Nivolumab
Nivolumab (brand name Opdivo) is a therapeutic monoclonal antibody used in cancer treatment — a fully human immunoglobulin G4 (IgG4) immune checkpoint inhibitor directed against Programmed cell death 1 (PD-1), a receptor expressed on the surface of activated T-lymphocytes.
Nivolumab (brand name Opdivo) is a therapeutic monoclonal antibody used in cancer treatment — a fully human immunoglobulin G4 (IgG4) immune checkpoint inhibitor directed against Programmed cell death 1 (PD-1), a receptor expressed on the surface of activated T-lymphocytes. Developed by Bristol-Myers Squibb and first approved by the FDA in 2014, it is administered intravenously and has since been approved across a broad range of malignancies, including melanoma, non-small cell lung cancer (NSCLC), renal cell carcinoma (RCC), hepatocellular carcinoma, head and neck squamous cell carcinoma, esophageal squamous cell carcinoma, bladder cancer, colorectal cancer, and classical Hodgkin lymphoma.
Mechanistically, nivolumab binds PD-1 and blocks its engagement by the ligands CD274 molecule and PD-L2, which tumor cells and cells of the tumor microenvironment express to deliver inhibitory signals to infiltrating T cells. Interrupting PD-1/PD-L1 signaling relieves this suppression and restores T-cell effector function, including interferon gamma production and cytotoxic killing of tumor cells, thereby countering a central mechanism of immune evasion. Because the same axis dampens T-cell activity in non-malignant settings, PD-1 blockade has also been explored experimentally for immunosuppressive states such as sepsis. In clinical oncology, nivolumab is given as monotherapy or in combination regimens: paired with the anti-CTLA-4 antibody ipilimumab for dual checkpoint blockade, in which PD-1 inhibition reinvigorates exhausted effector T cells while CTLA-4 inhibition promotes T-cell priming and expansion; with tyrosine kinase inhibitors such as cabozantinib in renal cell carcinoma; or alongside conventional chemotherapy. These combinations generally increase antitumor activity at the cost of more frequent immune-related adverse events, such as checkpoint inhibitor pneumonitis, colitis, and endocrinopathies. Candidate predictors of benefit — PD-L1 expression, tumor mutational burden, and microsatellite instability — are widely studied, but their reliability differs by tumor type, and mechanisms of primary and acquired resistance to PD-(L)1 blockade remain an active area of investigation.
Where the papers sit
41 papers from the last 6 months study nivolumab directly · updated from PubMed 10 Oct 2026
Study type 7 clinical trials · 18 observational · 6 human data · 3 preclinical · 7 unclassified
Themes 5 themes · 1 paradigm shift
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Real-World Nivolumab Outcomes
Adjuvant nivolumab is being assessed in routine practice, especially after resection of stage III–IV melanoma, with survival and treatment-related toxicity as recurring endpoints. Real-world cohorts extend use to cancer of unknown primary and upper-tract urothelial cancer, while outcomes vary with stage and patient condition. Brain metastases, cachexia, probiotics and treatment discontinuation appear as potential modifiers. The set remains clinically heterogeneous rather than establishing one treatment strategy.
10 papers · 24.4%
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Nivolumab in Lung Cancer
Nivolumab-based immunotherapy is moving into perioperative and combination treatment for non-small cell lung cancer. Ipilimumab combinations are being evaluated across PD-L1–low metastatic disease, while chemotherapy is being added before surgery and TG4010 is being tested as a vaccine partner. Real-world work is testing rechallenge and treatment sequencing after progression, but early detriment signals and discontinuation concerns temper enthusiasm. Adjuvant benefit and the effects of COVID-19 vaccination and opioid use remain active questions.
9 papers · 22%
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Immunotherapy in Kidney Cancer
First-line metastatic renal cell carcinoma treatment is centered on nivolumab combinations with ipilimumab or tyrosine-kinase inhibitors such as cabozantinib. Studies are extending this approach to papillary and other non-clear cell disease, where evidence remains less established. Rechallenge and the timing of second-line nivolumab are being examined alongside progression-free survival, safety and prognostic scoring. Comparative effectiveness and cost analyses are increasingly shaping regimen selection.
