Ipilimumab and Lenalidomide in Advanced Cancer

Completed · Phase 1

Conditions studied: Advanced Cancers

In brief

The goal of this clinical research study is to find the highest tolerable dose of the combination of Yervoy® (ipilimumab) with Revlimid® (lenalidomide) that can be given to patients with advanced cancer. The safety of these drugs will also be studied. Ipilimumab is designed to increase the immune system's ability to fight cancer. Lenalidomide is designed to change the body's immune system. It may also interfere with the development of tiny blood vessels that help support tumor growth. This may decrease the growth of cancer cells.

Key facts

Study ID

NCT01750983

Run by

M.D. Anderson Cancer Center

People needed

101

Starts

2013-03-01

Expected to finish

2019-02-21

Last updated by the study team

2019-02-25

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Patients with advanced or metastatic cancers with no available standard therapy are eligible to enter the Phase 1 portion of this study.
• Patients must be >/= 18 years.
• 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).
• ECOG performance status </= 2.
• Patients must have adequate organ and marrow function defined as: absolute neutrophil count >/= 1,000/mL platelets >/=50,000/mL; CrCl >/=60mL/min by Cockcroft -Gault calculation; total bilirubin </= 2x ULN (exceptions may apply to benign non-malignant indirect hyperbilirubinemia such as Gilbert syndrome); ALT(SGPT) </= 5X ULN; willingness to 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.
• Patients must be able to understand and be willing to sign a written informed consent document.

You may not qualify if…

• Uncontrolled intercurrent illness, including, but not limited to, uncontrolled infection, uncontrolled asthma, need for hemodialysis, need for ventilatory support.
• Pregnant or lactating women.
• History of hypersensitivity to ipilimumab.
• History of hypersensitivity to lenalidomide.
• Patients unwilling or unable to sign informed consent document.
• Patients on hemodialysis.
• History of organ transplantation.
• History of autoimmune disease, including inflammatory bowel disease.
• History of severe motor or sensory neuropathy, or any other autoimmune disorder which is deemed to be significant.
• Patients with a prior history of Grade 4 rash associated with thalidomide treatment.
• History of Angioedema.

Where it is running

• University of Texas MD Anderson Cancer Center — Houston, Texas, United States

Full record on ClinicalTrials.gov

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