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.
Interventional
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Maximum Tolerated Dose (MTD)
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.
12 weeks
Yes
Sapna P. Patel, MD
Principal Investigator
UT MD Anderson Cancer Center
United States: Food and Drug Administration
2011-0919
NCT01585194
November 2012
Name | Location |
---|---|
UT MD Anderson Cancer Center | Houston, Texas 77030 |