., Ph.D. Use of circulating tumor DNA (ctDNA) in the detection of residual disease and recurrence for patients with testicular cancer February 27, 11:30 AM PT | Abstract #800 Presenter: Tanya Jindal, BS, BA Predictive value of early circulating tumor DNA (ctDNA) response in advanced urothelial carcinoma (aUC) treated with enfortumab vedotin plus pembrolizumab (EVP). February 28, 7:00 AM PT | Abstract #541 Presenter: David F. McDermott, M.D. Circulating tumor DNA (ctDNA) analysis in participants (pts) with advanced clear cell renal cell carcinoma (ccRCC) treated with first-line pembrolizumab (pembro) monotherapy from the phase 2 KEYNOTE-427 study. About Natera Natera™ is a global leader in cell-free DNA and precision medicine, dedicated to oncology, women’s health, and organ health. We aim to make personalized genetic testing and diagnostics part of the standard-of-care to protect health and inform earlier, more targeted interventions that help lead to longer, healthier lives. Natera’s tests are supported by more than 350 peer-reviewed publications that demonstrate excellent performance. Natera operates ISO 13485-certified and CAP-accredited laboratories certified under the Clinical Laboratory Improvement Amendments (CLIA) in Austin, Texas, and San Carlos, California, and through Foresight Diagnostics, its subsidiary, operates an ISO 27001-certified and CAP-accredited laboratory certified under CLIA in Boulder, Colorado. For more information, visit www.natera.com. Forward-Looking Statements All statements other than statements of historical facts contained in this press release are forward-looking statements and are not a representation that Natera’s plans, estimates, or expectations will be achieved. These forward-looking statements represent Natera’s expectations as of the date of this press release, and Natera disclaims any obligation to update the forward-looking statements. These forward-looking statements are subject to known and unknown risks and uncertainties that may cause actual results to differ materially, including with respect to our efforts to develop and commercialize new product offerings, whether the results of clinical or other studies will support the use of our product offerings, the impact of results of such studies, our expectations of the reliability, accuracy, and performance of our tests, or of the benefits of our tests and product offerings to patients, providers, and payers. Additional risks and uncertainties are discussed in greater detail in "Risk Factors" in Natera’s recent filings on Forms 10-K and 10-Q, and in other filings Natera makes with the SEC from time to time. These documents are available at www.natera.com/investors and www.sec.gov.

Clinical ResultPhase 2ASCOPhase 3

26 Feb 2026

·www.prnewswire.com

Head and Neck Cancer Therapeutics Market to Reach USD 2.6 Billion by 2032, Driven by Immunotherapy and Precision Oncology - Credence Research Inc.

