Clinical trial NCT02889861: IMCgp100-401 Rollover Study
Official title: An Open-label, Multi-center, Rollover Study in Patients With Advanced Melanoma After Completing an IMCgp100 Clinical Study
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Malignant Melanoma
Keywords: Uveal melanoma
Cutaneous melanoma
Lead sponsor: Immunocore Ltd
Sponsor class: INDUSTRY
First posted: 2016-09-07
Enrollment: 3
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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).

Detailed description: 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). Parent studies that are eligible for participants 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 participants 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.

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

Primary outcomes:
measure: Incidence of Adverse Events: Number of Participants With Treatment-Emergent Adverse Events
timeFrame: Up to 2 years and 4 months
Secondary outcomes:
measure: Tolerability: Dose Interruptions by Participant - Number of Cycles
timeFrame: Up to 2 years and 4 months
measure: Tolerability: Dose Interruptions by Participant - Duration
timeFrame: Up to 2 years and 4 months
measure: Tolerability: Dose Reductions by Participant - Actual Total Dose Received
timeFrame: Up to 2 years and 4 months
measure: Tolerability: Dose Reductions by Participant - Dose Intensity
timeFrame: Up to 2 years and 4 months
measure: Tolerability: Dose Reductions by Participant - Relative Dose Intensity
timeFrame: Up to 2 years and 4 months
measure: Overall Survival Status of All Participants Treated With IMCgp100: Number of Months
timeFrame: Up to 2 years and 4 months
measure: Assessments of Anti-IMCgp100 Antibody Formation: Number of Participants With Anti-IMCgp100 Antibody Formation
timeFrame: Up to 2 years and 4 months
Other outcomes:
Locations:
city: New York
country: United States
facility: Memorial Slone Kettering Cancer Center
state: New York
city: Oxford
country: United Kingdom
facility: Dept of Oncology & Haematology, Churchill Hospital
state: Oxfordshire
city: Glasgow
country: United Kingdom
facility: Dept of Medical Oncology, Beatson West of Scotland Cancer Centre
Study officials:
References: