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Last update 05 Mar 2026

Nivolumab

Last update 05 Mar 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+ [488]

Inactive Indication

Acidemia, IsovalericAcquired Immunodeficiency SyndromeAcute bilineal leukemia+ [147]

Originator Organization

Ono Pharmaceutical Co., Ltd.

Bristol Myers Squibb Co.

Active Organization

Bristol Myers Squibb Co.

City of Hope National Medical Center

Ono Pharmaceutical Co., Ltd.

+ [31]

Inactive Organization

Bristol-Myers Squibb Srl

Vedanta Biosciences, Inc.

The University of Texas Southwestern Medical Center

+ [14]

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)

Structure/Sequence

Sequence Code 93681H

Source: *****

Sequence Code 93684L

Source: *****

1,945

Clinical Trials associated with Nivolumab

NCT07444619

/ Not yet recruitingPhase 1IIT

A Phase I Study of Pazopanib in Combination With Trabectedin, Ipilimumab and Nivolumab (TraPIN) in Pediatric and Young Adult Patients With Recurrent Soft Tissue Sarcomas

The goal of this study is to build on the experience of the SAINT trial by evaluating the safety and efficacy of the addition of pazopanib to their published chemotherapy regimen.

Start Date31 Aug 2026

Sponsor / Collaborator

The University of Texas MD Anderson Cancer Center

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]

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: Abdrakhmanov, Ramil ; Zukov, Ruslan ; 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.

2,155

News (Medical) associated with Nivolumab

04 Mar 2026

·allsci.com

Inovio, Akeso to try BsAb + DNA plasmid combo in glioblastoma

US-based biopharma Inovio Pharmaceuticals and China-based Akeso, Inc. announced a clinical collaboration to evaluate a glioblastoma combination therapy pairing Inovio’s DNA medicine candidate INO-5412 with Akeso’s bispecific antibody cadonilimab. The collaboration will assess the combination in a Phase II adaptive platform trial in patients with glioblastoma multiforme (GBM), the most common and lethal primary brain malignancy in adults. Financial terms of the collaboration were not disclosed. The collaboration centers on two distinct immunotherapy assets contributed by each party. Inovio contributes INO-5412, a combination regimen comprising INO-5401, a DNA plasmid encoding three tumor-associated antigens (hTERT, WT1, and PSMA), and INO-9012, a DNA plasmid encoding the pro-inflammatory cytokine interleukin-12 (IL-12). Akeso contributes cadonilimab, also known as AK104, a PD-1/CTLA-4 bispecific antibody (BsAb) designed to achieve dual immune checkpoint blockade with a single molecule. The combination will be studied within the INSIGhT adaptive platform trial framework. Each company retains ownership of its respective drug candidate with no commercial rights involved in the deal. Scientific rationale for the glioblastoma combination regimen The pairing of INO-5412 with cadonilimab reflects a strategy to address GBM’s immunosuppressive tumor microenvironment from multiple angles. INO-5412 is designed to generate antigen-specific cytotoxic T lymphocyte responses against GBM cells expressing hTERT, WT1, and PSMA, while the IL-12 component encoded by INO-9012 is intended to amplify and sustain those responses by promoting a pro-inflammatory