Overview

Ipilimumab and Lenalidomide in Advanced Cancer

Status:
Completed

Trial end date:
2019-02-21

Target enrollment:
0

Participant gender:
All

Summary

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.

Phase:

Phase 1

Accepts Healthy Volunteers?

Details

Lead Sponsor:

M.D. Anderson Cancer Center

Treatments:

Antibodies, Monoclonal
Ipilimumab
Lenalidomide
Thalidomide

Criteria

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 >/=50,000/mL; CrCl >/=60mL/min by Cockcroft -Gault
calculation; total bilirubin indirect hyperbilirubinemia such as Gilbert syndrome); ALT(SGPT) 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.

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.