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