LONDON, Feb. 26, 2026 /PRNewswire/ -- The "Head and Neck Cancer Therapeutics Market – Growth, Share, Opportunities & Competitive Analysis, 2024 – 2032" report has been added to the offering of Credence Research Inc. The global head and neck cancer therapeutics market is projected to grow from USD 1.58 billion in 2024 to USD 2.6 billion by 2032, reflecting a CAGR of 6.8% over 2024–2032. Growth is supported by rising incidence, expanding use of immunotherapy and targeted therapies, and broader adoption of precision medicine, subject to access and reimbursement constraints across regions. Key Attributes Historical Period: 2020–2023 Base Year: 2024 Forecast Period: 2025–2032 Head and Neck Cancer Therapeutics Market Size 2024: USD 1.58 Billion Head and Neck Cancer Therapeutics Market Size 2032: USD 2.6 Billion Head and Neck Cancer Therapeutics Market CAGR (2024–2032): 6.8% Access crucial information at unmatched prices! Request your sample report today and start making informed decisions powered by Credence Research Inc. - Rising Prevalence of Head and Neck Cancers Higher prevalence and diagnosis rates of head and neck cancers underpin demand for therapeutics. Tobacco use, alcohol consumption, and HPV infection remain key risk factors in many markets. Some public health agencies report that HPV accounts for a substantial share of throat and mouth cancers, reshaping incidence patterns by subsite and region. These factors expand the treated population and support demand across first-line, recurrent, and metastatic care settings. Population aging further increases risk in many countries, adding to the addressable patient base. However, treatment uptake still depends on stage at diagnosis, timely referral to specialist centers, and patient ability to access and afford care. Advancements in Targeted and Immunotherapy Treatments Targeted therapies and immunotherapies have broadened the available treatment toolkit, particularly in recurrent or metastatic disease and biomarker-defined subgroups. EGFR-directed approaches and monoclonal antibodies are used in certain regimens. Checkpoint inhibitors, including pembrolizumab, have shown survival benefits in selected populations. These modalities can offer different efficacy and safety profiles versus conventional chemotherapy. Clinical benefit, though, varies by tumor type, line of therapy, biomarker status, and patient health. Ongoing clinical trials and label expansions continue to adjust where and how these agents are positioned within treatment pathways. Growing Adoption of Immunotherapy Immunotherapy is becoming a key component of the head and neck cancer treatment landscape. Immune checkpoint inhibitors and other immune-based approaches are gaining traction due to their ability to boost anti-tumor immune responses and extend survival in certain settings. For instance, GeoVax's Phase 2 trial of gene therapy Gedeptin combined with pembrolizumab (Keytruda) in recurrent head and neck cancer aims for pathologic complete responses in 36 patients, reflecting growing interest in immune-based strategies. Regulatory approvals and expanding clinical experience have supported the inclusion of immunotherapy in more treatment protocols. This trend reflects a broader shift in oncology toward immune-modulating approaches, although cost and eligibility criteria still constrain uptake. Market Challenges High Treatment Costs The high cost of advanced treatment options remains a major restraint. Immunotherapies, targeted therapies, and precision diagnostics often carry substantial price tags, which can limit access for many patients, especially in low- and middle-income regions. Expenses from prolonged therapies, companion diagnostics, and supportive care add further burden to patients and health systems. This financial pressure can constrain adoption, even where clinical benefit is demonstrated. Limited Access to Advanced Healthcare Infrastructure Access to specialized oncology services remains uneven. Many patients in developing and underdeveloped regions cannot reach centers that provide advanced therapies or complex diagnostics. Rural