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Opdivo (nivolumab)

Opdivo® (nivolumab) is a type of immunotherapy. It is used to treat melanoma in the following ways:1

  • Alone for newly diagnosed advanced melanoma
  • Alone as adjuvant treatment for melanoma that was completely removed by surgery
  • In combination for newly diagnosed advanced melanoma

Opdivo can be used alone or with a medication called Yervoy® (ipilimumab). Neither of these drugs comes in generic form. Opdivo is similar to Keytruda® (pembrolizumab), another drug approved to treat unresectable or metastatic melanoma.

Opdivo is approved to treat other cancers as well, including: non-small cell lung cancer, kidney cancer, classical Hodgkin lymphoma, head and neck squamous cell carcinoma, bladder cancer, along with others.1

How does Opdivo work?

Melanoma cells disguise themselves in order to hide from your immune system’s T-cells. Opdivo works because it prevents cancer cells from disguising themselves. Opdivo is described in many ways, including:

  • immune checkpoint inhibitor
  • anti-PD-1 therapy
  • PD-1 inhibitor

T-cells (T-lymphocytes) are a type of white blood cell.2 T-cells fight cancer and infection. They travel through the body, checking whether the cells they find are normal (healthy) or foreign (unhealthy). A receptor on the outside surface, called PD-1, does the checking. PD-1 stands for “programmed death receptor-1.”

Cancer cells try to hide from T-cells. They have proteins called PD-L1 or PD-L2 (programmed death ligand-1 or 2) on their outside surface. When PD-L1 or PD-L2 binds (connects) to PD-1, it basically acts like an “off switch” for the T-cell. This makes the T-cell ignore the cancer cell.

Opdivo binds to the PD-1 receptor.1 This blocks the receptor from interacting with PD-L1 or PD-L2. The T-cell is able to identify and attack the cancer cell.

How effective is Opdivo?

In people without a BRAF mutation who had not received other melanoma medications, Opdivo:3

  • Increased overall survival time.
  • Increased the time until the cancer progressed.

The details of this study are described below. Two other studies of Opdivo are still going on. The early results are promising. Additional results will help doctors and patients understand how Opdivo affects survival and cancer progression.

Previously untreated patients without BRAF mutation. Opdivo was compared with chemotherapy in 418 patients.3 The patients in this study had never been treated with Yervoy. They did not have a BRAF mutation. People with a BRAF mutation have more treatment options than people without the mutation. This is because certain medications only work for cancer with BRAF mutation.

Forty percent (40%) of patients in this study responded to Opdivo. Approximately 14% of patients responded to chemotherapy.3 “Response” has to do with whether the tumor shrinks or grows more slowly while on treatment. Response is only about tumor changes and it does not measure whether you—as a whole patient—have improved. Response is also different from survival. Response to treatment can be partial or complete.

Median progression-free survival was 5.1 months for the people treated with Opdivo.3 Progression-free survival is how long a person survives after treatment without the cancer getting worse. Median progression-free survival means that at 5.1 months, half of the group had cancer progression and half had not.

At 12 months, approximately 73% of people treated with Opdivo were alive.3 In comparison, approximately 42% of people treated with chemotherapy were alive.

Patients previously treated with Yervoy and targeted therapy. In another study of 405 patients, Opdivo was compared with chemotherapy.4 These patients had already been treated with Yervoy. Some also had tried a BRAF or MEK inhibitor.

About one-third (32%) of the first 120 patients treated with Opdivo responded to treatment.4 In comparison, only 8% of patients responded to chemotherapy. Progression-free survival with Opdivo was 4.7 months.5 This study is still ongoing. More results, including overall survival outcomes, should be coming.