milieu at the tumor site. Cadonilimab’s simultaneous blockade of PD-1 and CTLA-4 is intended to release the brakes on T cell activity that the tumor microenvironment imposes through checkpoint-mediated suppression. The rationale for combining these modalities rests on the hypothesis that antigen-directed immune priming (via INO-5412) paired with checkpoint de-repression (via cadonilimab) could produce a more durable anti-tumor response than either approach alone. This is particularly relevant in GBM, where single-agent checkpoint inhibitors have so far failed to demonstrate survival benefits in randomized trials. Development status of participating molecules Inovio has been developing INO-5412 in GBM for several years, previously reporting interim and progression-free survival data from a Phase I/II trial of the combo regimen used in conjunction with cemiplimab (Regeneron’s PD-1 inhibitor) in newly diagnosed GBM patients at the ASCO Annual Meeting in 2022. The collaboration with Akeso marks a shift from a monospecific PD-1 antibody to bispecific targeting. The move to a dual-checkpoint agent reflects the broader oncology field’s interest in whether simultaneous PD-1 and CTLA-4 blockade can overcome resistance patterns observed with PD-1 monotherapy in GBM immunotherapy treatment settings. Cadonilimab has been developed primarily in China across multiple solid tumor indications, including cervical cancer, non-small cell lung cancer, hepatocellular carcinoma, gastric cancer, and esophageal cancer. The molecule’s Fc-null design is intended to reduce Fc-mediated effector functions that can contribute to immune-related adverse events, a persistent limitation of combining separate PD-1 and CTLA-4 antibodies. The GBM indication represents a new therapeutic frontier for cadonilimab. Akeso has not previously disclosed clinical activity for this asset in brain tumors. The blood-brain barrier and the immunologically privileged nature of the central nervous system present distinct pharmacological challenges that will need to be addressed in the trial design. Competitive landscape for GBM immunotherapy GBM remains one of the most treatment-resistant cancers. The standard of care has not changed materially in two decades and consists of maximal safe surgical resection followed by radiotherapy with concomitant and adjuvant temozolomide. Median survival is approximately 15 to 18 months, and nearly all patients experience recurrence. Several other immunotherapy approaches are in clinical testing for GBM. Immunomic Therapeutics is evaluating ITI-1001, a multi-antigen DNA vaccine, in a Phase I trialin newly diagnosed GBM. Roswell Park Cancer Institute has advanced SurVaxM, a survivin-targeting peptide vaccine, into Phase II testing. None of these programs have yet advanced to late-stage registration trials. In the checkpoint inhibitor space, nivolumab failed to demonstrate an overall survival benefit over bevacizumab in the CheckMate 143 trial in recurrent GBM, and pembrolizumab has shown limited single-agent activity in this indication. The combination of a tumor-antigen-directed vaccine with a bispecific checkpoint inhibitor, as proposed in the Inovio-Akeso collaboration, represents a mechanistically distinct approach that has not been tested previously in GBM.

