Opdivo (nivolumab) / Ono Pharmaceutical, BMS - LARVOL DELTA

Neoadjuvant immunotherapy leads to pathological responses in MMR-proficient and MMR-deficient early-stage colon cancers. (PubMed, Nat Med) - P2 | "In the exploratory NICHE study (ClinicalTrials.gov: NCT03026140), patients with dMMR or pMMR tumors received a single dose of ipilimumab and two doses of nivolumab before surgery, the pMMR group with or without celecoxib. CD8PD-1 T cell infiltration was predictive of response in pMMR tumors. These data indicate that neoadjuvant immunotherapy may have the potential to become the standard of care for a defined group of colon cancer patients when validated in larger studies with at least 3 years of disease-free survival data."

Clinical • Journal • Colon Cancer • Colorectal Cancer • Gastrointestinal Cancer • Oncology • Solid Tumor

Ipilimumab with or without nivolumab in PD-1 or PD-L1 blockade refractory metastatic melanoma: a randomized phase 2 trial. (PubMed, Nat Med) - P2 | "In conclusion, primary resistance to PD-1 blockade therapy can be reversed in some patients with the combination of CTLA-4 and PD-1 blockade. Clinicaltrials.gov identifier: NCT03033576 ."

Journal • Metastases • P2 data • Melanoma • Oncology • Solid Tumor • CD8 • PD-L1

Efficacy and safety of nivolumab monotherapy in patients with unresectable clear cell sarcoma and alveolar soft part sarcoma (OSCAR Trial/NCCH1510). (PubMed, Cancer) - "The primary end point of the ORR was not met for CCS and ASPS on the central review. Further studies are needed to evaluate ICIs in patients with ASPS."

Journal • Monotherapy • Alveolar Soft Tissue Sarcoma • Genito-urinary Cancer • Melanoma • Oncology • Renal Cell Carcinoma • Sarcoma • Solid Tumor • TFE3

Nivolumab+AVD in Advanced-Stage Classic Hodgkin's Lymphoma. (PubMed, N Engl J Med) - P3 | "N+AVD resulted in longer progression-free survival than BV+AVD in adolescents and adults with stage III or IV advanced-stage classic Hodgkin's lymphoma and had a better side-effect profile. (Funded by the National Cancer Institute of the National Institutes of Health and others; S1826 ClinicalTrials.gov number, NCT03907488.)."

Clinical • Journal • Metastases • Hematological Malignancies • Hodgkin Lymphoma • Lymphoma • Oncology • Pediatrics

Nivolumab plus chemotherapy or ipilimumab in gastroesophageal cancer: exploratory biomarker analyses of a randomized phase 3 trial. (PubMed, Nat Med) - "Low stroma gene expression signature scores were associated with OS benefit with nivolumab-based regimens; high regulatory T cell signatures were associated with OS benefit only with nivolumab-plus-ipilimumab. Our analyses suggest that distinct and overlapping pathways contribute to the efficacy of nivolumab-based regimens in gastroesophageal adenocarcinoma."

Biomarker • Journal • P3 data • Epstein-Barr Virus Infections • Esophageal Adenocarcinoma • Esophageal Cancer • Gastric Cancer • Gastroesophageal Cancer • Oncology • Solid Tumor • KRAS • PD-L1

NIVOPOSTOP (GORTEC 2018-01): A phase III randomized trial of adjuvant nivolumab added to radio-chemotherapy in patients with resected head and neck squamous cell carcinoma at high risk of relapse. (ASCO 2025) - P3 | "Funded by Bristol Myers Squibb Clinical Trial Registration Number: NCT03576417 Background: The standard of care (SOC) over the past two decades for resected locally advanced SCCHN (LA-SCCHN) with high-risk of relapse is adjuvant cisplatin-radiotherapy (CRT). Adjuvant NIVO added to CRT after surgery provided a statistically and clinically meaningful DFS improvement in PD-L1 all-comers patients. This is the first time in over 2 decades that a therapy demonstrated superiority over SOC CRT in patients with resected LA-SCCHN at high-risk of relapse."

