Ipilimumab and Lenalidomide in Advanced Cancer

Part of paid clinical trials in Houston, Texas.

Sponsor
M.D. Anderson Cancer Center
Study ID
NCT01750983
Phase
PHASE1
Status
Completed

Conditions

  • Advanced Cancers

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

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.
  • 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.

Study Details

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 Dates

Start date
Mar 31, 2013
Status verified
Feb 2019
Primary completion
Feb 21, 2019
Completion
Feb 21, 2019

Study Design

Enrollment
101 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Ipilimumab + Lenalidomide
    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.

Primary Outcome Measure

Maximum Tolerated Dose (MTD) of Ipilimumab in Combination With Lenalidomide [ Time Frame: 28 days ]

Locations (1)

FacilityCityStateZIPSite coordinators
University of Texas MD Anderson Cancer CenterHoustonTexas77030-

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By research site
University of Texas MD Anderson Cancer Center· Houston, TX

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