IMCgp100-401 Rollover Study
Status: | Active, not recruiting |
---|---|
Conditions: | Skin Cancer |
Therapuetic Areas: | Oncology |
Healthy: | No |
Age Range: | 18 - Any |
Updated: | 12/22/2018 |
Start Date: | January 18, 2017 |
End Date: | August 2020 |
An Open-label, Multi-center, Rollover Study in Patients With Advanced Melanoma After Completing an IMCgp100 Clinical Study
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).
eligible patients with advanced melanoma who have previously participated in an IMCgp100
study (parent study).
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). Parent studies that are eligible for patients to continue to receive
IMCgp100 in this rollover study must have completed and satisfied its primary endpoints or
have been terminated by the Sponsor for reasons other than safety.
Eligible patients will have tolerated IMCgp100 for a minimum of 4 weeks of dosing without
significant toxicities that would preclude further dosing in the opinion of the principal
investigator or Sponsor.
eligible patients with advanced melanoma who have previously participated in an IMCgp100
study (parent study). Parent studies that are eligible for patients to continue to receive
IMCgp100 in this rollover study must have completed and satisfied its primary endpoints or
have been terminated by the Sponsor for reasons other than safety.
Eligible patients will have tolerated IMCgp100 for a minimum of 4 weeks of dosing without
significant toxicities that would preclude further dosing in the opinion of the principal
investigator or Sponsor.
Inclusion Criteria:
1. 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)
2. Patient is currently receiving clinical benefit from the treatment with IMCgp100, as
determined by the principal investigator from the parent study
3. 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
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. 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
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 patients must be post-menopausal (no menstrual period for at least
12 months prior to Screening), or surgically sterile
4. 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
We found this trial at
2
sites
New York, New York 10065
Principal Investigator: Alexander Shoustari, MD
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Oxford, Oxfordshire OX3 7LE
Principal Investigator: Mark Middleton, MD
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