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Melanoma is a type of skin cancer that occurs in melanocytes, the cells that color the skin and make moles.

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.

  • 90% of melanoma
    cases are linked
    to exposure
    to UV rays

  • The number of
    new cases is

  • Does not
    by age, gender
    or race

  • 10-year survival
    rate for metastatic
    disease is less
    than 10%


    Active and recruiting participants






    Phase 1/2


    IMO-2125 + ipilimumab; IMO-2125 + pembrolizumab



Trial Background and Goals

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.

Trial Overview

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.

Eligibility Criteria

To qualify for this study, participants must:

  • Have confirmed metastatic melanoma with measurable stage III or stage IVA, IVB or IVC disease; the melanoma must have started as cutaneous (skin), ocular (eye) or mucosal (mucus membrane)
  • Have at least 2 measurable tumor lesions ≥ 1.0 cm that can be accessed for biopsy
  • Have disease that progressed after treatment with a PD-1 inhibitor administered either alone or in combination with another therapy, or shown no response to treatment of at least 12 weeks

In addition to the above, participants should not:

  • Be on steroid therapy higher than 7.5 mg/day of prednisone
  • Have evidence of cancer in the central nervous system (CNS) or have another primary malignancy that has not been in remission for at least 3 years
  • Have received treatment with IFN-alpha within the previous 6 months prior to enrolling in this study
  • Have active autoimmune disease or systemic infections requiring antibiotics

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 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.

Participating Sites

This study will be conducted at 5 sites across the United States.

To learn more about how to contact a study site, please email or call 1-877-888-6550 ext. 2 (U.S. toll free) or 617-679-5500.

  • 1. Recruiting

    The University of Texas MD Anderson Cancer Center
    1400 Holcombe Blvd. FC 11 Floor, Unit 430
    Houston, TX 77030
    Investigator: Adi Diab, MD

  • 2. Recruiting

    Melanoma, Urological, Head & Neck
    Vanderbilt-Ingram Cancer Center
    2141 Blakemore Avenue
    Nashville, TN 37203
    Investigator: Douglas Johnson, MD

  • 3. Recruiting

    Roswell Park Cancer Center
    Elm and Carlton Streets
    Buffalo, NY 14263
    Investigator: Igor Puzanov, MD

  • 4. Recruiting

    University of Arizona
    1515 N. Campbell Ave, Room 2912
    Tucson, AZ 85724
    Investigator: Montaser Shaheen, MD

  • 5. Recruiting

    University of Utah, Huntsman Cancer Institute
    2000 Circle of Hope, Room 2440A
    Salt Lake City, UT 84112
    Investigator: Robert Andtbacka, MD

Contact Information

To learn more about this study or to reach a study site, please contact:

1-877-888-6550 ext. 2 (U.S. toll free) or 617-679-5500