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Brief Title: SYNERGY-AI: Artificial Intelligence Based Precision Oncology Clinical Trial Matching and Registry

SYNERGY-AI: Artificial Intelligence Based Precision Oncology Clinical Trial Matching and Registry

INTRODUCTION

  • Org Study ID: SYNERGY-AI
  • Secondary ID: N/A
  • NTC ID: NCT03452774
  • Sponsor: Massive Bio, Inc.

BRIEF SUMMARY


International registry for cancer patients evaluating the feasibility and clinical utility of
an Artificial Intelligence-based precision oncology clinical trial matching tool, powered by
a virtual tumor boards (VTB) program, and its clinical impact on pts with advanced cancer to
facilitate clinical trial enrollment (CTE), as well as the financial impact, and potential
outcomes of the intervention.

DETAILED DESCRIPTION


The SYNERGY Registry is an international prospective, observational cohort study of eligible
adult and pediatric pts with advanced solid and hematological malignancies, for whom the
decision to consider CTE has already been made by their primary providers (PP). Using a
proprietary application programming interface (API) linked to existing electronic health
records (EHR) platforms, individual clinical data is extracted, analyzed and matched to a
parametric database of existing institutional and non-institutional CT. Machine learning
algorithms allow for dynamic matching based on CT allocation and availability for optimized
matching. Patients voluntarily enroll into the registry, which is non-interventional with no
protocol-mandated tests/procedures - all treatment decisions are made at the discretion of PP
in consultation with their pts, based on the AI CT matching report, and VTB support. CTE will
be assessed on variables including biomarkers, barriers to enrollment. Study duration
anticipated as ~36 mo (~24-mo enrollment followed by 12 mo of data collection, to occur every
3 mo). The primary analysis will be performed 12 mo after last pt enrolled. The impact time
to initiation of CTE on PFS and OS will be estimated by Kaplan-Meier and Cox multivariable
survival analysis. Enrollment is ongoing, with a target of ≥1500 patients.


  • Overall Status
    Recruiting
  • Start Date
    January 1, 2018
  • Phase
  • Study Type
    Observational [Patient Registry]

PRIMARY OUTCOMES

Primary Outcome 1 - Measure: Proportion of patients Eligible for CTE versus Actual CTE

Primary Outcome 1 - Timeframe: Through study completion, an average of 1 year

CONDITION

  • Cancer
  • Metastatic
  • Cancer
  • Cancer of Pancreas
  • Cancer of Liver
  • Cancer of Stomach
  • Cancer Liver
  • Cancer of Rectum
  • Cancer of Kidney
  • Cancer of Esophagus
  • Cancer of Cervix
  • Cancer of Colon
  • Cancer of Larynx
  • Cancer
  • Lung
  • Cancer
  • Breast
  • Cancer
  • Advanced
  • Cancer Prostate
  • Cancer of Neck
  • Cancer of Skin
  • Neuroendocrine Tumors
  • Carcinoma
  • Mismatch Repair Deficiency
  • BRCA Gene Rearrangement
  • Non Hodgkin Lymphoma
  • Leukemia
  • Non Small Cell Lung Cancer
  • Cholangiocarcinoma
  • Glioblastoma
  • Central Nervous System Tumor
  • Melanoma
  • Urothelial Carcinoma
  • Bladder Cancer
  • Ovarian Cancer
  • Endometrial Cancer
  • Testicular Cancer
  • Breast Cancer
  • COVID

ELIGIBILITY


Inclusion Criteria:

- Pts with solid and hematological malignancies;

- Pts cancer-related biomarkers, gene variants, fusion and rearrangements (by
immunohistochemistry, PCR, FISH or NGS): PD-L1, MSI (MMR), Claudin18.2, Tumor
mutational burden/load (TMB), ABL1, ACVR1B, AKT1, AKT2, AKT3, ALK, APC, AR, ATM, ATRX,
AURKA, AURKB, BAP1, BCL2, BCL6, BRAF, BRCA1, BRCA2, BTK, CCND1, CCND2, CCND3, CDK4,
CDK6, CDKN1A/B, CEBPA, CHEK1, CHEK2, CSF1R, CTNNB1, DAXX, DDR1/2, DNMT3A, EGFR, ERBB2,
ERBB3, ERBB4, ERCC4, ER, ESR1, FANCA, FAS, FBXW7, FGFR1, FGFR2, FGFR3, FGFR4, FLT3,
GATA3, GATA6, GNAS, HDAC1, HGF, HRAS, IDH1, IDH2, IGF1R, JAK1, JAK2, JAK3, KDR
(VEGFR2), KIT, KRAS, MAP2K2 (MEK2), MAP3K1, MCL1, MDM2, MDM4, MEN1, MET, MSH2, MSH3,
MSH6, MTOR, MUTYH, MYC, MYCL (MYCL1), NF1, NF2, NOTCH1, NPM1, NRAS, NTRK1, NTRK2,
NTRK3, PALB2, PARP1, PARP2, PARP3, PBRM1, PDCD1 (PD1), PDCD1LG2 (PD-L2), PDGFRA,
PDGFRB, PIK3C, PMS2, POLD1, POLE, PRDM1, PTCH1, PTEN, RAF1, RB1, RET, RICTOR, ROS1,
RPTOR, SDHA/B/C, SMAD, SMARC, SMO, STK11, TGFBR2, TP53, TSC1, TSC2, VEGFA, VHL, WT1,
ZNF217, ZNF703, among others.

These biomarkers should be determined by local laboratory, external vendor, or next
generation sequencing platform

- Decision to consider clinical trial pre-screening enrollment (CTE) by primary provider
and/or patient

Exclusion Criteria:

- ECOG PS > 2;

- Abnormal organ function;

- Hospice enrollment

Gender: All

Minimum Age: N/A

Maximum Age: N/A

Healthy Volunteers: No

OFFICIAL INFORMATION

Name: Selin Kurnaz, PhD

Role: Principal Investigator

Affiliation: Massive Bio, Inc.

Overall Contact

Name: Selin Kurnaz, PhD

Phone: +1(917) 336-3319

Email: skurnaz@massivebio.com

LOCATION

Facility Status Contact
Facility: Massive Bio, Inc
New York, New York 10006
United States 		Status: Recruiting Contact:
Kristin Johnston, RN
844-627-7246
support@massivebio.com

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