Melanoma Clinical Trial

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

Summary

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.

View Full Description

Full Description

This is a Phase I/II clinical study of IMCgp100 in participants with advanced uveal melanoma.

This is a Phase I/II study of IMCgp100 administered on a weekly basis with an intra-patient escalation dosing regimen. The intra-patient escalation occurred at the third weekly dose on Cycle 1 Day 15 (C1D15). 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 with the goal to achieve a long-term dosing regimen at a dose higher than that identified for the weekly dosing regimen (RP2D-QW). The dose escalation identified the intra-patient escalation regimen (RP2D-IE).

The Phase I portion of the study was a standard 3+3 dose escalation design.The recommended Phase II dose of the intra-patient escalation dose regimen (RP2D-IE) was identified and expansion cohorts in metastatic uveal melanoma was accrued based on prior therapy.

View Eligibility Criteria

Eligibility Criteria

Inclusion Criteria:

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.

Exclusion Criteria:

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.

Study is for people with:

Melanoma

Phase:

Phase 1

Estimated Enrollment:

146

Study ID:

NCT02570308

Recruitment Status:

Completed

Sponsor:

Immunocore Ltd

Check Your Eligibility

Let’s see if you might be eligible for this study.

What is your age and gender ?

Submit

There are 26 Locations for this study

See Locations Near You

University California, San Diego Moores Cancer Center
La Jolla California, 92093, United States
The Angeles Clinic and Research Institute - W LA Office
Los Angeles California, 90025, United States
California Pacific Medical Center
San Francisco California, 94115, United States
University of Colorado Denver Anschutz Medical Campus
Aurora Colorado, 80045, United States
Georgetown University - Lombardi Comprehensive Cancer Center
Washington District of Columbia, 20007, United States
University of Miami Hospital Clinics/Sylvester Comprehensive Cancer Center
Miami Florida, 33136, United States
H. Lee Moffitt Cancer Center and Research Institute, Inc
Tampa Florida, 33612, United States
The University of Chicago Medical Center
Chicago Illinois, 60637, United States
Washington University, School of Medicine
Saint Louis Missouri, 63110, United States
Roswell Park Cancer Institute
Buffalo New York, 14263, United States
Columbia University Medical Center - The New York Presbyterian Hospital
New York New York, 10032, United States
Memorial Sloan Kettering Hospital
New York New York, 10065, United States
Dean A. Mcgee Eye Institute
Oklahoma City Oklahoma, 73104, United States
Providence Portland Medical Center
Portland Oregon, 97213, United States
Thomas Jefferson University Medical Oncology Clinic
Philadelphia Pennsylvania, 19107, United States
Vanderbilt University Medical Center
Nashville Tennessee, 37232, United States
Baylor Scott & White Health
Temple Texas, 76508, United States
Princess Margaret Cancer Center
Toronto Ontario, M5G2M, Canada
Universitaetsklinikum Heidelberg
Heidelberg Baden Wuerttemberg, 69120, Germany
Charite Universitaetsmedizin Berlin - Campus Benjamin Franklin
Berlin , 12200, Germany
ICO l'Hospitalet - Hospital Duran i Reynals
L'Hospitalet De Llobregat Barcelona, 08908, Spain
Hospital Universitario La Paz
Madrid , 28046, Spain
Hospital Universitario Virgen Macarena
Sevilla , 41009, Spain
Hospital General Universitario de Valencia
Valencia , 46014, Spain
The Clatterbridge Cancer Centre
Wirral Merseyside, CH63 , United Kingdom
Mount Vernon Cancer Centre
Northwood Middlesex, HA6 2, United Kingdom

How clear is this clinincal trial information?

Study is for people with:

Melanoma

Phase:

Phase 1

Estimated Enrollment:

146

Study ID:

NCT02570308

Recruitment Status:

Completed

Sponsor:


Immunocore Ltd

How clear is this clinincal trial information?

×

Introducing, the Journey Bar

Use this bar to access information about the steps in your cancer journey.