Clinical • Late-breaking abstract • P3 data • Head and Neck Cancer • Oncology • Oral Cancer • Solid Tumor • Squamous Cell Carcinoma • Squamous Cell Carcinoma of Head and Neck • PD-L1

Zanzalintinib (zanza) + nivolumab (nivo) ± relatlimab (rela) in patients (pts) with previously untreated clear cell renal cell carcinoma (ccRCC): Results from an expansion cohort of the phase 1b STELLAR-002 study. (ASCO 2025) - P1 | "First-line zanza had acceptable tolerability in combination with nivo or nivo/rela with a low rate of PPE; zanza+nivo showed promising preliminary activity in pts with adv/met ccRCC."

Clinical • P1 data • Clear Cell Renal Cell Carcinoma • Dermatology • Genito-urinary Cancer • Hypertension • Oncology • Solid Tumor • AXL

Nivolumab-AVD Versus Brentuximab Vedotin-AVD in Older Patients With Advanced-Stage Classic Hodgkin Lymphoma Enrolled on S1826. (PubMed, J Clin Oncol) - "Patient-reported outcomes of key adverse events confirmed the improved toxicity profile of N-AVD over BV-AVD. N-AVD was better tolerated and more effective than BV-AVD and is therefore a new standard of care for older patients with advanced-stage cHL fit for anthracycline-based combination therapy."

Journal • Classical Hodgkin Lymphoma • Febrile Neutropenia • Hematological Disorders • Hematological Malignancies • Hodgkin Lymphoma • Infectious Disease • Lymphoma • Neutropenia • Oncology • Pain • Septic Shock

Preliminary safety and efficacy of givastomig, a novel claudin 18.2/4-1BB bispecific antibody, in combination with nivolumab and mFOLFOX in metastatic gastroesophageal carcinoma (mGEC) (ESMO-GI 2025) - P1 | "Giva with nivolumab and mFOLFOX was well tolerated up to 12 mg/kg Q2W and shows encouraging preliminary activity in 1L metastatic GEC. Dose expansion is ongoing."

Clinical • Combination therapy • Metastases • Esophageal Adenocarcinoma • Esophageal Cancer • Gastric Cancer • Gastroesophageal Cancer • Oncology • Solid Tumor • CLDN18

Adjuvant Chemotherapy (CT) vs CT-immunotherapy for R0 Stage IB-IIIA NSCLC Patients (NADIM ADJUVANT): a Randomized, Phase 3 Trial (IASLC-WCLC 2025) - "Eligible patients were randomized 1:1 to receive either adjuvant chemotherapy that included carboplatin AUC5 plus paclitaxel 200 mg/m2 every 3 weeks for 4 cycles, followed by observation (control arm), or the same chemotherapy plus nivolumab 360 mg every 3 weeks for 4 cycles, followed by maintenance nivolumab 480 mg every 4 weeks for 6 cycles (experimental arm). Interim results from the NADIM ADJUVANT trial suggest that adjuvant chemo-immunotherapy reduces the risk of recurrence in patients with completely resected stage IB-IIIA NSCLC and has an acceptable safety profile. Although DFS did not reach statistical significance at this instance, sensitivity analyses support consistent clinical benefit. MRD assessment identified a subgroup of patients with a poorer prognosis."

Clinical • P3 data • Gastroenterology • Gastrointestinal Disorder • Immunology • Lung Cancer • Non Small Cell Lung Cancer • Pneumonia • Solid Tumor

Randomized phase II clinical trial of cisplatin/carboplatin and etoposide (PE) alone or in combination with nivolumab as frontline therapy for extensive-stage small cell lung cancer (ES-SCLC): ECOG-ACRIN EA5161. (PubMed, Cancer) - "The combination of PE and nivolumab improves both PFS and OS for patients with ES-SCLC. No new safety signals were observed."

