Feasibility and Phase 2a Study of Relatlimab and Nivolumab (Opdualag™) in Adolescent and Young Adult Patients Newly Diagnosed With Replication Repair Deficient High-Grade Glioma (HGG), Including Diffuse Intrinsic Pontine Glioma (DIPG)

The goal of this study is to further evaluate feasibility and tolerability of Opdualag for patients with replication repair deficient HGG, including DIPG.

Start Date01 Mar 2027

Sponsor / Collaborator

Nationwide Children's Hospital

NCT07459543

/ Not yet recruitingPhase 4

A Phase 4, Single Arm, Open Label Study to Evaluate Safety, Tolerability, and Efficacy of Nivolumab + Relatlimab Fixed-Dose Combination (FDC) in Participants With Previously Untreated, Unresectable or Metastatic Melanoma in India.

The purpose of this study is to assess the safety and tolerability of Nivolumab + Relatlimab Fixed-Dose Combination (FDC) in untreated, unresectable or metastatic melanoma participants in India

Start Date15 Nov 2026

Sponsor / Collaborator

Bristol Myers Squibb Co.

NCT06319196

/ RecruitingPhase 2IIT

Clear Me: Interception Trial to Detect and Clear Molecular Residual Disease in Patients With High Risk Melanoma

Clear-Me is a biomarker-driven phase II study that tests whether the combination anti- lymphocyte-activation gene-3 (LAG3)/anti-programmed cell death protein 1(PD-1) inhibition Bristol-Myers Squibb (BMS986213) is superior to anti-PD-1 inhibition in patients with detectable circulating tumor deoxyribonucleic acid (ctDNA) following definitive surgery for high risk melanoma. Patients will be allocated to either Arm A or Arm B via the process of randomization. The randomization process will be stratified according to stage (Stage 2A/2B/3A/3B/3C/3D or 4), to ensure absolute balance between stage groups. The investigators are choosing only 1 stratification factor, disease stage, as the investigators consider stage being the most significant prognosticating variable. Each stage represents a biologically distinct entity with varying recurrence rate outcomes. Block randomization will be performed to ensure equal sample sizes in the combination and monotherapy arms. At least 54 patients will be included in the randomized part of the study. The investigators are expecting approximately 20% of the patients to have detectable ctDNA after definite surgery. Therefore, approximately 270 patients are expected to be enrolled and tested for ctDNA in the entire study.

Start Date27 Aug 2026

Sponsor / Collaborator

University Health Network

100 Clinical Results associated with Nivolumab/Relatlimab

100 Translational Medicine associated with Nivolumab/Relatlimab

100 Patents (Medical) associated with Nivolumab/Relatlimab

Literatures (Medical) associated with Nivolumab/Relatlimab

26 Nov 2025·Cureus Journal of Medical Science

Drug-Induced Bullous Pemphigoid Triggered by Immune Checkpoint Inhibitor Opdualag in an Elderly Patient With Recurrent Metastatic Melanoma: A Case Report and Treatment Course With Dupilumab

Article

Author: Lutwak, Moises ; Kerdel, Francisco ; Lutwak, Daniel ; Moreno, Brian A

Bullous pemphigoid (BP) is an autoimmune subepidermal blistering disorder most commonly affecting elderly individuals and may be triggered by medications, including immune checkpoint inhibitors (ICIs). We present the case of an 81-year-old male with a history of recurrent metastatic melanoma previously treated with nivolumab and relatlimab (Opdualag), who developed a persistent pruritic eruption following initiation of dual PD-1/LAG-3 blockade. Despite discontinuation of immunotherapy six months before dermatologic evaluation and use of multiple topical corticosteroids and oral antihistamines, symptoms persisted. A punch biopsy and direct immunofluorescence demonstrated linear IgG and C3 deposition along the basement membrane zone, consistent with BP. On initial dermatologic examination, urticarial pink plaques involved approximately 50% of the body surface area, with lesions affecting the left medial inferior chest and epigastric region. Treatment with subcutaneous dupilumab was initiated alongside clobetasol 0.05% ointment. At follow-up, the patient reported persistent activity, receiving intramuscular triamcinolone acetonide and adjunctive therapies, including hydroxyzine, hydrocortisone 2.5% cream (for groin), and triamcinolone 0.1% ointment. By the second week of treatment, new plaques continued to appear daily without subjective improvement. Objective scoring with the Bullous Pemphigoid Disease Area Index was not obtained. This case illustrates the diagnostic and therapeutic challenges in managing ICI-induced BP and highlights the early course of dupilumab therapy, which had not yet produced clinical improvement at the time of last follow-up. Continued therapy was planned, and no adverse effects were reported.

