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Nivolumab was the second PD-1 blocker and is often combined with ipilimumab. Long-term data show about half of advanced melanoma patients alive at 10 years on the combination.
Approved across melanoma (CheckMate 067 combination), NSCLC, RCC, Hodgkin, head and neck, urothelial, MSI-H CRC (CheckMate 8HW first-line), gastric/oesophageal, HCC, mesothelioma, and perioperative NSCLC. March 2026: first-line advanced classical Hodgkin lymphoma with AVD (SWOG S1826) for ages 12+. Partner of relatlimab (Opdualag) and of the oncolytic virus Tudriqev.
Backbone ribbon from PDB 5WT9. RCSB PDB 5WT9. The ribbon widens where the chain is folded into a regular pattern and narrows where it is a loose loop.
Fully human IgG4 anti-PD-1. Connects to PD-1.
1.Antibody binds PD-1 on T cells
Source: US prescribing information (DailyMed). Doses are for orientation; the current label governs.
Given by infusion or injection in a clinic or hospital outpatient department, so it is a Part B drug: Medicare pays 80% after the Part B deductible and the patient owes 20% coinsurance, uncapped in Original Medicare unless a Medigap policy applies. HCPCS J9299. Opdivo Qvantig (subcutaneous, with hyaluronidase) is clinician-administered and also Part B.
Covered under the medical benefit with prior authorisation confirming diagnosis, biomarker status and line of therapy; site-of-care policies may steer infusions away from hospital outpatient departments.
20% Part B coinsurance on a high-cost infusion adds up quickly: Medigap Plan G or N, Medicare Advantage maximum out-of-pocket, Medicaid dual eligibility, or a charity fund are the usual buffers.
Sources: Medicare.gov: Chemotherapy · Medicare.gov: Prescription drugs (outpatient, Part B). Not medical or financial advice; verify with your plan.
Sources: NICE TA484 · SMC advice: nivolumab. Funding decisions are indication-specific and change monthly; verify with NICE and your treating team.
First PD-1 inhibitor approved worldwide (melanoma, Japan) source
Unresectable or metastatic melanoma and progression following ipilimumab and, if BRAF V600 mutation positive, a BRAF inhibitor
Advanced melanoma after ipilimumab (accelerated) source
Squamous NSCLC after platinum: first PD-1 in lung cancer source
In combination with ipilimumab for BRAF V600 wild-type unresectable or metastatic melanoma
Accelerated approval on a surrogate endpoint, with a confirmatory trial required.
With ipilimumab, BRAF wild-type melanoma (CheckMate 067) source
1) In combination with ipilimumab for unresectable or metastatic melanoma to remove the restriction for treatment of only patients with BRAF wild-type melanoma; 2) As a single agent for BRAF V600 mutation positive unresectable or metastatic melanoma to remove the restriction that such patients should have disease progression following ipilimumab and a BRAF inhibitor
Accelerated approval on a surrogate endpoint, with a confirmatory trial required.
For the treatment of classical Hodgkin Lymphoma that has relapsed or progressed after autologous hematopoietic stem cell transplantation (HSCT) and post-transplantation brentuximab vedotin
Accelerated approval on a surrogate endpoint, with a confirmatory trial required.
Locally advanced or metastatic urothelial carcinoma that: • progressed during or following platinum-containing chemotherapy • progressed within 12 months of neoadjuvant or adjuvant platinum-containing chemotherapy
Accelerated approval on a surrogate endpoint, with a confirmatory trial required.
Treatment of adult patients with classical Hodgkin lymphoma that has relapsed or progressed after: Autologous hematopoietic stem cell transplantation (HSCT) and brentuximab vedotin, Or 3 or more lines of systemic therapy that includes autologous HSCT
Accelerated approval on a surrogate endpoint, with a confirmatory trial required.
For the treatment of adult and pediatric patients 12 years and older with microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) metastatic colorectal cancer (CRC) that has progressed following treatment with a fluoropyrimidine, oxaliplatin, and irinotecan
Accelerated approval on a surrogate endpoint, with a confirmatory trial required.
Hepatocellular carcinoma previously treated with sorafenib
Accelerated approval on a surrogate endpoint, with a confirmatory trial required.
With ipilimumab, intermediate/poor-risk RCC (CheckMate 214) source
In combination with ipilimumab, is indicated for the treatment of adults and pediatric patients 12 years and older with microsatellite instability-high (MSI-H) or DNA mismatch repair deficient (dMMR), metastatic colorectal cancer that has progressed following treatment with a fluoropyrimidine, oxaliplatin, and irinotecan
Accelerated approval on a surrogate endpoint, with a confirmatory trial required.
