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

Last updated: October 25, 2025
Sponsor: Massive Bio, Inc.
Overall Status: Active - Recruiting

Phase

N/A

Condition

Follicular Lymphoma

Melanoma

Neoplasms

Treatment

Clinical Trial Matching

Clinical Study ID

NCT03452774
SYNERGY-AI
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Pts with solid and hematological malignancies;

  • Pts cancer-related biomarkers, gene variants, fusion and rearrangements (byimmunohistochemistry, 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 primaryprovider and/or patient

Exclusion

Exclusion Criteria:

  • ECOG PS > 2;

  • Abnormal organ function;

  • Hospice enrollment

Study Design

Total Participants: 50000
Treatment Group(s): 1
Primary Treatment: Clinical Trial Matching
Phase:
Study Start date:
January 01, 2018
Estimated Completion Date:
June 30, 2040

Study 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.

Connect with a study center

  • Massive Bio SYNERGY-AI site

    San Juan 4568127, 00917
    Puerto Rico

    Active - Recruiting

  • Massive Bio SYNERGY-AI site

    Birmingham 4049979, Alabama 4829764 35294
    United States

    Active - Recruiting

  • Massive Bio SYNERGY-AI site

    Mobile 4076598, Alabama 4829764 36604
    United States

    Active - Recruiting

  • Massive Bio SYNERGY-AI site

    Scottsdale 5313457, Arizona 5551752 85260
    United States

    Active - Recruiting

  • Massive Bio SYNERGY-AI site

    Little Rock 4119403, Arkansas 4099753 72205
    United States

    Active - Recruiting

  • Massive Bio SYNERGY-AI site

    Duarte 5344147, California 5332921 91010
    United States

    Active - Recruiting

  • Massive Bio SYNERGY-AI site

    Irvine 5359777, California 5332921 92618
    United States

    Active - Recruiting

  • Massive Bio SYNERGY-AI site

    La Jolla 5363943, California 5332921 92093
    United States

    Active - Recruiting

  • Massive Bio SYNERGY-AI site

    Orange 5379513, California 5332921 92868
    United States

    Active - Recruiting

  • Massive Bio SYNERGY-AI site

    San Francisco 5391959, California 5332921 94143
    United States

    Active - Recruiting

  • Massive Bio SYNERGY-AI site

    Stanford 5398563, California 5332921 94305
    United States

    Active - Recruiting

  • Massive Bio SYNERGY-AI site

    Aurora 5412347, Colorado 5417618 80045
    United States

    Active - Recruiting

  • Massive Bio SYNERGY-AI site

    Denver 5419384, Colorado 5417618 80218
    United States

    Active - Recruiting

  • Massive Bio SYNERGY-AI site

    Littleton 5429032, Colorado 5417618 80129
    United States

    Active - Recruiting

  • Massive Bio SYNERGY-AI site

    Hartford 4835797, Connecticut 4831725 06102
    United States

    Active - Recruiting

  • Massive Bio SYNERGY-AI site

    Norwalk 4839822, Connecticut 4831725 06856
    United States

    Active - Recruiting

  • Massive Bio SYNERGY-AI site

    Newark 4143861, Delaware 4142224 19713
    United States

    Active - Recruiting

  • Massive Bio SYNERGY-AI site

    Boca Raton 4148411, Florida 4155751 33487
    United States

    Site Not Available

  • Massive Bio SYNERGY-AI site

    Jacksonville 4160021, Florida 4155751 32224
    United States

    Active - Recruiting

  • Massive Bio SYNERGY-AI site

    Miami 4164138, Florida 4155751 33136
    United States

    Active - Recruiting

  • Massive Bio SYNERGY-AI site

    Tampa 4174757, Florida 4155751 33612
    United States

    Active - Recruiting

  • Massive Bio SYNERGY-AI site

    Atlanta 4180439, Georgia 4197000 30322
    United States

    Active - Recruiting

  • Massive Bio SYNERGY-AI site

    Savannah 4221552, Georgia 4197000 31405
    United States

    Active - Recruiting

  • Massive Bio SYNERGY-AI site

    Boise 5586437, Idaho 5596512 83706
    United States

    Active - Recruiting

  • Massive Bio SYNERGY-AI site

    Chicago 4887398, Illinois 4896861 60611
    United States

    Active - Recruiting

  • Massive Bio SYNERGY-AI site

    Iowa City 4862034, Iowa 4862182 52242
    United States

    Active - Recruiting

  • Massive Bio SYNERGY-AI site

    New Orleans 4335045, Louisiana 4331987 70112
    United States

    Active - Recruiting

  • Massive Bio SYNERGY-AI site

    Scarborough 4977882, Maine 4971068 04074
    United States

    Active - Recruiting

  • Massive Bio SYNERGY-AI site

    Baltimore 4347778, Maryland 4361885 21218
    United States

    Active - Recruiting

  • Massive Bio SYNERGY-AI site

    Bethesda 4348599, Maryland 4361885 20892
    United States

    Active - Recruiting

  • Massive Bio SYNERGY-AI site

    Silver Spring 4369596, Maryland 4361885 20904
    United States

    Active - Recruiting

  • Massive Bio SYNERGY-AI site

    Towson 4371582, Maryland 4361885 21204
    United States

    Active - Recruiting