01 Oct 2025·EUROPEAN JOURNAL OF PHARMACOLOGY

Safety profile of nivolumab-relatlimab in cancer patients: a living pharmacovigilance study of clinical trials and postmarketing data (version 1.0)

Review

Author: Wu, Chengmi ; Zhou, Jingyi ; Wu, Qian ; Jiang, Jie ; Yang, Ziwen ; Zhu, Jianhong ; Li, Sha ; Wu, Junyan

In 2022, the FDA approved nivolumab-relatlimab for the treatment of unresectable or metastatic melanoma. In the present study, we conducted a living pharmacovigilance study, integrating data from clinical trials and the FDA Adverse Event Reporting System (FAERS) database, to assess the safety profile of nivolumab-relatlimab. Treatment related adverse events (TRAEs) in trials of nivolumab-relatlimab available in electronic databases were systematically searched. The outcomes included were all-grade (grades 1-5) and high-grade (grades 3-5) TRAEs, considering both overall and individual aspects. Meta-analysis was conducted to calculate the incidence and risk ratio of TRAEs associated with nivolumab-relatlimab. Certainty of evidence was assessed using the GRADE system. Adverse events reports were extracted from the FAERS database, and a disproportionality analysis was carried out to estimate the safety signals of AEs associated with nivolumab-relatlimab. A total of 12 trials were included, the incidence of all-grade and high-grade TRAEs for nivolumab-relatlimab was 74.11 % and 38.05 %, respectively. Compared with nivolumab monotherapy, therapy with nivolumab-relatlimab was associated with a significantly increased risk of high-grade TRAEs, and some individual specified all-grade TRAEs, including hypothyroidism/thyroiditis, rash, diarrhea/colitis, hepatitis, adrenal insufficiency, hypophysitis, arthralgia and myalgia. Disproportionality analyses of FAERS pharmacovigilance data identified 39 positive signals, with 18 AEs not mentioned in the drug label. Nivolumab-relatlimab showed significantly higher reporting frequencies for 15 AEs than nivolumab monotherapy. Our study provides valuable insights into the potential safety profile of nivolumab-relatlimab, the results of this living study will be updated to incorporate new, robust evidence as it becomes available.

11 Jan 2025·Gastroenterology Report

Single-cell transcriptomic landscape indicates the potential role of immunotherapy in metastatic pancreatic angiosarcoma

Article

Author: Yang, Yizhen ; Chen, Luohai ; Zeng, Zhirong ; Peng, Sui ; Xie, Yubin ; Liu, Man ; Lin, Xiaoxuan ; Chen, Minhu ; Zhang, Ning

Abstract:

Background:

Pancreatic angiosarcoma is a rare and highly aggressive tumor originating from lymphatic or vascular endothelial cells, with poor prognosis and few effective treatments. In this study, we aimed to characterize the tumor ecosystem of metastatic pancreatic angiosarcoma, along with its potential treatment strategies.

Methods:

Single-cell RNA-sequencing and bioinformatics analysis were performed on samples obtained from one patient, including at total of 16,841 cells from pancreatic angiosarcoma liver metastasis and adjacent normal liver tissue.

