Nous-209 Genetic Vaccine for the Treatment of Microsatellite Unstable Solid Tumors (NCT04041310)
A Phase I/II, Multicenter, Open-Label Study of Nous-209 Genetic Vaccine for the Treatment of Microsatellite Unstable Solid Tumors
🩺 Plain-English Summary (8th-Grade Level)
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.
Who can join: Review the eligibility criteria below.
Location: City of Hope Comprehensive Cancer Center — Duarte, California
Age range: 18 Years
🧪 Interventions in This Study
📋 "Do I Qualify?" — 1-Minute Self Screener
Instant ChecklistFull eligibility criteria are available on the official NIH protocol. View the criteria ↗
📍 All Participating Trial Locations (46 Sites)
Showing the first 25 of 46 sites.
- City of Hope Comprehensive Cancer Center — Duarte, California
- City of Hope Comprehensive Cancer Center — Irvine, California
- USC Norris Comprehensive Cancer Center — Los Angeles, California
- USC Norris Comprehensive Cancer Center — Newport Beach, California
- Mt. Sinai — Miami Beach, Florida
- Boca Raton Clinical Research — Plantation, Florida
- Goshen Center for Cancer Care — Goshen, Indiana
- Johns Hopkins University — Baltimore, Maryland
- Washington University School of Medicine, Division of Oncology — St Louis, Missouri
- Roswell Park Comprehensive Cancer Center — Buffalo, New York
- NYU Langone Medical Center — New York, New York
- Weill Cornell Medicine / New York-Presbyterian Hospital — New York, New York
- MD Anderson Cancer Center (MDACC) — Houston, Texas
- Cliniques Universitaires Saint-Luc - Centre du Cancer — Brussels,
- Centre Hospitalier de l'Ardenne - Libramont - Clinique du Sein — Libramont,
- CHU de Liège — Liège,
- Mount Sinai Hospital — Toronto,
- Princess Margaret Cancer Center — Toronto,
- Aorn Sg Moscati — Avellino,
- Candiolo cancer Center,FPO IRCCS — Candiolo,
- IRCCS Ospedale San Raffaele — Milan,
- Fondazione IRCCS Istituto Nazionale dei Tumori — Milan,
- Ospedale Niguarda — Milan,
- AOUS Policlinico Le Scotte — Siena,
- Hospital Universitario de A Coruna — A Coruña,
📞 Contact the Study Coordinator
Phone: (800) 826-4673
Coordinator details come directly from the registered NIH protocol. Confirm the study is still recruiting before traveling.
💰 Cost, Insurance & Patient Rights
- 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
- Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
- Voluntary Participation: You may withdraw at any time without affecting your standard medical care.
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Explore by condition: All Solid Tumor, Adult clinical trials
💡 How to Participate
- Check the checklist above to see if you may qualify.
- Contact the study coordinator using the phone/email above.
- Ask about the visit schedule, what is covered at no cost, and any travel support.
- Confirm with your own doctor before making a decision.