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Phase I/II Study of Ipilimumab for Uveal Melanoma


Phase 1/Phase 2
18 Years
N/A
Open (Enrolling)
Both
Melanoma

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Trial Information

Phase I/II Study of Ipilimumab for Uveal Melanoma


Study Drug Administration:

If you are found to be eligible to take part in this study, you will be assigned to a study
group based on when you join this study. Up to 4 groups of 3 participants will be enrolled
in the Phase I portion of the study. Up to 129 participants will be enrolled in Phase II.
This includes up to 83 participants with a history of uveal melanoma that is at high risk to
spread and up to 46 patients with metastatic cancer.

If you are enrolled in the Phase I portion, the dose of ipilimumab you receive will depend
on when you joined this study. Two (2) dose levels will be tested in each status type of
uveal melanoma: participants with a history of uveal melanoma that is at high risk to spread
(the "adjuvant" group) and participants with metastatic cancer.

The first group of participants in each cancer status type will receive the lowest dose
level of ipilimumab. The next group of participants will receive a higher dose of
ipilimumab than the group before it, if intolerable side effects are seen in no more than
1/3 of participants at the lower dose. This process is designed to find the highest
tolerable dose of ipilimumab.

If you are enrolled in the Phase II portion, you will receive ipilimumab at the highest dose
that was tolerated in the Phase I portion.

You will receive ipilimumab by vein over 90 minutes (+/- 15 minutes) each time.

You will receive ipilimumab every 3 weeks (+/- 3 days) for a total of 4 doses (Weeks 1, 4,
7, and 10). Starting at Week 24, if you are in the adjuvant group, you will receive
ipilimumab every 12 weeks (+/- 7 days) for up to 1 year (Weeks 24, 36, and 48). Starting at
Week 24, if you are in the metastatic group, you will receive ipilimumab every 12 weeks (+/-
7 days) for as long as the study doctor thinks it is in your best interest.

Study Visits:

At Weeks 1, 4, 7, 10, 12, 18, 24, and every 12 weeks after that:

- You will have a physical exam, including measurement of your vital signs and weight.
If your screening visit occurred within 14 days of your first on-study visit, it will
not need to be repeated on Day 1 of Cycle 1.

- You will be asked about any symptoms or side effects you may have had and any drugs you
may be taking.

- Your performance status will be recorded.

- Blood (about 1 tablespoon) will be drawn for routine tests.

- If you are able to become pregnant, you will have a blood (about 1 teaspoon) or urine
pregnancy test.

If you are in the metastatic group, at Weeks 12, 18, 24, and every 12 weeks after that, you
will have scans such as a CT scan to check the status of the disease.

If you are in the adjuvant group, you will have scans such as a CT scan to check the status
of the disease at Week 24 and every 6 months after that.

Length of Treatment:

If you are in the adjuvant group and in Phase II, you may continue taking the study drug for
up to 1 year. All other study participants may continue taking the study drug for as long
as the doctor thinks it is in your best interest.

You may no longer be able to take the study drug if the disease gets worse, if intolerable
side effects occur, or if you are unable to follow study directions.

Your participation on the study will be over once you have completed the end-of-treatment
visit, and follow-up.

End-of-Treatment Visit:

After you are finished taking the study drug:

- You will have a physical exam, including measurement of your vital signs.

- You will be asked about any symptoms or side effects you may have had and any side
drugs you may be taking.

- Blood (about 1 tablespoon) will be drawn for routine tests.

- If your doctor thinks it is needed, you will have scans such as a CT scan to check the
status of the disease.

Follow-Up:

For at least 60 days after you are finished taking the study drug, you will have follow-up
by phone or at the clinic. You will be asked how you are doing.

This is an investigational study. Ipilimumab is FDA approved and commercially available to
treat metastatic melanoma, including uveal melanoma. It is investigational to study
ipilimumab in a group of patients that has uveal melanoma, specifically, and to give it in
the dosing schedules in this study.

Up to 141 patients will take part in this study. All will be enrolled at MD Anderson.


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 AST/ALT metastases, Bilirubin 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 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.

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Maximum Tolerated Dose (MTD)

Outcome Description:

Tumor assessments occur at baseline, week 24, and every 6 months thereafter for the adjuvant arm. Tumor assessments occur at baseline, week 12, week 16, week 20, week 24, and every 12 weeks thereafter for the metastatic arm. Tumor assessments in the form of CT chest, abdomen, and pelvis with oral and intravenous contrast or alternative body imaging at the discretion of investigator.

Outcome Time Frame:

12 weeks

Safety Issue:

Yes

Principal Investigator

Sapna P. Patel, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

UT MD Anderson Cancer Center

Authority:

United States: Food and Drug Administration

Study ID:

2011-0919

NCT ID:

NCT01585194

Start Date:

November 2012

Completion Date:

Related Keywords:

  • Melanoma
  • Melanoma
  • History of Uveal Melanoma
  • Metastatic
  • Ipilimumab
  • Yervoy
  • BMS-734016
  • MDX010
  • Melanoma
  • Uveal Neoplasms

Name

Location

UT MD Anderson Cancer CenterHouston, Texas  77030