Results:

Pancreatic angiosarcoma cells exhibited marked upregulation of nuclear factor kappa-B (NF-κB), hypoxia-inducible factor 1 (HIF-1), and myelocytomatosis oncogene (MYC) proto-oncogene signaling pathways, while presenting limited upregulation of actionable therapeutic targets except for cyclin-dependent kinase 4 (CDK4) and epidermal growth factor receptor. Several immune checkpoint genes, including cytotoxic T-lymphocyte-associated protein 4 (CTLA4), lymphocyte-activation gene 3 (LAG3), programmed cell death protein 1 (PDCD1), and cluster of differentiation 86 (CD86), were upregulated in tumor-infiltrating T cells, natural killer (NK) cells, and myeloid cells. Furthermore, intercellular interaction profiling demonstrated enhanced activity of the programmed death-ligand 1 (PD-L1) and CD86 signaling pathways within the tumor microenvironment. The gene-set scores of T/NK-cell exhaustion, regulatory T cell, and macrophage angiogenesis were significantly higher in tumor tissues compared with adjacent normal tissues. However, the phagocytosis scores of macrophages within the tumor-infiltrating region were significantly lower than those in the adjacent normal tissues.

Conclusions:

Our findings outlined an immunosuppressive and angiogenic tumor ecosystem in pancreatic angiosarcoma liver metastasis, suggesting that pancreatic angiosarcoma may be insensitive to most targeted therapies. Conversely, immunotherapies targeting LAG3, PD-L1, and CD86 (e.g. isatuximab, Opdualag, and abatacept) and anti-angiogenic agents may be therapeutically effective and worthy of subsequent exploration.

112

News (Medical) associated with Nivolumab/Relatlimab

10 Jun 2026

·www.biospace.com

Cytospire Therapeutics Appoints Samit Hirawat, M.D., as Non-Executive Director

Dr Hirawat i s the former CMO and Head of Global Drug Development at Bristol Myers Squibb and former EVP and Head of Oncology Development at Novartis Augments Cytospire’s clinical development experience as Cytospire prepares CYT X300 , its lead pan - gamma delta T cell engager , for clinical trials LONDON, UK – June, 10 2026 – Cytospire Therapeutics Limited (“Cytospire”), a UK based biotech developing differentiated multispecific immune cell engager antibodies designed to enhance and direct the activity of the body’s own immune system, today announces that Samit Hirawat, M.D., has been appointed as a non-executive director to the company’s board of directors. Dr Hirawat, an internationally recognized senior biopharmaceutical executive, has more than 30 years of experience in drug development spanning tenures at large global pharmaceutical and prestigious research organizations. Most recently, Dr Hirawat served as Chief Medical Officer, Executive Vice President, and Head of Global Drug Development at Bristol Myers Squibb, where he oversaw the worldwide clinical development portfolio and advanced multiple transformative therapies across diverse therapeutic areas. This included global approvals for 12 new molecular entities including Breyanzi (lisocabtagene), Abecma (idecabtagene), Opdualag (nivolumab + relatlimab), Augtyro (repotrectinib) and Krezati (adagrasib). Prior to that, he spent more than a decade at Novartis Pharmaceuticals in roles of increasing strategic and operational responsibility, culminating in his position as Executive Vice President and Head of Oncology Development. Dr Hirawat earned his Bachelor of Medicine and Bachelor of Surgery (MBBS) from Sawai Man Singh Medical College in Jaipur, India. He conducted his Internal Medicine residency and Medical Oncology fellowship in New York at North Shore University Hospital. Dr Hirawat has published more than 150 peer-reviewed manuscripts and abstracts across major therapeutic areas. “ Samit is a recognised leader in the field of clinical development and having the ability to access his vast expertise as a member of the Cytospire board will be an invaluable asset as we advance our innovative pipeline of pan-gamma delta T cell engagers ”  said Natalie Mount , Chief Executive Officer of Cytospire .  Peter Goodfellow, Non-Executive Chair of Cytospire added “ Samit is a fantastic addition to the Cytospire Board of Directors. He joins th e company at a particularly exciting time as the lead development programme, CYT X300, is being advanced into clinical trials as a treatment for EGFR-positive solid tumours, such as colorectal, head and neck and non-small cell lung cancers ”. “ I’m delighted to be joining Cytospire’s Board during this pivotal time in the Company’s journey” said Dr Samit Hirawat . “ Cytospire’s pan-gamma delta T cell engager technology has significant differentiation over conventional CD3 T cell engager approaches and huge potential to improve outcomes for patients in multiple cancer indications . I look forward to collaborating with the Cytospire team and contributing my experience to help advance the se important new therapies ”. Cytospire’s pan-gamma delta T cell engagers are uniquely engineered to target all gamma delta T cells rather than only specific subtypes. Through this approach, Cytospire seeks to overcome patient heterogeneity and generate broader, more effective antitumour immune responses through the activation of both tissue/tumour resident and blood resident effector cells. Cytospire recently announced the closing of an oversubscribed £61 million ($83 million) Series A financing supported by a strong syndicate of specialist biotech investors (see press release Cytospire Therapeutics announces Series A financing ). About Cytospire Therapeutics Cytospire is developing an innovative portfolio of differentiated multispecific engager antibodies to enhance and direct the activity of innate and adaptive effector immune cells.  Our core technology allows binding and activation of both tissue/tumour and blood resident gamma delta T cells. This opens a path to safer and more efficacious targeting of well-validated antigens that are intractable to CD3 T cell engagers due to toxicity. There are broad opportunities for Cytospire’s gamma delta T cell engagers in solid and haematological malignancies, as well as in autoimmune disease.  Based in London, UK, Cytospire Therapeutics is backed by a strong syndicate of life science investors including Abingworth, 4BIO Capital, Servier Ventures, British Business Bank, Sound Bioventures, LifeArc Ventures and Criteria Bio Ventures. For more information, visit  Contacts Andrew Fadden, Chief Business Officer contact@cytospiretx.com Frazer Hall, Mark Swallow MEDiSTRAVA cytospire@medistrava.com