Clinical • Journal • P2 data • Lung Cancer • Oncology • Small Cell Lung Cancer • Solid Tumor

A blinded, exploratory phase II trial of nivolumab and the GDF-15 neutralizing antibody visugromab or placebo as neoadjuvant treatment of patients with muscle-invasive bladder cancer (MIBC): Primary results of the GDFather-NEO trial (ESMO 2025) - P2 | "Conclusions In anti-PD(L)-1-naïve MIBC, GDF-15 blockade by visugromab tripled the effect size of nivolumab in neoadjuvant therapy, with excellent tolerability. N/V combination warrants further investigation in larger neoadjuvant trials with a tumor response-guided bladder preservation approach."

Clinical • Late-breaking abstract • P2 data • Bladder Cancer • Genito-urinary Cancer • Oncology • GDF15

Efficacy of cabozantinib and nivolumab in cluster 1/2 metastatic clear cell renal cell carcinoma: Results from OPTIC RCC, a phase II trial of a novel RNAseq-based biomarker (ESMO 2025) - P2 | "Methods OPTIC RCC (NCT 05361720) is a prospective phase II multicenter study that assigns patients to either nivolumab/cabozantinib (angiogenic tumors, cluster 1/2) or ipilimumab/nivolumab (inflamed tumors, cluster 4/5) using a machine learning model developed from the IMmotion 151 RNAseq-based cluster definitions and the Tempus xR whole transcriptome assay...Nine patients (35%) experienced an SAE (any grade), including 4 thromboembolic events. Conclusions Using RNAseq data to assign patients with angiogenic tumors to nivolumab/cabozantinib increases ORR relative to unselected historical controls."

Biomarker • Clinical • IO biomarker • Metastases • P2 data • Clear Cell Renal Cell Carcinoma • Genito-urinary Cancer • Oncology • Pancreatic Cancer • Renal Cell Carcinoma • Solid Tumor

Relevance of the CPS score and tumor nephrectomy in the SUNNIFORECAST trial comparing ipilimumab/nivolumab versus standard of care in non-clear cell renal cell cancer (ESMO 2025) - P2 | "In pts. without nephrectomy, Ipi/Nivo seems to be more effective than SOC for OS."

Genito-urinary Cancer • Non Clear Cell Renal Cell Carcinoma • Oncology • Solid Tumor

Exploratory analysis of chromophobe renal cell carcinoma in the SUNNIFORECAST trial comparing Ipilimumab plus Nivolumab vs standard of care as first-line treatment (ESMO 2025) - P2 | "Conversely, chRCC pts with CPS < 1 seemed to benefit more from TKI. Our findings support the use of ICI-based therapies and suggest a possible role for PD-L1-testing in treatment decisions for nccRCC warranting further validation."

Clinical • IO biomarker • Genito-urinary Cancer • Non Clear Cell Renal Cell Carcinoma • Oncology • Renal Cell Carcinoma • Solid Tumor

Adjuvant nivolumab vs placebo for high-risk muscle-invasive urothelial carcinoma: 5-year efficacy and ctDNA results from CheckMate 274 (ESMO 2025) - P3 | "ctDNA analysis was consistent with prior observations of adjuvant immune checkpoint inhibitor blockade in MIUC. These long-term results support adjuvant NIVO as a standard of care in pts with high-risk MIUC."

Circulating tumor DNA • Clinical • IO biomarker • Oncology • Solid Tumor • Urothelial Cancer • PD-L1

Nivolumab plus ipilimumab vs nivolumab monotherapy for microsatellite instability-high/mismatch repair-deficient (MSI-H/dMMR) metastatic colorectal cancer (mCRC): New results from CheckMate 8HW (ESMO 2025) - P3 | "b Descriptive data.NE, not estimable; NR, not reached. Conclusions NIVO + IPI showed clinically meaningful efficacy improvements vs NIVO in the 1L setting and across all lines in pts with centrally confirmed MSI-H/dMMR mCRC, further supporting NIVO + IPI as the standard of care for MSI-H/dMMR mCRC."

dMMR • Late-breaking abstract • Metastases • Mismatch repair • Monotherapy • MSI-H • Colorectal Cancer • Gastrointestinal Cancer • Microsatellite Instability • Oncology • MSI

