Opdualag (nivolumab/relatlimab-rmbw) / BMS, Ono Pharma - LARVOL DELTA

A Study of IO102/IO103, Nivolumab, and Relatlimab in People With Melanoma (clinicaltrials.gov) - P2 | N=43 | Active, not recruiting | Sponsor: Memorial Sloan Kettering Cancer Center | Recruiting ➔ Active, not recruiting

Enrollment closed • Melanoma • Oncology • Solid Tumor • BRAF

RELATIVITY 059: A Study to Assess Relatlimab and Nivolumab Fixed-dose Combination in Chinese Participants With Advanced Solid Tumors (clinicaltrials.gov) - P1/2 | N=24 | Completed | Sponsor: Bristol-Myers Squibb | Active, not recruiting ➔ Completed

Trial completion • Solid Tumor

Opdualag vs. Cemiplimab/Fianlimab in Relation to the Immunological Response in Tumor and Peripheral Blood in Unresectable or Metastatic Melanoma (clinicaltrials.gov) - P=N/A | N=20 | Recruiting | Sponsor: John Kirkwood | Not yet recruiting ➔ Recruiting

Enrollment open • Hepatocellular Cancer • Melanoma • Oncology • Solid Tumor

Neo ReNi II: A Phase 2 Clinical Trial of Neoadjuvant Relatlimab and Nivolumab in High Risk, Clinical Stage II Cutaneous Melanoma (clinicaltrials.gov) - P2 | N=20 | Active, not recruiting | Sponsor: Melanoma Institute Australia | Recruiting ➔ Active, not recruiting

Enrollment closed • Cutaneous Melanoma • Melanoma • Oncology • Solid Tumor • BRAF

Favezelimab in Combination with Pembrolizumab in Patients with Anti–PD-1–Naive Relapsed or Refractory Classical Hodgkin Lymphoma: Updated Analysis of an Open-Label Phase 1/2 Study (ASH 2023) - P1/2 | "With additional follow-up, the combination of favezelimab and pembrolizumab continued to demonstrate sustained antitumor activity and manageable safety in patients with anti–PD-1–naive R/R cHL. Analyses are underway to identify biomarkers predictive of response to the combination of favezelimab and pembrolizumab. Further studies to investigate this combination are warranted."

Clinical • Combination therapy • IO biomarker • P1/2 data • Classical Hodgkin Lymphoma • Endocrine Disorders • Fatigue • Gastroenterology • Gastrointestinal Disorder • Hematological Malignancies • Hepatology • Hodgkin Lymphoma • Immunology • Lymphoma • Melanoma • Oncology • Pneumonia • Solid Tumor • LAG3

Mice humanized for the immune system as validated tool for therapeutic antibody development (SITC 2025) - "We developed the human A375 melanoma model in huCD34+ NCG mice to evaluate the combination strategy of relatlimab (anti-LAG-3 antibody) and nivolumab (anti-PD-1 antibody) approved at the beginning of 2024 as a first-line treatment for specific melanoma indications...Moreover, solitomab efficacy was further potentiated by combination treatment with an Evotec proprietary co-stimulatory bispecific antibody.Conclusions Mice humanized for the immune system exhibiting either multiple lineages (CD34+ huNCG) or just T-cell lineage (huPBMC) proved themselves suitable tools to assess non-mouse cross-reactive anti-tumor immunotherapy assets. Expertise in handling such models and deep knowledge in their benefits and limitations are required to selecting the most valuable model to perform preclinical studies predictive of human therapeutic response."

Preclinical • Breast Cancer • Melanoma • Oncology • Solid Tumor • CD34

Opdualag vs. Cemiplimab/Fianlimab in Relation to the Immunological Response in Tumor and Peripheral Blood in Unresectable or Metastatic Melanoma (clinicaltrials.gov) - P=N/A | N=20 | Not yet recruiting | Sponsor: John Kirkwood

New trial • Hepatocellular Cancer • Melanoma • Oncology • Solid Tumor

Beyond the Skin: A Case of Melanoma With Gastric Metastasis Detected in Life (ACG 2025) - "Despite immunotherapy, his disease progressed on pembrolizumab with subsequent metastases to the brain, lung, and bladder, so he was transitioned to nivolumab and relatlimab-rmbw.Two years into treatment, he was evaluated with a CT scan for abdominal pain and severe anemia (hemoglobin 6.9) requiring blood transfusion. Biopsy showed similar immunostaining to the previous lymph node biopsy, consistent with melanoma.Because of the extensive metastatic disease burden, the oncology team recommended palliative measures due to poor prognosis. Gastric involvement in melanoma remains underreported in living patients, with most data derived from autopsies. Our case adds to the limited literature by illustrating a diagnosis during life confirmed by endoscopy and immunohistochemical staining, reinforcing the need to suspect gastrointestinal spread in patients with metastatic melanoma and anemia.AI was used to refine language and punctuation only.Figure: Figure-1: Endoscopic images..."

