Ipilimumab and Lenalidomide in Advanced Cancer

NCT01750983 | Completed Phase 1 FDA Drug

• 2 other identifiers: 2012-0795NCI-2013-00607
• Study Type: interventional
• Target: 101
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Advanced Cancers

Keywords

Advanced Cancers; Advanced Malignancies; Metastatic cancers; Ipilimumab; Yervoy; BMS-734016; MDX010; Lenalidomide; CC-5013; Revlimid

Outcome Measures

Primary Outcomes (2)

• Maximum Tolerated Dose (MTD) of Ipilimumab in Combination With Lenalidomide

  Maximum tolerated dose (MTD) defined as highest dose studied in which the incidence of dose limiting toxicity (DLT) was less than 33%.

  28 days

• Dose-Limiting Toxicities (DLT) of Ipilimumab in Combination With Lenalidomide

  Dose-limiting toxicity (DLT) defined as any clinically grade 3 or 4 non-hematologic toxicity as defined in NCI CTC v4.0, expected and believed to be related to study medications (except nausea and vomiting, electrolyte imbalances responsive to appropriate regimens or alopecia), any grade 4 hematologic toxicity lasting at least 3 weeks or longer (as defined by the NCI-CTC v4.0) or associated with bleeding and/or sepsis; any grade 4 nausea or vomiting \> 5 days despite maximum anti-nausea regimens, and any other grade 3 non-hematologic toxicity including symptoms/signs of vascular leak or cytokine release syndrome; or any severe or life-threatening complication or abnormality not defined in NCI-CTCAE v4.0 that is attributable to the therapy.

  28 days

Secondary Outcomes (1)

• Tumor Response

  Every 8 weeks

Study Arms (1)

Ipilimumab + Lenalidomide

EXPERIMENTAL

Dose Escalation Group Ipilimumab Starting Dose: 1.5 mg by vein over 90 minutes on Day 1 of each 28 day cycle. Dose Escalation Group Lenalidomide Starting Dose: 10 mg by mouth on Days 1-21 of each 28 day cycle. Dose Expansion Group Starting Dose for Ipilimumab and Lenalidomide: Maximum tolerated dose (MTD) from Dose Escalation Groups.

Drug: Ipilimumab; Drug: Lenalidomide

Interventions

Ipilimumab DRUG

Dose Escalation Group Starting Dose: 1.5 mg by vein over 90 minutes on Day 1 of each 28 day cycle. Dose Expansion Group Starting Dose for Ipilimumab: Maximum tolerated dose (MTD) from Dose Escalation Group.

Also known as: Yervoy, BMS-734016, MDX010

Ipilimumab + Lenalidomide

Lenalidomide DRUG

Dose Escalation Group Starting Dose: 10 mg by mouth on Days 1-21 of each 28 day cycle. Dose Expansion Group Starting Dose for Lenalidomide: Maximum tolerated dose (MTD) from Dose Escalation Group.

Also known as: CC-5013, Revlimid

Ipilimumab + Lenalidomide

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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.

Sponsors & Collaborators

• M.D. Anderson Cancer Center: lead

Study Sites (1)

University of Texas MD Anderson Cancer Center

Houston, Texas, 77030, United States

Location

Related Links

• University of Texas MD Anderson Cancer Center Website

MeSH Terms

Conditions

Neoplasms

Interventions

Ipilimumab; Lenalidomide

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins; Phthalimides; Phthalic Acids; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals; Piperidones; Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Isoindoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Officials

• Filip Janku, MD, PHD

  M.D. Anderson Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 13, 2012
• First Posted: December 17, 2012
• Study Start: March 1, 2013
• Primary Completion: February 21, 2019
• Study Completion: February 21, 2019
• Last Updated: February 25, 2019

Record last verified: 2019-02

Locations

US (1)