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Indications

Prescribing Information

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Potential OPDIVO® (nivolumab) user teaching his grandson how to wax a surfboard.
Potential OPDIVO® (nivolumab) user teaching his grandson how to wax a surfboard.

Clinical trial results
for advanced gastroesophageal
cancer

For certain previously untreated adults with
advanced gastric cancer, gastroesophageal
junction cancer, and esophageal adenocarcinomas

Actor portrayals.
OPDIVO + chemotherapy is not approved for people
younger than 18 years of age.

An FDA-approved combination of immunotherapy and chemotherapy that helped people live longer compared to chemotherapy alone

About the clinical trial

In a clinical trial of 1,581 people with previously untreated advanced gastric cancer, gastroesophageal junction cancer, and esophageal adenocarcinomas, 789 people were given OPDIVO + chemotherapy and 792 people were given chemotherapy alone. The chemotherapy used for both groups in this clinical trial was modified FOLFOX-6 (leucovorin, fluorouracil, and oxaliplatin) or CapeOX (capecitabine and oxaliplatin).

People given OPDIVO + chemotherapy lived longer compared to chemotherapy alone

At 14 months, half the people given OPDIVO® + chemotherapy were alive.
OPDIVO + chemotherapy

Half the people were alive

At 12 months, half the people given chemotherapy were alive.
Chemotherapy alone

Half the people were alive

In the primary analysis with a follow-up time of 1 year, people given OPDIVO + chemotherapy had a 20% lower risk of dying than those given chemotherapy alone.

More people given OPDIVO + chemotherapy saw their tumors shrink or disappear completely compared to chemotherapy alone at 1 year (primary analysis)

OPDIVO + chemotherapy

Chemotherapy alone

Tumors disappeared completely (complete response)

10% saw tumors disappear completely in response to OPDIVO® + chemotherapy compared to 7% in response to chemotherapy.

Tumors shrank
(partial response)

37% saw tumors shrink in response to OPDIVO® + chemotherapy compared to 30% in response to chemotherapy.

Tumors shrank or disappeared completely (overall response)

47% given OPDIVO® + chemotherapy saw an overall response to treatment compared to compared to 37% given chemotherapy.

Words to know

Overall response rate is the percentage of patients who responded to treatment. These patients saw their tumors either shrink or disappear completely.

Partial response is when a tumor reacts to treatment and shrinks.

Complete response is when a tumor reacts to treatment and disappears completely. This is the disappearance of any measurable tumors in response to treatment. This does not mean the cancer has been cured.

OPDIVO + chemotherapy will not work for everyone. Individual results may vary.

“The first words out of my mouth were: ‘Let’s get a game plan.’”

Rob’s story

Rob is a husband, father of two, and former coach for kids' sports teams. See how he, his wife, and his doctor made a game plan with OPDIVO + chemotherapy for advanced esophageal cancer.

Rob, a husband and father of two, discusses his experience with OPDIVO® (nivolumab) + chemotherapy for advanced esophageal cancer.

Should I ask my doctor about OPDIVO + chemotherapy?

Talk to your doctor about a potential first treatment option for advanced gastroesophageal cancer.

Potential OPDIVO® (nivolumab) user sitting and looking out into the shore.
Hands exploring how OPDIVO® (nivolumab) works and learning how this treatment may help fight cancer.

How treatment works

See how this treatment may help your body fight cancer

OPDIVO® (nivolumab) side effects.

Side effects

View side effects of treatment and learn how to manage them

Nurse monitoring a gentleman's infusion of OPDIVO® (nivolumab) immunotherapy treatment.

Getting an infusion

See your recommended treatment plan and what to expect from an infusion

For certain previously untreated adults with advanced gastric cancer, gastroesophageal junction cancer, and esophageal adenocarcinomas

OPDIVO® (nivolumab) is a prescription medicine used in combination with chemotherapy that contains fluoropyrimidine and platinum to treat adults with cancer of the stomach (gastric), junction between the stomach and esophagus (gastroesophageal junction), and esophagus that is a type called adenocarcinoma and cannot be removed with surgery or has spread to other parts of the body.

It is not known if OPDIVO is safe and effective in children younger than 12 years of age with melanoma or MSI-H or dMMR metastatic colorectal cancer.


It is not known if OPDIVO is safe and effective in children for the treatment of any other cancers.