Metastatic SCLC with progression after platinum-based chemotherapy and at least one other line of therapy
Accelerated approval on a surrogate endpoint, with a confirmatory trial required.
Unresectable or metastatic melanoma and progression following ipilimumab and, if BRAF V600 mutation positive, a BRAF inhibitor
Confirmed: the accelerated approval of 2014 converted to traditional approval 4.2 years after it was granted.
In combination with ipilimumab for BRAF V600 wild-type unresectable or metastatic melanoma
Confirmed: the accelerated approval of 2015 converted to traditional approval 3.4 years after it was granted.
1) In combination with ipilimumab for unresectable or metastatic melanoma to remove the restriction for treatment of only patients with BRAF wild-type melanoma; 2) As a single agent for BRAF V600 mutation positive unresectable or metastatic melanoma to remove the restriction that such patients should have disease progression following ipilimumab and a BRAF inhibitor
Confirmed: the accelerated approval of 2016 converted to traditional approval 3.1 years after it was granted.
In combination with ipilimumab, for the treatment of patients with hepatocellular carcinoma (HCC) who have been previously treated with sorafenib
Accelerated approval on a surrogate endpoint, with a confirmatory trial required.
Metastatic SCLC with progression after platinum-based chemotherapy and at least one other line of therapy
Withdrawn: the indication came off the label 2.4 years after its accelerated approval.
Hepatocellular carcinoma previously treated with sorafenib
Withdrawn: the indication came off the label 3.8 years after its accelerated approval.
Locally advanced or metastatic urothelial carcinoma that: • progressed during or following platinum-containing chemotherapy • progressed within 12 months of neoadjuvant or adjuvant platinum-containing chemotherapy
Confirmed: the accelerated approval of 2017 converted to traditional approval 4.5 years after it was granted.
Neoadjuvant NSCLC with chemotherapy (CheckMate 816) source
Formulation: As monotherapy or as monotherapy following treatment with intravenous nivolumab and ipilimumab combination therapy for the treatment of adult patients with microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) metastatic colorectal cancer that has progressed following treatment with a fluoropyrimidine, oxaliplatin, and irinotecan .
Subcutaneous nivolumab (Opdivo Qvantig) source
Formulation: Treatment of adult patients with hepatocellular carcinoma (HCC) who have been previously treated with sorafenib and following treatment with intravenous nivolumab and ipilimumab .
Accelerated approval on a surrogate endpoint, with a confirmatory trial required. source
For the treatment of adult and pediatric patients 12 years and older with microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) metastatic colorectal cancer (CRC) that has progressed following treatment with a fluoropyrimidine, oxaliplatin, and irinotecan
Confirmed: the accelerated approval of 2017 converted to traditional approval 7.7 years after it was granted.
In combination with ipilimumab, is indicated for the treatment of adults and pediatric patients 12 years and older with microsatellite instability-high (MSI-H) or DNA mismatch repair deficient (dMMR), metastatic colorectal cancer that has progressed following treatment with a fluoropyrimidine, oxaliplatin, and irinotecan
Confirmed: the accelerated approval of 2018 converted to traditional approval 6.7 years after it was granted.
In combination with ipilimumab, for the treatment of patients with hepatocellular carcinoma (HCC) who have been previously treated with sorafenib
Confirmed: the accelerated approval of 2020 converted to traditional approval 5.1 years after it was granted.
Formulation: As monotherapy or as monotherapy following treatment with intravenous nivolumab and ipilimumab combination therapy for the treatment of adult patients with microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) metastatic colorectal cancer that has progressed following treatment with a fluoropyrimidine, oxaliplatin, and irinotecan .
Confirmed: the accelerated approval of 2024 converted to traditional approval 0.8 years after it was granted. source
Formulation: Treatment of adult patients with hepatocellular carcinoma (HCC) who have been previously treated with sorafenib and following treatment with intravenous nivolumab and ipilimumab .
Confirmed: the accelerated approval of 2024 converted to traditional approval 0.8 years after it was granted. source
First-line advanced classical Hodgkin lymphoma with AVD, age ≥12 (SWOG S1826) source
For the treatment of classical Hodgkin Lymphoma that has relapsed or progressed after autologous hematopoietic stem cell transplantation (HSCT) and post-transplantation brentuximab vedotin
Confirmed: the accelerated approval of 2016 converted to traditional approval 9.8 years after it was granted.