areas face gaps in diagnostic capacity, specialist availability, and timely referrals. This imbalance contributes to late-stage diagnosis and reduces the effectiveness of available interventions. The disparity in infrastructure and trained personnel remains a significant barrier to broader adoption of advanced therapeutics. Market Opportunities The increasing adoption of precision medicine presents a key opportunity. Advances in genomic profiling and biomarker identification support development of targeted therapies and more personalized regimens. Tailored treatment strategies can improve clinical outcomes and reduce unnecessary exposure to less effective options. Growing use of immunotherapy and combination regimens offers further opportunity. Integrating checkpoint inhibitors and other immune-based therapies with established treatments can improve survival and address resistance patterns. Firms that focus on novel combinations and biomarker-guided approaches can capture new growth segments. Improving healthcare infrastructure and access in emerging markets also expands opportunity. Investments in oncology centers, diagnostics, and reimbursement schemes can unlock new demand. Strategic collaborations, local trials, and adaptive pricing models can help companies build presence in these regions. Market Segmentation By Therapy Type Chemotherapy Immunotherapy Targeted Therapy By Route of Administration Injectable Oral By Distribution Channel Hospital Pharmacies Retail and Specialty Pharmacies Online Pharmacies By Region North America: United States, Canada Europe: United Kingdom, Germany, France, and others Asia-Pacific: China, India, Japan Latin America: Brazil, Mexico Middle East and Africa: South Africa, United Arab Emirates, and others Browse Complete Report Originally Published by Credence Research - Regional Analysis North America North America is described as accounting for around 40% of global revenue. The region benefits from established oncology infrastructure, high adoption of advanced therapies, and strong clinical research activity. Some sources cite more than 65,000 new head and neck cancer cases per year, supporting consistent treatment demand. Uptake of checkpoint inhibitors such as pembrolizumab and nivolumab has influenced treatment patterns in eligible patients. Reimbursement policies play a central role in shaping access and choice of therapy. Europe Europe is described as contributing around 30% of global share. Public health coverage, oncology research funding, and awareness campaigns support early detection and treatment access. Annual incidence is cited at more than 150,000 cases, with rising HPV-linked disease reported in some subtypes. EU-level initiatives and national programs support personalized medicine and development of novel therapies. Vaccination and prevention may affect long-term incidence, but near-term demand is driven by existing diagnosed populations. Key Player Analysis AstraZeneca Bristol-Myers Squibb Company Clinigen Group plc. Coherus BioSciences Eli Lilly and Company Hoffmann-La Roche Ltd. Merck & Co. Sanofi Takeda Pharmaceutical Company Limited Teva Pharmaceutical Industries Ltd Recent Developments In February 2025, Merus N.V. reported that the U.S. FDA granted Breakthrough Therapy Designation for petosemtamab in combination with pembrolizumab for first-line treatment of adults with recurrent or metastatic PD-L1–positive head and neck squamous cell carcinoma (CPS ≥ 1). In March 2025, Aprea Therapeutics signed a Material Transfer Agreement with MD Anderson Cancer Center to evaluate its WEE1 inhibitor, APR-1051, in HPV-positive and HPV-negative head and neck cancers. The work includes preclinical studies on replication stress and evaluation of combination strategies, including with immune checkpoint inhibitors. In April 2025, Akeso, Inc. received U.S. FDA approval for penpulimab-kcqx (a PD-1 monoclonal antibody) in combination with cisplatin or carboplatin and gemcitabine for adult recurrent or metastatic non-keratinizing nasopharyngeal carcinoma (NPC). In June 2025, Exelixis discontinued development of zanzalintinib for