ong Term Follow-Up of Participants Exposed to GSK3377794
- Conditions
- Synovial sarcomaMedDRA version: 20.0Level: PTClassification code 10042863Term: Synovial sarcomaSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)Therapeutic area: Diseases [C] - Cancer [C04]
- Registration Number
- EUCTR2018-004888-31-IT
- Lead Sponsor
- GLAXOSMITHKLINE RESEARCH AND DEVELOPMENT
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- All
- Target Recruitment
- 65
Type of Participant and Disease Characteristics
1. Participants who:
a. Have received at least one dose of GSK3377794 in the interventional study and
b. Have either completed the interventional study or have withdrawn from it
Participants who complete the interventional study will complete the assessments
outlined in the interventional protocol prior to starting on this study.
Sex
2. Male or Female participants. Contraceptive use by men or women should be
consistent with local regulations regarding the methods of contraception for those
participating in clinical studies.
a. Male Participants:
Male participants are eligible to participate if they agree to the following contraception guidelines, starting at the first dose of chemotherapy and for at least 12 months after receiving the T-cell infusion, or 4 months after there is no evidence of persistence/gene modified cells in the participant’s blood, whichever is longer. If participants have received pembrolizumab during the interventional study, they must use effective contraception for at least 4 months after the last dose of pembrolizumab if this time frame is longer than the duration of contraception required in the context of chemotherapy and gene modified cells.
- Refrain from donating sperm
PLUS either:
- Be abstinent from heterosexual or homosexual intercourse as their preferred and usual lifestyle (abstinent on a long term and persistent basis) and agree to remain abstinent
OR
- Must agree to use contraception/barrier as detailed below
o Agree to use a male condom and should also be advised of the benefit for a female partner to use a highly effective method of contraception as a condom may break or leak when having sexual intercourse with a woman of childbearing potential who is not currently pregnant
o Agree to use male condom when engaging in any activity that allows for passage of ejaculate to another person
b. Female Participants:
A female participant is eligible to participate if at least one of the following
conditions applies:
- Is not a woman of childbearing potential (WOCBP) as defined in Section 10.4.1 of the protocol
OR
- Is a WOCBP (as defined in Section 10.4.1) who will agree to use a barrier method
(male condom) and use a contraceptive method that is highly effective (with a
failure rate of <1% per year), as described in Section 10.4.2 for at least 12 months
after receiving the T-cell infusion, or 4 months after there is no evidence of persistence/ gene modified cells in the participant’s blood, whichever is longer. If WOCBP participants have received pembrolizumab during the interventional study, they must use effective contraception for at least 4 months after the last dose of pembrolizumab if this time frame is longer than the duration of contraception required in the context of chemotherapy and gene modified cells. WOCBP should also agree not to donate eggs (ova, oocytes) for the purpose of reproduction during this period. The investigator should evaluate the effectiveness of the contraceptive method.
- Additional requirements for pregnancy testing are located in Appendix 2
- The investigator is responsible for review of medical history, menstrual history,
and recent sexual activity to decrease the risk for inclusion in the interventional
study of a woman with an early undetected pregnancy
Informed Consent
3. Capable of giving signed informed consent as described in Appendix 1 which includes compliance with the requirements and
Not applicable
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method