Executive Change

18 May 2026

·www.fiercebiotech.com

Analysts ‘shaking heads’ after Regeneron melanoma drug fails to beat Keytruda in phase 3 trial

The failure of Regeneron’s “defining catalyst” of the first half of the year puts fresh pressure on the company, analysts said.\n A phase 3 trial of Regeneron’s LAG-3 inhibitor has missed its primary endpoint, leaving the biopharma reeling from the second failure of a key late-stage program in the past year.The trial assessed fianlimab in combination with Regeneron’s PD-1 inhibitor Libtayo as a first-line treatment for unresectable locally advanced or metastatic melanoma. Progression-free survival (PFS) on the drug combination was statistically no better than on Merck & Co.’s PD-1 inhibitor Keytruda, causing the trial to miss its primary endpoint.Median PFS was numerically longer with the fianlimab combination, at 11.5 months on the high dose, compared with 6.4 months on Keytruda. The statistical miss was driven by a late separation in the PFS curves, BMO Capital Markets analysts said in a note to investors after speaking with Regeneron.“It is clear that while mPFS was improved with high-dose fianlimab combo treatment, separation from monotherapy treatment did not occur until later in the study, leading to the not statistically significant result,” the analysts said. “Somewhat encouragingly, [Regeneron’s investor relations] did note a trend in [overall survival] improvement.” The p value was just the wrong side of statistical significance. But, as the analysts said, “close does not count.” The failure of Regeneron’s “defining catalyst” of the first half of the year puts fresh pressure on the company, according to the analysts, who said they were left “shaking our heads” by the latest flop.Pressure began to ratchet up almost one year ago, when Regeneron and Sanofi reported the failure of one of two phase 3 trials of their IL-33 drug itepekimab in chronic obstructive pulmonary disease. The back-to-back misses for key pipeline projects “amp up the pressure” on the next 12 to 18 months of clinical development at Regeneron, the analysts said.Regeneron has ways to salvage fianlimab. A phase 3 trial comparing the high-dose fianlimab combination to Bristol Myers Squibb’s LAG-3/PD-1 fixed-dose immunotherapy Opdualag is continuing. Regeneron sees showing an overall survival benefit over Opdualag and hitting the primary response rate endpoint of the head-to-head trial as paths back for fianlimab, Evercore ISI analysts said in a note to investors. Yet both BMO and Evercore analysts removed fianlimab from their models in response to the phase 3 flop. It is possible that Regeneron will show fianlimab is noninferior to Opdualag, BMO analysts said, but that is no longer the base-case assumption. BMO and Evercore analysts forecast $1.8 billion and $900 million in risk-adjusted peak sales, respectively, in melanoma before removing fianlimab from their models. With fianlimab now seen as a long shot, BMO analysts said “clean positive readouts” from Regeneron’s Factor XI program will be critical to regaining investor confidence. Regeneron is developing two Factor XI antibodies in a broad program, with initial pivotal data expected in 2027 and a series of readouts in the calendar for the coming years. Phase 3 data on the cemdisiran-pozelimab combination are another catalyst, BMO analysts said. Results from pivotal trials of the combination in geographic atrophy and paroxysmal nocturnal hemoglobinuria are due this year.

