A Study of the Intra-Patient Escalation Dosing Regimen With IMCgp100 in Patients With Advanced Uveal Melanoma

Completed · Phase 1/Phase 2

Conditions studied: Uveal Melanoma

In brief

IMCgp100-102 is a Phase I/II study of the weekly intra-patient escalation dose regimen with IMCgp100 as a single agent in participants with metastatic uveal melanoma (mUM). According to this regimen, all participants in the trial received 2 weekly doses of IMCgp100 at a dose level below the identified weekly recommended Phase II dose (RP2D-QW) and then a dose escalation commenced at the third weekly dose at C1D15. The Phase I testing of the intra-patient escalation dosing regimen is designed to achieve a higher exposure and maximal plasma concentration of IMCgp100 after doses at Cycle 1 Day 15 (C1D15) and thereafter.

Key facts

Study ID

NCT02570308

Run by

Immunocore Ltd

People needed

146

Starts

2016-02-29

Expected to finish

2022-10-17

Last updated by the study team

2023-03-21

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Male or female participants age ≥ 18 years of age at the time of informed consent.
• Ability to provide and understand written informed consent prior to any study procedures.
• Histologically or cytologically confirmed diagnosis of metastatic uveal melanoma (mUM).
• Surgically sterile participants or participants of child-bearing potential who agree to use highly effective methods of contraception during study dosing and for 6 months after last dose of study drug.
• Human leukocyte antigen (HLA)-A*0201 positive.
• ECOG Performance Status of 0 or 1 at Screening.
• Phase 2 will include participants with previously treated uveal melanoma in the metastatic setting.

You may not qualify if…

• Presence of symptomatic or untreated central nervous system (CNS) metastases, or CNS metastases that require doses of corticosteroids.
• History of severe hypersensitivity reactions to other biologic drugs or monoclonal antibodies.
• Participants with any out-of-range laboratory values.
• Clinically significant cardiac disease or impaired cardiac function.
• Active infection requiring systemic antibiotic therapy.
• Known history of HIV infection.
• Active hepatitis B virus (HBV) or hepatitis C virus (HCV) infection per institutional protocol.
• Participants receiving systemic treatment with systemic steroid therapy or any other immunosuppressive medication at any dose level that would interfere with the action of the study drugs in the opinion of the investigator.
• Malignant disease, other than that being treated in this study.
• Any medical condition that would, in the investigator's judgment, prevent participation in the clinical study due to safety concerns, compliance with clinical study procedures or interpretation of study results.
• Presence of NCI CTCAE ≥ grade 2 toxicity (except alopecia, peripheral neuropathy and ototoxicity, which are excluded if ≥ NCI CTCAE grade 3) due to prior cancer therapy.
• Pregnant, likely to become pregnant, or lactating women.

Where it is running

• University California, San Diego Moores Cancer Center — La Jolla, California, United States
• The Angeles Clinic and Research Institute - W LA Office — Los Angeles, California, United States
• California Pacific Medical Center — San Francisco, California, United States
• University of Colorado Denver Anschutz Medical Campus — Aurora, Colorado, United States
• Georgetown University - Lombardi Comprehensive Cancer Center — Washington D.C., District of Columbia, United States
• University of Miami Hospital Clinics/Sylvester Comprehensive Cancer Center — Miami, Florida, United States
• H. Lee Moffitt Cancer Center and Research Institute, Inc — Tampa, Florida, United States
• The University of Chicago Medical Center — Chicago, Illinois, United States
• Washington University, School of Medicine — St Louis, Missouri, United States
• Roswell Park Cancer Institute — Buffalo, New York, United States
• Columbia University Medical Center - The New York Presbyterian Hospital — New York, New York, United States
• Memorial Sloan Kettering Hospital — New York, New York, United States
• Dean A. Mcgee Eye Institute — Oklahoma City, Oklahoma, United States
• Providence Portland Medical Center — Portland, Oregon, United States
• Thomas Jefferson University Medical Oncology Clinic — Philadelphia, Pennsylvania, United States
• Vanderbilt University Medical Center — Nashville, Tennessee, United States
• Baylor Scott & White Health — Temple, Texas, United States
• Princess Margaret Cancer Center — Toronto, Ontario, Canada
• Universitaetsklinikum Heidelberg — Heidelberg, Baden-Wurttemberg, Germany
• Charite Universitaetsmedizin Berlin - Campus Benjamin Franklin — Berlin, Germany
• ICO l'Hospitalet - Hospital Duran i Reynals — L'Hospitalet de Llobregat, Barcelona, Spain
• Hospital Universitario La Paz — Madrid, Spain
• Hospital Universitario Virgen Macarena — Seville, Spain
• Hospital General Universitario de Valencia — Valencia, Spain
• The Clatterbridge Cancer Centre — Metropolitan Borough of Wirral, Merseyside, United Kingdom

Full record on ClinicalTrials.gov

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