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New hope for rare eye cancer: IMCgp100 shows promise in advanced uveal melanoma trial

NCT ID NCT03070392

Disease control Sponsor: Immunocore Ltd Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tested a new drug called IMCgp100 in 378 adults with a specific genetic type (HLA-A*0201) of advanced uveal melanoma, a rare eye cancer. Participants received either IMCgp100 or one of three standard treatments (dacarbazine, ipilimumab, or pembrolizumab). The main goal was to see if IMCgp100 helped people live longer. The trial also tracked side effects and how long the cancer stayed under control.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

378 people

The number who actually took part.

Started

Oct 2017

Finished

Sep 2025

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 99 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria 1. Male or female participants age ≥ 18 years of age at the time of informed consent 2. Ability to provide and understand written informed consent prior to any study procedures 3. Histologically or cytologically confirmed metastatic UM 4. Must meet the following criteria related to prior treatment: * No prior systemic therapy in the metastatic or advanced setting including chemotherapy, immunotherapy, or targeted therapy * No prior regional, liver-directed therapy including chemotherapy, radiotherapy, or embolization * Prior surgical resection of oligometastatic disease is allowed * Prior neoadjuvant or adjuvant therapy is allowed provided administered in the curative setting in participants with localized disease. Participants may not be re-treated with an Investigator's Choice therapy that was administered as adjuvant or neoadjuvant treatment. Additionally, participants who have received nivolumab as prior adjuvant/neoadjuvant treatment should not receive pembrolizumab as Investigator's Choice therapy. 5. HLA A\*0201 positive by central assay 6. Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1 at Screening 7. Participants have measurable disease or non-measurable disease according to RECIST v1.1 8. All other relevant medical conditions must be well-managed and stable, in the opinion of the investigator, for at least 28 days prior to first administration of study drug Exclusion Criteria 1. Out-of-range laboratory values 2. History of severe hypersensitivity reactions (eg, anaphylaxis) to other biologic drugs or monoclonal antibodies 3. Clinically significant cardiac disease or impaired cardiac function, 4. Presence of symptomatic or untreated central nervous system (CNS) metastases, or CNS metastases that require doses of corticosteroids within the prior 3 weeks to study Day 1. Participants with brain metastases are eligible if lesions have been treated with localized therapy and there is no evidence of PD for at least 4 weeks by magnetic resonance imaging (MRI) prior to the first dose of study drug 5. Active infection requiring systemic antibiotic therapy. Participants requiring systemic antibiotics for infection must have completed therapy at least 1 week prior to the first dose of study drug 6. Known history of human immunodeficiency virus infection (HIV). Testing for HIV status is not necessary unless clinically indicated 7. Active hepatitis B virus (HBV) or hepatitis C virus (HCV) infection per institutional protocol. Testing for HBV or HCV status is not necessary unless clinically indicated or the patient has a history of HBV or HCV infection 8. Malignant disease, other than that being treated in this study. Exceptions to this exclusion include the following: malignancies that were treated curatively and have not recurred within 2 years prior to study treatment; completely resected basal cell and squamous cell skin cancers; any malignancy considered to be indolent and that has never required therapy; and completely resected carcinoma in situ of any type 9. Any medical condition that would, in the investigator's or Sponsor's judgment, prevent the participants participation in the clinical study due to safety concerns, compliance with clinical study procedures or interpretation of study results 10. Participants receiving systemic steroid therapy or any other systemic immunosuppressive medication at any dose level, as these may interfere with the mechanism of action of study treatment. Local steroid therapies (eg, otic, ophthalmic, intra-articular, or inhaled medications) are acceptable 11. History of adrenal insufficiency 12. History of interstitial lung disease 13. History of pneumonitis that required corticosteroid treatment or current pneumonitis 14. History of colitis or inflammatory bowel disease 15. Major surgery within 2 weeks of the first dose of study drug (minimally invasive procedures such as bronchoscopy, tumor biopsy, insertion of a central venous access device, and insertion of a feeding tube are not considered major surgery and are not exclusionary) 16. Radiotherapy within 2 weeks of the first dose of study drug, with the exception of palliative radiotherapy to a limited field, such as for the treatment of bone pain or a focally painful tumor mass 17. Use of hematopoietic colony-stimulating growth factors (e.g., G-CSF, GM-CSF, M-CSF) ≤ 2 weeks prior to start of study drug. An erythroid-stimulating agent is allowed as long as it was initiated at least 2 weeks prior to the first dose of study treatment and the patient is not red blood cell transfusion dependent 18. Pregnant, likely to become pregnant, or lactating women (where pregnancy is defined as the state of a female after conception and until the termination of gestation) 19. Women of childbearing potential who are sexually active with a non-sterilized male partner, defined as all women physiologically capable of becoming pregnant, unless they are using highly effective contraception during study treatment (defined in Section 6.7), and must agree to continue using such precautions for 6 months after the final dose of investigational product; cessation of birth control after this point should be discussed with a responsible physician. Highly effective methods of contraception are described in Section 6.7 20. Male participants must be surgically sterile or use double barrier contraception methods from enrollment through treatment and for 6 months following administration of the last dose of study drug 21. Participant who are in an institution due to official or judicial order. 22. Participant who are the investigator or any subinvestigator, research assistant, pharmacist, study coordinator, or other staff thereof, directly involved in the conduct of the study. 23. Contraindication for treatment with Investigator's Choice alternatives (dacarbazine, ipilimumab and pembrolizumab) as per applicable labelling. Participant may have a contraindication to 1 or 2 of the choices if he/she is a candidate for dosing with at least 1 Investigator's Choice and meets all other study eligibility criteria.