18 May 2026

·endpoints.news

Regeneron's Phase 3 skin cancer miss adds to mounting failures in LAG-3

Regeneron Pharmaceuticals’ LAG-3 inhibitor called fianlimab has flunked a late-stage skin cancer trial, marking yet another blow for the drug class. The announcement follows a spate of recent clinical setbacks for candidates targeting the LAG-3 immune checkpoint. In March, Immutep’s eftilagimod alfa failed a Phase 3 lung cancer study. In February 2025, Bristol Myers Squibb’s fixed-dose combination of LAG-3 and PD-1 targeting drugs, known as Opdualag, failed in its bid to expand into the adjuvant setting in melanoma. Regeneron’s Phase 3 study is in first-line unresectable locally advanced or metastatic disease, and enrolled over 1,500 patients. Fianlimab, combined with the PD-1 inhibitor Libtayo, missed the trial’s progression-free survival primary endpoint. Jefferies analysts had only earmarked around $321 million in first-line melanoma peak sales for fianlimab. Even so, Regeneron’s $REGN stock was down about 10% premarket on Monday. If it had been successful, the fianlimab-Libtayo combo could have posed competition for Opdualag, which is the only LAG-3 drug approved for first-line melanoma. The high-dose fianlimab combination regimen produced an average 11.5-month PFS, while the low-dose regimen led to a 9.6-month PFS, according to Regeneron’s Friday release . While both of these figures were numerically higher than the average 6.4-month PFS achieved by Keytruda monotherapy in the study, neither was statistically significant. Regeneron plans to present full results from the trial at a future medical meeting. The drugmaker is still running two other Phase 3 melanoma studies of its fianlimab-Libtayo combo: one testing the regimen head-to-head against Opdualag in first-line disease and another against Keytruda in the adjuvant setting where patients have had their cancer surgically removed. That second study is closely watched as Opdualag failed in the same setting early last year. It is expected to have primary endpoint data in 2028, according to ClinicalTrials.gov. Opdualag has faced its share of clinical disappointments. Besides the miss in adjuvant melanoma, its positive mid-stage data in lung cancer drew skepticism in 2024 for relying on an analysis described as “cherry-picked.” Meanwhile, other drugmakers are exiting the LAG-3 space entirely. In 2024, Merck and Incyte shuttered their respective programs.

Phase 3Drug ApprovalClinical ResultImmunotherapy

100 Deals associated with Nivolumab/Relatlimab

R&D Status

Approved

10 top approved records.

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Indication	Country/Location	Organization	Date
Metastatic melanoma	European Union	Bristol-Myers Squibb Pharma EEIG	15 Sep 2022
Metastatic melanoma	Iceland	Bristol-Myers Squibb Pharma EEIG	15 Sep 2022
Metastatic melanoma	Liechtenstein	Bristol-Myers Squibb Pharma EEIG	15 Sep 2022
Metastatic melanoma	Norway	Bristol-Myers Squibb Pharma EEIG	15 Sep 2022
Unresectable Melanoma	European Union	Bristol-Myers Squibb Pharma EEIG	15 Sep 2022
Unresectable Melanoma	Iceland	Bristol-Myers Squibb Pharma EEIG	15 Sep 2022
Unresectable Melanoma	Liechtenstein	Bristol-Myers Squibb Pharma EEIG	15 Sep 2022
Unresectable Melanoma	Norway	Bristol-Myers Squibb Pharma EEIG	15 Sep 2022
Melanoma	United States	Bristol Myers Squibb Co.	18 Mar 2022

