Phase II Study of Nivolumab in combination with Ipilimumab for Uveal Melanoma
Sapna P. Patel
The goal of this clinical research study is to learn if ipilimumab and nivolumab can help to control uveal melanoma. Ipilimumab is designed to increase the immune system's ability to fight cancer. Nivolumab is an antibody (a protein that attacks foreign cells) that is designed to allow the body’s immune system to work against tumor cells.
Disease Group: Melanoma
Treatment Agent: Ipilimumab,Nivolumab
Treatment Location: Only at MDACC
Sponsor: Bristol Myers Squibb,NIH,University of Texas, MD Anderson Cancer Center,UTMDACC IRG - Clinical Research
STUDY OBJECTIVES Primary Objective Overall response rate Secondary Objectives Progression-free survival, median overall survival, one-year overall survival. Exploratory Objectives Exploratory Objectives include tissue and blood correlates to define immune infiltration and signatures as a result of treatment with nivolumab plus ipilimumab.
IRB Review and Approval Date: 04/28/2015
Recruitment Status: Open
Projected Accrual: N/A
1) Willing and able to give written informed consent.
2) History of uveal melanoma and documented metastatic disease with at least one measurable lesion is required. which is >/= 1 cm x 1 cm (on spiral CT or equivalent).
3) Any number of prior therapies is allowed.
4) Required values for initial laboratory tests: WBC >/= 2000/uL, ANC >/= 1500/uL, Platelets >/= 100 x 10^3/uL, Hemoglobin >/= 9 g/dL, Creatinine </= 1.5 x ULN or creatinine clearance (CrCl) > 40 mL/min (using the Cockcroft-Gault formula): Female CrCl = (140 - age in years) x weight in kg x 0.85, 72 x serum creatinine in mg/dL, Male CrCl = (140 - age in years) x weight in kg x 1.00 72 x serum creatinine in mg/dL, AST/ALT</= 3 x ULN for patients without liver metastasis,</= 5 x ULN for liver metastases, Bilirubin </= 1.5 x ULN, (except patients with Gilbert’s Syndrome, who must have a total bilirubin less than 3.0 mg/dL)
5) In suspected patients no active or chronic infection with HIV, Hepatitis B, or Hepatitis C.
6) Performance status ECOG 0-1.
7) Men and women, >/= 18 years of age. Because no dosing or adverse event data are currently available on the use of ipilimumab in patients </= 18 years of age, minors are excluded from this study.
8) Baseline imaging in the form of CT chest, abdomen, pelvis with oral and intravenous contrast within 28 days of study entry. For patients with a contrast allergy, choice of alternative body imaging will be at the discretion of the investigator or his designee. MRI of the brain is only needed if clinically indicated.
9) Prior to start of treatment must be more than 21 days elapsed from surgery, radiation therapy, or prior chemotherapy. More than 42 days elapsed from prior immune therapy including vaccines.
10) Women of childbearing potential (WOCBP) and fertile men with partners of childbearing potential must be using an adequate method of contraception to avoid pregnancy throughout the study and for up to 26 weeks after the last dose of investigational product, in such a manner that the risk of pregnancy is minimized.
1) Untreated primary uveal melanoma except in cases where metastatic
disease is diagnosed at the time of primary disease.
2) Metastatic uveal melanoma patients with bone-only disease.
3) Any other malignancy from which the patient has been disease-free for less than 2 years, with the exception of adequately treated and cured basal or squamous cell skin cancer, superficial bladder cancer or carcinoma in situ of the cervix, breast, or prostate.
4) Subjects with active, known or suspected autoimmune disease. Subjects with vitiligo, type I diabetes mellitus, residual hypothyroidism due to autoimmune condition only requiring hormone replacement, psoriasis not requiring systemic treatment,
5) Any underlying medical or psychiatric condition, which in the opinion of the investigator will make the administration of ipilimumab hazardous or obscure the interpretation of AEs, such as a condition associated with frequent diarrhea.
6) Any non-oncology vaccine therapy used for prevention of infectious diseases (for up to 1 month before or after any dose of ipilimumab).
7) Concomitant therapy with any of the following: tamoxifen, toremifene, IL 2, interferon, or other non-study immunotherapy regimens; cytotoxic chemotherapy; immunosuppressive agents; other investigation therapies; or chronic use of systemic corticosteroids greater than physiologic replacement doses. Ocular steroid use is acceptable.
8) Women of childbearing potential (WOCBP)who: (a.) are unwilling or unable to use an acceptable method of contraception to avoid pregnancy for their entire study period and for up to 26 weeks after cessation of study drug, or (b.) have a positive pregnancy test at baseline, or (c.) are pregnant or breastfeeding.
9) Prisoners or subjects who are compulsorily detained (involuntarily incarcerated) for treatment of either a psychiatric or physical (e.g., infectious) illness.
Information and next steps
Sapna P. Patel
Melanoma Medical Oncology
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