Trial Title:
KPMNG Study of MOlecular Profiling Guided Therapy Based on Genomic Alterations in Advanced Solid Tumors II
NCT ID:
NCT05525858
Condition:
Solid Tumor
Advanced Solid Tumor
Metastatic Cancer
Conditions: Official terms:
Neoplasms
Bevacizumab
Trastuzumab
Atezolizumab
Pertuzumab
Ado-Trastuzumab Emtansine
Erlotinib Hydrochloride
Vemurafenib
Maytansine
Pralsetinib
Alectinib
Entrectinib
Study type:
Observational
Overall status:
Recruiting
Study design:
Time perspective:
Prospective
Intervention:
Intervention type:
Drug
Intervention name:
Alectinib
Description:
ALK fusion or mutations, Mutations or amplification in any of the following: RET
Arm group label:
Tier 1. Therapeutic use of investigational products (KOSMOS-II drugs)
Other name:
Alecensa
Intervention type:
Drug
Intervention name:
Atezolizumab
Description:
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)
Arm group label:
Tier 1. Therapeutic use of investigational products (KOSMOS-II drugs)
Other name:
Tecentriq
Intervention type:
Drug
Intervention name:
Erlotinib
Description:
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
Arm group label:
Tier 1. Therapeutic use of investigational products (KOSMOS-II drugs)
Other name:
Tarceva
Intervention type:
Drug
Intervention name:
Trastuzumab + Pertuzumab
Description:
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
Arm group label:
Tier 1. Therapeutic use of investigational products (KOSMOS-II drugs)
Other name:
Herceptin + Perjeta
Intervention type:
Drug
Intervention name:
Trastuzumab emtansine
Description:
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
Arm group label:
Tier 1. Therapeutic use of investigational products (KOSMOS-II drugs)
Other name:
Kadcyla
Intervention type:
Drug
Intervention name:
Vemurafenib
Description:
BRAF_V600E/D/K/R mutations
Arm group label:
Tier 1. Therapeutic use of investigational products (KOSMOS-II drugs)
Other name:
Zelboraf
Intervention type:
Drug
Intervention name:
Bevacizumab + Erlotinib
Description:
FH inactivating mutations or approved by the KOSMOS Molecular Tumor Board
Arm group label:
Tier 1. Therapeutic use of investigational products (KOSMOS-II drugs)
Other name:
Avastin + Tarceva
Intervention type:
Drug
Intervention name:
Entrectinib
Description:
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
Arm group label:
Tier 1. Therapeutic use of investigational products (KOSMOS-II drugs)
Other name:
Rozlytrek
Intervention type:
Drug
Intervention name:
Pralsetinib
Description:
RET fusion or mutations; CCDC6 RET, RET V804L, RET V804M, RET M918T, KIF5B-RET, RET C634W
or approved by the KOSMOS Molecular Tumor Board
Arm group label:
Tier 1. Therapeutic use of investigational products (KOSMOS-II drugs)
Other name:
Gavreto
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)
Detailed description:
A. The KOSMOS-II study will recruit locally advanced or metastatic solid tumor patients
who had disease progression on standard first line anti-cancer treatment and/or has no
standard treatment option, in order to prove MTB value to guide treatment within local
clinical practice.
B. After site physicians confirm that NGS results of patients are available, they
preliminarily decide initial treatment before MTB submission and collect informed consent
form, and then patients can register to the KOSMOS-II study. Site physicians upload
patients' clinical, pathologic, and genomic data for MTB submission. If site physician
cannot determine initial treatment before MTB, site physician can record 'initial
treatment cannot be determined' and can register the patient for MTB.
C. MTB records its treatment recommendations within available drugs list based on
uploaded data, then site physicians make a final treatment decision, after informing
patient about MTB decision and assessment of patients' final health status and
preference.
D. Patients who have insufficient genomic information from their NGS results (e.g., lack
of variant calling format file or uninterpretable reports) or who are candidates of
immunotherapy will submit their tissue and/or blood, for central NGS testing and
exploratory biomarker analysis.
