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

Recruiting

• Conditions: Cancer of Rectum; Cancer of Kidney; Cancer of Larynx; Leukemia; Glioblastoma; Ovarian Cancer; Myelofibrosis; Myelodysplastic Syndromes; Cancer, Advanced; Carcinoma
• Interventions: Other: Clinical Trial Matching

• Registration Number: NCT03452774
• Lead 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 ≥50,000 patients.

Study Timeline

• Study Start: 2018-01-01
• Study First Submitted: 2018-02-13
• Study First Submitted QC: 2018-02-24
• Study First Posted: 2018-03-02
• Status Verified: 2024-03
• Last Update Submitted: 2024-03-12
• Last Update Posted: 2024-03-15
• Primary Completion: 2026-12
• Study Completion: 2027-06

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 50000

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Study Group	Clinical Trial Matching	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).

Primary Outcome Measures

Name	Time	Method
Proportion of patients Eligible for CTE versus Actual CTE	Through study completion, an average of 1 year	CTE Accrual

Secondary Outcome Measures

Name	Time	Method
Time from Intervention to Actual CTE (months)	Through study completion, an average of 1 year	Time to CTE
Impact of CTE on Overall Survival (OS), estimated by Kaplan-Meier and Cox multivariable survival analysis	4 years	OS
Impact of CTE on Progression-Free Survival (PFS), estimated by Kaplan-Meier and Cox multivariable survival analysis	4 years	PFS
Identification of Barriers to CTE	Through study completion, an average of 1 year	To identify barriers to accruals to clinical trials, as measured and reported by a questionnaire
Virtual Tumor Board Utilization	Through study completion, an average of 1 year	VTB Use Rate
Real World Data Analytics	Through study completion, an average of 1 year	To Analyze Individual Standard of Care Chemotherapy Utilization (nominal), across treatment lines (numeric); data will be combined and aggregated to report chemotherapy utilization rate (%).

Trial Locations

Locations (1)

Massive Bio, Inc; 🇺🇸 New York, New York, United States