IMCgp100-401 is a rollover study that is designed to provide continued access to IMCgp100 for
eligible patients with advanced melanoma who have previously participated in an IMCgp100
study (parent study).
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Locations near you
Unfortunately, there are no recruiting locations near you. Please check the list with all locations below.
Full eligibility criteria for NCT02889861
Ages eligible for Study
18 Years and older
Genders eligible for Study
Accepts Healthy Volunteers
Patient is currently participating in an Immunocore-sponsored study of IMCgp100 and is actively receiving IMCgp100. Patient must have fulfilled all required assessments in the parent study (unless the study is being terminated)
Patient is currently receiving clinical benefit from the treatment with IMCgp100, as determined by the principal investigator from the parent study
Patient has demonstrated compliance with the parent study requirements, as assessed by the principal investigator and patient is able to comply with the necessary visits and assessments as part of the rollover study
Written informed consent must be obtained prior to enrolling in the rollover study and receiving the study treatment. If consent cannot be expressed in writing, then the consent must be formally documented and witnessed, ideally via an independent trusted witness
Patient has been permanently discontinued from any IMCgp100 study or from IMCgp100 treatment in the parent study due to unequivocal progressive disease, unacceptable toxicity, non-compliance to study procedures, withdrawal of consent, or any other reason
Pregnant or nursing (lactating) women, where pregnancy is defined as the state of a female after conception and until the termination of gestation, confirmed by a positive human chorionic gonadotropin laboratory test
Women of child-bearing potential who are sexually active with a non-sterilized male partner, defined as all women physiologically capable of becoming pregnant, unless they are using 2 methods of highly effective contraception from Screening, 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 include barrier methods, intrauterine devices or hormonal methods. Periodic abstinence, the rhythm method, and the withdrawal method are not acceptable methods of birth control. Women of child-bearing potential must have a negative serum pregnancy test at Screening. Otherwise, female patients must be post-menopausal (no menstrual period for at least 12 months prior to Screening), or surgically sterile
Male patients who are not surgically sterile unless they are using a double barrier contraception method from enrollment through treatment and for 6 months following administration of the last dose of study drug
All locations for NCT02889861
United States (1)
Memorial Slone Kettering Cancer Center
New York, New York, United States, 10065
United Kingdom (2)
Dept of Oncology & Haematology, Churchill Hospital
Oxford, Oxfordshire, United Kingdom, OX3 7LJ
Dept of Medical Oncology, Beatson West of Scotland Cancer Centre
Glasgow, United Kingdom, G12 OYN
View full eligibility
Tris trial is registered with FDA with number: NCT02889861. The sponsor of the trial is Immunocore Ltd and it is looking for 3 volunteers for the current phase.
Official trial title: An Open-label, Multi-center, Rollover Study in Patients With Advanced Melanoma After Completing an IMCgp100 Clinical Study
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