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

• Sponsor: Massive Bio, Inc.
• Information provided by (Responsible Party): Massive Bio, Inc.

Study Description

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.

Condition or disease

Intervention/treatment

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

Other: Clinical Trial Matching

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.

Study Design

• Study Type: Observational [Patient Registry]
• Estimated Enrollment: 1500 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Target Follow-Up Duration: 36 Months
• Official Title: SYNERGY-AI: Artificial Intelligence Based Precision Oncology Clinical Trial Matching and Registry
• Actual Study Start Date: January 1, 2018
• Estimated Primary Completion Date: December 2021
• Estimated Study Completion Date: December 2022

Groups and Cohorts

Group/Cohort

Intervention/treatment

Study Group; 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).

Other: Clinical Trial Matching; 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.

Outcome Measures

Primary Outcome Measures :

1. Proportion of patients Eligible for CTE versus Actual CTE [ Time Frame: Through study completion, an average of 1 year ]
   CTE Accrual

Secondary Outcome Measures :

1. Impact of CTE on Overall Survival (OS), estimated by Kaplan-Meier and Cox multivariable survival analysis [ Time Frame: 4 years ]
   OS
2. Impact of CTE on Progression-Free Survival (PFS), estimated by Kaplan-Meier and Cox multivariable survival analysis [ Time Frame: 4 years ]
   PFS
3. Identification of Barriers to CTE [ Time Frame: Through study completion, an average of 1 year ]
   To identify barriers to accruals to clinical trials, as measured and reported by a questionnaire
4. Real World Data Analytics [ Time Frame: 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 (%).
5. Virtual Tumor Board Utilization [ Time Frame: Through study completion, an average of 1 year ]
   VTB Use Rate
6. Time from Intervention to Actual CTE (months) [ Time Frame: Through study completion, an average of 1 year ]
   Time to CTE

Eligibility Criteria

• Ages Eligible for Study: Child, Adult, Older Adult
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No
• Sampling Method: Non-Probability Sample

Study Population

Observational cohort study of eligible adult and pediatric pts with advanced solid and hematological malignancies, for whom the decision to consider clinical trial enrollment (CTE) has already been made by their primary providers (PP).

Criteria

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

Contacts and Locations

Contacts

Contact: Selin Kurnaz, PhD; +1(917) 336-3319; skurnaz@massbio.io

Contact: Kristin Johnston, RN; +1(917) 336-3319; kjohnston@massbio.io

Locations

United States, New York

Massive Bio, Inc; Recruiting

New York, New York, United States, 10006

Contact: Kristin Johnston, RN 844-627-7246 support@massbio.io

Sponsors and Collaborators

Massive Bio, Inc.

Investigators

• Principal Investigator: Selin Kurnaz, PhD; Massive Bio, Inc.

More Information

Additional Information:

Feasibility of precision oncology virtual tumour boards to optimise direct point-of-care management and clinical trial enrolment of advanced cancer patients: New models for personalised oncology  SYNERGY-AI - Journal of Clinical Oncology (JCO) 

• Responsible Party: Massive Bio, Inc.
• ClinicalTrials.gov Identifier: NCT03452774 History of Changes
• Other Study ID Numbers: SYNERGY-AI
• First Posted: March 2, 2018
• Last Update Posted: March 7, 2019
• Last Verified: March 2019

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Massive Bio, Inc.:

artificial intelligence; virtual tumor board; clinical trial; clinical trial matching; electronic medical record; machine learning; cost of care; targeted therapy; immunotherapy; precision medicine; precision oncology; cancer; value based care; real world data; data analytics

Additional relevant MeSH terms:

Carcinoma; Neoplasms; Carcinoma, Non-Small-Cell Lung; Lymphoma, Non-Hodgkin; Glioblastoma; Urinary Bladder Neoplasms; Endometrial Neoplasms; Neuroendocrine Tumors; Cholangiocarcinoma; Carcinoma, Transitional Cell; Nervous System Neoplasms; Central Nervous System Neoplasms; Testicular Neoplasms; Pancreatic Neoplasms; Breast Neoplasms; Stomach Neoplasms; Esophageal Neoplasms; Lung Neoplasms; Liver Neoplasms; Colonic Neoplasms; Uterine Cervical Neoplasms; Brain Neoplasms; Neoplastic Syndromes, Hereditary; Colorectal Neoplasms; Rectal Neoplasms; Kidney Neoplasms; Carcinoma, Renal Cell; Head and Neck Neoplasms; Skin Neoplasms; Laryngeal Neoplasms