Nivolumab (Opdivo)
PD-1 checkpoint inhibitor immunotherapy for multiple solid tumors including melanoma, lung cancer, and kidney cancer.
What is nivolumab?
What it targets
Nivolumab blocks PD-1, a checkpoint protein on T cells that cancer hijacks to escape immune detection. Restoring PD-1 signaling reactivates anti-tumor immunity.
Who it may help
Patients with approved cancer types who have adequate organ function, good performance status, and no severe uncontrolled autoimmune disease. PD-L1 or MSI/MMR testing may guide eligibility.
Why testing matters
Baseline blood tests, imaging, and cancer confirmation are essential. PD-L1 testing is required or recommended for some indications. MSI-H/dMMR testing is critical for colorectal cancer eligibility.
Which cancers can nivolumab treat?
Nivolumab is approved for multiple cancer types. The exact role depends on cancer type, stage, prior treatment, and whether nivolumab is used alone or in combination.
| Melanoma (unresectable or metastatic) | Approved as monotherapy or with ipilimumab. First-line or later-line depending on prior treatment. Also approved as adjuvant (after surgery) for high-risk disease. |
| Non-small cell lung cancer (NSCLC) | Used in advanced/metastatic NSCLC with or without chemotherapy. Approved as first-line for high PD-L1 expression and in combination with chemotherapy. Also approved for perioperative use. |
| Renal cell carcinoma (RCC) | First-line for intermediate/poor-risk advanced disease with ipilimumab (upgraded to preferred in NCCN 2026). Also approved with cabozantinib or as monotherapy for disease progressing after prior treatment. |
| Head and neck squamous cell cancer | Approved for recurrent or metastatic disease that progressed on or after platinum-based chemotherapy. Can be used alone or in combination with chemotherapy depending on setting. |
| Gastric, GEJ, and esophageal adenocarcinoma | Approved in combination with chemotherapy for first-line metastatic disease. Also approved as adjuvant (after surgery) for resectable disease with prior chemoradiotherapy. |
| Esophageal squamous cell carcinoma | Approved as first-line monotherapy or combination therapy for advanced/metastatic disease depending on PD-L1 status and region. Also approved as adjuvant after chemoradiotherapy. |
| Colorectal cancer (MSI-H/dMMR) | Approved with or without ipilimumab for unresectable/metastatic MSI-H/dMMR disease. Approved as monotherapy after progression on fluoropyrimidine, oxaliplatin, and irinotecan. |
| Hepatocellular carcinoma (HCC) | First-line with ipilimumab for unresectable/metastatic HCC (approved April 2025). Also approved as monotherapy for disease progressing after sorafenib. |
| Urothelial carcinoma (bladder cancer) | Approved for locally advanced or metastatic disease. Can be first-line with cisplatin and gemcitabine or later-line after platinum chemotherapy. |
| Classical Hodgkin lymphoma (cHL) | Approved for relapsed/refractory disease. Recently approved in combination with AVD (doxorubicin, vinblastine, dacarbazine) as first-line for newly diagnosed stage III or IV cHL. |
| Malignant pleural mesothelioma | Approved with ipilimumab for unresectable, advanced, or metastatic disease. Combination therapy shows improved outcomes over single-agent options. |
Who is eligible for nivolumab?
Eligibility depends on confirmed cancer diagnosis, cancer type, stage, prior treatments, organ function, and absence of major contraindications. Specific biomarker testing may be required.
- Confirmed cancer diagnosis and stage appropriate for nivolumab according to approved indications in your country.
- Adequate organ function: liver, kidney, and heart. Your oncologist will order specific tests to confirm.
- ECOG performance status 0 or 1 (able to perform daily activities with minimal to no limitation).
- No uncontrolled autoimmune disease, severe active infection, or recent organ transplant.
- Not pregnant or breastfeeding. Effective contraception required during and for 5 months after treatment.
- For some cancers: PD-L1 testing, MSI-H/dMMR testing, or other biomarker testing may be required before starting.
- No recent live vaccine. Live vaccines should be avoided during nivolumab treatment.
- Willing to undergo regular monitoring with blood tests and imaging during treatment.
How does nivolumab work?
- Immune checkpoint recognition
- Cancer cell hiding mechanism
- PD-1 blockade and immune activation
- Anti-tumor response
Unlike chemotherapy, nivolumab harnesses your own immune system to fight cancer, which is why side effects and response patterns differ significantly.