advanced head and neck cancer, citing a more competitive FGFR-inhibitor landscape. In June 2025, the U.S. FDA approved peri-operative pembrolizumab following KEYNOTE-689 results reporting event-free survival benefit. In July 2025, Rakuten Medical, Inc. expanded patient recruitment to Japan and reported plans to expand to Eastern Europe for its Phase 3 ASP-1929 photoimmunotherapy program in combination with pembrolizumab as first-line therapy for recurrent head and neck squamous cell carcinoma. In September 2025, Transgene reported positive Phase 1 results for TG4050 in operable head and neck squamous cell carcinoma. In October 2025, Bicara Therapeutics, Inc. reported that the U.S. FDA granted Breakthrough Therapy Designation for ficerafusp alfa in combination with pembrolizumab for first-line treatment of head and neck squamous cell carcinoma (HNSCC). In December 2025, Pyxis Oncology reported positive preliminary Phase 1 data for micvotabart pelidotin (MICVO) in patients with recurrent or metastatic head and neck squamous cell carcinoma. Report Coverage The research report offers an in-depth analysis by Therapy Type, Route of Administration, and Distribution Channel. It profiles leading market players, outlining their business overviews, product portfolios, investment focus, revenue streams, and key applications. The report also examines the competitive environment, SWOT positions, key market trends, and primary drivers and restraints. It reviews market dynamics, regulatory frameworks, and technological advances shaping the sector. The analysis includes assessment of macroeconomic factors and healthcare system changes affecting demand. Finally, the report provides strategic recommendations for new entrants and established companies to navigate regulatory complexity, optimize portfolios, and capture growth opportunities in both mature and emerging markets. Browse Complete Report Originally Published by Credence Research - Related Reports – Neoantigen-Based Personalized Cancer Therapeutic Vaccines Market Colorectal Cancer Therapeutics Market Head and Neck Cancer Therapeutics Market Lung Cancer Therapeutics Market Cancer Therapeutics Market Checkpoint Inhibitor Refractory Cancer Market Antisense RNAi Therapeutics Market U.K. Monoclonal Antibodies Therapeutics Market Italy Monoclonal Antibodies Therapeutics Market France Monoclonal Antibodies Therapeutics Market Europe Monoclonal Antibodies Therapeutics Market Australia Monoclonal Antibodies Therapeutics Market U.S. Monoclonal Antibodies Therapeutics Market mRNA Therapeutics Market Brain Metastasis Therapeutics Market About Us Credence Research Inc is a global market intelligence and consulting firm founded in 2015. It delivers deep market insights, quantitative analysis, and strategic guidance to business leaders, investors, governments, NGOs, and non-profit groups worldwide. The company helps organizations evaluate markets, understand trends, reduce risk, and make data-driven decisions that support growth and competitive strategy. Credence Research is known for rigorous research methods and comprehensive analytics. The firm produces detailed reports covering market size, forecasts, growth drivers, trends, and competitive landscapes across many industries. Each report often includes frameworks like PESTLE and Porter's Five Forces to give a complete view of market dynamics and future potential. Credence Research also provides tailored consulting services, due diligence support, go-to-market planning, and pre-IPO research to strengthen client strategies and investment narratives. Its insights come from both primary and secondary research, expert interviews, and advanced data modelling. The firm's client base spans Europe, the Americas, Asia-Pacific, and the Middle East/Africa. To find out more, visit or follow us on X.com, LinkedIn and Facebook Contact Us – Credence Research Inc, Tower C-1105, S 25, Akash Tower, Vishal Nagar, Pimple Nilakh, Haveli, Pune – 411027, India USA: +1-888-600-6441 Email: [email protected] Visit Our Website: Logo - SOURCE Credence Research Inc. 21% more press release views with Request a Demo

