It is the most serious type of skin cancer because it can spread or metastasize to other tissues and organs in the body. Metastatic melanoma often spreads to the tissue under the skin, lymph nodes, lungs, liver and brain. Recent advances in treatment have significantly extended survival in some patients with metastatic melanoma. However, new treatments are still urgently needed to help more patients control their disease.
Active and recruiting participants
IMO-2125 + ipilimumab; IMO-2125 + pembrolizumab
This Phase 1/2 dose-escalation study is designed to evaluate the safety and tolerability of the investigational medication IMO-2125 in combination with ipilimumab (Yervoy®) or pembrolizumab (Keytruda®) in people with metastatic melanoma. In addition, the study will evaluate multiple IMO-2125 dose levels with the goal of identifying the best dose for future clinical trials. The study will also assess how patients respond to treatment, and allow researchers to learn if IMO-2125 in combination with other immunotherapies can help to improve melanoma symptoms and progression.
IMO-2125 is an investigational medication that has not been approved by the U.S. Food and Drug Administration (FDA) for melanoma or any other disease. IMO-2125 is a powerful activator of the body’s natural immune system. In combination with approved immunotherapies for melanoma like ipilimumab and pembrolizumab, it is believed that the combination will provide more effective tumor control based upon the results of preclinical research.
Ipilimumab is a medication that has been approved by the FDA for the treatment of metastatic melanoma. Ipilimumab is a type of drug called a checkpoint inhibitor that works by allowing the immune system to attack cancer cells. It is designed to block an immune checkpoint protein called cytotoxic T-lymphocyte-associated protein 4 (CTLA-4), which is believed to help tumors evade immune attack. Ipilimumab is given to patients by intravenous (IV) infusion.
Pembrolizumab is a medication that has been approved by the FDA for the treatment of metastatic melanoma. Pembrolizumab is a type of immunotherapy that works by targeting PD-1, a signaling receptor that helps cancer cells hide from the body’s immune system. Pembrolizumab blocks the PD-1 pathway and helps the immune system target and fight cancer cells. Pembrolizumab is given to patients by IV infusion.
Yervoy is a registered trademark of Bristol Myers Squibb. Keytruda is a registered trademark of Merck.
This study will be conducted in 2 parts. The Phase 1 dose-escalation portion will evaluate the safety and tolerability of multiple dose levels in order to identify the optimal dose for further study. The Phase 2 portion of the study will assess the efficacy of IMO-2125 at the recommended dose level identified during Phase 1.
In the Phase 1 portion of the study, participants will be assigned to receive one of several escalating dose levels of IMO-2125 in combination with ipilimumab (Yervoy®) or pembrolizumab (Keytruda®). All participants will receive the approved dose of either ipilimumab or pembrolizumab according to the prescribing information.
In the Phase 2 portion of the study, participants will receive the recommended dose of IMO-2125 identified during the Phase 1 portion along with ipilimumab or pembrolizumab. Participants may receive up to 7 cycles of IMO-2125 with either combination treatment. If a patient is enrolled in the ipilimumab combination group, he/she may receive up to 4 cycles of ipilimumab along with IMO-2125 followed by up to 3 cycles of IMO-2125 alone. If a participant is in the pembrolizumab combination group, he/she may receive up to 7 cycles of pembrolizumab along with IMO-2125.
Tests and procedures during the study include measurements and photographs of melanoma lesions, physical exams, blood and urine tests and tumor biopsies.
At the end of participation in the study, participants will be monitored with routine clinic visits and restaging radiologic scans every 2-3 months until they show signs of progressive disease or start a new treatment for their melanoma.
To qualify for this study, participants must:
In addition to the above, participants should not:
Additionally, participants who have previously been treated with a PD-1 or CTLA-4 inhibitor, if applicable, shouldn’t have discontinued treatment due to a bad (adverse) reaction that made it impossible to continue receiving the medication.
A list of eligibility criteria, including information on laboratory criteria, is available online at ClinicalTrials.gov or by contacting the study site.
For specific questions related to your eligibility for a clinical trial we encourage you to speak with your healthcare team or a study site investigator.
This study will be conducted at 5 sites across the United States.
The University of Texas MD Anderson Cancer Center
1400 Holcombe Blvd. FC 11 Floor, Unit 430
Houston, TX 77030
Investigator: Adi Diab, MD
Melanoma, Urological, Head & Neck
Vanderbilt-Ingram Cancer Center
2141 Blakemore Avenue
Nashville, TN 37203
Investigator: Douglas Johnson, MD
Roswell Park Cancer Center
Elm and Carlton Streets
Buffalo, NY 14263
Investigator: Igor Puzanov, MD
University of Arizona
1515 N. Campbell Ave, Room 2912
Tucson, AZ 85724
Investigator: Montaser Shaheen, MD
University of Utah, Huntsman Cancer Institute
2000 Circle of Hope, Room 2440A
Salt Lake City, UT 84112
Investigator: Robert Andtbacka, MD