  • Massive Bio SYNERGY-AI site

    Worcester 4956184, Massachusetts 6254926 01655
    United States

    Active - Recruiting

  • Massive Bio SYNERGY-AI site

    Ann Arbor 4984247, Michigan 5001836 48109
    United States

    Active - Recruiting

  • Massive Bio SYNERGY-AI site

    Lansing 4998830, Michigan 5001836 48912
    United States

    Active - Recruiting

  • Massive Bio SYNERGY-AI site

    Duluth 5024719, Minnesota 5037779 55805
    United States

    Active - Recruiting

  • Massive Bio SYNERGY-AI site

    Hattiesburg 4429295, Mississippi 4436296 39401
    United States

    Active - Recruiting

  • Massive Bio SYNERGY-AI site

    Kansas City 4393217, Missouri 4398678 64111
    United States

    Active - Recruiting

  • Massive Bio SYNERGY-AI site

    St Louis 4407066, Missouri 4398678 63110
    United States

    Active - Recruiting

  • Massive Bio SYNERGY-AI site

    Billings 5640350, Montana 5667009 59102
    United States

    Active - Recruiting

  • Massive Bio SYNERGY-AI site

    Omaha 5074472, Nebraska 5073708 68124
    United States

    Active - Recruiting

  • Massive Bio SYNERGY-AI site

    New Brunswick 5101717, New Jersey 5101760 08901
    United States

    Active - Recruiting

  • Massive Bio SYNERGY-AI site

    Albuquerque 5454711, New Mexico 5481136 87131
    United States

    Active - Recruiting

  • Massive Bio, Inc

    New York, New York 10006
    United States

    Site Not Available

  • Massive Bio SYNERGY-AI site

    Buffalo 5110629, New York 5128638 14263
    United States

    Active - Recruiting

  • Massive Bio SYNERGY-AI site

    Hempstead 5120478, New York 5128638 11042
    United States

    Active - Recruiting

  • Massive Bio SYNERGY-AI site

    Manhasset 5125766, New York 5128638 11030
    United States

    Active - Recruiting

  • Massive Bio SYNERGY-AI site

    New York 5128581, New York 5128638 10006
    United States

    Active - Recruiting

  • Massive Bio, Inc

    New York 5128581, New York 5128638 10006
    United States

    Active - Recruiting

  • Massive Bio SYNERGY-AI site

    Staten Island 5139568, New York 5128638 10314
    United States

    Active - Recruiting

  • Massive Bio SYNERGY-AI site

    Chapel Hill 4460162, North Carolina 4482348 27514
    United States

    Active - Recruiting

  • Massive Bio SYNERGY-AI site

    Winston-Salem 4499612, North Carolina 4482348 27157
    United States

    Active - Recruiting

  • Massive Bio SYNERGY-AI site

    Fargo 5059163, North Dakota 5690763 58102
    United States

    Active - Recruiting

  • Massive Bio SYNERGY-AI site

    Cincinnati 4508722, Ohio 5165418 45219
    United States

    Active - Recruiting

  • Massive Bio SYNERGY-AI site

    Columbus 4509177, Ohio 5165418 43210
    United States

    Active - Recruiting

  • Massive Bio SYNERGY-AI site

    Mayfield Heights 5162188, Ohio 5165418 44124
    United States

    Active - Recruiting

  • Massive Bio SYNERGY-AI site

    Tulsa 4553433, Oklahoma 4544379 74146
    United States

    Active - Recruiting

  • Massive Bio SYNERGY-AI site

    Portland 5746545, Oregon 5744337 97239
    United States

    Active - Recruiting

  • Massive Bio SYNERGY-AI site

    Philadelphia 4560349, Pennsylvania 6254927 19044
    United States

    Active - Recruiting

  • Massive Bio SYNERGY-AI site

    Providence 5224151, Rhode Island 5224323 02903
    United States

    Active - Recruiting

  • Massive Bio SYNERGY-AI site

    Greenville 4580543, South Carolina 4597040 29605
    United States

    Active - Recruiting

  • Massive Bio SYNERGY-AI site

    Memphis 4641239, Tennessee 4662168 38105
    United States

    Active - Recruiting

  • Massive Bio SYNERGY-AI site

    Nashville 4644585, Tennessee 4662168 37203
    United States

    Active - Recruiting

  • Massive Bio SYNERGY-AI site

    Dallas 4684888, Texas 4736286 75246
    United States

    Active - Recruiting

  • Massive Bio SYNERGY-AI site

    Houston 4699066, Texas 4736286 77030
    United States

    Active - Recruiting

  • Massive Bio SYNERGY-AI site

    Temple 4735966, Texas 4736286 76508
    United States

    Active - Recruiting

  • Massive Bio SYNERGY-AI site

    Salt Lake City 5780993, Utah 5549030 84112
    United States

    Active - Recruiting

  • Massive Bio SYNERGY-AI site

    Charlottesville 4752031, Virginia 6254928 22908
    United States

    Active - Recruiting

  • Massive Bio SYNERGY-AI site

    Seattle 5809844, Washington 5815135 98109
    United States

    Active - Recruiting

  • Massive Bio SYNERGY-AI site

    Morgantown 4815352, West Virginia 4826850 26506
    United States

    Active - Recruiting

  • Massive Bio SYNERGY-AI site

    Milwaukee 5263045, Wisconsin 5279468 53226
    United States

    Active - Recruiting

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