ImmunotherapyDrug ApprovalClinical ResultPhase 2Breakthrough Therapy

26 Feb 2026

·www.biospace.com

Delcath Systems Reports Fourth Quarter and Full Year 2025 Results

Conference Call Today at 8:30 a.m. Eastern Time QUEENSBURY, N.Y.--(BUSINESS WIRE)--Delcath Systems, Inc. (Nasdaq: DCTH) (“Delcath” or the “Company”), an interventional oncology company focused on the treatment of primary and metastatic cancers of the liver, today reported financial results and business highlights for the fourth quarter and full year-ended December 31, 2025. Fourth Quarter and Full Year 2025 Financial Results Total fourth quarter and full year revenue of $20.7 million and $85.2 million, respectively HEPZATO KIT ™ fourth quarter and full year revenue of $19.0 million and $78.8 million, respectively CHEMOSAT ® fourth quarter and full year revenue of $1.7 million and $6.4 million, respectively Gross margins of 85% for the fourth quarter and 86% for the full year Fourth quarter net loss of $1.9 million and full year net income of $2.7 million Non-GAAP positive adjusted EBITDA for the fourth quarter and full year of $2.4 million and $25.1 million, respectively Repurchased 628,572 common shares for $6.0 million through December 31, 2025 under the approved $25 million Share Buyback Program As of December 31, 2025, the Company had approximately $91.0 million of cash and short-term investments and no debt Business Highlights Currently 28 active centers Approximately 140% growth in HEPZATO procedure volume in 2025 compared to 2024 Announced the publication of additional results from the FOCUS study, “Subgroup Analyses of the Phase 3 FOCUS Study of Melphalan/Hepatic Delivery System in Patients with Unresectable Metastatic Uveal Melanoma” in Journal of Cancer Research and Clinical Oncology Announced the publication of results from multiple studies by independent investigators, including: Results from the Phase 2 CHOPIN trial sponsored by Leiden University Medical Center evaluating CHEMOSAT with ipilimumab and nivolumab in metastatic uveal melanoma at the 2025 European Society of Medical Oncology Annual Congress showing a significant improvement in one-year progression-free survival versus CHEMOSAT alone A long-term retrospective study conducted by researchers at the University Hospital Tübingen, Germany, “Characterization of long-term survivors with liver metastases from uveal melanoma diagnosed between 2005 and 2021”, in International Journal of Cancer A long-term retrospective study conducted by researchers at the Asklepios Hospital Barmbek, Germany, “Survival Outcome After Percutaneous Hepatic Perfusion with High-Dose Melphalan for Liver-Dominant Metastatic Uveal Melanoma: A 10-Year Single-Center Experience” in Cancers “2025 was a pivotal year in which we delivered robust procedure-volume growth, positive operating cashflow and successfully navigated temporary headwinds to stabilize the HEPZATO revenue base in the fourth quarter,” said Gerard Michel, President and Chief Executive Officer of Delcath “With 28 active treatment centers now delivering therapy and compelling CHOPIN data demonstrating clear clinical benefit when PHP is sequenced with checkpoint inhibitors, we enter 2026 with strong momentum. Through continued site activations, commercial expansion, and heightened physician awareness of the CHOPIN results, we expect accelerated adoption and utilization that will drive long-term value for patients and shareholders alike.” 2026 Full Year Financial Guidance The Company’s financial outlook for fiscal year 2026: Total CHEMOSAT and HEPZATO KIT revenue to be at least $100 million, reflecting an increase in HEPZATO KIT volume of at least 20% over 2025, and Gross margins in the range of 84% to 87%. Fourth Quarter and Full Year 2025 Results Total revenue for the quarter ended December 31, 2025 was $20.7 million compared to $15.1 million for the same period in the prior year. Revenue in the quarter includes sales of $19.0 million of HEPZATO in the U.S. and $1.7 million of CHEMOSAT in Europe. Total revenue for the year-ended December 31, 2025 was $85.2 million compared to $37.2 million for the same period in the prior year. Revenue in 2025 includes sales of $78.8 million of HEPZATO in the U.S. and $6.4 million of CHEMOSAT in Europe. Research and development expenses for the quarter and year-ended December 31, 2025, were $9.4 million and $29.2 million, respectively compared to $2.9 million and $13.9 million for the same periods in the prior year. The increase is primarily due to costs associated with expanding the clinical team including share-based compensation expense related to an increase in headcount and initiation of the Phase 2 clinical trial evaluating HEPZATO in combination with standard of care for mCRC and mBC. In 2024, these costs are primarily related to medical affairs and regulatory costs associated with the approved products. Selling, general and administrative expenses for the quarter and year-ended December 31, 2025, were $10.5 million and $43.5 million, respectively compared to $7.0 million and $29.6 million for the same periods in the prior year. The increase is primarily due to continued commercial expansion