Nous-209 Genetic Vaccine for the Treatment of Microsatellite Unstable Solid Tumors
Public ClinicalTrials.gov record NCT04041310. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
A Phase I/II, Multicenter, Open-Label Study of Nous-209 Genetic Vaccine for the Treatment of Microsatellite Unstable Solid Tumors
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
Ref: Protocol Version 9.1 05 December 2024. NOUS-209-01 is a multicenter, open-label, multiple cohorts, clinical study, designed to evaluate safety, tolerability, and immunogenicity, and to detect any preliminary evidence of anti-tumor activity of Nous-209 genetic polyvalent vaccine plus pembrolizumab combination therapy in adult subjects with unresectable or metastatic deficient mismatch repair (dMMR) or MSI-H CRC, gastric, or gastro-esophageal junction (G-E junction) tumors. Nous-209 is based on a heterologous prime/boost regimen composed of the Great Ape Adenovirus GAd20-209-FSP used for priming and Modified Vaccinia virus Ankara MVA-209-FSP used for boosting. The Phase I portion of the study is a first-in-human (FIH) clinical study with a primary objective to elucidate the safety and tolerability of Nous-209 in addition to establishing the recommended Phase 2 dose (RP2D), whereas the Phase II was introduced to assess efficacy as the primary objective.
Study identification
- NCT ID
- NCT04041310
- Recruitment status
- Active, not recruiting
- Study type
- Interventional
- Phase
- Phase 1, Phase 2
- Enrollment
- 115 participants
Conditions and interventions
Conditions
Interventions
- GAd-209-FSP low dose Biological
- MVA-209-FSP low dose Biological
- GAd-209-FSP high dose Biological
- MVA-209-FSP high dose Biological
- GAd20-209-FSP, RP2D Biological
- MVA-209-FSP, RP2D Biological
- KEYTRUDA® Drug
Biological · Drug
Eligibility (public fields only)
- Age range
- 18 Years and older
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Oct 20, 2019
- Primary completion
- Oct 29, 2026
- Completion
- Oct 29, 2026
- Last update posted
- Feb 12, 2026
2019 – 2026
United States locations
- U.S. sites
- 13
- U.S. states
- 7
- U.S. cities
- 12
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| City of Hope Comprehensive Cancer Center | Duarte | California | 91010 | — |
| City of Hope Comprehensive Cancer Center | Irvine | California | 92618 | — |
| USC Norris Comprehensive Cancer Center | Los Angeles | California | 90089 | — |
| USC Norris Comprehensive Cancer Center | Newport Beach | California | 92663 | — |
| Mt. Sinai | Miami Beach | Florida | 33140 | — |
| Boca Raton Clinical Research | Plantation | Florida | 33322 | — |
| Goshen Center for Cancer Care | Goshen | Indiana | 46526 | — |
| Johns Hopkins University | Baltimore | Maryland | 21287 | — |
| Washington University School of Medicine, Division of Oncology | St Louis | Missouri | 63110 | — |
| Roswell Park Comprehensive Cancer Center | Buffalo | New York | 14203 | — |
| NYU Langone Medical Center | New York | New York | 10016 | — |
| Weill Cornell Medicine / New York-Presbyterian Hospital | New York | New York | 10021 | — |
| MD Anderson Cancer Center (MDACC) | Houston | Texas | 77030 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 33 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT04041310, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Feb 12, 2026 · Synced Sep 6, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT04041310 live on ClinicalTrials.gov.