- #ICONBOX LINK IN JEVELIN SKIN#
- #ICONBOX LINK IN JEVELIN TRIAL#
Short-term administration of systemic steroids (that is, for allergic reactions or the management of immune-related adverse events ) while on study is allowed.
#ICONBOX LINK IN JEVELIN TRIAL#
Concurrent systemic therapy with steroids or other immunosuppressive agents, or use of any investigational drug within 28 days before the start of trial treatment. Major surgery for any reason, except diagnostic biopsy, within 4 weeks and/or if the participant has not fully recovered from the surgery within 4 weeks. Radiotherapy administered to superficial lesions is not allowed if such lesions are considered target lesions in the efficacy evaluation or may influence the efficacy evaluation of the investigational agent Concurrent anticancer treatment (for example, cytoreductive therapy, radiotherapy, immune therapy, or cytokine therapy except for erythropoietin). Prior therapy with any antibody/drug targeting T-cell coregulatory proteins (immune checkpoints) such as antiprogrammed death 1 (PD-1), anti-PD-L1, or anticytotoxic T-lymphocyte antigen-4 (CTLA-4) antibody for Part B, the Investigator must consult with the Medical Monitor and consider other co-regulatory targets such as 4-1BB. Concurrent treatment with a non permitted drug. Participation in another interventional clinical trial within the past 30 days (participation in observational studies is permitted). Estimated life expectancy of more than 12 weeks. 
Highly effective contraception for both male and female participants, if the risk of conception exists. Adequate hematological, hepatic and renal function (renal function considered adequate as per protocol definition). #ICONBOX LINK IN JEVELIN SKIN#
Disease must be measurable with at least 1 uni-dimensional measurable lesion by RECIST Version 1.1 (including skin lesions).Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1.Prior chemotherapy treatment in the adjuvant setting (no clinically detectable disease no metastatic disease) is allowable if the end of treatment occurred at least 6 months prior to study start) For Part B - Participants must not have received any prior systemic treatment for metastatic MCC.
Participants must have received at least 1 line of chemotherapy for metastatic MCC and must have progressed after the most recent line of chemotherapy. Part B: Duration of Response According to Response Evaluation Criteria in Solid Tumors Version (RECIST) 1.1. Part A: Number of Participants With Clinically Significant Abnormalities in Laboratory Values Reported as Treatment Emergent Adverse Events (TEAEs). Related TEAEs are defined as events with a relationship of missing, unknown, or yes. TEAEs included both Serious TEAEs and non-serious TEAEs. Treatment-emergent are events between first dose of study drug that were absent before treatment or that worsened relative to pre-treatment state up to 30 days after last administration. A serious adverse event (SAE) was an AE that resulted in any of the following outcomes: death life threatening persistent/significant disability/incapacity initial or prolonged inpatient hospitalization congenital anomaly/birth defect or was otherwise considered medically important. 
Related Adverse events (AE) were defined according to National Cancer Institute Common Terminology Criteria for Adverse Events Version 4.0 (NCI-CTCAE) as adverse events with relationship to study treatment reported by the investigator. CR or PR must be confirmed by a subsequent tumor assessment preferably at next scheduled 6-weekly assessment, but no sooner than 5 weeks after initial documentation of CR or PR.
PD:at least a20% increase in SLD, taking as reference smallest SLD recorded from baseline/appearance of 1or more new lesions and unequivocal progression of non-target lesions. SD:Neither sufficient increase to qualify for PD nor sufficient shrinkage to qualify for PR. PR:At least 30%reduction from baseline in sum of longest diameter(SLD) of all lesions. CR:Disappearance of all evidence of target/non-target lesions. Why Should I Register and Submit Results?Ĭonfirmed BOR was determined according to RECIST 1.1and as adjudicated by an Independent Endpoint Review Committee(IERC) and defined as best response of any of complete response (CR), partial response(PR), stable disease(SD) and progressive disease(PD) recorded from date of randomization until disease progression/recurrence(taking smallest measurement recorded since start of treatment as reference).
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