9 papers · 22%
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Combination Therapy in Liver Cancer
Dual checkpoint and antiangiogenic strategies are being developed to overcome resistance in unresectable hepatocellular carcinoma. Lenvatinib with nivolumab and nivolumab with ipilimumab provide the main clinical approaches, including the CheckMate 9DW program. Nanoparticle delivery and exosome vaccines extend this strategy toward immune remodeling and tumor eradication in preclinical models. The field is moving from single-agent PD-1 blockade toward rational combinations, but clinical durability remains unsettled.
7 papers · 17.1%
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Others — Immune-Related Toxicity
Immune checkpoint treatment is repeatedly linked to uncommon inflammatory toxicities, including colitis, pancreatitis, folliculitis and pneumonitis with pneumomediastinum. These case reports emphasize organ-specific recognition and management of adverse events during prolonged nivolumab or combination therapy. The cluster also contains isolated reports of tumor responses in cholangiocarcinoma, gallbladder cancer and epithelioid angiomyolipoma. It therefore lacks a single direction beyond documenting the expanding clinical consequences of checkpoint blockade.
6 papers · 14.6%
Nivolumab combinations do not reliably improve outcomes and may produce early treatment failure in substantial subsets of NSCLC
The TG4010 vaccine plus nivolumab trial in ICI-naive non-small cell lung cancer and the nivolumab–ipilimumab-based first-line trials in metastatic non-small cell lung cancer found instead that combination immunotherapy was not uniformly effective: the vaccine combination produced a response in only 1 of 12 evaluable patients, while nivolumab plus ipilimumab was associated with rapid progression in 40% of patients compared with 26% receiving chemotherapy. These independent findings challenge the assumption that adding an immune-activating partner or a second checkpoint inhibitor reliably strengthens nivolumab treatment, and they shift attention toward identifying patients at risk of early detriment rather than treating combination therapy as intrinsically superior 42684015Sep 42360104Jun.
Papers
The 41 papers from the last 6 months that study nivolumab directly, newest first, by theme and by study type. Study types come from PubMed publication types and MeSH headings.
By theme
Real-World Nivolumab Outcomes (10)
- Association of Cachexia-Related Status With Treatment Outcomes in Advanced Gastric Cancer Receiving First-Line Therapy With or Without Nivolumab. Journal of gastrointestinal cancer · 11 Sept 2026 PMID 42726376
- Real-World Use of Adjuvant Nivolumab for Resected Stage III-IV Melanoma: 2-Year Analysis of AdjuMel. Dermatology and therapy · 29 Aug 2026 PMID 42667537
- Real-world Feasibility of Adjuvant Nivolumab for High-risk Upper Tract Urothelial Carcinoma After Radical Nephroureterectomy. In vivo (Athens, Greece) · 28 Aug 2026 PMID 42665381
- Real-world safety and effectiveness of nivolumab in patients with cancer of unknown primary: results from a nationwide post-marketing surveillance in Japan. International journal of clinical oncology · 26 Aug 2026 PMID 42645637
- Survival outcomes of adjuvant therapy in resected stage III melanoma: Results from a real-life cohort study (TAMARIS). European journal of cancer (Oxford, England : 1990) · 29 Jun 2026 PMID 42372635
- Temperature Dependent Motions of N-Terminal Loop in PD-1 Determine the Affinity Towards Nivolumab. Journal of molecular recognition : JMR · 27 May 2026 PMID 42199044
- Association of Probiotics with Effectiveness of Nivolumab or Pembrolizumab in Patients with Esophageal Cancer Taking Proton Pump Inhibitors: A Multicenter Retrospective Study. Journal of gastrointestinal cancer · 25 May 2026 PMID 42183961
