Also known as: Opdivo Qvantig
Nivolumab is a programmed death receptor-1 (PD-1) blocking monoclonal antibody used across multiple cancers, including melanoma, lung cancer, renal cell carcinoma, head and neck cancer, urothelial carcinoma, gastrointestinal cancers, and mesothelioma. It is marketed as Opdivo and frequently used in monotherapy and combination regimens. The FDA first approved it on December 22, 2014.
Blockbuster drugs worth hundreds of billions face generic competition as patents expire through 2032. Indian drugmakers could capture $3-5 billion of the opportunity, while GSK and Bristol Myers Squibb prepare for revenue losses.
Four biomarkers—MMR, HER2, PD-L1, and Claudin 18.2—are now validated for advanced esophageal cancer, guiding immunotherapy and targeted treatment decisions. Checkpoint inhibitors show clear benefit in MSI-H and PD-L1-positive subgroups, with long-term survival observed. NCCN guidelines recommend broad testing to personalize therapy.
A phase 2 trial showed neoadjuvant pembrolizumab achieved a 71% pathological complete response rate in resectable desmoplastic melanoma. A real-world study found ipilimumab monotherapy after anti-PD-1 progression yielded an ORR of 10.8% and median OS of 7.6 months in advanced melanoma.
Multiple recent studies evaluate different immunotherapy approaches for advanced NSCLC, including long-term benefits for nivolumab plus ipilimumab with chemotherapy in PD-L1-negative tumors, limited advantages from PD-(L)1 rechallenge strategies, and early positive signals from combining TIGIT and PD-1 inhibitors in PD-L1-high patients.
Patients with stage 4 lung, sarcoma, and gastro-oesophageal cancer describe their experiences with targeted therapies, chemotherapy, and immunotherapy, highlighting varying outcomes and financial challenges.
A world-first clinical trial testing immunotherapy for glioblastoma has opened in the US. The GIANT trial will evaluate Nivolumab and Relatlimab before surgery, with results expected in about two years. Three patients have been enrolled so far.
Global oncology drug spending is projected to reach $467 billion by 2030, driven by novel modalities like ADCs and bispecifics, but growth will slow due to patent expirations for key drugs like Keytruda and Lynparza. R&D is shifting, with novel modalities accounting for 33% of clinical trials in 2025. The industry is also seeing broader innovation and investment, with new blockbuster contenders emerging across multiple therapeutic areas.
Dual immunotherapy allowed 70.6% of MSI-H gastric cancer patients to avoid surgery in the INFINITY trial. German off-label immunotherapy shows 20-25% response rates, requiring careful patient selection.
Multiple oncology trials present recent results, including cabozantinib-nivolumab activity in non-clear cell RCC, savolitinib efficacy in MET-amplified gastric cancer, and induction nivolumab feasibility in HPV-driven oropharyngeal cancer.
Three trials show ultra-low-dose checkpoint inhibitors retain efficacy with reduced toxicity and dramatically lower costs. DELII and Patil et al. trials tested low-dose nivolumab in solid tumors and HNSCC; NIVIPIT tested intratumoral low-dose ipilimumab in melanoma.
| NCT ID | Title | Status | Phase |
|---|---|---|---|
| NCT07770100 |
Concurrent Immunotherapy and Systemic Therapy With Stereotactic Body Radiation Therapy (SBRT) for Stage IV Cancers (COINSSS IV) |
NOT_YET_RECRUITING | PHASE2 |
| NCT07720284 |
An Open-label Study to Investigate the Efficacy and Safety of Dato-DXd + Rilvegostomig vs SoC in Adult Participants With High-risk MIUC |
RECRUITING | PHASE3 |
| NCT07718139 |
Demographics, Clinical Characteristics and Outcomes in Resected Non-Small Cell Lung Cancer Patients Receiving Immunotherapy in Europe and Canada |
ACTIVE_NOT_RECRUITING | |
| NCT07700979 |
Phase 3 Study of Cadonilimab Combined With Chemotherapy vs Chemotherapy in Combination With or Without Nivolumab for the 1L Treatment of Participants With HER2-negative, Previously Untreated, Unresectable or Metastatic Gastric/GEJ Adenocarcinoma |
NOT_YET_RECRUITING | PHASE3 |
| NCT07694986 |
Trial of Therapies With IT cDC1s Combined w/ IT Trastuzamab for Her+ or IT Nivolumab for Her- BC LMD |
RECRUITING | PHASE2 |
| NCT07689175 |
Adaptive Dosing of Immune Checkpoint Inhibitors for Hepatocellular Carcinoma |
NOT_YET_RECRUITING | PHASE2 |
| NCT07679841 |
Safety and Efficacy of Nivolumab and Imiquimod Combination in Vulvar Squamous Cell Carcinoma Patients |
NOT_YET_RECRUITING | PHASE1/PHASE2 |
| NCT07672223 |
A Study of SYS6010 Plus Anti-PD-(L)-1 Monoclonal Antibody as Adjuvant Therapy in Non-small Cell Lung Cancer (NSCLC) |
NOT_YET_RECRUITING | PHASE3 |
| NCT07664176 |
NgFUS NIVO: NeuroNavigation-Guided Focused Ultrasound With Nivolumab in Relapsed and Progressive DMG and Other High Grade Brain Tumors |
NOT_YET_RECRUITING | PHASE1 |
| NCT07663786 |
Evaluation of Esophagogastric Cancer Treatment With Nivolumab in Daily Clinical Practice |
ACTIVE_NOT_RECRUITING |