Tests required before starting nivolumab
These tests confirm your eligibility, establish baseline health status, and guide dosing and monitoring during treatment.
| Complete blood count (CBC) | Confirms adequate white blood cells, red blood cells, and platelets before starting. Repeated during treatment to monitor for immune-related blood abnormalities. |
| Liver function tests (AST, ALT, bilirubin) | Establishes baseline liver function. Nivolumab can cause immune-related hepatitis, so baseline values are essential for monitoring. |
| Kidney function tests (creatinine, eGFR) | Confirms adequate kidney function before treatment and during monitoring. Nivolumab can rarely cause kidney inflammation. |
| Thyroid function tests (TSH, T4) | Baseline thyroid assessment. Nivolumab can trigger thyroid dysfunction (hypothyroidism or hyperthyroidism) in some patients, so baseline measurement is important. |
| PD-L1 immunohistochemistry (IHC) | Required or recommended for many cancers to guide treatment decisions. Your oncologist will explain your PD-L1 status and how it affects your treatment plan. |
| MSI-H/dMMR testing (for colorectal cancer) | Essential for colorectal cancer patients. Determines eligibility and guides whether nivolumab is used alone or with ipilimumab. |
| Imaging (CT, PET-CT, or MRI) | Establishes baseline tumor burden and disease extent. Helps measure response to treatment during follow-up. Repeat imaging typically occurs every 8 to 12 weeks. |
| Pregnancy test (if applicable) | Required for women of childbearing potential before starting nivolumab, as it may harm a developing baby. |
How is nivolumab given?
Nivolumab is given as an intravenous infusion in a hospital or dedicated infusion centre. Dosing and schedule vary by cancer type, combination therapy, and treatment phase.
| Dose for monotherapy | Typical monotherapy doses are 240 mg intravenously every 2 weeks, 360 mg every 3 weeks, or 480 mg every 4 weeks. Your oncologist determines the dose and schedule based on your cancer type and treatment plan. |
| Dose with ipilimumab combination | When combined with ipilimumab, nivolumab is typically given at 3 mg/kg (up to 360 mg) every 3 weeks for 4 cycles, then nivolumab alone as maintenance. |
| Dose with chemotherapy | When combined with chemotherapy for lung cancer, gastric cancer, or esophageal cancer, nivolumab dose is typically 240 mg every 2 weeks concurrent with chemotherapy cycles. |
| Subcutaneous option (Opdivo Qvantig) | A subcutaneous formulation (nivolumab with hyaluronidase) was FDA approved in December 2024 and is now available as an alternative to IV infusion for eligible patients. |
| Infusion time | Intravenous nivolumab is typically infused over 30 to 60 minutes. You will be monitored during and for a period after the infusion for any reactions. |
| Duration of treatment | Treatment continues until cancer progression, intolerable side effects, or up to 2 years of continuous therapy. Some patients who achieve stable disease may continue beyond 2 years per their oncologist's judgment. |
| Missed dose | Do not skip scheduled doses. If you miss an appointment, contact your oncology team immediately to reschedule. Do not attempt to 'make up' a dose on your own. |
Clinical evidence and benefits
Nivolumab has demonstrated durable responses and improved survival in multiple cancer types. Benefits vary by cancer, prior treatment, and individual factors.
| Melanoma response | In landmark CheckMate trials, nivolumab as monotherapy achieved durable complete responses in approximately 10-15% of patients and partial responses in additional patients with advanced melanoma. |
| NSCLC survival improvement | In CheckMate 057, nivolumab monotherapy for previously treated NSCLC showed median overall survival of approximately 12.2 months versus 9.4 months with chemotherapy. |
| RCC first-line combination | CheckMate 214 demonstrated that nivolumab plus ipilimumab significantly improved overall survival compared to sunitinib in intermediate/poor-risk RCC, leading to NCCN preferred status. |
| HCC first-line combination | CheckMate 9DW (April 2025 FDA approval) showed nivolumab plus ipilimumab improved overall survival for unresectable/metastatic HCC compared to standard regimens. |
| MSI-H colorectal cancer | Nivolumab as monotherapy has shown substantial response rates in MSI-H/dMMR metastatic CRC, with some patients achieving durable complete remissions. |
| Quality of life benefit | For many patients, immunotherapy offers improved quality of life compared to chemotherapy. Side effects like hair loss, nausea, and neuropathy are less common with nivolumab. |
Individual responses vary significantly. These represent published clinical trial data. Your oncologist will discuss expected outcomes for your specific situation.
