MDACC Study Summary 2011-0919

Study Summary
No. 2011-0919:.......Melanoma......Sapna P. Patel......Melanoma Medical Oncology

Study Summary Title



Study Summary Number:	2011-0919

Study Title:	Phase I/II Study of Ipilimumab for Uveal Melanoma

Physician

New Patient Referral



Name:	Sapna P. Patel	Patients Call:	800-392-1611 (in U.S.A.) 713-792-6161 (outside U.S.A.)

Dept:	Melanoma Medical Oncology	Referring MD Call:	800-392-1611 (in U.S.A.) 713-792-6161 (outside U.S.A.)

Phone:	713-792-2921 Contact us about clinical trials

General Information



Disease Group:	Melanoma	Supported By:	Bristol Myers Squibb

Phase of Study:	Phase I/Phase II	Return Visit:

Treatment Agents:	Ipilimumab	Home Care:

Treatment Loc:	Only at MDACC

Estimated Length of Stay in Houston:


Description/ Intervention:	The goal of this clinical research study is to learn the highest tolerable dose of ipilimumab that can be given to patients with uveal melanoma. Researchers also want to learn if ipilimumab can help to control the disease. Ipilimumab is designed to increase the immune system's ability to fight cancer.

Study Objectives / Outcomes

STUDY OBJECTIVES
Primary Objective
Adjuvant arm: Distant metastasis-free survival at 36 months and to determine the MTD and safety of the drug.
Metastatic arm: Overall survival rate and to determine the MTD and safety of the drug.

Secondary Objectives
Adjuvant arm: Median distant metastasis-free survival, median overall survival and immune biomarker studies.
Metastatic arm: Overall response rate, progression-free survival, one-year overall survival, and immune biomarker studies.

Study Status Information



Study Activation / Registration Date:

IRB Review and Approval Date:	11/29/2012

Study Type:	Phase Ii Or Phase I/Ii

Recruitment Status:	Open

Projected Accrual:	N/A

Enrollment Eligibility

If you do not meet the enrollment eligibility, there may be other treatment options for you. Please Contact the Referral Office for more information.

Inclusion Criteria:

1) Willing and able to give written informed consent.

2) History of uveal melanoma. For the adjuvant arm, eligible patients must have completed local therapy for the eye no more than 12 months prior to enrollment. For the metastatic arm, documented metastatic disease with at least one measurable lesion is required which is >/=1 cm x 1 cm (on spiral CT or equivalent)

3) For the adjuvant arm, patients must be identified as high-risk based on any of the following: Class 2 gene expression signature using DecisionDx-UM and/or complete testing, or monosomy 3 and/or apical thickness greater than 8.0-mm. If a patient is eligible for both Cohort 1 and Cohort 2 based on multiple factors, the patient will be enrolled on Cohort 1.

4) Any number of prior therapies is allowed.

5) Required values for initial laboratory tests: WBC >/= 2000/uL, ANC >/= 1000/uL, Platelets >/= 75 x 103/uL, Hemoglobin >/= 9 g/dL, Creatinine </= 2.0 x ULN, AST/ALT</= 2.5 x ULN for patients without liver metastasis,</= 5 x ULN for liver metastases, Bilirubin </= 2.0 x ULN, (except patients with Gilbert's Syndrome, who must have a total bilirubin less than 3.0 mg/dL)

6) No active or chronic infection with HIV, Hepatitis B, or Hepatitis C.

7) Performance status ECOG 0-1.

8) 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.

9) 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.

10) 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.

11) 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.

Exclusion Criteria:

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) Autoimmune disease: Patients with a history of inflammatory bowel disease, including ulcerative colitis and Crohn's Disease, are excluded from this study, as are patients with a history of symptomatic disease (e.g., rheumatoid arthritis, systemic progressive sclerosis [scleroderma], systemic lupus erythematosus, autoimmune vasculitis [e.g., Wegener's Granulomatosis]); motor neuropathy considered of autoimmune origin (e.g. Guillain-Barre Syndrome and Myasthenia Gravis).

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) A history of prior treatment with ipilimumab or prior CD137 agonist or CTLA 4 inhibitor or agonist.

8) 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. Ocular steroid use is acceptable.

9) 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.

10) Prisoners or subjects who are compulsorily detained (involuntarily incarcerated) for treatment of either a psychiatric or physical (e.g., infectious) illness.

Links

Registration Number: NCT01585194
Study Information on Clinical Trials Registry (clinicaltrials.gov)