IMCgp100-401 Rollover Study
Condition: Malignant Melanoma
MeSH terms: Melanoma
Intervention: IMCgp100
Intervention description: Bispecific soluble human leukocyte antigen-A2 (HLA-A2) restricted gp100-specific TCR fused to anti-CD3
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 3.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Uveal melanoma; Cutaneous melanoma

Summary:

      IMCgp100-401 is a rollover study that is designed to provide continued access to IMCgp100 for
      eligible participants with advanced melanoma who have previously participated in an IMCgp100
      study (parent study).
    

Eligibility criteria:

        Inclusion Criteria:

          1. Participant is currently participating in an Immunocore-sponsored study of IMCgp100
             and is actively receiving IMCgp100. Participant must have fulfilled all required
             assessments in the parent study (unless the study is being terminated)

          2. Participant is currently receiving clinical benefit from the treatment with IMCgp100,
             as determined by the principal investigator from the parent study

          3. Participant has demonstrated compliance with the parent study requirements, as
             assessed by the principal investigator and participant is able to comply with the
             necessary visits and assessments as part of the rollover study

          4. 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

        Exclusion Criteria:

          1. Participant 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

          2. 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

          3. 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 participants must be post-menopausal (no menstrual period for at
             least 12 months prior to Screening), or surgically sterile

          4. Male participants 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