ClinicalTrials.gg
RecruitingNCT03452774Updated Oct 28, 2025

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

An observational study in Cancer, Metastatic, Cancer and Cancer of Pancreas, sponsored by Massive Bio, Inc.. Recruiting at 68 sites in 2 countries. Per ClinicalTrials.gov, last updated 2025-10-28.

Sponsored by Massive Bio, Inc. · Observational

From the registry’s dates

  • Started Jan 2018; still recruiting 8 years 10 months later.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
50,000
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-12

Among 2,053 studies in Neoplasm Metastasis with a site in United States — 348 open to participants now, 544 under way, 58 of them phase 3. Neoplasm Metastasis · United States.

Planned enrollment
Largest of 139
50,000 · median 100
Started
2018
with 73 others
Observational
139 of 2,053
28 open now
Primary completion
2038-12
later than 541 of 541 live
Registered
1,232nd of 2,053
by date

Among the 2,053 studies in Neoplasm Metastasis with a site in United States, this one has the largest planned enrollment of the 139 observational ones, is one of 74 that started in 2018, is one of 139 observational ones, reaches primary completion later than 541 of the 541 other live ones, and was the 1,232nd registered.

By phase

2,053 studies; the count open now beside each. This study's row is marked.

Phase 1709 · 130 open
Phase 2566 · 60 open
Phase 1/2267 · 63 open
No phase166 · 37 open
Phase 3164 · 21 open
Observationalthis study139 · 28 open
Phase 2/322 · 6 open
Phase 415 · 2 open
Other kind5 · 1 open

By the year they started

First in 1978; this study’s year is marked. 74 started in 2018.

Size and results

Median enrollment 43 across the 1,862 interventional studies, 100 across the 139 observational. Of the 1,389 that completed or were terminated, 601 (43%) have results posted.

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Watch this landscapeDownload CSVWith an account: a weekly mail of what changed among 2,053 studies in Neoplasm Metastasis with a site in United States, or all of them as a file.
02

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.

Read the 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.

03

Conditions studied

  • 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
  • Myelofibrosis
  • Myeloproliferative Neoplasm
  • Myeloproliferative Disorders
  • Follicular Lymphoma
  • Mantle Cell Lymphoma
  • Marginal Zone Lymphoma
  • Myelodysplastic Syndromes

Keywords

  • 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
04

Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
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).

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Pts with solid and hematological ;
  • Pts cancer-related biomarkers, gene variants, fusion and rearrangements (by immunohistochemistry, PCR, FISH or NGS): , MSI (MMR), Claudin18.2, /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

Exclusion Criteria:

  • PS > 2;
  • Abnormal organ function;
  • Hospice enrollment
Terms in these criteria, in plain language(4)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Cancer (malignancy)

Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.

Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.

PD-1, PD-L1 and checkpoint inhibitors

PD-1, PD-L1 and CTLA-4 are proteins that act as brakes on the immune system. Checkpoint inhibitors, such as pembrolizumab or nivolumab, block them so the immune system can attack a cancer.

PD-L1 can also be measured in a tumour sample. Some scores count stained tumour cells only (TPS); others also count certain immune cells (CPS). The study names the score and the minimum it uses.

HER2

HER2 is a protein, made from the ERBB2 gene, that drives the growth of some cancers. A study may look for a level of the protein, extra copies of the gene, or a particular change in it.

In breast cancer, protein tests are read as HER2-positive, HER2-low or HER2-negative; other cancers use their own rules. Check which test result the study requires.

ECOG performance status

A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.

0
Fully active, no restrictions.
1
Limited in strenuous activity, but walking and able to do light work, such as housework or office work.
2
Walking and able to look after yourself, but unable to work; up and about more than half of waking hours.
3
Able to look after yourself only in part; in bed or a chair more than half of waking hours.
4
Unable to look after yourself at all; in bed or a chair all day.

Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.

05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
50,000 participants (estimated)
Target follow-up
36 Months
Patient registry
Yes

Groups and cohorts

  • 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

Interventions

  • OtherClinical 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.

06

What researchers measure

Primary outcomes

  1. Proportion of patients Eligible for CTE versus Actual CTE

    CTE Accrual

    Time frame: Through study completion, an average of 1 year

Secondary outcomes

  1. Impact of CTE on Overall Survival (OS), estimated by Kaplan-Meier and Cox multivariable survival analysis

    OS

    Time frame: 4 years

  2. Impact of CTE on Progression-Free Survival (PFS), estimated by Kaplan-Meier and Cox multivariable survival analysis

    PFS

    Time frame: 4 years

  3. Identification of Barriers to CTE

    To identify barriers to accruals to clinical trials, as measured and reported by a questionnaire

    Time frame: Through study completion, an average of 1 year

  4. Real World Data Analytics

    To Analyze Individual Standard of Care Chemotherapy Utilization (nominal), across treatment lines (numeric); data will be combined and aggregated to report chemotherapy utilization rate (%).

