Study on Pembrolizumab and Ipilimumab for Melanoma After Previous Immunotherapy
Sponsor: University of Chicago
ClinicalTrials ID:NCT02743819
This clinical trial is testing a combination of two immunotherapy drugs, pembrolizumab and ipilimumab, to see if they can help treat advanced melanoma in patients who have already received other immunotherapy treatments. The study will look at how well the combination works, how long it keeps the cancer from getting worse, and how safe it is.
Patient Parameters
| Parameter | Options |
|---|
Program Overview
This Phase II study is exploring whether combining two immunotherapy drugs, pembrolizumab and ipilimumab, can benefit patients with advanced melanoma who have previously been treated with other immunotherapy drugs. The study will measure how well the combination works in shrinking tumors, how long it can keep the cancer from progressing, and its safety. Researchers will also study blood and tumor samples to find factors that might predict how well patients respond to this treatment.
Description
The main goal of this study is to find out how effective the combination of pembrolizumab and ipilimumab is in treating advanced melanoma after previous immunotherapy. Researchers will measure the response rate using specific criteria. They will also look at how long patients remain free from cancer progression and assess the safety of the treatment. Additionally, the study will explore changes in the tumor environment and other biological samples before and after adding ipilimumab to pembrolizumab.
Eligibility Criteria
Inclusion Criteria
- Be willing and able to provide written consent to participate.
- Be 18 years or older.
- Have melanoma that has either progressed or remained stable for at least 24 weeks after previous treatment with an anti-PD1/L1 antibody.
- Have measurable cancer based on specific criteria.
- Have a performance status score of 0 or 1, indicating full activity or some restriction in strenuous activities.
- Have adequate organ function as shown by specific blood tests.
- Women of childbearing potential must have a negative pregnancy test before starting treatment and agree to use two methods of birth control during the study and for 120 days after the last dose.
- Men must agree to use contraception during the study and for 120 days after the last dose.
Exclusion Criteria
- Have participated in another clinical trial within 4 weeks before starting this study, except for certain immunotherapy treatments.
- Have an immune system deficiency or are taking immunosuppressive medications.
- Have active tuberculosis.
- Have an allergy to pembrolizumab or its ingredients.
- Have received certain cancer treatments within 4 weeks before starting this study and have not recovered from side effects.
- Have another active cancer that requires treatment, except for certain skin cancers or cervical cancer.
- Have active brain metastases or cancer in the brain lining, unless previously treated and stable.
- Have an active autoimmune disease requiring treatment in the past 2 years.
- Have uveal or ocular melanoma.
- Have a history of lung inflammation or active infection needing treatment.
- Have any condition or treatment that might interfere with the study.
- Have psychiatric or substance abuse issues affecting participation.
- Are pregnant, breastfeeding, or planning to conceive during the study.
- Have previously received anti-CTLA4 therapy.
- Have HIV, active Hepatitis B, or Hepatitis C.
- Have received a live vaccine within 30 days before starting the study.
Locations
| FACILITY | ZIP | CITY | STATE |
|---|---|---|---|
| University of South Alabama | 36604 | Mobile | Alabama |
| Mount Sinai Medical Center of Florida | 33140 | Miami Beach | Florida |
| H. Lee Moffitt Cancer Center and Research Institute | 33612 | Tampa | Florida |
| University of Chicago | 60637 | Chicago | Illinois |
| Decatur Memorial Hospital | 62526 | Decatur | Illinois |
| NorthShore University HealthSystem | 60201 | Evanston | Illinois |
| Oncology Specialists S.C. | 60068 | Park Ridge | Illinois |
| Illinois Cancer Care | 61615 | Peoria | Illinois |
| Fort Wayne Medical Oncology and Hematology, Inc. | 46804 | Fort Wayne | Indiana |
| Virginia Commonwealth University/ Massey Cancer Center | 23298 | Richmond | Virginia |
Get This Program In Your Inbox
Receive detailed information about this treatment opportunity to review with your healthcare provider.