Opdivo plus Yervoy. In this trial, 945 patients were assigned to treatment with Opdivo or Yervoy or both.6 The patients in this study had never been treated with medication for melanoma. In each arm, the percentage who responded to treatment were:1

  • Opdivo + Yervoy: 50%
  • Opdivo: 40%
  • Yervoy: 14%

The median progression-free survival was:6

  • Opdivo + Yervoy: 11.5 months
  • Opdivo: 6.9 months
  • Yervoy: 2.9 months

This study is still ongoing. More results, including overall survival outcomes, should be coming.

How is Opdivo given?

Before receiving Opdivo, read the Medication Guide that comes in the package. If you are also receiving Yervoy, read the Medication Guide for that medication too. Talk to your doctor about how often and how many treatments you will need.

Opdivo is taken through an intravenous (IV) line. Your doctor will administer Opdivo. It takes about 30 minutes to administer the medication.1 Opdivo can be given every 2 to 4 weeks. Talk to your prescriber about the different dosing options.

If you are also taking Yervoy, you will take both medications on the same day. This combination is given every 3 weeks. Usually, a total of 4 doses of the combination are given.1

What are the side effects of Opdivo?

The most common side effects of Opdivo are:1

  • Feeling tired
  • Muscle, bone, or joint pain
  • Diarrhea or constipation
  • Cough or shortness of breath
  • Back pain
  • Fever
  • Rash or itchy skin
  • Nausea
  • Decreased appetite
  • Upper respiratory tract infection
  • Weakness

Opdivo can cause your immune system to attack normal (healthy) organs and tissue. Rare but serious possible side effects are:

  • Lung inflammation (pneumonitis)
  • Intestinal inflammation (colitis)
  • Liver inflammation (hepatitis)
  • Problems with hormone glands (thyroid, pituitary, adrenal, pancreas)
  • Kidney inflammation and kidney failure
  • Skin problems
  • Brain inflammation
  • Other problems (changes in eye sight, severe muscle pain, severe or lasting muscle or joint pain)

Opdivo is infused (put) into your vein through an IV line. Severe, life-threatening infusion reactions can occur. Symptoms include chills, shaking, difficulty breathing, itching, rash, flushing, dizziness, fever, and feeling like you may pass out.1

Who should not take Opdivo?

Opdivo can harm an unborn baby.1 Women who could become pregnant should use effective birth control during treatment. Continue using birth control for at least 5 months after the last dose of Opdivo. Do not breastfeed while being treated with Opdivo.

Tell your doctor about any medical conditions you have, especially:

  • Immune system problems (such as Crohn’s disease, ulcerative colitis, lupus).
  • Previous organ transplant.
  • Lung or breathing problems.
  • Liver problems.

What precautions are needed when taking Opdivo?

You will need regular blood tests to check for side effects of Opdivo. Your doctor may prescribe corticosteroids or hormone replacement medicines to treat certain side effects.1

Women who can become pregnant should use birth control during and for at least 5 months after treatment.1 Women should not breastfeed during treatment.

Written by: Sarah O'Brien | Last reviewed: October 2018.
  1. Opdivo® [prescribing information]. Princeton, NJ: Bristol-Myers Squibb Company; February 2017.
  2. PubMed Health. T-Lymphocytes (T-Cells). Accessed April 7, 2017 at:
  3. Robert C, Long GV, Brady B, et al. Nivolumab in previously untreated melanoma without BRAF mutation. N Engl J Med. 2015;372:320-330.
  4. Weber JS, D'Angelo SP, Minor D, et al. Nivolumab versus chemotherapy in patients with advanced melanoma who progressed after anti-CTLA-4 treatment (CheckMate 037): a randomised, controlled, open-label, phase 3 trial. Lancet Oncol. 2015;16:375-384.
  5. NCCN Clinical Practice Guidelines in Oncology. Melanoma. Version 1.2017. Published November 10, 2016.
  6. Larkin J, Chiarion-Sileni V, Gonzalez R, et al. Combined nivolumab and ipilimumab or monotherapy in untreated melanoma. N Engl J Med. 2015;373:23-34.