E. Recommended treatment option There are three different options including (1) Tier 1:
Therapeutic use of investigational products (KOSMOS-II drugs), (2) Tier 2: alternative
treatment options, and (3) Tier 3: clinical trials
Criteria for eligibility:
Study pop:
Histologically proven locally advanced or metastatic solid tumor patients with disease
progression on standard first line anti-cancer treatment and/or has no standard treatment
option
Sampling method:
Non-Probability Sample
Criteria:
Inclusion Criteria:
- 19 years of age or older
- Histologically proven locally advanced or metastatic solid tumors*** who showed
disease progression on standard first line anti-cancer treatment and/or has no
standard treatment option
*** very rare diseases without standard treatment option which form solid mass, such
as Erdheim Chester disease can be enrolled after KOSMOS MTB approval
- A genomic test results must be available in a MFDS-accredited for laboratories
offering service, or in part of clinical trial/study or other commercial labs
approved and certified by regulatory bodies compatible with MFDS, such as CLIA. A
genomic test can be conducted with tumor tissue as well as plasma circulating tumor
DNA.
1. Results from genomic profiling tests performed after diagnosis with
metastatic/advanced disease to registration are acceptable. NGS results
performed within three years prior to registration are preferred. Those
patients with NGS results from primary tumor or more than 3 years prior to
enrollment can be registered and whether NGS data is acceptable will be subject
to MTB decision.
2. NGS panels should be i. Tested in a lab that is accredited by one or more
quality assurance program (e.g., Korean Institute of Genomic Testing
Evaluation, The Korean Society of Pathologists, Korean Society for Laboratory
Medicine, Korea Laboratory Accreditation Scheme, etc.) ii. Patients who have
insufficient genomic information from their NGS results (e.g., lack of variant
calling format file or uninterpretable reports) or who are candidates of
immunotherapy will submit their tissue and/or blood, for central NGS testing
and exploratory biomarker analysis.
- Ability to understand and the willingness to sign a written informed consent
document
- Life expectancy of at least 12 weeks
- Adequate recovery from most recent systemic or local treatment for cancer.
Exclusion Criteria:
- Patients receiving any anti-cancer treatment (local treatment, chemotherapy,
immunotherapy, targeted therapy) within 2 weeks prior to the start of study
treatment
- Any clinical condition, according to the opinion of site physicians, which makes
molecular profiling guided therapy not at the best interest of the participating
patient.
- Patients who have ongoing toxicities of ≥ CTCAE 2, other than peripheral neuropathy,
related to previous anti-cancer treatment. Patients with ongoing peripheral
neuropathy of ≥ CTCAE 3 will be excluded. Laboratory abnormalities ≥ CTCAE 2
considered as not clinically significant by the study physician will be allowed.
- Pregnant or breastfeeding, or intending to become pregnant during the study
Gender:
All
Minimum age:
19 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Soonchunhyang University Hospital Bucheon
Address:
City:
Bucheon
Country:
Korea, Republic of
Status:
Recruiting
Contact:
Last name:
Jina Yun
Facility:
Name:
Chungbuk National University Hospital
Address:
City:
Chungju
Country:
Korea, Republic of
Status:
Recruiting
Contact:
Last name:
Yae-Won Yang
Facility:
Name:
Keimyung University Dongsan Hospital
Address:
City:
Daegu
Country:
Korea, Republic of
Status:
Recruiting
Contact:
Last name:
Keon-Uk Park
Facility:
Name:
Kyungpook National University Chilgok Hospital
Address:
City:
Daegu
Country:
Korea, Republic of
Status:
Recruiting
Contact:
Last name:
In-Hee Lee
Facility:
Name:
Yeungnam University Medical Center
Address:
City:
Daegu
Country:
Korea, Republic of
Status:
Recruiting
Contact:
Last name:
Ji-Yoon Jeong
Facility:
Name:
Chungnam National University Hospital
Address:
City:
Daejeon
Country:
Korea, Republic of
Status:
Recruiting
Contact:
Last name:
So-ra Kang
Facility:
Name:
National Cancer Center
Address:
City:
Goyang
Country:
Korea, Republic of
Status:
Recruiting
Contact:
Last name:
Wonyoung Choi
Facility:
Name:
Chonnam National University Hwasun Hospital
Address:
City:
Hwasun
Country:
Korea, Republic of
Status:
Recruiting
Contact:
Last name:
Sang Hee Cho
Facility:
Name:
Gachon University Gil Medical Center
Address:
City:
Incheon
Country:
Korea, Republic of
Status:
Recruiting
Contact:
Last name:
YoungSaing Kim
Facility:
Name:
The Catholic University of Korea, Incheon St. Mary's Hospital
Address:
City:
Incheon
Country:
Korea, Republic of
Status:
Recruiting
Contact:
Last name:
JaeHo Byun
Facility:
Name:
Jeonbuk National University Hospital
Address:
City:
Jeonju
Country:
Korea, Republic of
Status:
Recruiting
Contact:
Last name:
So-Yeon Jeon
Facility:
Name:
Gyeongsang National University Hospital
Address:
City:
Jinju
Country:
Korea, Republic of
Status:
Recruiting
Contact:
Last name:
Gyeong-Won Lee
Facility:
Name:
Dong-A University Hospital
Address:
City:
Pusan
Country:
Korea, Republic of
Status:
Recruiting
Contact:
Last name:
Seok-Jae Huh
Facility:
Name:
Cha University Bundang Medical Center
Address:
City:
Seongnam
Country:
Korea, Republic of
Status:
Recruiting
Contact:
Last name:
Beo-Deul Kang
Facility:
Name:
Seoul National University Bundang Hospital
Address:
City:
Seongnam
Country:
Korea, Republic of
Status:
Recruiting
Contact:
Last name:
Jee Hyun Kim
Facility:
Name:
Asan Medical Center
Address:
City:
Seoul
Country:
Korea, Republic of
Status:
Recruiting
Contact:
Last name:
Min-Hee Ryu
Facility:
Name:
Chung-ang University Hospital
Address:
City:
Seoul
Country:
Korea, Republic of
Status:
Recruiting
Contact:
Last name:
Yong-Ho Noh
Facility:
Name:
Ewha womans university Mokdong Hospital
Address:
City:
Seoul
Country:
Korea, Republic of
Status:
Recruiting
Contact:
Last name:
Kyung-Eun Lee
Facility:
Name:
Gangbuk Samsung Hospital
Address:
City:
Seoul
Country:
Korea, Republic of
Status:
Recruiting
Contact:
Last name:
Dong-Hoe Koo
Facility:
Name:
Hanyang University Hospital
Address:
City:
Seoul
Country:
Korea, Republic of
Status:
Recruiting
Contact:
Last name:
Kwon-Oh Park
Facility:
Name:
Korea University Anam Hospital
Address:
City:
Seoul
Country:
Korea, Republic of
Status:
Recruiting
Contact:
Last name:
Jiwon Lee
Facility:
Name:
Korea University Guro Hospital
Address:
City:
Seoul
Country:
Korea, Republic of
Status:
Recruiting
Contact:
Last name:
Eunju Kang
Facility:
Name:
Samsung Medical Center
Address:
City:
Seoul
Country:
Korea, Republic of
Status:
Recruiting
Contact:
Last name:
Jin-Young Kim
Facility:
Name:
Seoul National University Hospital
Address:
City:
Seoul
Country:
Korea, Republic of
Status:
Recruiting
Contact:
Last name:
Tae-Yong Kim
Facility:
Name:
The Catholic University of Korea, Seoul ST. Mary's Hospital
Address:
City:
Seoul
Country:
Korea, Republic of
Status:
Recruiting
Contact:
Last name:
Se-Jun Park
Facility:
Name:
The Catholic University of Korea, Yeouido St. Mary's Hospital
Address:
City:
Seoul
Country:
Korea, Republic of
Status:
Recruiting
Contact:
Last name:
In-Sook Woo
Facility:
Name:
Yonsei Cancer Hospital
Address:
City:
Seoul
Country:
Korea, Republic of
Status:
Recruiting
Contact:
Last name:
Min-Kyu Jung
Facility:
Name:
Ajou University Hospital
Address:
City:
Suwon
Country:
Korea, Republic of
Status:
Recruiting
Contact:
Last name:
Tae-hwan Kim
Facility:
Name:
The Catholic University of Korea, ST. Vincent's Hospital
Address:
City:
Suwon
Country:
Korea, Republic of
Status:
Recruiting
Contact:
Last name:
Ho-Jung An
Facility:
Name:
Ulsan University Hospital
Address:
City:
Ulsan
Country:
Korea, Republic of
Status:
Recruiting
Contact:
Last name:
Hyeon-Su Im
Facility:
Name:
Wonju Severance Christian Hospital
Address:
City:
Wŏnju
Country:
Korea, Republic of
Status:
Recruiting
Contact:
Last name:
Seung-Taek Lim
Facility:
Name:
Pusan National University Yangsan Hospital
Address:
City:
Yangsan
Country:
Korea, Republic of
Status:
Recruiting
Contact:
Last name:
JungHoon Kim
Start date:
September 28, 2022
Completion date:
March 2027
Lead sponsor:
Agency:
Seoul National University Bundang Hospital
Agency class:
Other
Collaborator:
Agency:
Korean Cancer Study Group
Agency class:
Other
Collaborator:
Agency:
Roche Pharma AG
Agency class:
Industry
Source:
Seoul National University Bundang Hospital
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05525858