Developing

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Neoplasms	Phase 3	United States	Bristol Myers Squibb Co.	07 Oct 2024
Neoplasms	Phase 3	Japan	Bristol Myers Squibb Co.	07 Oct 2024
Neoplasms	Phase 3	Argentina	Bristol Myers Squibb Co.	07 Oct 2024
Neoplasms	Phase 3	Australia	Bristol Myers Squibb Co.	07 Oct 2024
Neoplasms	Phase 3	Austria	Bristol Myers Squibb Co.	07 Oct 2024
Neoplasms	Phase 3	Belgium	Bristol Myers Squibb Co.	07 Oct 2024
Neoplasms	Phase 3	Brazil	Bristol Myers Squibb Co.	07 Oct 2024
Neoplasms	Phase 3	Chile	Bristol Myers Squibb Co.	07 Oct 2024
Neoplasms	Phase 3	Colombia	Bristol Myers Squibb Co.	07 Oct 2024
Neoplasms	Phase 3	Denmark	Bristol Myers Squibb Co.	07 Oct 2024

Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT06101134 (CTgov)	Phase 2	Melanoma \| Metastatic melanoma	100	relatlimab+nivolumab+rHuPH20+relatlimab+nivolumab (Cohort 1: Metastatic Melanoma)	naemldtcxm = fyrgsddnys extfahqblr (rxmemmllfe, siqbqkxiwf - uwookrhscf) View more	-	09 Apr 2026
				nivolumab+nivolumab+rHuPH20 (Cohort 2: Resected Melanoma)	naemldtcxm = xlxautvdxk extfahqblr (rxmemmllfe, wrrakncciw - euquhwlyxi) View more
NCT05002569 (RELATIVITY-098, CTgov)	Phase 3	Melanoma \| Metastatic melanoma	1,093	nivolumab+relatlimab (Treatment 1)	sbcehgnerq(cklgpxaitd) = qydlphmenb dhxclxywsl (jcqhznhnaq, bpwsccmvqu - gqyxatssyd) View more	-	08 Jan 2026
				nivolumab (Treatment 2)	sbcehgnerq(cklgpxaitd) = bmrutwdema dhxclxywsl (jcqhznhnaq, oebsouqxxu - kvyfxxzykn) View more
NCT05002569 (RELATIVITY-098, Company_Website) Manual	Phase 3	Melanoma Adjuvant	-	Opdualag	idnojljrfy(tbojnzjrno) = did not meet its primary endpoint. tzndwdryok (gahbuivikv ) Not Met	Negative	13 Feb 2025
				Opdivo
ESMO2024 Manual	Not Applicable	Melanoma Second line \| First line \| Neoadjuvant	205	Nivolumab/Relatlimab	zyceetmdfb(htwoyvcsrr) = amhtvkdrma zpybmziioz (iyqreptvkb ) View more	Positive	14 Sep 2024
				Nivolumab/Relatlimab (subsequent line(C2))	zyceetmdfb(htwoyvcsrr) = ywikpgqruo zpybmziioz (iyqreptvkb ) View more
NEWS Manual	Phase 2/3	Melanoma	714	Opdualag	loycqjehox(epwlwuqwgl) = psmeidjiha lloqykuvhj (vrkxydmemk )	Positive	03 Jan 2024
				nivolumab	loycqjehox(epwlwuqwgl) = nzxuagppkl lloqykuvhj (vrkxydmemk )
NCT03662659 (RELATIVITY-060, CTgov)	Phase 2	Gastrooesophageal junction cancer \| Gastroesophageal junction adenocarcinoma	274	BMS986213 (BMS986213 + Chemotherapy)	gollrbtdzl = mzczxxcswi vyfkfwudnk (bodxijkwvu, ikzkodrxwt - yibhyuqewv) View more	-	09 May 2022
				Nivolumab (Nivolumab + Chemotherapy)	gollrbtdzl = anhrgcnykz vyfkfwudnk (bodxijkwvu, hhzdsushiu - vmeodakcis) View more

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