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Yervoy (Ipilimumab) - Summary

 
 



WARNING: IMMUNE-MEDIATED ADVERSE REACTIONS

YERVOY can result in severe and fatal immune-mediated adverse reactions due to T-cell activation and proliferation. These immune-mediated reactions may involve any organ system; however, the most common severe immune-mediated adverse reactions are enterocolitis, hepatitis, dermatitis (including toxic epidermal necrolysis), neuropathy, and endocrinopathy. The majority of these immune-mediated reactions initially manifested during treatment; however, a minority occurred weeks to months after discontinuation of YERVOY.

Permanently discontinue YERVOY and initiate systemic high-dose corticosteroid therapy for severe immune-mediated reactions. [See Dosage and Administration.]

Assess patients for signs and symptoms of enterocolitis, dermatitis, neuropathy, and endocrinopathy and evaluate clinical chemistries including liver function tests and thyroid function tests at baseline and before each dose. [See Warnings and Precautions (5.1, 5.2, 5.3, 5.4, 5.5).]

 

YERVOY SUMMARY

YERVOY (ipilimumab) is a recombinant, human monoclonal antibody that binds to the cytotoxic T-lymphocyte-associated antigen 4 (CTLA-4). Ipilimumab is an IgG1 kappa immunoglobulin with an approximate molecular weight of 148 kDa. Ipilimumab is produced in mammalian (Chinese hamster ovary) cell culture.

YERVOY (ipilimumab) is indicated for the treatment of unresectable or metastatic melanoma.


See all Yervoy indications & dosage >>

NEWS HIGHLIGHTS

Published Studies Related to Yervoy (Ipilimumab)

Q-TWiST analysis comparing ipilimumab/dacarbazine vs placebo/dacarbazine for patients with stage III/IV melanoma. [2013]
in this trial... CONCLUSION: During the first year of study, there was little difference between

Assessment of association between BRAF-V600E mutation status in melanomas and clinical response to ipilimumab. [2012]
Ipilimumab, a fully human monoclonal antibody against cytotoxic T lymphocyte antigen-4, has demonstrated significant improvement in overall survival in previously treated advanced melanoma patients. The BRAF inhibitor, vemurafenib, has shown up to 78% objective response rates in melanoma patients harboring the BRAF-V600E mutation but not in patients lacking the mutation...

Ipilimumab targeting CD28-CTLA-4 axis: new hope in the treatment of melanoma. [2012]
Ipilimumab, a fully human monoclonal antibody that binds to CTLA-4 (cytotoxic T lymphocyte-associated antigen 4), is the new hope in the treatment of patients with advanced melanoma.Further research is necessary to elucidate role of ipilimumab in adjuvant setting as well as in synergy with other novel modalities for the treatment of metastatic melanoma.

Ipilimumab plus dacarbazine for previously untreated metastatic melanoma. [2011]
patients with previously untreated metastatic melanoma... CONCLUSIONS: Ipilimumab (at a dose of 10 mg per kilogram) in combination with

Nivolumab and ipilimumab versus ipilimumab in untreated melanoma. [2015]
melanoma... CONCLUSIONS: The objective-response rate and the progression-free survival among

more studies >>

Clinical Trials Related to Yervoy (Ipilimumab)

Ipilimumab and Stereotactic Body Radiation Therapy (SBRT) in Advanced Solid Tumors [Recruiting]
The goal of this clinical research study is to find the highest tolerable dose of ipilimumab and SBRT. The safety and effectiveness of these treatments given consecutively will also be studied.

Bevacizumab Plus Ipilimumab in Patients With Unresectable Stage III or IV Melanoma [Active, not recruiting]
The purpose of this research study is to determine the safety of using the study drugs bevacizumab and ipilimumab together, and the doses in combination which can be given to people safely. This study also seeks to investigate whether using both study drugs lengthens the amount of time before the participants melanoma worsens.

Concurrent Ipilimumab and Stereotactic Ablative Radiation Therapy (SART) for Oligometastatic But Unresectable Melanoma [Recruiting]
The purpose of this study is to evaluate if precisely-targeted radiation therapy, known as stereotactic ablative radiotherapy (SART), given during treatment with the drug ipilimumab (Yervoy) will improve survival for patients with melanoma that has spread to five or fewer sites (oligometastatic). Blood samples will be collected for research purposes. Planned studies include exploration of certain gene mutations and serum markers as predictors of response to ipilimumab treatment. Research lab studies will also evaluate if circulating tumor cells (CTC) can be accurately detected and isolated from the blood using novel laboratory techniques and if they are a prognostic/predictive marker for treatment response. Test results will not be given to participants or their physicians. In some cases, CTC may be grown for long-term cell lines for further research.

Ipilimumab and Lenalidomide in Advanced Cancer [Recruiting]
The goal of this clinical research study is to find the highest tolerable dose of the combination of Yervoy® (ipilimumab) with Revlimid® (lenalidomide) that can be given to patients with advanced cancer. The safety of these drugs will also be studied. Ipilimumab is designed to increase the immune system's ability to fight cancer. Lenalidomide is designed to change the body's immune system. It may also interfere with the development of tiny blood vessels that help support tumor growth. This may decrease the growth of cancer cells.

A Combination of Ipilimumab and Fotemustine for Treat Unresectable Locally Advanced or Metastatic Melanoma [Completed]
This study is designed to assess the safety and efficacy of a combination of ipilimumab and fotemustine in Patients with Unresectable Locally Advanced or Metastatic Malignant Melanoma.

more trials >>

Reports of Suspected Yervoy (Ipilimumab) Side Effects

Death (191)Neoplasm Malignant (135)Diarrhoea (134)Rash (58)Colitis (54)Nausea (50)Pruritus (48)Fatigue (44)Headache (30)Decreased Appetite (29)more >>


Page last updated: 2015-08-10

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