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Association details:
Evidence:
Evidence Level:
Sensitive: C2 – Inclusion Criteria
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Title:

Regorafenib, C-kit Mutated Malignant Melanoma, 2nd Line Therapy

Excerpt:
...c-kit mutations 3....
Trial ID:
Evidence Level:
Sensitive: C3 – Early Trials
Title:

A phase II study on the efficacy of regorafenib in treating patients with c-KIT-mutated metastatic malignant melanoma that progressed after previous treatment (KCSG-UN-14-13)

Published date:
08/28/2023
Excerpt:
DCR at 8 weeks was 73.9%, with 2 patients (8.7%) achieving complete response, 5 (21.7%) achieving partial response, and 10 (43.5%) showing stable disease. ORR was 30.4% (7/23). The median follow-up period was 15.2 months (95% confidence interval [CI], 10.0–21.5), and median OS and PFS were 21.5 months (95% CI, 15.1–27.9) and 7.1 months (95% CI, 5.0–9.2), respectively....Regorafenib in second- or later-line settings demonstrated significant activity in patients with metastatic melanoma harboring c-KIT mutations.
DOI:
https://doi.org/10.1016/j.ejca.2023.113312
Trial ID:
Evidence Level:
Sensitive: C3 – Early Trials
Title:

A phase II study to evaluate the efficacy of regorafenib in C-KIT mutated metastatic malignant melanoma patients who have progressed on first-line treatment: A Multicenter Trial of Korean Cancer Study Group (UN-14-13)

Published date:
10/12/2022
Excerpt:
We conducted a multicenter phase II clinical trial of regorafenib in patients with metastatic melanoma positive for C-KIT mutations whose disease progressed after at least one line of systemic treatment....The DCR was 73.9%, with 2 patients (8.7%) showing complete response, 5 patients (21.7%) partial response, and 10 patients (43.5%) showing stable disease, and ORR was 30.4% (7/23 patients). Median follow-up duration was 15.2 months (95% confidential interval [CI], 10.0 – 21.5), and median PFS and OS were 7.0 months (95% CI, 1.5 – 12.5) and 16.3 months (95% CI, 12.6 – 19.9), respectively.