Two-year clinical update and first biomarker analyses of the phase III NADINA trial comparing neoadjuvant nivolumab plus ipilimumab versus adjuvant nivolumab in resectable stage III melanoma (ESMO 2025) - P3 | "RFS at 2y for neoadj pts with pathologic partial- or non-response was 67.2% with adj dabrafenib + trametinib (BRAFV600; n=43) and 37.7% with adj NIVO (BRAFwt; n=21). of pts Unfavorable 24mo EFS (95% CI) HR (95% CI) Nominal p-value IFNγ Neoadj 74 87.7% (79.9-96.3) 59 65.4% (53.8-79.6) 0.29 (0.13-0.64) 0.002 IFNγ Adj 85 66.8% (57.2-77.9) 67 36.6% (26.3-50.9) 0.41 (0.25-0.67) <0.001 PD-L1 Neoadj 70 87.6% (79.7-96.2) 60 73.3% (62.4-86.0) 0.39 (0.17-0.90) 0.028 PD-L1 Adj 61 67.2% (56.0-80.6) 51 32.0% (21.4-47.9) 0.32 (0.18-0.56) <0.001 TMB Neoadj 59 91.5% (84.7-98.9) 78 62.0% (51.4-74.8) 0.25 (0.10-0.62) 0.002 Conclusions With an additional 10 months FU, neoadj IPI + NIVO continues to demonstrate superior outcomes to adj NIVO in resectable stage III melanoma. IFNγ, PD-L1, and TMB serve as predictive biomarkers for improved treatment outcomes."

Biomarker • Clinical • IO biomarker • Late-breaking abstract • P3 data • Tumor mutational burden • Melanoma • Oncology • Skin Cancer • Solid Tumor • IFNG • PD-L1 • TMB

Multicenter phase II trial of ipilimumab and nivolumab in metastatic or unresectable perivascular epithelioid cell tumor (PEComa): a substudy of Dual Anti-CTLA-4 and Anti-PD-1 blockade in Rare Tumors (DART) SWOG S1609 (Cohort 38). (PubMed, J Immunother Cancer) - "The combination of ipilimumab and nivolumab demonstrated responses in 18.8% of patients with advanced malignant PEComas. Dual immunotherapy may be an alternative treatment option for certain patients, including those who are unable to tolerate or do not desire prolonged treatment with chemotherapy or mTOR inhibition or have failed to respond to other therapies. Ipilimumab and nivolumab warrants further investigation in this and other rare soft tissue sarcomas."

IO biomarker • Journal • P2 data • Dermatology • Fatigue • Oncology • Pruritus • Sarcoma • Soft Tissue Sarcoma • Solid Tumor • ATRX • TFE3 • TP53

Pembrolizumab plus lenvatinib as second-line treatment in patients with pleural mesothelioma (PEMMELA): cohort 2 of a single-arm, phase 2 study. (PubMed, Lancet Oncol) - P2 | "This study met its primary endpoint, showing high clinical activity of pembrolizumab plus lenvatinib, but with substantial toxicity, in patients with pleural mesothelioma who had progressed after first-line nivolumab plus ipilimumab. This drug combination is promising for future studies in pleural mesothelioma."

Journal • P2 data • Cardiovascular • Fatigue • Hypertension • Malignant Pleural Mesothelioma • Mesothelioma • Oncology • Pleural Mesothelioma • Solid Tumor

Neo-n (neon): three-year event-free survival and ultrasensitive ctdna dynamics in early triple-negative breast cancer (tnbc) treated with neoadjuvant carboplatin/paclitaxel and nivolumab (SABCS 2025) - "Full efficacy (EFS/Overall survival), TIL and ctDNA data will be presented.ConclusionsA short-course, non-anthracycline carboplatin/paclitaxel plus nivolumab achieves durable 3-year disease control in early TNBC. An on treatment tumor-informed SV-ctDNA measurement is associated with EFS, complementing surgical endpoints.These findings support ultrasensitive ctDNA for risk-stratification tool and provide a rationale for early on treatment ctDNA-guided escalation/de-escalation strategies to refine neoadjuvant chemo-immunotherapy for early TNBC patients."

