A Phase I Trial of Ipilimumab (Anti CTLA- 4 Antibody) in Combination With Lenalidomide (IMiD) in Patients With Advanced Malignancies
18 Years
N/A
Both
Advanced Cancers
Trial Information
A Phase I Trial of Ipilimumab (Anti CTLA- 4 Antibody) in Combination With Lenalidomide (IMiD) in Patients With Advanced Malignancies
Study Groups:
Dose escalation:
If you are found to be eligible to take part in this study, you will be assigned to a dose
level of the study drugs based on when you join the study.
Up to 5 dose levels of ipilimumab with lenalidomide will be tested. Up to 6 participants
will be enrolled at each dose level. The first group of participants will receive the
lowest dose level. Each new group will receive a higher dose than the group before it, if
no intolerable side effects were seen. This will continue until the highest tolerable dose
of ipilimumab with lenalidomide is found.
Dose expansion:
Once the highest tolerable dose of ipilimumab with lenalidomide is found, up to 14 more
participants may be enrolled. This will be to further study the safety of the combination
of drugs at that dose and the level of effectiveness of the study drugs in a certain tumor
group. This group will be called the dose expansion group.
Study Drug Administration:
Each study cycle is 28 days.
You will take lenalidomide by mouth on Days 1-21 of each cycle. You will swallow the
capsules whole with water once a day. Do not break, chew, or open your capsules. The doctor
will discuss this with you.
You will receive ipilimumab by vein over 90 minutes on Day 1 of each cycle. You will be
monitored for side effects for 1-2 hours after the infusion.
Study Visits:
Every study visit:
-You will be asked if you have had any side effects.
Cycle 1:
- On Day 1: blood (about 4 teaspoons) will be drawn for routine tests.
- Between Days 2 and 7: If you are able to become pregnant, you will have a blood (about
1 teaspoon) or urine pregnancy test.
- Between Days 8 and 14: Blood (about 4 teaspoons) 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.
- Between Days 15 and 21: Blood (about 4 teaspoons) 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.
- Between Days 22 and 28: Blood (about 4 teaspoons) will be drawn for routine tests. Your
medical history will be recorded.
Cycle 2:
- Between Days 2 and 7: Blood (about 4 teaspoons) will be drawn for routine tests.
- Between Days 8 and 14: Blood (about 4 teaspoons) will be drawn for routine tests.
- Between Days 15 and 21: Blood (about 4 teaspoons) will be drawn for routine tests.
- Between Days 22 and 28: Blood (about 4 teaspoons) will be drawn for routine tests. Your
medical history will be recorded.
Every other cycle (every 8 weeks):
-You will have an x-ray, CT scan, and/or PET/CT scan to check the status of the disease.
Blood (about 1 tablespoon) will be drawn for tumor marker testing.
Before starting Cycle 3 and all following cycles:
- Your medical history will be recorded.
- You will have a physical exam, including measurement of your weight and vital signs.
- You will be asked about any health problems you may have and any other drugs or herbal
supplements you may be taking.
- Your performance status will be recorded.
- Blood (about 4 teaspoons) will be drawn for routine tests. Blood may be drawn more
often if your doctor thinks it is needed.
- If you are able to become pregnant, you will have a blood (about 1 teaspoon) or urine
pregnancy test.
At the End of the study:
- Directly at the end of the study: If you are able to become pregnant, you will have a
blood (about 1 teaspoon) or urine pregnancy test.
- 28 days after therapy with lenalidomide stopped: If you are able to become pregnant,
you will have a blood (about 1 teaspoon) or urine pregnancy test.
Length of Dosing:
You may receive up to 4 doses of ipilimumab. You may continue receiving lenalidomide for as
long as the doctor thinks it is in your best interest. You will no longer be able to take
the study drugs if the disease gets worse, if intolerable side effects occur, or if you are
unable to follow study directions.
You will be off study after your follow-up visit.
Follow-up:
You will have a follow-up-visit within 30 days after your last dose of study drugs. You will
be asked about any health problems you may have and if you have had any side effects. If
your study doctor thinks it is needed, you may have follow-up for a longer period of time.