Side effects of nivolumab
Nivolumab activates the immune system, which can cause inflammation in various parts of the body. Most side effects are manageable, but some require prompt medical attention.
| Fatigue | Very common. Usually improves with rest and supportive care. May persist during and after treatment. |
| Skin reactions (rash, itching, dryness) | Common. Usually mild to moderate and manageable with topical creams or antihistamines. Rarely severe. |
| Diarrhea or abdominal discomfort | Common. Usually mild. Can be managed with diet changes and anti-diarrheal medications if needed. Severe cases require steroids and specialist evaluation. |
| Nausea or reduced appetite | Common but often mild. Anti-nausea medications and small frequent meals help. Seek help if severe. |
| Joint or muscle pain | Common. Usually manageable with analgesics. Rarely severe enough to halt treatment. |
| Cough or shortness of breath | Can occur due to immune-related pneumonitis. Mild cases improve without stopping treatment. Severe cases require steroids and possible treatment pause. |
| Thyroid problems | Hypothyroidism (low thyroid) is common and manageable with thyroid replacement. Hyperthyroidism (high thyroid) is less common but requires specialist management. |
| Immune-related hepatitis | Liver inflammation detected on blood tests. Mild cases may require monitoring only. Moderate to severe cases require steroids and possible treatment interruption. |
| Immune-related colitis | Severe diarrhea and abdominal pain from colon inflammation. Managed with steroids. Severe cases may require hospitalization. |
| Infusion reaction | Chills, fever, or rash during or shortly after infusion. Usually mild and managed by slowing the infusion. Premedication helps prevent recurrence. |
Contact your doctor immediately if you develop:
- Severe or persistent diarrhea, severe abdominal pain, or bloody stools.
- Difficulty breathing, severe cough, chest pain, or shortness of breath.
- Yellow eyes or skin, dark urine, or severe fatigue (signs of liver problems).
- Confusion, severe headache, vision changes, or severe weakness.
- Fever over 100.4 F (38 C), signs of infection, or any rapidly worsening symptom.
- Severe rash, blistering, or skin peeling affecting large body areas.
Safety precautions and drug interactions
Tell your oncologist and pharmacist about all medicines, supplements, and herbal products. Nivolumab has few major drug interactions, but certain conditions require special caution.
- Autoimmune disease (lupus, rheumatoid arthritis, IBD, multiple sclerosis). Nivolumab may trigger or worsen autoimmune conditions. Risk-benefit must be carefully evaluated.
- Previous organ transplant or stem cell transplant. Nivolumab may increase rejection risk. Specialist consultation essential.
- Chronic viral infections (hepatitis B, hepatitis C, HIV). Nivolumab may reactivate latent infections. Blood tests are needed before starting.
- Lung disease or history of chest radiation. Nivolumab increases pneumonitis risk. Baseline lung function testing recommended.
- Heart disease or myocarditis history. Nivolumab can rarely cause heart inflammation. Baseline cardiac assessment advised.
- Live vaccines. Avoid live vaccines during nivolumab treatment. Inactivated vaccines are safe.
- Pregnancy or breastfeeding. Nivolumab may harm a developing baby. Use effective contraception during and for 5 months after treatment. Do not breastfeed.
- Concurrent steroids or immune-suppressing drugs. These can interfere with nivolumab effectiveness. Dose adjustments or alternatives may be needed.
Nivolumab combination treatments
Nivolumab is frequently combined with other drugs to improve outcomes. The best combination depends on cancer type, prior treatment, and treatment goal.
| Nivolumab + ipilimumab (Yervoy) | Approved for melanoma, RCC, MSI-H colorectal cancer, mesothelioma, and HCC. Combination generally more effective but with increased side effects. Typically 4 cycles of combination followed by nivolumab maintenance. |
| Nivolumab + chemotherapy | Approved for NSCLC, gastric cancer, esophageal cancer, and urothelial carcinoma. Combines immune checkpoint blockade with cytotoxic chemotherapy for enhanced response. |
| Nivolumab + cabozantinib (Cabometyx) | Approved for advanced RCC. Combines immunotherapy with targeted therapy for improved survival, especially in intermediate/poor-risk disease. |
| Nivolumab + AVD (for Hodgkin lymphoma) | Recently approved (2026) for newly diagnosed stage III-IV classical Hodgkin lymphoma. First-line immunochemotherapy combination offering improved outcomes. |
| Nivolumab maintenance after combination | After initial combination therapy (e.g., nivolumab + ipilimumab), patients often continue nivolumab monotherapy as maintenance to sustain responses. |
| Sequential or switching strategies | If nivolumab stops working, your oncologist may switch to another immunotherapy, targeted therapy, chemotherapy, radiation, or clinical trials depending on cancer type and prior treatments. |
If nivolumab stops working
Resistance or disease progression can occur. Understanding potential mechanisms guides next-line options.