- Discontinuation of combo immunotherapy and outcome of patients with melanoma brain metastases. Journal for immunotherapy of cancer · 4 May 2026 PMID 42082273
- Phase II trial of combination radiation, hormone, and immunotherapy in grade group 5 prostate cancer. Journal for immunotherapy of cancer · 4 May 2026 PMID 42082271
- NP-101 in combination with nivolumab and ipilimumab in metastatic extrapulmonary neuroendocrine carcinomas (EP-NECs): A pilot study. Endocrine-related cancer · 21 Apr 2026 PMID 42012995
Nivolumab in Lung Cancer (9)
- A phase II multi-institutional single arm trial evaluating TG4010 vaccine plus nivolumab in non-small cell lung cancer. Oncoimmunology · 2 Sept 2026 PMID 42684015
- Codelivery of nivolumab and galunisertib by EGFR-targeted spherical polymeric nanoparticles for effective treatment of non-small cell lung cancer. International journal of pharmaceutics · 26 Aug 2026 PMID 42648563
- Association between opioid use and treatment discontinuation in patients receiving nivolumab: a real-world database study. Supportive care in cancer : official journal of the Multinational Association of Supportive Care in Cancer · 14 Aug 2026 PMID 42601535
- Nivolumab plus ipilimumab-based treatment in Japanese patients with metastatic non-small cell lung cancer and tumor PD-L1 < 1%: a pooled analysis. International journal of clinical oncology · 11 Aug 2026 PMID 42579028
- Impact of COVID-19 Vaccine Type on the Efficacy and Safety of Nivolumab in Patients With Metastatic Non-small-cell Lung Cancer: A Multicenter Study. In vivo (Athens, Greece) · 30 Jun 2026 PMID 42379805
- Early Detriment Analysis of First-Line Nivolumab plus Ipilimumab-Based Therapy in Patients with Metastatic Non-Small Cell Lung Cancer. Clinical cancer research : an official journal of the American Association for Cancer Research · 26 Jun 2026 PMID 42360104
- Neoadjuvant nivolumab plus chemotherapy in resectable NSCLC: A pharmacological outcome study. Pakistan journal of pharmaceutical sciences · 9 Jun 2026 PMID 42262212
- Adjuvant Nivolumab vs Observation in Resected Non-Small Cell Lung Cancer: A Randomized Clinical Trial. JAMA · 1 Jun 2026 PMID 42224490
- Treatment Sequencing and Immunotherapy Rechallenge in Advanced Non-Small-Cell Lung Cancer: Final 24-Month Real-World Results from the French LIST Study. Oncology and therapy · 3 May 2026 PMID 42071088
Immunotherapy in Kidney Cancer (9)
- Timing of Second-Line Nivolumab and Survival in Metastatic Renal Cell Carcinoma. Clinical genitourinary cancer · 5 Sept 2026 PMID 42700745
- Cost‑effectiveness of first‑line immunotherapy-based combination regimens for advanced renal cell carcinoma in China and the United States. Human vaccines & immunotherapeutics · 22 Aug 2026 PMID 42630013
- Real-World Outcomes and Prognostic Factors of Immune Checkpoint Inhibitor Rechallenge for Metastatic Renal Cell Carcinoma: A Multicenter Study. International journal of urology : official journal of the Japanese Urological Association · 1 Jul 2026 PMID 42385189
- Efficacy and safety of cabozantinib plus nivolumab in advanced non-clear cell renal cell carcinoma: a nationwide multicenter study. Oncoimmunology · 29 Jun 2026 PMID 42366526
- Real-world outcomes of ipilimumab plus nivolumab in esophageal squamous cell carcinoma: a multi-institutional large cohort study. Cancer immunology, immunotherapy : CII · 14 Jun 2026 PMID 42289036
- Papillary renal cell carcinoma - exploratory results of the SUNNIFORECAST trial comparing Ipilimumab plus Nivolumab vs standard of care as first line therapy based on central pathological review. European journal of cancer (Oxford, England : 1990) · 3 Jun 2026 PMID 42235464