activities including marketing-related expenses and additional personnel on the commercial team. In addition, the increase in personnel along with higher grant date exercise prices has increased the share-based compensation expense. Net loss for the quarter ended December 31, 2025 was $1.9 million and net income for the full year was $2.7 million, compared to net loss of $3.4 million and $26.4 million for the same periods in the prior year. Non-GAAP positive adjusted EBITDA for the quarter and year-ended December 31, 2025 was $2.4 million and $25.1 million compared to adjusted EBITDA gain of $4.6 million and loss of $2.5 million for the same periods in the prior year. A table reconciling non-GAAP measures is included in this press release for reference. As of December 31, 2025, the Company had $91.0 million in cash and investments, and no debt. Conference Call Information To participate in this event, dial in approximately 5 to 10 minutes before the beginning of the call. Event Date: Thursday, February 26, 2026 Time: 8:30 AM Eastern Time Participant Numbers: Toll Free: 1-877-407-3982 International: 1-201-493-6780 Webcast: A replay of the webinar will be available shortly after the conclusion of the call and will be archived on the company's website . GAAP v. Non-GAAP Measures Delcath’s reported earnings are prepared in accordance with generally accepted accounting principles in the United States, or GAAP, and represent earnings as reported to the Securities and Exchange Commission. Delcath has provided in this release certain financial information that has not been prepared in accordance with GAAP. Delcath’s management believes that the non-GAAP adjusted EBITDA described in this release, which includes adjustments for specific items that are generally not indicative of our core operations, provides additional information that is useful to investors in understanding Delcath’s underlying performance, business and performance trends, and helps facilitate period-to-period comparisons and comparisons of its financial measures with other companies in Delcath’s industry. However, the non-GAAP financial measures that Delcath uses may differ from measures that other companies may use. Non-GAAP financial measures are not required to be uniformly applied, are not audited and should not be considered in isolation or as substitutes for results prepared in accordance with GAAP. About Delcath Systems, Inc., HEPZATO KIT and CHEMOSAT Delcath Systems, Inc. is an interventional oncology company focused on the treatment of primary and metastatic liver cancers. The company's proprietary products, HEPZATO KIT (HEPZATO (melphalan) for Injection/Hepatic Delivery System) and CHEMOSAT Hepatic Delivery System (HDS) for Melphalan percutaneous hepatic perfusion (PHP), are designed to administer high-dose chemotherapy to the liver while controlling systemic exposure and associated side effects during a PHP procedure. In the United States, HEPZATO KIT is considered a combination drug and device product and is regulated and approved for sale as a drug by the FDA. HEPZATO KIT is comprised of the chemotherapeutic drug melphalan and Delcath’s proprietary HDS. The HDS is used to isolate the hepatic venous blood from the systemic circulation while simultaneously filtrating hepatic venous blood during melphalan infusion and washout. The use of the HDS results in loco-regional delivery of a relatively high melphalan dose, which can potentially induce a clinically meaningful tumor response with minimal hepatotoxicity and reduce systemic exposure. HEPZATO KIT is approved in the United States as a liver-directed treatment for adult patients with metastatic uveal melanoma (mUM) with unresectable hepatic metastases affecting less than 50% of the liver and no extrahepatic disease, or extrahepatic disease limited to the bone, lymph nodes, subcutaneous tissues, or lung that is amenable to resection or radiation. Please see the full Prescribing Information, including BOXED WARNING for the HEPZATO KIT . In Europe, the device-only configuration of the HDS is regulated as a Class III medical device and is approved for sale under the trade name CHEMOSAT Hepatic Delivery System for Melphalan, or CHEMOSAT, where it has been used in the conduct of percutaneous hepatic perfusion procedures at major medical centers to treat a wide range of cancers of the liver. Safe Harbor / Forward-Looking Statements The Private Securities Litigation Reform Act of 1995 provides a safe harbor for forward-looking statements made by the Company or on its behalf. This press release contains forward-looking statements, including the Company’s statements regarding the possible synergy seen in the successful Phase 2 CHOPIN Trial being transferable to clinical practice; Company’s 2026 financial outlook, which are subject to certain risks and uncertainties, that can cause actual results to differ materially from those described. The words “anticipate,” “believe,” “continue,” “could,” “estimate,” “expect,” “intend,” “may,” “plan,” “potential,” “predict,” “project,” “should,” “target,” “will,” “would” and similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. Factors that may cause such