Enroll in Research > Research Search & Enroll Tool > Nous-209 Genetic Vaccine for the Treatment of MSI-H Colorectal, Gastric and Gastro-esophageal junction Tumors
Nous-209 Genetic Vaccine for the Treatment of MSI-H Colorectal, Gastric and Gastro-esophageal junction Tumors

Nous-209 Genetic Vaccine for the Treatment of MSI-H Colorectal, Gastric and Gastro-esophageal junction Tumors

Clinicaltrials.gov identifier:
NCT04041310

Treatment:
Colorectal

Study Contact Information:

Questions about the study can be directed to the study contacts listed below or to Dr. Patricia Delaite at p.delaite@nouscom.com


Nous-209 Genetic Vaccine for the Treatment of Microsatellite -High (MSI-H) Colorectal, Gastric and Gastro-esophageal junction Tumors

About the Study

The goal of this cancer treatment study is to find the best dose and learn how safe and effective this cancer vaccine is for treating advanced colorectal, gastric and gastro-esophageal junction tumors that test positive for the biomarkers MSI-High or dMMR. Participants will receive the vaccine in combination with the immunotherapy drug Keytruda (pembrolizumab).

What the Study Entails

  • Participants will receive Keytruda (pembrolizumab) every two weeks for up to 106 weeks if their cancer has not progressed and they are tolerating the agent. 
  • Participants will receive the vaccine injections at weeks 4, 7, 10 and 13.
  • Participants will be followed for up to 110 weeks, with a 4 week followup after their last Keytruda injection. 

Type of Study

This is a non-randomized, open-label study. All participants will receive the study agent and pembrolizumab. 

Study Sites

State City Facility Contact Info
California Duarte City of Hope Michael Tajon, PhD by phone at: 626-218-7073 ext 87073 or by email at:   mtajon@coh.org  
Maryland Baltimore Johns Hopkins  Davis Liu by phone: 410-955-6632
Massachusetts Boston Dana-Farber Cancer Institute Dr. Marios Giannakis by email at: Marios_Giannakis@dfci.harvard.edu   
Michigan Detroit Barbara Ann Karmanos Cancer Institute Victoria LaBush by phone: 313-576-8411 or by email: labushv@karmanos.org 
Missouri St. Louis Washington University School of Medicine, Division of Oncology Jesse Huffman by phone: 314-747-6268 or by email: jessehuffman@wustl.edu   
New York Buffalo Roswell Park Comprehensive Cancer Center Dr. Sarbajit Mukherjee, MD by email: Sarbajit.Mukherjee@roswellpark.org
New York Weill Cornell Medicine / New York-Presbyterian Hospital Dr. Manish A. Shah by phone: 646-962-6200 or by email mas9313@med.cornell.edu 
New York Northwell Health Cancer Institute

Sarah Davis by phone: 516-734-7632 or email sdavis22@northwell.edu 
or Edison Sham by phone: 516-734-7632 or email: esham@northwell.edu 

Texas Houston MD Anderson Cancer Center Dr. Michael J Overman, MD by email: MOverman@mdanderson.org

 

This Study is Open To:

People may participate who:

  • Have microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR)  advanced colorectal, gastric or gastro-esophageal junction cancer.
  • Have cancers that progressed after at least one prior line of treatment OR who are not able to receive chemotherapy.
  • Have not previously received immunotherapy with an anti-PD-1 or anti-PD-L1 checkpoint inhibitor.
  • Must agree to have a first biopsy at baseline from a lesion that can be biopsied OR have tissue from a prior biopsy that is no older than 6 months.
  • Must agree to have a second on-treatment biopsy unless a second biopsy is considered to be unsafe.
This Study is Not Open To:

People cannot participate if they:

  • Have a history of active or suspected autoimmune disease, including ulcerative colitis and Crohn's Disease, rheumatoid arthritis, systemic progressive sclerosis [scleroderma], systemic lupus erythematosus, and others.
  • Have active brain or central nervous system (CNS) metastases and/or carcinomatous meningitis. Patients with previously treated brain metastases may participate provided they are stable.
  • Are receiving growth factors including, but not limited to, granulocyte colony stimulating factor (G-CSF), granulocyte macrophage-colony stimulating factor (GM-CSF), erythropoietin, etc. within 4 weeks of study drugs administration.
  • Had prior treatment with an anti-PD-1, or PD-L1 or PD-L2 agent or an antibody targeting other immuno-regulatory receptors or mechanisms.
  • Have ascites. A subject who is clinically stable following treatment for this condition (including therapeutic paracentesis no more than once a week) is eligible.
  • Have known history of Human Immunodeficiency Virus or have a known active Hepatitis B or C.
  • Has any history of anaphylaxis in reaction to a vaccination.
  • Has history of allergy to egg proteins.
  • Are pregnant or breastfeeding.
  • Have a known history of a second malignancy except if the patient has undergone potentially curative therapy with no evidence of that disease recurrence for 2 years since initiation of that therapy.