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Conditions

The condition(s) this trial relates to.

melanoma uveal melanoma

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Uveal melanoma

Contacts and locations

Locations

  • Beatson West of Scotland Cancer Centre

    Glasgow, G12 0YN, United Kingdom

  • Byers Eye Institute, Stanford University

    Palo Alto, California, 94303, United States

  • California Pacific Medical Center

    San Francisco, California, 94115, United States

  • Central Adelaide Local Health Network, Royal Adelaide Hospital Cancer Center

    Adelaide, South Australia, 5000, Australia

  • Centre Atoine Lacassagne

    Nice, 6189, France

  • Centrum Onkologii - Instytut im. Marii Sklodowskiej-Curie

    Warsaw, 02-781, Poland

  • Charite - Campus Benjamin Franklin

    Berlin, 12200/12203, Germany

  • Columbia University Medical Center

    New York, New York, 10032, United States

  • Cross Cancer Institute

    Edmonton, Alberta, T6G 1Z2, Canada

  • Dana Farber Cancer Institute

    Boston, Massachusetts, 02115, United States

  • Dnipropetrovsk State Medical Academy

    Dnipro, 49102, Ukraine

  • Duke University Health System

    Durham, North Carolina, 27710, United States

  • Federal State Budget Institution National Medical Research Center of Oncology

    Saint Petersburg, 197758, Russia

  • Federal State Budgetary Institution N.N. Blokhin National Medical Research Center of Oncology

    Moscow, 115478, Russia

  • Fondazione ICCRS

    Milan, 20133, Italy

  • Hospital Clínico Universitario de Santiago de Compostela

    Santiago de Compostela, ES-Spain, 15706, Spain

  • Hospital Universitario General de Valencia

    Valencia, ES-Spain, 46014, Spain

  • Hospital Universitario La Paz

    Madrid, ES-Spain, 28046, Spain

  • Hospital Universitario Virgen Macarena

    Seville, 41009, Spain

  • Houston Methodist Cancer Center

    Houston, Texas, 77030, United States

  • Institut Catala d'Oncologia (ICO) - L'Hospitalet

    L'Hospitalet de Llobregat, ES-Spain, 08908, Spain

  • Institut Curie

    Paris, 75005, France

  • Institut Roi Albert II Cliniques Universitaires St-Luc

    Brussels, Belgium

  • Istituto Nazionale Tumori - IRCCS Fondazione "G. Pascale" - UOC Melanoma, Immunoterapia Oncologica e Terapie Innovative

    Naples, 80131, Italy

  • Klinik und Poliklinik für Dermatologie und Allergologie

    Munich, 80337, Germany

  • Kyiv Munitipal Hospital

    Kyiv, 02094, Ukraine

  • LUMC Medical Oncology

    Leiden, 2333, Netherlands

  • Massachusetts General Hospital

    Boston, Massachusetts, 02114, United States

  • Memorial Sloan Kettering Cancer Center

    New York, New York, 10065, United States

  • Mount Vernon Cancer Centre

    Northwood, Middlesex, HA6 2RN, United Kingdom

  • Nationales Centrum für Tumorerkrankungen

    Heidelberg, 69120, Germany

  • Northwestern University

    Chicago, Illinois, 60611, United States

  • Peter MacCallum Cancer Center

    Melbourne, Victoria, 3000, Australia

  • Portland Providence Medical Center

    Portland, Oregon, 97213, United States

  • Princess Margaret Cancer Centre

    Toronto, M5G 2M9, Canada

  • Roswell Park Cancer Institute

    Buffalo, New York, 14263, United States

  • Saint Vincents Hospital

    Darlinghurst, New South Wales, 2010, Australia

  • The Angeles Clinic and Research Institute

    Los Angeles, California, 90025, United States

  • The Clatterbridge Cancer Centre

    Bebington, Wirral, CH63 4JY, United Kingdom

  • The Ohio State University

    Columbus, Ohio, 43210, United States

  • The University of Chicago Medicine

    Chicago, Illinois, 60637, United States

  • Thomas Jefferson University Hospital

    Philadelphia, Pennsylvania, 19107, United States

  • UCLA Medical Center

    Los Angeles, California, 90024, United States

  • Universitaetsklinikum Koeln Dermatologie und Venerologie

    Cologne, North Rhine-Westphalia, 50937, Germany

  • Universite Catholique de Louvain Centre du Cancer, Medical Oncology

    Brussels, Belgium

  • University Hospital Essen

    Essen, Germany

  • University of Colorado

    Aurora, Colorado, 80045, United States

  • University of Hamburg

    Hamburg, 20246, Germany

  • University of Iowa

    Iowa City, Iowa, 52242, United States

  • University of Miami - Sylvester Comprehensive Cancer Center

    Miami, Florida, 33136, United States

  • University of Oklahoma

    Oklahoma City, Oklahoma, 73104, United States

  • University of Pittsburgh Medical Center

    Pittsburgh, Pennsylvania, 15232, United States

  • University of Zurich Hospital

    Zurich, 8091, Switzerland

  • Universitätsklinikum Carl Gustav Carus

    Dresden, 01307, Germany

  • Uzhhorod Central City Clinical Hospital

    Uzhhorod, 8800, Ukraine

  • Washington University School of Medicine

    St Louis, Missouri, 63110, United States

  • Winship Cancer Institute of Emory University

    Atlanta, Georgia, 30322, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.