differences include, but are not limited to, uncertainties relating to: the Company’s commercialization plans and its ability to successfully commercialize the HEPZATO KIT; contributions to adjusted EBITDA; the Company’s successful management of the HEPZATO KIT supply chain, including securing adequate supply of critical components necessary to manufacture and assemble the HEPZATO KIT; successful FDA inspections of the facilities of the Company and those of its third-party suppliers/manufacturers; the Company’s successful implementation and management of the HEPZATO KIT Risk Evaluation and Mitigation Strategy; the potential benefits of the HEPZATO KIT as a treatment for patients with primary and metastatic disease in the liver; the Company’s ability to obtain reimbursement for the HEPZATO KIT; and the Company’s ability to successfully enter into any necessary purchase and sale agreements with users of the HEPZATO KIT. For additional information about these factors, and others that may impact the Company, please see the Company’s filings with the Securities and Exchange Commission, including those on Forms 10-K, 10-Q, and 8-K. However, new risk factors and uncertainties may emerge from time to time, and it is not possible to predict all risk factors and uncertainties. Accordingly, you should not place undue reliance on these forward-looking statements, which speak only as of the date they are made. We undertake no obligation to publicly update or revise these forward-looking statements to reflect events or circumstances after the date they are made. DELCATH SYSTEMS, INC. Condensed Consolidated Balance Sheets (Unaudited) (in thousands, except share and per share data) December 31, 2025 December 31, 2024 Assets Current assets Cash and cash equivalents $ 43,454 $ 32,412 Short-term investments 47,582 20,821 Accounts receivable 11,744 10,890 Inventories 10,252 6,933 Prepaid expenses and other current assets 6,498 2,704 Total current assets 119,530 73,760 Property, plant and equipment, net 3,166 1,790 Right-of-use assets 936 1,039 Total assets $ 123,632 $ 76,589 Liabilities and Stockholders’ Equity Current liabilities Accounts payable $ 2,658 $ 961 Accrued expenses 8,191 5,078 Lease liabilities, current 101 105 Total current liabilities 10,950 6,144 Lease liabilities, non-current 835 933 Other liabilities, non-current 628 766 Total liabilities 12,413 7,843 Commitments and contingencies Stockholders’ equity Preferred stock, $.01 par value; 10,000,000 shares authorized; 24,819 and 11,357 shares issued and outstanding at December 31, 2023 and 2022, respectively — — Common stock, $.01 par value; 80,000,000 shares authorized; 22,761,554 shares and 10,046,571 shares issued and outstanding at December 31, 2023 and 2022, respectively 347 331 Additional paid-in capital 639,145 599,881 Accumulated deficit (528,848 ) (531,548 ) Accumulated other comprehensive income 575 82 Total stockholders’ equity 111,219 68,746 Total liabilities and stockholders’ equity $ 123,632 $ 76,589 DELCATH SYSTEMS, INC. Condensed Consolidated Statements of Operations and Comprehensive Income (Loss) (Unaudited) (in thousands, except share and per share data) Three months ended December 31, Year ended December 31, 2025 2024 2025 2024 Product revenue 20,728 15,100 $ 85,231 $ 37,205 Cost of goods sold (3,010 ) (2,126 ) (11,797 ) (6,188 ) Gross profit 17,718 12,974 73,434 31,017 Operating expenses: Research and development expenses 9,371 2,914 29,246 13,874 Selling, general and administrative expenses 10,531 7,021 43,528 29,553 Total operating expenses 19,902 9,935 72,774 43,427 Operating income (loss) (2,184 ) 3,039 660 (12,410 ) Change in fair value of warrant liability — (6,679 ) — (14,071 ) Interest income, net 857 295 2,920 125 Other expense (7 ) (53 ) (70 ) (30 ) Income (loss) before income taxes (1,334 ) (3,398 ) 3,510 (26,386 ) Income tax expense 562 — 810 — Net income (loss) (1,896 ) (3,398 ) 2,700 (26,386 ) Other comprehensive income (loss): Unrealized gain on investments adjustments (198 ) 125 394 (22 ) Foreign currency translation adjustments (102 ) (54 ) 99 (31 ) Total comprehensive income (loss) $ (2,196 ) $ (3,327 ) $ 3,193 $ (26,439 ) Common share data: Basic income (loss) per common share $ (0.05 ) $ (0.11 ) $ 0.08 $ (0.93 ) Weighted average number of basic shares outstanding 36,445,905 32,014,365 35,821,157 28,511,393 Diluted income (loss) per common share $ (0.05 ) $ (0.11 ) $ 0.07 $ (0.93 ) Weighted average number of diluted shares outstanding 36,445,905 32,014,365 39,919,557 28,511,393 DELCATH SYSTEMS, INC. Reconciliation of Reported Net Income (Loss) (GAAP) to Adjusted EBITDA (NON-GAAP Measure) (Unaudited) (in thousands) Three months ended December 31, Twelve months ended December 31, 2025 2024 2025 2024 Net income (loss) $ (1,896 ) $ (3,398 ) $ 2,700 $ (26,386 ) Stock-based compensation expense 4,512 1,612 24,232 9,767 Depreciation 80 38 238 134 Net interest (income) expense (857 ) (295 ) (2,920 ) (125 ) Fair value warrant adjustment — 6,679 — 14,071 Income tax expense 562 — 810 — Adjusted EBITDA (Non-GAAP) $ 2,401 $ 4,636 $ 25,060 $ (2,539 ) Contacts Investor Relations Contact: ICR Healthcare investorrelations@delcath.com