Clinical • IO biomarker • Anemia • Cutaneous Melanoma • Melanoma • Solid Tumor • BRAF • NCAM1 • PTPRC • SOX10

Patient preferences for stages II-IV melanoma treatments in the UK: results from a cross-sectional study. (PubMed, Melanoma Manag) - "Based on the hypothetical drug profile presented in the DCE, the fixed dose combination of nivolumab and relatlimab was the preferred regimen in the metastatic disease setting while either pembrolizumab or nivolumab were preferred in the adjuvant setting.Our study highlights the importance of considering patients' prioritization of treatment efficacy as the primary factor when making decisions about melanoma care, both in the adjuvant and metastatic settings. Although efficacy and safety were attributed to have relatively similar importance for treatment preference in the adjuvant setting, patients with more advanced disease or those carrying the BRAF mutation placed heightened emphasis on treatment efficacy."

IO biomarker • Journal • Observational data • Melanoma • Oncology • Solid Tumor • BRAF

Beyond the Adenoma: A Rare Case of Colonic Melanoma Metastasis (ACG 2025) - "We report a case of metastatic melanoma found incidentally within colonic polyps during evaluation for symptomatic anemia.Case Description/ A 76-year-old male with metastatic melanoma (lungs, brain, left ear) was receiving Opdualag and Mektovi. His history included non-small cell lung cancer, atrial fibrillation on apixaban, CAD, and stage III CKD...First line systemic therapy includes anti–PD–1 agents (e.g. nivolumab, pembrolizumab), alone or with anti–CTLA–4. BRAF V600E/K-mutated tumors may respond to BRAF/MEK inhibitors. In conclusion, awareness of this rare entity is key to accurate diagnosis and timely oncologic management.Figure: High-power (40X) H&E-stained section of ascending colon shows malignant melanoma cells with abundant melanin pigment (circled) and prominent "cherry-red" nucleoli (arrows).Figure: Melan-A immunohistochemical stain of the ascending colon, highlighting malignant melanoma cells in brown."

Clinical • IO biomarker • Anemia • Atrial Fibrillation • Chronic Kidney Disease • Colon Cancer • Colonic Polyps • Colorectal Cancer • Fatigue • Gastroenterology • Gastrointestinal Disorder • Lung Cancer • Melanoma • Non Small Cell Lung Cancer • Pulmonary Disease • Solid Tumor • MLANA • SOX10

ICI-Mediated Lymphocytic Colitis in a Patient with Metastatic BRAF-Mutant Malignant Melanoma (ACG 2025) - "This case highlights the diagnostic approach and management of an emerging subset of ICI colitis – ICI-mediated lymphocytic colitis – in a patient with advanced BRAF-mutant melanoma.Case Description/ A 72-year-old male with a history of metastatic BRAF-mutant malignant melanoma (on encorafenib, binimetinib, and Opdualag) presented with two weeks of severe nausea, vomiting, and diarrhea. The patient also had a prior history of ICI-associated acute interstitial nephritis (AIN), for which he was tapering off prednisone.Upon presenting to the emergency department (ED), the patient was hemodynamically stable...The patient was started on intravenous methylprednisolone 80 mg daily, which was later increased to 160 mg daily due to inadequate symptom resolution...The patient's symptoms improved with corticosteroids, budesonide, and infliximab, emphasizing the importance of early recognition and treatment. This case contributes to the growing body of evidence supporting the..."

Clinical • IO biomarker • Metastases • Gastroenterology • Gastrointestinal Disorder • Immunology • Melanoma • Nephrology • Solid Tumor • BRAF

A Rare Case of Metastatic Melanoma to Porta Hepatis: A Case Study (ACG 2025) - "Immunotherapy with Opdualag was promptly started prior to hospitalization and tumor regression response was confirmed two months after initiation with PET scan, though persistent abdominal pain necessitated palliative care coordination. The occurrence of metastatic melanoma presenting with obstructive jaundice and involving the porta hepatis is rare, with only a handful of cases reporting metastasis to the liver rather than isolated porta hepatis as with our patient...In this context, distinguishing between lymphoma and metastatic melanoma based solely on initial imaging findings may lead to a poor outcome. Our case aims to present a unique case of obstructive jaundice and its diagnostic complexities."

