Sample suitable for analysis of circulating tumour DNA using Foundation Liquid assay MX39795 Study Design Inclusion criteria Histologically confirmed CUP nonspecific subset No prior lines of therapy ID: 790256
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Slide1
*Tissue sample suitable for initial diagnosis of CUP at study site, confirmation of CUP diagnosis and generation of Foundation One comprehensive genomic profile at central laboratory
‡
Sample suitable for analysis of circulating tumour DNA using Foundation Liquid assay
MX39795 Study Design
Inclusion criteria
Histologically confirmed CUP (non-specific subset)
No prior lines of therapy
ECOG PS 0–1
≥1 measurable lesion
N=790
Induction
Carboplatin + paclitaxel or cisplatin + gemcitabine
(3 cycles)
Non-responders
PD or intolerable toxicity
n=318 (40%)
Responders
CR, PR or SD
n=472 (60%)
Investigator choice (following Molecular Tumour Board advice)
n=354
Alectinib (
ALK
or
RET
rearrangements)
Erlotinib + bevacizumab (
EGFR
Mut+)
Trastuzumab + pertuzumab + continued
induction chemo (
ERBB2
)
Vismodegib (
PTCH1
, SUFU or SMO)
Vemurafenib + cobimetinib (BRAF MutV600)
Ipatasertib (AKT1 or PI3K)
Olaparib (BRCA1, BRCA2 or HRD)
Atezolizumab (TMB high or MSI-high)
Atezolizumab + continued induction chemo (patients with no other option)
R3:1
n=118
Investigator choice (following Molecular Tumour Board advice)
Assigned as per randomised arm
Carboplatin + paclitaxel or cisplatin + gemcitabine (3 cycles)
Screening
Genomic profilingTissue* and blood‡plus select biomarkers (e.g. PD-L1)
Primary endpoint: pooled PFS from 9 molecularly guided regimens vs chemo in responders to induction chemo [PFS1]Secondary endpoint: OS
Category 1
Category 2
Slide2* A more comprehensive list can be found in the study protocol.
Selected inclusion criteria for CUPISCO
Inclusion criteria*
Histologically confirmed metastatic or advanced
unresectable
CUP as defined in
ESMO
guidelines
No prior lines of systemic CUP therapy
ECOG performance status of 0 or 1
Eligible
for platinum-based
doublet chemotherapy
Adequate hematologic and
end-organ
function
At least one lesion that is measurable (RECIST v1.1)
≥
18 years of
age
Life
expectancy ≥ 12 weeks
Sufficient
FFPE tumour tissue sample for:
Diagnosis of CUP at the study site’s local laboratory and
FoundationOne
® comprehensive genomic profiling at a central reference pathology laboratory
Inclusion
Slide3Selected exclusion criteria for CUPISCO
Exclusion criteria*
*
A more comprehensive list can be found in the study protocol
.
CUP: cancer of unknown primary site.
Roche data on file, study protocol MX39795
version 1.1
.
Favourable prognostic subset
(e.g., resectable)
Non-CUP neoplasms
Immunohistochemistry profile
that provides a definitive clinical suspicion of a primary cancer with a specific treatment
Leptomeningeal disease
Brain
or spinal
cord
metastases
Exclusion