Financial StatementPhase 2Drug ApprovalClinical ResultPhase 3

100 Deals associated with Nivolumab

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KEGG	Wiki	ATC	Drug Bank
D10316	Nivolumab	L01XC17	DB09035

R&D Status

Approved

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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

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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
Neoplasm Metastasis	Phase 3	Poland	Bristol Myers Squibb Co.	02 Feb 2022
Malignant melanoma stage IV	Phase 3	United States	Bristol-Myers Squibb International Corp.	03 Dec 2021
Malignant melanoma stage IV	Phase 3	China	Bristol-Myers Squibb International Corp.	03 Dec 2021
Malignant melanoma stage IV	Phase 3	Argentina	Bristol-Myers Squibb International Corp.	03 Dec 2021

Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT02314169 (NCI9673, Pubmed \| J Clin Oncol)	Phase 2	Anal canal squamous cell carcinoma	100	Nivolumab	asnvelwlao(bzvednxnto) = vyncbpdlqe msamljrcxo (rgowkzixtu, 1.9 - 3.8) View more	Negative	20 Feb 2026
				Nivolumab + Ipilimumab	asnvelwlao(bzvednxnto) = vtdltltbul msamljrcxo (rgowkzixtu, 2.0 - 5.6) View more
NCT03366766 (CTgov)	Phase 2	Non-small cell lung cancer stage I \| Resectable Lung Non-Small Cell Carcinoma \| Non-small cell lung cancer stage IIIA ... View more	14	Nivolumab+cisplatin+Pemetrexed Disodium (Cohort I (Nivolumab, Cisplatin, Pemetrexed Disodium))	jwifkjjedw = gktozigehf eeztmpforu (tiszjmcwsa, ytcfpdjaef - fgilwrcqis) View more	-	20 Feb 2026
				nivolumab+Gemcitabine Hydrochloride (Cohort I (Nivolumab, Cisplatin, Gemcitabine Hydrochloride))	yccogjxtfb = mswfiewstu kgwzhxuxvk (qwmxdqnymq, hyhhssatjr - ariaepiwrc)
NCT02224781 (DREAMseq \| ECOG-ACRIN EA6134, CTgov)	Phase 3	Melanoma, Cutaneous Malignant \| Melanoma recurrent \| Metastatic melanoma ... View more	267	Multigated Acquisition Scan+ipilimumab+Nivolumab (Arm A (Immunotherapy))	kaatgsnblk = rkdgxffnaz eecwqqcprl (lfasjetfpc, bigyjebflb - zkrlnetrvc) View more	-	18 Feb 2026
				Multigated Acquisition Scan+Dabrafenib Mesylate+Trametinib Dimethyl Sulfoxide (Arm B (BRAF Inhibitor Therapy))	kaatgsnblk = bczvqtmyam eecwqqcprl (lfasjetfpc, fuvjohklbg - szrjeufqfv) View more
NCT03785873 (BilT-03 \| BilT03, CTgov)	Phase 1/2	Advanced biliary tract cancer	34	Nivolumab+leucovorin+Nanoliposomal-Irinotecan+5-fluorouracil	xemopkstbi = ypuhvwhydo cfalqqolnu (yeguelbhab, lqrayrzkdf - klcjjoylcf) View more	-	13 Feb 2026
NCT03388190 (METIMMOX, CTgov)	Phase 2	Metastatic Colorectal Carcinoma	80	Leucovorin+oxaliplatin+fluorouracil (Control Arm)	kvqjxmozto(ttgetavgsd) = vehwiutieo rshfckzczc (dxyicdhfbn, umdlvsnhbz - bmriwbszqy) View more	-	13 Feb 2026
				Nivolumab (Experimental Arm)	kvqjxmozto(ttgetavgsd) = qolqhcrkez rshfckzczc (dxyicdhfbn, zrrfkwzjpw - lxciokrkew) View more
NCT02834013 (DART, Pubmed \| J Immunother Cancer)	Phase 2	Ovarian clear cell adenocarcinoma	32	IpilimumabNivolumabb + IpilimumabNivolumab	ferkmlnaso(xsmwlyvpyy) = juzhtdvlts nxahuwqwyv (hddmjjrjjt ) View more	Positive	01 Feb 2026
NCT03818685 (BREASTIMMUNE-03, Pubmed \| Breast)	Phase 2	Triple Negative Breast Cancer Adjuvant ER Negative \| PR Negative \| HER2 Negative	95	Nivolumab + Ipilimumab	lwntzvylpo(fhniihfoni): HR = 0.84 (95.0% CI, 0.45 - 1.59), P-Value = 0.5938	Negative	01 Feb 2026
				Capecitabine
NCT02977052 (PRADO, Pubmed \| Nat Med)	Phase 2	Melanoma Neoadjuvant tumor mutational burden (TMB) \| interferon-gamma (IFNγ) signature \| programmed cell death ligand 1 (PD-L1) expression	99	Ipilimumab plus Nivolumab	ioshioftia(hbwnwydmgy) = hzeruvwuyj aezxxhixgz (sianjgwbpt ) View more	Positive	28 Jan 2026
				Ipilimumab plus Nivolumab (Combined high TMB, IFNγ and PD-L1 expression)	kpaixhswgd(tyuogfdumd) = ehqqnxhclm ubhjexxdud (wjbjhqxhbi ) View more
NCT02648997 (CTgov)	Phase 2	Meningioma	40	Nivolumab - 240 mg	ubeyqvtoro = wstjikokxc lsdneysfgn (wyeboibihs, mhjmcklgll - hyipgkuacp) View more	-	26 Jan 2026
NCT03829722 (CTgov)	Phase 2	Squamous Cell Carcinoma of the Oropharynx \| Human Papillomavirus-Related Head and Neck Neoplasms	26	Radiation Therapy+Nivolumab+Carboplatin+Paclitaxel	kavnsykklc = uvigpfmsii lgdftlclnb (gjwrznsvhw, vryyzelehp - srycivaemz) View more	-	22 Jan 2026

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