Phase 2VaccineImmunotherapyPhase 1License out/in

03 Mar 2026

·www.biospace.com

Delcath Systems Announces Publication of CHOPIN Clinical Trial Results in The Lancet Oncology

Publication Highlights Promise of Combined Percutaneous Hepatic Perfusion and Immunotherapy in Metastatic Uveal Melanoma 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 liver cancers, today announced the publication of the full results from the investigator-initiated CHOPIN randomized Phase 2 clinical trial, led by Principal Investigator Professor Ellen Kapiteijn, MD, from Leiden University Medical Center’s Department of Medical Oncology. The publication, titled “Percutaneous hepatic perfusion combined with ipilimumab and nivolumab for metastatic uveal melanoma (CHOPIN): a single-centre, open-label, randomised, phase 2 trial” is published in The Lancet Oncology and presents detailed analyses from the trial, building on the positive topline results previously presented at the European Society for Medical Oncology (ESMO) Congress in October 2025. The link to the article can be found at: (25)00720-X/abstract . “The detailed analyses in this publication reinforce the synergistic potential of combining PHP with immunotherapy, showing not only superior PFS and OS but also enhanced hepatic control and deeper, more durable responses. This approach represents a significant advancement for patients with this challenging disease, where liver-dominant metastases drive poor outcomes,” said Professor Ellen Kapiteijn, MD, Principal Investigator and Lead Author from Leiden University Medical Center’s Department of Medical Oncology. “The full publication in The Lancet Oncology validates the impressive efficacy of combining our liver-directed PHP therapy with immune checkpoint inhibition,” said Gerard Michel, Chief Executive Officer of Delcath Systems. “By more than tripling the 1-year progression-free survival rate and nearly doubling the 2-year overall survival, these results strongly underscore the clinical value of this combination and give us even greater confidence in adoption by treating physicians and patients. We are also encouraged by the potential to explore this paradigm in other liver-dominant cancers.” The CHOPIN trial randomized 76 patients with metastatic uveal melanoma (mUM; n=38 per arm) to percutaneous hepatic perfusion (PHP) with melphalan using Delcath’s CHEMOSAT® Hepatic Delivery System (HDS) alone or in combination with ipilimumab plus nivolumab. In both arms patients received two PHP treatments (weeks 1 and 7). In the combination arm patients also received ipilimumab (1 mg/kg) plus nivolumab (3 mg/kg) in weeks 0, 3, 6, and 9, with no maintenance therapy. Key results (intention-to-treat population): Primary endpoint – 1-year progression-free survival (PFS) : 54.7% vs 15.8% (adjusted HR 0.34 [95% CI 0.19–0.60]; p=0.0002), Median PFS: 12.8 months vs 8.3 months Overall Survival (OS) : Median 23.1 months vs 19.6 months (HR 0.39 [95% CI 0.20–0.77]; p=0.0065) 2-year OS: 49.6% vs 22.1% Objective Response Rate (ORR) : 76.3% vs 39.5% Complete response (CR) rate: 13% vs 3% Safety Grade 3 or higher treatment-related adverse events occurred significantly more frequently in the combination arm (82%) than in the PHP-alone arm (41%); p=0.0006. The rate in the combination arm was similar to that reported in the FOCUS trial (81%). The most common grade 3/4 events were thrombocytopenia (34% vs 14%), leukopenia (26% vs 14%), γ-glutamyl transferase increase (18% vs 8%), and anemia (13% vs 3%). Most events were self-limiting or manageable with standard supportive care; no new safety signals were identified. One treatment-related death (immune-related triple M syndrome) occurred in the combination arm. Overall, the authors conclude that the combination of PHP with ipilimumab and nivolumab offers a promising new approach for patients with metastatic uveal melanoma. 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. Forward-Looking Statements The Private Securities Litigation Reform Act of 1995 provides a safe harbor for forward-looking statements made by Delcath or on its behalf. This press release contains forward-looking statements, including statements regarding the possible synergy seen in the successful Phase 2 CHOPIN Trial being transferable to other cancers with liver-dominant disease; statements regarding the potential of CHEMOSAT Hepatic Delivery System and HEPZATO KIT to improve outcomes for patients with metastatic uveal melanoma and other cancers with liver-dominant disease; statements regarding the potential to drive increased adoption of HEPZATO KIT; statements regarding Delcath’s commitment to raising awareness of the innovative approach taken in the CHOPIN Trial, and accelerating the referral of patients to treatment sites; and statements regarding Delcath’s continued growth and leadership in liver-directed oncology, 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. This release contains forward-looking statements, including statements regarding the expected release of clinical trial results, which are subject to risks and uncertainties. Factors that could affect these forward-looking statements include, but are not limited to, delays in the presentation of the data, or other unforeseen issues relating to the release of the clinical trial results. For a detailed discussion of these and other risks, please refer to Delcath’s filings with the SEC. Contacts Investor Relations Contact: ICR Healthcare investorrelations@delcath.com

Phase 2Clinical ResultDrug ApprovalImmunotherapy

27 Feb 2026

·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

100 Deals associated with Nivolumab

External Link

KEGG	Wiki	ATC	Drug Bank
D10316	Nivolumab	L01XC17	DB09035

R&D Status

Approved

10 top approved records.

to view more data

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
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