| Primary resistance | Some patients do not respond to nivolumab from the start. This may be due to low PD-L1 expression, high tumor mutation burden variations, or immunosuppressive tumor microenvironment. |
| Acquired resistance | After initial response, cancer can progress. Mechanisms include loss of PD-L1 expression, immune cell exhaustion, activation of alternative pathways, or development of new mutations. |
| Pseudoprogression | Rarely, tumors initially enlarge before shrinking due to immune activation. Repeat imaging or specialist evaluation helps distinguish true progression from pseudoprogression. |
| Next-line options | Switch to another checkpoint inhibitor, combine with chemotherapy, targeted therapy, radiation, or explore clinical trials. Repeat biopsy and biomarker testing may guide the choice. |
| Checkpoint inhibitor switches | Some patients who progress on nivolumab respond to pembrolizumab or atezolizumab. Combined approaches or different checkpoint inhibitor pairs are being tested in trials. |
Cost of nivolumab by country
Nivolumab costs vary widely depending on country, dose, treatment duration, hospital charges, and local pricing. Generic and biosimilar options are emerging.
| USA | Monthly costs range from $12,000 to $15,000 for innovator Opdivo. Patient assistance programs from Bristol Myers Squibb offer financial support for uninsured or underinsured patients. |
| UK and EU | Cost varies by country. In UK, NHS typically covers approved indications. Out-of-pocket costs are minimal. Private prescriptions are more expensive but covered by some insurance plans. |
| India | Innovator Opdivo/Opdyta is available but costly. Biosimilar nivolumab (Zydus and others) approved by CDSCO offers affordable access. Costs range from generic biosimilar at roughly 10-20% of innovator price. |
| China | Opdivo is available in major hospitals. Costs depend on local hospital pricing and reimbursement. Some regions offer medical insurance coverage. Generic biosimilars under development may improve affordability. |
| Payment and assistance | Check for patient assistance programs, hospital financial support, insurance coverage, and clinical trial access. CancerFax can help explore cost-reduction strategies and access programs. |
Availability of nivolumab globally
Nivolumab is widely available in major cancer-treatment regions. Approved uses and pricing differ by country.
USA
FDA approved since 2014 for multiple indications. Available as intravenous Opdivo and subcutaneous Opdivo Qvantig (approved Dec 2024). Readily available at cancer centres and infusion facilities nationwide.
Europe
EMA approved for multiple indications. Available as Opdivo and Opdivo Qvantig. Covered by national health systems in many EU countries. Some regions may have formulary restrictions based on indication.
India
Innovator Opdyo/Opdyta available but costly. Zydus biosimilar nivolumab approved July 2024 and cleared for market January 2026. Multiple companies developing biosimilars. Excellent affordability through biosimilar options.
China
NMPA approved for multiple indications. Available in major cancer hospitals in Beijing, Shanghai, Guangzhou, and other major cities. Local supply and pricing vary by province and reimbursement status.
Singapore & East Asia
Available in major cancer centres. Approved by Health Sciences Authority (Singapore) and similar regulators. Higher costs in smaller nations. Some patients travel to regional hubs for treatment.
Australia
Approved by TGA (Therapeutic Goods Administration). Listed on PBS (Pharmaceutical Benefits Scheme) for eligible patients, making it affordable. Available through public and private hospitals.