- CDK4/6 inhibition uncovers subtype-specific vulnerabilities and immune-related responses in esophageal squamous cell carcinoma. Cell death & disease · 29 May 2026 PMID 42215475
- Comparison of effectiveness and safety of pembrolizumab plus lenvatinib versus nivolumab plus cabozantinib for metastatic renal cell carcinoma: a real-world study. International journal of clinical oncology · 27 May 2026 PMID 42204034
- Three-factor Clinical Score for First-line Nivolumab Plus Ipilimumab in Metastatic Renal Cell Carcinoma. Anticancer research · 27 May 2026 PMID 42203341
Combination Therapy in Liver Cancer (7)
- Combination of exosome vaccines, lenvatinib, and anti-PD-1 eradicates tumor in autochthonous hepatocellular carcinoma mice. Cell reports. Medicine · 23 Jul 2026 PMID 42492521
- Moxibustion combined with anti-PD-1 antibodies improves immunosuppression in septic mice potentially through the PD-1/PD-L1 pathway. Immunologic research · 17 Jun 2026 PMID 42307810
- Nivolumab in combination with lenvatinib in unresectable hepatocellular carcinoma: The IKF-t006/IMMUNIB translational phase-2 study. European journal of cancer (Oxford, England : 1990) · 12 Jun 2026 PMID 42284972
- Combos New and Old Counter PD-(L)1 Resistance, Treat Rare Cancers. Cancer discovery · 4 Jun 2026 PMID 42240229
- Antiangiogenic DPPA-nanoparticles combined with an immune checkpoint inhibitor for the treatment of unresectable hepatocellular carcinoma. Materials today. Bio · 11 May 2026 PMID 42111772
- The case for tumour-agnostic reimbursement of dual immunotherapy. European journal of cancer (Oxford, England : 1990) · 9 May 2026 PMID 42106259
- A plain language summary of the CheckMate 9DW study: nivolumab in combination with ipilimumab for unresectable hepatocellular carcinoma (advanced liver cancer). Future oncology (London, England) · 15 Apr 2026 PMID 41981891
Others — Immune-Related Toxicity (6)
- Analysis of a case of immune-related pancreatitis induced by anti-PD-1 antibody therapy for gastric cancer: A case report. Medicine · 9 Oct 2026 PMID 42854075
- Immune-related colitis following head and neck reconstructive surgery in a patient receiving long-term nivolumab. BMJ case reports · 6 Oct 2026 PMID 42838709
- Complete response to dual immune checkpoint blockade in a patient with Birt-Hogg-Dubé syndrome and epithelioid angiomyolipoma. Journal for immunotherapy of cancer · 29 Jul 2026 PMID 42527032
- Checkpoint Inhibitor Pneumonitis With Pneumomediastinum Following Nivolumab-AVD in Classic Hodgkin Lymphoma: A Case Report. Journal of pediatric hematology/oncology · 11 Jun 2026 PMID 42274365
- Nivolumab-induced folliculitis: A case of immune-related cutaneous adverse reaction. Indian journal of pharmacology · 30 Apr 2026 PMID 42060814
- Nivolumab and Ipilimumab Combination Treatment in Patients with Advanced Intrahepatic Cholangiocarcinoma and Gallbladder Cancer: Results from the Phase II MoST-CIRCUIT Trial. Clinical cancer research : an official journal of the American Association for Cancer Research · 24 Apr 2026 PMID 42029635
By study type
Clinical trials (7)
- A phase II multi-institutional single arm trial evaluating TG4010 vaccine plus nivolumab in non-small cell lung cancer. Oncoimmunology · 2 Sept 2026 PMID 42684015
- Early Detriment Analysis of First-Line Nivolumab plus Ipilimumab-Based Therapy in Patients with Metastatic Non-Small Cell Lung Cancer. Clinical cancer research : an official journal of the American Association for Cancer Research · 26 Jun 2026 PMID 42360104
- Nivolumab in combination with lenvatinib in unresectable hepatocellular carcinoma: The IKF-t006/IMMUNIB translational phase-2 study. European journal of cancer (Oxford, England : 1990) · 12 Jun 2026 PMID 42284972
- Papillary renal cell carcinoma - exploratory results of the SUNNIFORECAST trial comparing Ipilimumab plus Nivolumab vs standard of care as first line therapy based on central pathological review. European journal of cancer (Oxford, England : 1990) · 3 Jun 2026 PMID 42235464