Treatment of adult patients with classical Hodgkin lymphoma that has relapsed or progressed after: Autologous hematopoietic stem cell transplantation (HSCT) and brentuximab vedotin, Or 3 or more lines of systemic therapy that includes autologous HSCT
Confirmed: the accelerated approval of 2017 converted to traditional approval 8.9 years after it was granted.
Accelerated approval of vusolimogene oderparepvec in combination with nivolumab, unresectable advanced cutaneous melanoma source
| Region | Year | Indication |
|---|---|---|
| US | 2014 | Melanoma |
| US | 2026 | Untreated advanced classical Hodgkin lymphoma with AVD, age ≥12 |
| US | 2025 | Unresectable or metastatic MSI-high or dMMR colorectal cancer, with ipilimumab · Approved 8 April 2025 on CheckMate 8HW. |
| England (NICE) | 2025 | Untreated unresectable or metastatic MSI-high or dMMR colorectal cancer, with ipilimumab · TA1065, published 28 May 2025, within the marketing authorisation and subject to the commercial arrangements; TA716 (July 2021) covers previously treated disease. |
| England (NICE) | 2020 | Locally advanced or metastatic squamous non-small-cell lung cancer after chemotherapy · TA655, published 21 October 2020, stopped at 2 years of uninterrupted treatment and only for patients who have not had a PD-1 or PD-L1 inhibitor before (CheckMate 017). |
| England (NICE) | 2021 | Locally advanced or metastatic PD-L1-positive non-squamous non-small-cell lung cancer after chemotherapy · TA713, published 7 July 2021, stopped at 2 years and only for patients who have not had a PD-1 or PD-L1 inhibitor before (CheckMate 057). |
| England (NICE) | 2021 | Untreated metastatic non-small-cell lung cancer without an EGFR or ALK alteration, with ipilimumab and two cycles of platinum doublet chemotherapy: not recommended · TA724, published 8 September 2021, does not recommend the CheckMate 9LA regimen, so it is not routinely funded in England. |
| England (NICE) | 2023 | Neoadjuvant treatment of resectable non-small-cell lung cancer (4 cm or more, or node positive), with chemotherapy · TA876, published 22 March 2023 (CheckMate 816). |
| England (NICE) | 2026 | Resectable non-small-cell lung cancer at high risk of recurrence without an EGFR mutation or ALK rearrangement: neoadjuvant with platinum chemotherapy then adjuvant alone · TA1127, published 4 February 2026 (CheckMate 77T); NICE asks that the least expensive of nivolumab, pembrolizumab and durvalumab is used. |
| Adverse event | Any grade | Grade 3+ |
|---|---|---|
| Immune-mediated rash | 9% | 1.1% |
| Hypothyroidism | 8% | 0.2% |
| Pneumonitis | 3.1% | 1% |
| Colitis | 2.9% | 1.7% |
| Hepatitis | 1.8% | 1.5% |
| Nephritis | 1.2% | 0.6% |
| Adrenal insufficiency | 1% | 0.4% |
| Colitis with ipilimumab (1+3 mg/kg) | 25% | 14.4% |
| Hepatitis with ipilimumab | 15% | 13.4% |
Monotherapy pooled unless stated. Rates read from the US prescribing information. Blank cells mean the figure was not sourced, not that it is zero.
Read for the class this product belongs to (immune checkpoint inhibitors) unless the answer names the product. Population figures from the cohorts named, not a prediction for one person. Blank where no source gives a recovery figure.
| Country | Reimbursement | List price | Assistance |
|---|---|---|---|
| United States | Medicare Part B (physician-administered); commercial plans per formulary | not disclosed | bmsaccesssupport.com |
| United Kingdom | NICE: recommended across melanoma, NSCLC, RCC, Hodgkin, HNSCC, gastric/oesophageal, urothelial, MSI-H CRC indications | not disclosed | - |
List prices are manufacturer or Medicare figures where publicly disclosed; net prices after rebates are usually lower. Reimbursement changes; check the payer.
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Single-agent PD-1 blockade remains the immunotherapy standard after chemotherapy in metastatic anal cancer; CTLA-4 blockade adds toxicity without benefit.
