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General Information

Opdivo (nivolumab) is a programmed death receptor-1 (PD-1) blocking antibody.

Opdivo is specifically indicated for adult and pediatric (12 years and older) 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, as a single agent or in combination with ipilimumab.

Opdivo is supplied as an injection for intravenous administration. The recommended dose is as follows:

Single Agent The recommended dose of Opdivo as a single agent is 240 mg every 2 weeks administered as an intravenous infusion over 30 minutes until disease progression or unacceptable toxicity.

With Ipilimumab The recommended dose of Opdivo is 3 mg/kg administered as an intravenous infusion over 30 minutes, followed by ipilimumab 1 mg/kg administered as an intravenous infusion over 30 minutes on the same day, every 3 weeks for 4 doses. After completing 4 doses of the combination, administer Opdivo 240 mg as a single agent every 2 weeks as an intravenous infusion over 30 minutes until disease progression or unacceptable toxicity.

Clinical Results

FDA Approval

These indications are approved under accelerated approval based on overall response rate and duration of response. Continued approval for these indications may be contingent upon verification and description of clinical benefit in confirmatory trials.

CHECKMATE-142 was a multicenter, non-randomized, multiple parallel-cohort, open-label study conducted in patients with locally determined dMMR or MSI-H metastatic CRC (mCRC) who had disease progression during or after prior treatment with fluoropyrimidine-, oxaliplatin-, or irinotecan-based chemotherapy. Patients enrolled in the single agent Opdivo MSI-H mCRC cohort received Opdivo 3 mg/kg by intravenous infusion (IV) every 2 weeks. Patients enrolled in the Opdivo plus ipilimumab MSI-H mCRC cohort received Opdivo 3 mg/kg and ipilimumab 1 mg/kg IV every 3 weeks for 4 doses, followed by Opdivo 3 mg/kg IV as a single agent every 2 weeks. Treatment in both cohorts continued until unacceptable toxicity or radiographic progression. Tumor assessments were conducted every 6 weeks for the first 24 weeks and every 12 weeks thereafter. Efficacy outcome measures included overall response rate (ORR) and duration of response (DOR) as assessed by an independent radiographic review committee (IRRC) using Response Evaluation Criteria in Solid Tumors (RECIST v1.1). A total of 74 patients were enrolled in the single-agent MSI-H mCRC Opdivo cohort. A total of 119 patients were enrolled in the Opdivo plus ipilimumab MSI-H mCRC cohort. In the CheckMate -142 trial, among patients (53/74) who received prior treatment with a fluoropyrimidine, oxaliplatin, and irinotecan, 28% responded to treatment with Opdivo. The percentage of patients with a complete response was 1.9% (1/53) and the percentage of patients with a partial response was 26% (14/53). Among these responders, the median duration of response was not reached (range: 2.8+-22.1+ months). Among all enrolled patients, 32% responded to treatment with Opdivo; 2.7% (2/74) experienced a complete response, 30% (22/74) experienced a partial response.

Side Effects

Adverse effects associated with the use of Opdivo as a single agent may include, but are not limited to, the following:

fatigue

rash

musculoskeletal pain

pruritus

diarrhea

nausea

asthenia

cough

dyspnea

constipation

decreased appetite

back pain

arthralgia

upper respiratory tract infection

pyrexia

headache

abdominal pain

Adverse effects associated with the use of Opdivo in combination with ipilimumab may include, but are not limited to, the following: