Tips

How many patients are enrolled in ipilimumab Phase 3 study?

How many patients are enrolled in ipilimumab Phase 3 study?

In this randomized, double-blind, phase 3 study, we enrolled patients at 125 centers in 13 countries in North America, South America, Europe, and Africa.

How is ipilimumab used to treat metastatic melanoma?

There were 14 deaths related to the study drugs (2.1%), and 7 were associated with immune-related adverse events. Ipilimumab, with or without a gp100 peptide vaccine, as compared with gp100 alone, improved overall survival in patients with previously treated metastatic melanoma.

Are there any adverse events with ipilimumab alone?

Grade 3 or 4 immune-related adverse events occurred in 10 to 15% of patients treated with ipilimumab and in 3% treated with gp100 alone. There were 14 deaths related to the study drugs (2.1%), and 7 were associated with immune-related adverse events.

How often should I take ipilimumab and nivolumab?

Patients receive ipilimumab IV over 90 minutes and anti-GITR agonistic monoclonal antibody BMS-986156 IV over 60 minutes on day 1. Treatment repeats every 21 days for up to 4 cycles in the absence of disease progression or unacceptable toxicity. Beginning day 1 of cycle 5 (day 85), patients receive nivolumab IV over 30 minutes.

When did ipilimumab get approved for prostate cancer?

Ipilimumab gained FDA approval in early 2011. In 2008/09 Medarex performed a phase I/II dose escalation clinical trial of ipilimumab in metastatic hormone-refractory prostate cancer (HRPC). Some of the patients with advanced prostate cancer had their tumors drastically shrink, promoting further trials.

How often should I take nivolumab and ipilimumab?

On 16 April 2018, the FDA approved the combination therapy nivolumab and ipilimumab for advanced renal cell carcinoma, both owned by Bristol-Myers Squibb. The recommended dosing is nivolumab (3 mg/kg) followed by ipilimumab (1 mg/kg) weekly every 3 weeks for 4 doses, then nivolumab for 240 mg for every 2 weeks. This section needs expansion.

When did Medarex start testing ipilimumab in lung cancer?

Medarex ran a phase II trial of ipilimumab in addition to platinum-based chemotherapy ( carboplatin) in patients with small cell and non-small cell lung cancer. It was scheduled to run from February 2008 to December 2011.

How to determine the antitumor activity of ipilimumab?

To determine antitumor activity of ipilimumab therapy with BMS-986156 (30 or 100 mg) as well as nivolumab with BMS-986156 (30 mg) with SBRT treatment for 1-4 lung lesions in both the SBRT treated lesion and non-irradiate tumors. II.