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.
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.
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.
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.
ABL111 received FDA agreement on an accelerated approval pathway for metastatic gastric cancer as the first patient was dosed in a global phase 2 trial. The companies said ORR will support accelerated approval and phase 2 is evaluating ABL111 with nivolumab and mFOLFOX6.
Intravenous and subcutaneous nivolumab in advanced melanoma had similar safety profiles, with no major differences in systemic side effects. The main distinction was mild, manageable injection site reactions with subcutaneous administration.
European biotechs are exploring new immunotherapy targets beyond PD-1/PD-L1, including BTLA, TIGIT, and SLAMF6. Lund University researchers discovered a SLAMF6-mediated immune evasion mechanism. BioNTech and GenMab are advancing next-generation ICIs and bispecific antibodies through strategic partnerships.
Recent biosimilar and biologic developments included Health Canada approval of denosumab biosimilars, FDA review actions, and new licensing and commercialisation agreements. Other updates covered court, trial and reimbursement agenda decisions.
A 12-week supervised remote exercise program for patients with metastatic renal cell carcinoma undergoing immunotherapy showed significant improvements in health-related quality of life, fatigue, and symptom burden in a case series of 19 patients.
| NCT ID | Title | Status | Phase |
|---|---|---|---|
| NCT07576725 |
Low Dose, Reduced Frequency Nivolumab for the Treatment of Unresectable or Metastatic Cancer, AFFORD IO Trial |
NOT_YET_RECRUITING | PHASE2 |
| NCT07572123 |
Evaluating the Addition of Maintenance Immunotherapy Compared to the Usual Treatment of Chemotherapy and Autologous Stem Cell Transplant Alone for High-risk Patients With Relapsed or Refractory Hodgkin Lymphoma |
NOT_YET_RECRUITING | PHASE2/PHASE3 |
| NCT07551583 |
Phase 2 Study Of Nivolumab Plus AVD In Pediatric, Adolescent, And Young Adult Patients With CHL |
NOT_YET_RECRUITING | PHASE2 |
| NCT07546812 |
Study of Denikitug (GS-1811) Given Alone or With Nivolumab or Chemotherapy in Adults With Metastatic Gastric, Gastroesophageal Junction (GEJ), and Esophageal Adenocarcinomas |
RECRUITING | PHASE2 |
| NCT07541170 |
A Study to Evaluate the Efficacy and Safety of Divarasib Compared With Investigator's Choice of Immunotherapy or Observation in Participants With Resected Stage II-III KRAS G12C-Positive Non-Small Cell Lung Cancer (NSCLC) |
NOT_YET_RECRUITING | PHASE3 |
| NCT07532902 |
A Study of BMS-986504 With Standard-of-Care Therapy for People With Solid Tumor Cancer |
RECRUITING | PHASE1 |
| NCT07529873 |
Phase II Study of Ficerafusp Alfa in Combination With Nivolumab in Patients With Platinum-refractory Head and Neck Squamous Cell Carcinoma |
NOT_YET_RECRUITING | PHASE2 |
| NCT07529613 |
Trastuzumab Deruxtecan Plus Nivolumab Plus Capecitabine Plus Oxaliplatin for HER2 Low Gastric and Gastroesophageal Junction Adenocarcinoma |
COMPLETED | PHASE1/PHASE2 |
| NCT07527858 |
Study of Denikitug (GS-1811) Given Alone or With Nivolumab or With Chemotherapy in Adults With Advanced Colorectal Cancer |
NOT_YET_RECRUITING | PHASE2 |
| NCT07523763 |
Neoadjuvant Low-dose Immunotherapy in Locally Advanced MMR-deficient Colorectal Cancer |
ACTIVE_NOT_RECRUITING | PHASE2 |