- Adjuvant Nivolumab vs Observation in Resected Non-Small Cell Lung Cancer: A Randomized Clinical Trial. JAMA · 1 Jun 2026 PMID 42224490
- Phase II trial of combination radiation, hormone, and immunotherapy in grade group 5 prostate cancer. Journal for immunotherapy of cancer · 4 May 2026 PMID 42082271
- Nivolumab and Ipilimumab Combination Treatment in Patients with Advanced Intrahepatic Cholangiocarcinoma and Gallbladder Cancer: Results from the Phase II MoST-CIRCUIT Trial. Clinical cancer research : an official journal of the American Association for Cancer Research · 24 Apr 2026 PMID 42029635
Observational studies and case reports (18)
- Analysis of a case of immune-related pancreatitis induced by anti-PD-1 antibody therapy for gastric cancer: A case report. Medicine · 9 Oct 2026 PMID 42854075
- Immune-related colitis following head and neck reconstructive surgery in a patient receiving long-term nivolumab. BMJ case reports · 6 Oct 2026 PMID 42838709
- Association of Cachexia-Related Status With Treatment Outcomes in Advanced Gastric Cancer Receiving First-Line Therapy With or Without Nivolumab. Journal of gastrointestinal cancer · 11 Sept 2026 PMID 42726376
- Timing of Second-Line Nivolumab and Survival in Metastatic Renal Cell Carcinoma. Clinical genitourinary cancer · 5 Sept 2026 PMID 42700745
- Real-world Feasibility of Adjuvant Nivolumab for High-risk Upper Tract Urothelial Carcinoma After Radical Nephroureterectomy. In vivo (Athens, Greece) · 28 Aug 2026 PMID 42665381
- Association between opioid use and treatment discontinuation in patients receiving nivolumab: a real-world database study. Supportive care in cancer : official journal of the Multinational Association of Supportive Care in Cancer · 14 Aug 2026 PMID 42601535
- Complete response to dual immune checkpoint blockade in a patient with Birt-Hogg-Dubé syndrome and epithelioid angiomyolipoma. Journal for immunotherapy of cancer · 29 Jul 2026 PMID 42527032
- Real-World Outcomes and Prognostic Factors of Immune Checkpoint Inhibitor Rechallenge for Metastatic Renal Cell Carcinoma: A Multicenter Study. International journal of urology : official journal of the Japanese Urological Association · 1 Jul 2026 PMID 42385189
- Impact of COVID-19 Vaccine Type on the Efficacy and Safety of Nivolumab in Patients With Metastatic Non-small-cell Lung Cancer: A Multicenter Study. In vivo (Athens, Greece) · 30 Jun 2026 PMID 42379805
- Survival outcomes of adjuvant therapy in resected stage III melanoma: Results from a real-life cohort study (TAMARIS). European journal of cancer (Oxford, England : 1990) · 29 Jun 2026 PMID 42372635
- Efficacy and safety of cabozantinib plus nivolumab in advanced non-clear cell renal cell carcinoma: a nationwide multicenter study. Oncoimmunology · 29 Jun 2026 PMID 42366526
- Checkpoint Inhibitor Pneumonitis With Pneumomediastinum Following Nivolumab-AVD in Classic Hodgkin Lymphoma: A Case Report. Journal of pediatric hematology/oncology · 11 Jun 2026 PMID 42274365
- Neoadjuvant nivolumab plus chemotherapy in resectable NSCLC: A pharmacological outcome study. Pakistan journal of pharmaceutical sciences · 9 Jun 2026 PMID 42262212
- Comparison of effectiveness and safety of pembrolizumab plus lenvatinib versus nivolumab plus cabozantinib for metastatic renal cell carcinoma: a real-world study. International journal of clinical oncology · 27 May 2026 PMID 42204034
- Three-factor Clinical Score for First-line Nivolumab Plus Ipilimumab in Metastatic Renal Cell Carcinoma. Anticancer research · 27 May 2026 PMID 42203341
