Clinical trial · Interventional
Ipilimumab and Lenalidomide in Advanced Cancer
A Phase I Trial of Ipilimumab (Anti CTLA- 4 Antibody) in Combination With Lenalidomide (IMiD) in Patients With Advanced Malignancies
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Advanced Cancers | Malignant Neoplasm | CURATED_BROADER | 0.78 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Ipilimumab | Drug | Ipilimumab | ALIAS |
| Lenalidomide | Drug | Lenalidomide | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Ipilimumab + Lenalidomide
- description
- 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.
- interventionNames
- Drug: Ipilimumab
- Drug: Lenalidomide
Primary outcomes (2)
- measure
- Maximum Tolerated Dose (MTD) of Ipilimumab in Combination With Lenalidomide
- timeFrame
- 28 days
- description
- Maximum tolerated dose (MTD) defined as highest dose studied in which the incidence of dose limiting toxicity (DLT) was less than 33%.
- measure
- Dose-Limiting Toxicities (DLT) of Ipilimumab in Combination With Lenalidomide
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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 \</= 2. 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 \</= 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. 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.
References
Publications (0)
Data not yet available