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Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT04322955 (Cyto-KIK, ASCO_GU2026)	Phase 2	Kidney Neoplasms First line	38	cabozantinib+nivolumab (metastatic clear cell renal cell carcinoma)	ktylcvovhs(onfyzudebi) = hhmpkkvrgh zzobccndqk (umyotcatal ) View more	Positive	26 Feb 2026
NCT04126070 (ASCO_GU2026)	Phase 2	Hormone-dependent prostate cancer inflamed tumors \| DNA damage repair alterations	47	ADT+DOCE+ NIVO (Cohort 1 (DDR altered))	zrdbmlnxcc(fhsoqvxbaj) = jmwsjiwvui tjlwialtqx (nmfzslrvgx, 15 - 66) View more	Negative	26 Feb 2026
				ADT+DOCE+ NIVO (Cohort 2 (PD-L1/CD8 high))	zrdbmlnxcc(fhsoqvxbaj) = ttujqxgknd tjlwialtqx (nmfzslrvgx, 5.9 - 32) View more
ASCO_GU2026	Phase 3	Metastatic Renal Cell Carcinoma	518	nivolumab+cabozantinib	hrepzfdypv(pegxbyurkc) = pfnacthyqr ohenpbchfb (ujwlozqadh ) View more	Positive	26 Feb 2026
				pembrolizumab+lenvatinib	hrepzfdypv(pegxbyurkc) = iznkyffdag ohenpbchfb (ujwlozqadh ) View more
NCT03294304 (BLASST-01, ASCO_GU2026)	Phase 2	Muscle Invasive Bladder Carcinoma Neoadjuvant non-luminal molecular subtypes	74	Neoadjuvant nivolumab + gemcitabine-cisplatin	oqjdzstxce(uccxjrynkm) = zbzppuvziq kocwaqquqx (enblotmqnf ) View more	Positive	26 Feb 2026
				Neoadjuvant nivolumab + nab-paclitaxel	oqjdzstxce(uccxjrynkm) = ejfzhxndmx kocwaqquqx (enblotmqnf ) View more
NCT06708949 (RELATIVITY-047, ASCO_GU2026)	Phase 2	Advanced Renal Cell Carcinoma First line	60	Nivolumab 480 mg Q4W, Relatlimab 160 mg Q4W, Ipilimumab 1 mg/kg Q8W (Metastatic clear cell renal cell carcinoma)	zvpmxaaius(imwcapsdjs) = ewbuamwufy gybhnbcroi (bkwwvbaztn )	Positive	26 Feb 2026
				Nivolumab 480 mg Q3W, Ipilimumab 1mg/kg Q3W (Metastatic clear cell renal cell carcinoma)	zvpmxaaius(imwcapsdjs) = xhzbaktoqv gybhnbcroi (bkwwvbaztn )
NCT05048212 (ASCO_GU2026)	Phase 2	Brain metastases	11	Nivolumab+Ipilimumab+Cabozantinib	poonhumios(ogmttoddqd) = scoabvgyjz ksvswzsdfa (gmilqlfhhz ) View more	Positive	26 Feb 2026
ASCO_GU2026	Not Applicable	Renal Cell Carcinoma	56	ipilimumab plus nivolumab	myxtgmtwpn(oqhskatsvl) = iohvhfscpv pwnpnpucqi (iwalkfkupc, 4.8 - 21.2) View more	Positive	26 Feb 2026
				nivolumab	myxtgmtwpn(oqhskatsvl) = foecilyiye pwnpnpucqi (iwalkfkupc, 9.1 - 15.8) View more
ASCO_GU2026	Not Applicable	Metastatic Clear Cell Renal Cell Carcinoma First line	514	nivolumab + ipilimumab (Total)	nlcuknknwc(gmsxjoisbf) = kekhxbtgul jduawozhpq (kjilxemefl, 4.5 - 7.7)	Negative	26 Feb 2026
				nivolumab + ipilimumab (ISUP Grade ≤3)	nlcuknknwc(gmsxjoisbf) = nadqcuflie jduawozhpq (kjilxemefl, 2.0 - 3.8)
NCT04090710 (CYTOSHRINK, ASCO_GU2026)	Phase 2	Kidney Neoplasms First line	67	Ipilimumab/nivolumab + SBRT	yiiaprteuu(iuvkckneom) = qcjizkvezm ukpvfwwlqr (mmbdqzfpgc, 21 - 49) View more	Negative	26 Feb 2026
				Ipilimumab/nivolumab alone	yiiaprteuu(iuvkckneom) = vupkmznukx ukpvfwwlqr (mmbdqzfpgc, 27 - 66) View more
ASCO_GU2026	Not Applicable	Metastatic Renal Cell Carcinoma First line	195	Nivolumab plus Cabozantinib	ybolzvehgc(vhhreskwle) = gdzgknacsq bqgppuxgut (vpxanyzkao ) View more	Positive	26 Feb 2026
				Nivolumab plus Cabozantinib	qlpsibrfqp(vfqsssafyy) = vbbdzmbrus xfmazwvfso (ujkxxhaxxv ) View more

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