Case study • Clinical • Metastases • Bipolar Disorder • Cholestasis • CNS Disorders • Gastroenterology • Hematological Malignancies • Hepatology • Lymphoma • Melanoma • Mood Disorders • Palliative care • Psychiatry • Solid Tumor • BRAF

Metastatic Melanoma in the Pancreas Head: A Case Report (ACG 2025) - "Patient was restarted on combination immunotherapy (Opdualag), but follow-up PET showed no response... This case highlights the need to consider pancreatic metastasis in melanoma patients with new abdominal symptoms. While treatment options include immunotherapy, radiotherapy, and surgery, prognosis remains poor, with median survival of 6–12 months. Early recognition and histologic confirmation are vital for guiding management."

Case report • Clinical • Metastases • Anemia • Hepatology • Melanoma • Pancreatic Adenocarcinoma • Pancreatic Cancer • Renal Disease • Sarcoma • Solid Tumor

Pooled outcomes with first-line nivolumab + relatlimab (NIVO + RELA) in patients (pts) with advanced melanoma (MEL) (ESMO 2025) - P1/2, P2/3 | "These results support NIVO + RELA as 1L treatment for advanced MEL. Table: 1619P Pooled 047 (n = 355) 020 ITT (n = 498) Acral (n = 50) Mucosal (n = 37) Cutaneous nonacral/other (n = 411) C (n = 66) E (n = 77) ORR , % (95% CI) 45.2 (40.7–49.7) 28.0 (16.2–42.5) 32.4 (18.0–49.8) 48.4 (43.5–53.4) 43.9 (38.7–49.3) 47.0 (34.6–59.7) 49.4 (37.8–61.0) PFS 2-y, % (95% CI) 41 (37–46) 18 (8–30) 24 (10–40) 46 (40–50) 40 (34–45) 34 (22–46) 56 (44–67) Median, mo (95% CI) 12.2 (8.3–17.0) 3.3 (2.8–6.5) 10.0 (2.8–16.6) 15.7 (11.0–25.0) 10.2 (6.5–15.7) 11.6 (3.7–16.6) 33.4 (11.0–NR) OS 2-y, % (95% CI) 63 (58–67) 37 (24–50) 36 (21–52) 68 (64–72) 62 (57–67) 56 (43–67) 73 (62–82) Median, mo (95% CI) 55.8 (38.6–NR) 12.6 (7.0–21.4) 18.9 (9.1–24.3) NR (55.8–NR) 53.3 (34.0–NR) 34.6 (18.9–NR) NR (40.0–NR) NR, not reached."

Clinical • Metastases • Melanoma • Oncology • Solid Tumor • RELA

PERIO-01: Intrahepatic Delivery of SD-101 by Pressure-Enabled Regional Immuno-oncology (PERIO), With Checkpoint Blockade in Adults With Metastatic Uveal Melanoma (clinicaltrials.gov) - P1 | N=67 | Terminated | Sponsor: TriSalus Life Sciences, Inc. | Active, not recruiting ➔ Terminated; The decision was made to terminate the study after the completion of Phase 1 enrollment and not proceed with Phase 2. Trial termination was not due to patient safety or data concerns.

Checkpoint inhibition • Trial termination • Eye Cancer • Melanoma • Oncology • Solid Tumor • Uveal Melanoma

Opdualag: Data readout from P3 RELATIVITY-127 trial (NCT05625399) for 1L melanoma in H2 2025 (Bristol-Myers Squibb) - Q3 2025 Results

P3 data • Melanoma • Oncology

Adjuvant nivolumab and relatlimab in stage III/IV melanoma: the randomized phase 3 RELATIVITY-098 trial. (PubMed, Nat Med) - P3 | "The absence of macroscopic tumor and reduced peripheral LAG-3+ T cells may explain the lack of added benefit of nivolumab plus relatlimab over nivolumab in resected versus metastatic melanoma. ClinicalTrials.gov identifier: NCT05002569 ."