If you are able to become pregnant, you will have a blood (about 1 teaspoon) or urine
pregnancy test.
It is important that you tell your doctor if you have any side effects while on this study.
You may be asked to return to the clinic for more tests until the side effects or abnormal
test results improve. Your dose of study drug may be changed and/or you may be given drugs
to help control the side effects.
If you need to have surgery, tell your doctor that you are taking lenalidomide and
ipilimumab. You may need to stop taking lenalidomide and ipilimumab until your wound heals
after some types of surgery.
For your safety, it is important that you follow the instructions for the study drug doses
and that you return for all the study visits.
This is an investigational study. Ipilimumab is FDA approved and commercially available to
treat metastatic melanoma. Lenalidomide is FDA approved and commercially available to treat
multiple myeloma and myelodysplastic syndrome. Giving the combination of ipilimumab and
lenalidomide to patients with advanced cancer is investigational.
Up to 101 patients will be enrolled in this study. All will be enrolled at MD Anderson.
Inclusion Criteria:
1. Patients with advanced or metastatic cancers with no available standard therapy are
eligible to enter the Phase 1 portion of this study.
2. Patients must be >/= 18 years.
3. Patients must be >/= 3 weeks beyond treatment with a cytotoxic chemotherapy regimen,
or therapeutic radiation, or major surgery. A confirmation (written or verbal) that
there is no risk of surgical complications from a patient's surgeon has to be
obtained prior to starting therapy in patients with a history of major surgery within
past 6 weeks. Patients may have received palliative localized radiation immediately
before or during treatment provided that radiation is not delivered to the only site
of disease being treated under this protocol. For biologic/targeted agents patients
must be >/= 5 half-lives or >/= 3 weeks form the last dose (whichever comes first).
4. ECOG performance status
5. Patients must have adequate organ and marrow function defined as: absolute neutrophil
count >/= 1,000/mL platelets >/=75,000/mL; CrCl >/=60mL/min by Cockcroft-Gault
calculation; total bilirubin participate in the RevAssist® program. Females: two effective contraceptive methods
should be used during therapy, during therapy interruptions, and for at least 4 weeks
after completing therapy. Males: must always use a latex condom during any sexual
contact with females of childbearing potential, even if they have undergone a
successful vasectomy.
6. Patients must be able to understand and be willing to sign a written informed consent
document.
Exclusion Criteria:
1. Uncontrolled intercurrent illness, including, but not limited to, uncontrolled
infection, uncontrolled asthma, need for hemodialysis, need for ventilatory support.
2. Pregnant or lactating women.
3. History of hypersensitivity to ipilimumab.
4. History of hypersensitivity to lenalidomide.
5. Patients unwilling or unable to sign informed consent document.
6. Patients on hemodialysis.
7. History of organ transplantation.
8. History of autoimmune disease, including inflammatory bowel disease.
9. History of severe motor or sensory neuropathy, or any other autoimmune disorder which
is deemed to be significant.
10. Patients with a prior history of Grade 4 rash associated with thalidomide treatment.
11. History of Angioedema.
Type of Study:
Interventional
Study Design:
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Maximum Tolerated Dose (MTD) of Ipilimumab in Combination With Lenalidomide
Outcome Description:
Maximum tolerated dose (MTD) defined as highest dose studied in which the incidence of dose limiting toxicity (DLT) was less than 33%.
Outcome Time Frame:
28 days
Safety Issue:
Yes
Principal Investigator
Filip Janku, MD, PHD
Investigator Role:
Principal Investigator
Investigator Affiliation:
UT MD Anderson Cancer Center
Authority:
United States: Food and Drug Administration
Study ID:
2012-0795
NCT ID:
NCT01750983
Start Date:
March 2013
Completion Date:
Related Keywords:
- Advanced Cancers
- Advanced Cancers
- Advanced Malignancies
- Metastatic cancers
- Ipilimumab
- Yervoy
- BMS-734016
- MDX010
- Lenalidomide
- CC-5013
- Revlimid
- Neoplasms
Name | Location |
|---|---|
| UT MD Anderson Cancer Center | Houston, Texas 77030 |