- Association of Probiotics with Effectiveness of Nivolumab or Pembrolizumab in Patients with Esophageal Cancer Taking Proton Pump Inhibitors: A Multicenter Retrospective Study. Journal of gastrointestinal cancer · 25 May 2026 PMID 42183961
- Discontinuation of combo immunotherapy and outcome of patients with melanoma brain metastases. Journal for immunotherapy of cancer · 4 May 2026 PMID 42082273
- Nivolumab-induced folliculitis: A case of immune-related cutaneous adverse reaction. Indian journal of pharmacology · 30 Apr 2026 PMID 42060814
Human data, design not indexed (6)
- Cost‑effectiveness of first‑line immunotherapy-based combination regimens for advanced renal cell carcinoma in China and the United States. Human vaccines & immunotherapeutics · 22 Aug 2026 PMID 42630013
- Nivolumab plus ipilimumab-based treatment in Japanese patients with metastatic non-small cell lung cancer and tumor PD-L1 < 1%: a pooled analysis. International journal of clinical oncology · 11 Aug 2026 PMID 42579028
- Combos New and Old Counter PD-(L)1 Resistance, Treat Rare Cancers. Cancer discovery · 4 Jun 2026 PMID 42240229
- Temperature Dependent Motions of N-Terminal Loop in PD-1 Determine the Affinity Towards Nivolumab. Journal of molecular recognition : JMR · 27 May 2026 PMID 42199044
- The case for tumour-agnostic reimbursement of dual immunotherapy. European journal of cancer (Oxford, England : 1990) · 9 May 2026 PMID 42106259
- NP-101 in combination with nivolumab and ipilimumab in metastatic extrapulmonary neuroendocrine carcinomas (EP-NECs): A pilot study. Endocrine-related cancer · 21 Apr 2026 PMID 42012995
Preclinical: animal, cell and lab studies (3)
- Codelivery of nivolumab and galunisertib by EGFR-targeted spherical polymeric nanoparticles for effective treatment of non-small cell lung cancer. International journal of pharmaceutics · 26 Aug 2026 PMID 42648563
- Combination of exosome vaccines, lenvatinib, and anti-PD-1 eradicates tumor in autochthonous hepatocellular carcinoma mice. Cell reports. Medicine · 23 Jul 2026 PMID 42492521
- Moxibustion combined with anti-PD-1 antibodies improves immunosuppression in septic mice potentially through the PD-1/PD-L1 pathway. Immunologic research · 17 Jun 2026 PMID 42307810
Unclassified: not yet indexed with MeSH (7)
- Real-World Use of Adjuvant Nivolumab for Resected Stage III-IV Melanoma: 2-Year Analysis of AdjuMel. Dermatology and therapy · 29 Aug 2026 PMID 42667537
- Real-world safety and effectiveness of nivolumab in patients with cancer of unknown primary: results from a nationwide post-marketing surveillance in Japan. International journal of clinical oncology · 26 Aug 2026 PMID 42645637
- Real-world outcomes of ipilimumab plus nivolumab in esophageal squamous cell carcinoma: a multi-institutional large cohort study. Cancer immunology, immunotherapy : CII · 14 Jun 2026 PMID 42289036
- CDK4/6 inhibition uncovers subtype-specific vulnerabilities and immune-related responses in esophageal squamous cell carcinoma. Cell death & disease · 29 May 2026 PMID 42215475
- Antiangiogenic DPPA-nanoparticles combined with an immune checkpoint inhibitor for the treatment of unresectable hepatocellular carcinoma. Materials today. Bio · 11 May 2026 PMID 42111772
- Treatment Sequencing and Immunotherapy Rechallenge in Advanced Non-Small-Cell Lung Cancer: Final 24-Month Real-World Results from the French LIST Study. Oncology and therapy · 3 May 2026 PMID 42071088
- A plain language summary of the CheckMate 9DW study: nivolumab in combination with ipilimumab for unresectable hepatocellular carcinoma (advanced liver cancer). Future oncology (London, England) · 15 Apr 2026 PMID 41981891
Written from 41 PubMed abstracts, each one listed by PMID above. Published: 2026-06-16. Last written: 2026-09-13 by GPT. Reviewed by a human editor on 2026-07-23. Drafted by language models from published abstracts; not medical advice.