Journal • P3 data • Melanoma • Oncology • Solid Tumor • LAG3

Adjuvant nivolumab and relatlimab in stage III/IV melanoma: the randomized phase 3 RELATIVITY-098 trial (Nature) - "The primary endpoint was recurrence-free survival (RFS), and the key secondary was overall survival; translational endpoints were exploratory. There was no difference in RFS for nivolumab plus relatlimab versus nivolumab (hazard ratio = 1.01; 95% confidence interval: 0.83–1.22; P = 0.928); therefore, overall survival was not tested. Translational data across trials showed lower circulating LAG-3+ T cells in the adjuvant setting (RELATIVITY-098) versus advanced melanoma (RELATIVITY-047), where LAG-3+ T cells were enriched in tumor versus blood. The absence of macroscopic tumor and reduced peripheral LAG-3+ T cells may explain the lack of added benefit of nivolumab plus relatlimab over nivolumab in resected versus metastatic melanoma."

P3 data • Melanoma

Real-World Use of Nivolumab plus Relatlimab in the Multi-Modal Management of Melanoma Brain Metastases (ASTRO 2025) - "Purpose/Objective(s): Fixed-dose combination nivolumab plus relatlimab (NIVO-RELA) improves progression-free survival (PFS) compared to nivolumab alone in untreated metastatic or unresectable melanoma. Fixed-dose NIVO-RELA can be safely used in the multi-modal management of MBM with encouraging IC disease control. Prospective trials to define its role in this setting are needed."

Clinical • Real-world • Real-world evidence • Melanoma • Solid Tumor • RELA

Phase II Study of Nivolumab in Combination With Relatlimab in Patients With Active Melanoma Brain Metastases (clinicaltrials.gov) - P2 | N=30 | Recruiting | Sponsor: M.D. Anderson Cancer Center | Trial completion date: Dec 2026 ➔ Jul 2028 | Trial primary completion date: Jul 2025 ➔ Jul 2028

Trial completion date • Trial primary completion date • Melanoma • Oncology • Solid Tumor • PD-L1

Analysis of treatment-free survival of patients with advanced melanoma receiving nivolumab as monotherapy or in combination with relatlimab in RELATIVITY-047. (PubMed, J Immunother Cancer) - P2/3 | "This analysis demonstrated TFS benefit during the 48 months since initiating nivolumab plus relatlimab compared with nivolumab alone in patients with advanced melanoma. A direct comparison between nivolumab plus relatlimab and nivolumab plus ipilimumab is needed to determine the differences between the regimens in TFS and those in traditional endpoints."

IO biomarker • Journal • Monotherapy • Genetic Disorders • Melanoma • Oncology • Skin Cancer • Solid Tumor • BRAF • PD-L1

CA209-1451: Neoadjuvant Opdualag Versus Nivolumab for Resectable High-Risk Basal Cell Carcinoma (clinicaltrials.gov) - P2 | N=30 | Recruiting | Sponsor: University of California, San Diego | Not yet recruiting ➔ Recruiting

Enrollment open • Basal Cell Carcinoma • Non-melanoma Skin Cancer • Oncology

RELATIVITY-123: A Study of Nivolumab-relatlimab Fixed-dose Combination Versus Regorafenib or TAS-102 in Participants With Later-lines of Metastatic Colorectal Cancer (clinicaltrials.gov) - P3 | N=770 | Terminated | Sponsor: Bristol-Myers Squibb | Active, not recruiting ➔ Terminated; Inability to meet protocol objectives

Trial termination • Colorectal Cancer • Oncology • Solid Tumor • PD-L1

Trial of Relatlimab, Nivolumab, and Ipilimumab in Patients With Asymptomatic and Symptomatic Melanoma Brain Metastases (clinicaltrials.gov) - P2 | N=60 | Recruiting | Sponsor: Stanford University | Not yet recruiting ➔ Recruiting

Enrollment open • Melanoma • Oncology • Solid Tumor

RELATIVITY-1093: A Study to Compare the Efficacy of Nivolumab and Relatlimab Plus Chemotherapy vs Pembrolizumab Plus Chemotherapy for Stage IV/Recurrent Non-squamous Non-small Cell Lung Cancer With PD-L1 Expression ≥ 1% (clinicaltrials.gov) - P3 | N=1000 | Recruiting | Sponsor: Bristol-Myers Squibb | Trial completion date: Nov 2033 ➔ Aug 2032

IO biomarker • Trial completion date • Lung Cancer • Lung Non-Squamous Non-Small Cell Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • PD-L1