Nivolumab in current clinical trials
Nivolumab continues to be studied in numerous trials for new cancer types, combinations, biomarker-enriched populations, and treatment sequences.
| New cancer indications | Ongoing trials explore nivolumab in pancreatic cancer, biliary cancer, ovarian cancer, and other cancers where efficacy remains under investigation. |
| Novel combinations | Trials combining nivolumab with targeted therapies, other checkpoint inhibitors (e.g., LAG-3 inhibitors), cancer vaccines, and cellular therapies are underway globally. |
| Biomarker-selected populations | Studies identifying which biomarkers predict nivolumab response (TMB, microsatellite instability, specific mutations) help optimize patient selection. |
| Early-stage disease | Adjuvant and neoadjuvant nivolumab trials for resectable cancers to reduce recurrence risk. Many have shown promising results and led to FDA approvals. |
| Resistance mechanism studies | Research investigating why some patients resist nivolumab and developing strategies to overcome resistance through combination approaches. |
Your treatment journey with nivolumab
Diagnosis and molecular testing
Baseline blood work and imaging
Oncology consultation and treatment planning
First infusion and early monitoring
Ongoing infusions and monitoring
Side effect management
Response assessment and continuation decisions
Treatment continuation and maintenance
Follow-up after stopping treatment
Questions to ask your oncologist about nivolumab
- Is nivolumab approved for my exact cancer type and stage in my country?
- Do I need PD-L1 or MSI-H/dMMR testing before starting nivolumab?
- Will I receive nivolumab alone or with other drugs?
- How often will I receive infusions and how long does each take?
- How will you measure whether nivolumab is working?
- What are the most serious side effects I should watch for?
- How will side effects be managed if they occur?
- What is the estimated cost of nivolumab, and are there financial assistance programs?
- How long will I continue nivolumab if it is working?
- What are my options if nivolumab stops working or I cannot tolerate it?
How CancerFax supports nivolumab patients
CancerFax helps patients understand nivolumab, navigate treatment options, and access care globally.
| Report review and explanation | Upload your pathology reports, PD-L1 results, MSI-H/dMMR testing, and imaging. Our team reviews and explains what these mean for nivolumab eligibility and expected outcomes. |
| Second opinion from immunotherapy specialists | Get a specialist oncology second opinion on your treatment plan. If you are considering nivolumab, our network includes doctors experienced with this immunotherapy across multiple cancer types. |
| Treatment access guidance | We help identify where nivolumab is available in India, China, and globally. We provide cost estimates and help explore patient assistance programs, clinical trials, and affordable biosimilar options. |
| Side effect management support | If you experience immune-related side effects during nivolumab, we can connect you with specialists in immune-related toxicity management and provide supportive care guidance. |
| Clinical trial matching | Nivolumab is studied in numerous trials for new combinations and indications. We help identify relevant trials in your region and coordinate enrollment if appropriate. |
| India and China treatment coordination | For patients seeking advanced cancer care in India or China, we coordinate hospital partnerships, medical records transfer, and on-ground logistics. Many Indian and Chinese centres offer nivolumab at lower costs. |
Frequently asked questions about nivolumab
Common questions from patients and caregivers about this immunotherapy
Nivolumab is an immunotherapy that works by blocking PD-1, a checkpoint on immune cells. Rather than directly killing cancer cells like chemotherapy does, nivolumab helps your immune system recognize and attack cancer. It is given as an intravenous infusion, typically every 2 to 4 weeks depending on the indication.
Response timelines vary by cancer type and individual patient factors. Some patients show response within 3 months, while others may take 6 months or longer. Your oncologist will use imaging and blood tests to measure response. Rarely, tumors may initially appear larger before shrinking—a phenomenon called pseudoprogression.
Nivolumab has few major drug interactions, but it is important to tell your oncologist and pharmacist about all medicines, supplements, and herbal products you take. Live vaccines should be avoided during treatment. Some medications that suppress the immune system may interfere with nivolumab's effectiveness.
Before starting nivolumab, you will typically need blood tests (CBC, liver function, kidney function, thyroid), imaging (CT or PET-CT), and confirmation of your cancer diagnosis through biopsy. For some cancers, PD-L1 or MSI/MMR testing may be required to guide treatment decisions.
Commonly reported side effects include high blood pressure, fatigue, diarrhea, reduced appetite and weight loss, nausea, hand-foot skin reaction, mouth sores, hoarseness, proteinuria, and low thyroid function. Most are manageable with dose adjustments and supportive medicines, but require regular monitoring. Serious side effects — severe hypertension, liver toxicity, kidney impairment, gastrointestinal perforation, and blood clots — can occur and require prompt medical attention.
Nivolumab may harm a developing baby and is not recommended during pregnancy. If you are of childbearing age, use effective contraception during treatment and for at least 5 months after your last dose. Tell your oncologist if you are pregnant, planning pregnancy, or breastfeeding before starting nivolumab.