For patients with advanced melanoma, immunotherapy offers a realistic chance of long-term survival and probably cure, and the ten-year data show that patients who are alive and progression-free at three years rarely die of melanoma afterwards. Nivolumab plus ipilimumab gives the best long-term results but at a high price in serious side effects; nivolumab alone or nivolumab plus relatlimab are alternatives for patients at lower risk or with autoimmune concerns. The trial is also a caution about surrogate endpoints: the survival plateau took years to become visible.
Nivolumab-ipilimumab is a first-line standard for microsatellite-unstable metastatic colorectal cancer alongside pembrolizumab, with the trade-off of more immune toxicity for deeper and more durable control.
The uninjected-lesion responses are the most important result any oncolytic virus trial has produced, because they are the first strong clinical evidence that the mechanism is systemic immunity rather than local lysis. The caution is the same as always: this is a single-arm cohort in a population with no standard option, and the randomised confirmatory trial has not read out.
Patients with melanoma that has spread to palpable lymph nodes should now be offered immunotherapy before rather than only after surgery: two cycles of low-dose ipilimumab with nivolumab, then surgery, with the pathology result deciding whether any more treatment is needed. Most patients respond well and are spared a year of adjuvant therapy. Serious side effects are more common than with nivolumab alone, mostly endocrine, and the approach requires close coordination between oncologists, surgeons and pathologists.
For colon cancer that is mismatch-repair deficient (about 10-15% of colon cancers, more in older patients), a single short course of immunotherapy before surgery is now a reasonable standard and is far more effective than chemotherapy, which has little effect in this subtype. It requires testing every colon cancer for mismatch repair at diagnosis, before surgery. Whether some patients can safely skip surgery, as in dMMR rectal cancer, is the next question.
Combination checkpoint blockade became a first-line standard for mismatch repair-deficient metastatic colorectal cancer in 2025; the later all-lines comparison against nivolumab alone showed the CTLA-4 antibody adds to the PD-1 antibody, the first phase 3 to prove that in this disease.
S1826 moved checkpoint blockade into first-line Hodgkin lymphoma and made N-AVD a preferred regimen for advanced disease in patients from adolescence to older age, while removing radiotherapy for most. It also showed the value of a single trial spanning paediatric and adult groups. Longer follow-up is needed for overall survival and late immune effects in young patients.
Query for this drug: (TITLE:"Nivolumab" OR ABSTRACT:"Nivolumab" OR TITLE:"Opdivo" OR ABSTRACT:"Opdivo" OR TITLE:"Opdivo Qvantig" OR ABSTRACT:"Opdivo Qvantig") AND (cancer OR tumor OR tumour OR oncology OR carcinoma OR lymphoma OR leukemia OR leukaemia OR myeloma OR sarcoma OR melanoma OR glioma). Results are unfiltered search hits about Nivolumab, not a curated reading list.
Shares Nivolumab alone or with ipilimumab in mucosal melanoma: pooled analysis, A Study of Nivolumab Combined With Ipilimumab Versus Nivolumab Alone in Participants With Advanced Kidney Cancer, Study of mRNA-4359 Administered Alone and in Combination With Immune Checkpoint Blockade in Participants With Advanced Solid Tumors, CheckMate 8HW: nivolumab plus ipilimumab versus nivolumab alone in MSI-high metastatic colorectal cancer.
Shares Automatic price cuts when a cancer drug's approved indications and volumes expand, Study of mRNA-4359 Administered Alone and in Combination With Immune Checkpoint Blockade in Participants With Advanced Solid Tumors, A Phase 1/2 Study of BA3071 in Patients With Solid Tumors, A Study to Evaluate the Safety, Tolerability, Drug Levels, and Preliminary Efficacy of BMS-986507 Combinations in Adult Participants With Advanced Solid Tumors.
Shares CheckMate 9DW, Paul Baas, CheckMate 648, Michael A. Postow.
Shares Matthew D. Galsky, Scott J. Antonia, Tasuku Honjo, CheckMate 057: nivolumab beats docetaxel after chemotherapy in non-squamous lung cancer.
Shares Matthew D. Galsky, Blood-brain Barrier (BBB) Opening Using Exablate Focused Ultrasound With Standard of Care Treatment of NSCLC Brain Mets, Price a cancer drug by how well it works in each cancer, Caution: PD-1 rechallenge after progression on immunotherapy (RCC).
Shares Myriam Chalabi, Neoadjuvant checkpoint inhibitor → surgery (or no surgery) in dMMR colorectal cancer, CheckMate 142, Immuno-oncology (IO) and checkpoint blockade.