    Time frame: Through study completion, an average of 1 year

  5. Virtual Tumor Board Utilization

    VTB Use Rate

    Time frame: Through study completion, an average of 1 year

  6. Time from Intervention to Actual CTE (months)

    Time to CTE

    Time frame: Through study completion, an average of 1 year

07

Study locations

68 of 68 sites recruiting
  • Massive Bio SYNERGY-AI site
    Birmingham, Alabama 35294, United States
    Recruiting
  • Massive Bio SYNERGY-AI site
    Mobile, Alabama 36604, United States
    Recruiting
  • Massive Bio SYNERGY-AI site
    Scottsdale, Arizona 85260, United States
    Recruiting
  • Massive Bio SYNERGY-AI site
    Little Rock, Arkansas 72205, United States
    Recruiting
  • Massive Bio SYNERGY-AI site
    Duarte, California 91010, United States
    Recruiting
  • Massive Bio SYNERGY-AI site
    Irvine, California 92618, United States
    Recruiting
  • Massive Bio SYNERGY-AI site
    La Jolla, California 92093, United States
    Recruiting
  • Massive Bio SYNERGY-AI site
    Orange, California 92868, United States
    Recruiting
  • Massive Bio SYNERGY-AI site
    San Francisco, California 94143, United States
    Recruiting
  • Massive Bio SYNERGY-AI site
    Stanford, California 94305, United States
    Recruiting
  • Massive Bio SYNERGY-AI site
    Aurora, Colorado 80045, United States
    Recruiting
  • Massive Bio SYNERGY-AI site
    Denver, Colorado 80218, United States
    Recruiting
  • Massive Bio SYNERGY-AI site
    Littleton, Colorado 80129, United States
    Recruiting
  • Massive Bio SYNERGY-AI site
    Hartford, Connecticut 06102, United States
    Recruiting
  • Massive Bio SYNERGY-AI site
    Norwalk, Connecticut 06856, United States
    Recruiting
  • Massive Bio SYNERGY-AI site
    Newark, Delaware 19713, United States
    Recruiting
  • Massive Bio SYNERGY-AI site
    Jacksonville, Florida 32224, United States
    Recruiting
  • Massive Bio SYNERGY-AI site
    Miami, Florida 33136, United States
    Recruiting
  • Massive Bio SYNERGY-AI site
    Tampa, Florida 33612, United States
    Recruiting
  • Massive Bio SYNERGY-AI site
    Atlanta, Georgia 30322, United States
    Recruiting
  • Massive Bio SYNERGY-AI site
    Savannah, Georgia 31405, United States
    Recruiting
  • Massive Bio SYNERGY-AI site
    Boise, Idaho 83706, United States
    Recruiting
  • Massive Bio SYNERGY-AI site
    Chicago, Illinois 60611, United States
    Recruiting
  • Massive Bio SYNERGY-AI site
    Iowa City, Iowa 52242, United States
    Recruiting
  • Massive Bio SYNERGY-AI site
    New Orleans, Louisiana 70112, United States
    Recruiting
  • Massive Bio SYNERGY-AI site
    Scarborough, Maine 04074, United States
    Recruiting
  • Massive Bio SYNERGY-AI site
    Baltimore, Maryland 21218, United States
    Recruiting
  • Massive Bio SYNERGY-AI site
    Bethesda, Maryland 20892, United States
    Recruiting
  • Massive Bio SYNERGY-AI site
    Silver Spring, Maryland 20904, United States
    Recruiting
  • Massive Bio SYNERGY-AI site
    Towson, Maryland 21204, United States
    Recruiting
  • Massive Bio SYNERGY-AI site
    Worcester, Massachusetts 01655, United States
    Recruiting
  • Massive Bio SYNERGY-AI site
    Ann Arbor, Michigan 48109, United States
    Recruiting
  • Massive Bio SYNERGY-AI site
    Lansing, Michigan 48912, United States
    Recruiting
  • Massive Bio SYNERGY-AI site
    Duluth, Minnesota 55805, United States
    Recruiting
  • Massive Bio SYNERGY-AI site
    Hattiesburg, Mississippi 39401, United States
    Recruiting
  • Massive Bio SYNERGY-AI site
    Kansas City, Missouri 64111, United States
    Recruiting
  • Massive Bio SYNERGY-AI site
    St Louis, Missouri 63110, United States
    Recruiting
  • Massive Bio SYNERGY-AI site
    Billings, Montana 59102, United States
    Recruiting
  • Massive Bio SYNERGY-AI site
    Omaha, Nebraska 68124, United States
    Recruiting
  • Massive Bio SYNERGY-AI site
