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

Massive Bio

Status: Enrolling

Conditions: Testicular Cancer; Glioblastoma; Cancer of Colon; Melanoma; Central Nervous System Tumor; Urothelial Carcinoma; Cancer of Esophagus; Cancer Liver; Cholangiocarcinoma; Non Small Cell Lung Cancer; Cancer; Non Hodgkin Lymphoma; Myelodysplastic Syndromes; Cancer, Lung; Endometrial Cancer; Mismatch Repair Deficiency; Cancer of Pancreas; Bladder Cancer; COVID; Cancer Prostate; BRCA Gene Rearrangement; Follicular Lymphoma; Cancer of Kidney; Cancer, Advanced; Cancer of Skin; Cancer of Rectum; Myelofibrosis; Breast Cancer; Cancer, Breast; Marginal Zone Lymphoma; Myeloproliferative Disorders; Neuroendocrine Tumors; Mantle Cell Lymphoma; Carcinoma; Cancer of Liver; Cancer, Metastatic; Ovarian Cancer; Leukemia; Cancer of Larynx; Myeloproliferative Neoplasm; Cancer of Cervix; Cancer of Stomach; Cancer of Neck

Treatments: Other: Clinical Trial Matching

Study type: Observational

Funder types: Industry

Identifiers

NCT03452774

SYNERGY-AI

Details and patient eligibility

About

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.

Full 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 ≥50,000 patients.

Enrollment: 50,000 estimated patients

Sex: All

Volunteers: No Healthy Volunteers

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, HER2/Neu, 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, CEACAM, NRG1, 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

Trial design

50,000 participants in 1 patient group

Study Group

Description:

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).

Treatment:

Other: Clinical Trial Matching