Circulating tumor DNA • Clinical • Breast Cancer • Oncology • Solid Tumor • Triple Negative Breast Cancer

Phase 2 ILUSTRO trial of 1L zolbetuximab plus mFOLFOX6 and nivolumab in patients with CLDN18.2+ locally advanced (LA) unresectable or metastatic gastric or gastroesophageal junction (mG/GEJ) adenocarcinoma. (ASCO-GI 2026) - P2, P3 | "Zolbetuximab + mFOLFOX6 and nivolumab showed promising activity in patients with CLDN18.2+, HER2−, LA unresectable or mG/GEJ adenocarcinoma, particularly in those with high CLDN18.2 expression. AEs were consistent with the safety profile of zolbetuximab + chemotherapy. The ongoing phase 3 LUCERNA trial (NCT06901531) is assessing 1L zolbetuximab + pembrolizumab and chemotherapy in patients with HER2−, LA unresectable or mG/GEJ adenocarcinoma with CLDN18.2+ and PD-L1+ tumors."

Clinical • IO biomarker • Late-breaking abstract • Metastases • P2 data • Gastric Adenocarcinoma • Gastroesophageal Junction Adenocarcinoma • Gastrointestinal Cancer • Oncology • CLDN18 • HER-2 • PD-L1

Nivolumab plus docetaxel versus placebo plus docetaxel for androgen receptor pathway inhibitor-pretreated and chemotherapy-naive metastatic castration-resistant prostate cancer (CheckMate 7DX): a double-blind, randomised, phase 3 trial. (PubMed, Lancet Oncol) - P3 | "Nivolumab plus docetaxel did not improve progression-free survival or overall survival versus placebo plus docetaxel in patients with ARPI-pretreated, chemotherapy-naive mCRPC. These findings do not support the use of combinations of anti-PD-1 immune checkpoint inhibitors and docetaxel in the treatment of unselected populations of patients with ARPI-pretreated, chemotherapy-naive mCRPC."

Clinical • Journal • P3 data • Cardiovascular • Castration-Resistant Prostate Cancer • Gastrointestinal Disorder • Genito-urinary Cancer • Hematological Disorders • Hepatology • Infectious Disease • Liver Failure • Neutropenia • Oncology • Pneumonia • Prostate Cancer • Respiratory Diseases • Septic Shock • Solid Tumor

Nivolumab plus ipilimumab vs lenvatinib or sorafenib as first-line treatment for unresectable hepatocellular carcinoma (HCC): 4-year follow-up of CheckMate 9DW. (ASCO-GI 2026) - P3 | "After 4 years of follow-up, 1L NIVO + IPI continued to show sustained efficacy benefit vs LEN/SOR in unresectable HCC and manageable safety with no new concerns. These results continue to support NIVO + IPI as a standard-of-care treatment in these patients. aPer BICR."

Clinical • Late-breaking abstract • Gastrointestinal Cancer • Hepatocellular Cancer • Oncology • Solid Tumor

Liposomal irinotecan, carboplatin or oxaliplatin (LyRICX) with or without nivolumab in the first-line treatment of metastatic or irresectable esophagogastric adenocarcinoma: A randomized phase 2 study. (ASCO-GI 2026) - "Until August 2022, patients were randomized (2:2:1) to one of three arms: 1) nanoliposomal irinotecan, leucovorin and fluorouracil (F-Nal-Iri); 2) capecitabine and carboplatin (CapCar); 3) capecitabine and oxaliplatin (CapOx). Relative to CapOx, CapCar and F-Nal-Iri yielded markedly lower rates of grade 2-4 neurotoxicity with similar PFS and no excess of other toxicities. Given its ease of use—no central line required—and its relatively low cost (all drugs off-patent), CapCar can be considered the most favorable first-line chemotherapy backbone."

Clinical • Late-breaking abstract • Metastases • P2 data • Esophageal Cancer • Gastric Adenocarcinoma • Gastroesophageal Cancer • Gastroesophageal Junction Adenocarcinoma • Gastrointestinal Cancer • Oncology • Solid Tumor • HER-2