    New Brunswick, New Jersey 08901, United States
    Recruiting
  • Massive Bio SYNERGY-AI site
    Albuquerque, New Mexico 87131, United States
    Recruiting
  • Massive Bio SYNERGY-AI site
    Buffalo, New York 14263, United States
    Recruiting
  • Massive Bio SYNERGY-AI site
    Hempstead, New York 11042, United States
    Recruiting
  • Massive Bio SYNERGY-AI site
    Manhasset, New York 11030, United States
    Recruiting
  • Massive Bio SYNERGY-AI site
    New York, New York 10006, United States
    Recruiting
  • Massive Bio SYNERGY-AI site
    Staten Island, New York 10314, United States
    Recruiting
  • Massive Bio SYNERGY-AI site
    Chapel Hill, North Carolina 27514, United States
    Recruiting
  • Massive Bio SYNERGY-AI site
    Winston-Salem, North Carolina 27157, United States
    Recruiting
  • Massive Bio SYNERGY-AI site
    Fargo, North Dakota 58102, United States
    Recruiting
  • Massive Bio SYNERGY-AI site
    Cincinnati, Ohio 45219, United States
    Recruiting
  • Massive Bio SYNERGY-AI site
    Columbus, Ohio 43210, United States
    Recruiting
  • Massive Bio SYNERGY-AI site
    Mayfield Heights, Ohio 44124, United States
    Recruiting
  • Massive Bio SYNERGY-AI site
    Tulsa, Oklahoma 74146, United States
    Recruiting
  • Massive Bio SYNERGY-AI site
    Portland, Oregon 97239, United States
    Recruiting
  • Massive Bio SYNERGY-AI site
    Philadelphia, Pennsylvania 19044, United States
    Recruiting
  • Massive Bio SYNERGY-AI site
    Providence, Rhode Island 02903, United States
    Recruiting
  • Massive Bio SYNERGY-AI site
    Greenville, South Carolina 29605, United States
    Recruiting
  • Massive Bio SYNERGY-AI site
    Memphis, Tennessee 38105, United States
    Recruiting
  • Massive Bio SYNERGY-AI site
    Nashville, Tennessee 37203, United States
    Recruiting
  • Massive Bio SYNERGY-AI site
    Dallas, Texas 75246, United States
    Recruiting
  • Massive Bio SYNERGY-AI site
    Houston, Texas 77030, United States
    Recruiting
  • Massive Bio SYNERGY-AI site
    Temple, Texas 76508, United States
    Recruiting
  • Massive Bio SYNERGY-AI site
    Salt Lake City, Utah 84112, United States
    Recruiting
  • Massive Bio SYNERGY-AI site
    Charlottesville, Virginia 22908, United States
    Recruiting
  • Massive Bio SYNERGY-AI site
    Seattle, Washington 98109, United States
    Recruiting
  • Massive Bio SYNERGY-AI site
    Morgantown, West Virginia 26506, United States
    Recruiting
  • Massive Bio SYNERGY-AI site
    Milwaukee, Wisconsin 53226, United States
    Recruiting
  • Massive Bio SYNERGY-AI site
    San Juan, 00917, Puerto Rico
    Recruiting
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Jan 2018 (actual). Primary completion is estimated for Dec 2038, 251 months after the start.

Of 240 observational studies under Neoplasm Metastasis, half reached primary completion within 66 months of starting (the median), counting those still running; a quarter within 35 and three quarters within 172. This study's planned 251 months is above that.

How these figures are worked out, and which studies are left out of them.

Registered
Feb 13, 2018
First posted
Mar 2, 2018
StartActual
Jan 1, 2018
Primary completionEst.
Dec 2038
CompletionEst.
Jun 2040
Last update
Oct 28, 2025
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Oct 28, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03452774
Lead sponsor
Massive Bio, Inc.
Responsible party
Sponsor
First posted
Mar 2, 2018
Start date
Jan 1, 2018
Primary completion
Dec 2038 (estimated)
Completion
Jun 2040 (estimated)
Last update
Oct 28, 2025

Study contacts

Fiona Evans, MS
Contact
fevans@massivebio.com
+1 (844) 627-7246
Diego Barrenechea, MD
Contact
dbarrenechea@massivebio.com
+ 1 (646) 586-2753
Selin Kurnaz, PhD
principal investigator · Massive Bio, Inc.

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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