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KPMNG Study of MOlecular Profiling Guided Therapy Based on Genomic Alterations in Advanced Solid Tumors II
Sponsor: Seoul National University Bundang Hospital
Summary
A national, prospective, multi-center, open-label, multi-cohort study comprised of a framework to screen patients for actionable targets and evaluation of molecular profiling guided therapy recommended by MTB based on genomic alterations using targeted and/or immunotherapies outside of the approved indications via local clinical practice (Tier 1 \& 2) and clinical trials (Tier 3)
Official title: KOrean Precision Medicine Networking Group Study of MOlecular Profiling Guided Therapy Based on Genomic Alterations in Advanced Solid Tumors II
Key Details
Gender
All
Age Range
19 Years - Any
Study Type
OBSERVATIONAL
Enrollment
1000
Start Date
2022-09-28
Completion Date
2027-03
Last Updated
2025-04-27
Healthy Volunteers
No
Interventions
Alectinib
ALK fusion or mutations, Mutations or amplification in any of the following: RET
Atezolizumab
MSI high status by any method Or Any mutation in any of these genes: MLH1 or MSH2 or MSH6 or PMS2 or EPCAM Or Any of the following mutations in POLE: R150X, P286R, P286H, S297F, Y298fs, F367S, V411, L424V, P436R, S459F, R665W, L698fs, R762W, R1519C, R1826W, D316H, D316G, R409W, L474P Or Any of the following mutations in POLD1: P112fs, A930fs, S478N Or Any mutation in the following: POLE not listed above, POLD1 not listed above, POLD2, POLD3, POLD4, POLQ or PRKDC Or Any loss of function mutations in BRCA1, BRCA2, ATM, MSH3, PMS1, MLH3, EXO1, RFC1, RFC2, RFC3, RFC4, RFC5, PCNA, RPA1, PRA2, PRA3, PRA4, or SSBP1 High tumor mutational burden decided by KOSMOS-II MTB (TMB ≥20/Mb in local NGS or if 10-20/Mb, confirmed by central NGS te sting)
Erlotinib
EGFR Exon 19 deletions in the region E746\_E759; Any of the following EGFR mutations: E709A, E709G, E709K, E884K, G719A, G719C, G719S, L858R, L861Q, L833V, S768I
Trastuzumab + Pertuzumab
ERBB2 amplification, or over-expression; or presence of any of the following ERBB2 mutations: G309A, G309E, S310F, S310Y, R678Q, I655V, D769H, D769Y, L755S, p.L75 5\_T759del, I767M, V777L, E321G, R896C; P780ins; delL755-T759 ERBB2 amplification or approved by the KOSMOS Molecular Tumor Board
Trastuzumab emtansine
ERBB2 amplification, or over-expression; or presence of any of the following ERBB2 mutations: G309A, G309E, S310F, S310Y, R678Q, I655V, D769H, D769Y,L755S, p.L75 5\_T759del, I767M, V777L, E321G, R896C; P780ins; delL755-T759 ERBB2 oncogenic mutations; G152V, X215\_splice, D277Y, G292C, N302K, V308M, G309A, S310F, S310Y, S244C, L651V, V659E, G660D, R678Q, V697L, G727A, T733I, L755A, L755P, L755S, D769H, D769Y, A775\_G776insSVMA, A775\_G776insYVMA (i.e.,Y772\_A775dup,M774\_A775insAYVME 770delinsEAYVM), G776\_V777 \> AVCV, G776\_V777 \> AVGCV, G776\_V777 \> VCV, G776\_V777insVC, G776C, G776delinsLCT, G776L, G776dleinsVC, G776L777\_G778insC, V777L, V777M, G778\_Y779insGSP, P780\_Y781insGSP (i.e.,G778\_P780dup), L786V, N813D, R840W, V842I, T862A, R896G, E1021Q or approved by the KOSMOS Molecular Tumor Board
Vemurafenib
BRAF\_V600E/D/K/R mutations
Bevacizumab + Erlotinib
FH inactivating mutations or approved by the KOSMOS Molecular Tumor Board
Entrectinib
ROS1 gene fusion using either a fluo rescence in situ hybridization (FISH) or next-generation sequencing (NGS) or approved by the KOSMOS Molecular Tumor Board
Pralsetinib
RET fusion or mutations; CCDC6 RET, RET V804L, RET V804M, RET M918T, KIF5B-RET, RET C634W or approved by the KOSMOS Molecular Tumor Board
Locations (32)
Soonchunhyang University Hospital Bucheon
Bucheon-si, South Korea
Chungbuk National University Hospital
Chungju, South Korea
Keimyung University Dongsan Hospital
Daegu, South Korea
Kyungpook National University Chilgok Hospital
Daegu, South Korea
Yeungnam University Medical Center
Daegu, South Korea
Chungnam National University Hospital
Daejeon, South Korea
National Cancer Center
Goyang, South Korea
Chonnam National University Hwasun Hospital
Hwasun, South Korea
Gachon University Gil Medical Center
Incheon, South Korea
The Catholic University of Korea, Incheon St. Mary's Hospital
Incheon, South Korea
Jeonbuk National University Hospital
Jeonju, South Korea
Gyeongsang National University Hospital
Jinju, South Korea
Dong-A University Hospital
Pusan, South Korea
Cha University Bundang Medical Center
Seongnam, South Korea
Seoul National University Bundang Hospital
Seongnam, South Korea
Asan Medical Center
Seoul, South Korea
Chung-ang University Hospital
Seoul, South Korea
Ewha womans university Mokdong Hospital
Seoul, South Korea
Gangbuk Samsung Hospital
Seoul, South Korea
Hanyang University Hospital
Seoul, South Korea
Korea University Anam Hospital
Seoul, South Korea
Korea University Guro Hospital
Seoul, South Korea
Samsung Medical Center
Seoul, South Korea
Seoul National University Hospital
Seoul, South Korea
The Catholic University of Korea, Seoul ST. Mary's Hospital
Seoul, South Korea
The Catholic University of Korea, Yeouido St. Mary's Hospital
Seoul, South Korea
Yonsei Cancer Hospital
Seoul, South Korea
Ajou University Hospital
Suwon, South Korea
The Catholic University of Korea, ST. Vincent's Hospital
Suwon, South Korea
Ulsan University Hospital
Ulsan, South Korea
Wonju Severance Christian Hospital
Wŏnju, South Korea
Pusan National University Yangsan Hospital
Yangsan, South Korea