CLINICAL TRIALS

There are currently several ongoing clinical trials working to evaluate the safety and effectiveness of new drugs and therapies for Lynch Syndrome.

Visit clinicaltrials.gov for more clinical trials. Search for Lynch Syndrome trials by entering Lynch Syndrome in the Condition or Disease search bar.

If you would like to participate in a clinical trial, talk to your doctor or genetics team, or contact the study coordinator to see if you are eligible.

 

 

PIPAC for the Treatment of Peritoneal Carcinomatosis in Patients With Ovarian, Uterine, Appendiceal, Colorectal, or Gastric Cancer - Currently recruiting

  • City of Hope Medical Center - Duarte, California

  • Mayo Clinic in Florida - Jacksonville, Florida

  • Northwell Health Cancer Institute at Huntington - Greenlawn, New York

Ovarian, uterine, gastric and colorectal cancer can be difficult to treat using traditional intravenous chemotherapy, especially when the tumors spread to a thin layer of tissue that lines the abdomen called the peritoneum. This phase I trial originally enrolled 16 patients. However, the results have been so promising it is expanding to 22 patients. It is open to patients with peritoneal carcinomatosis who have failed at least 1 cycle of standard chemotherapy.


Study of Induction PD-1 Blockade in Subjects With Locally Advanced Mismatch Repair Deficient Solid Tumors - Currently recruiting participants

  • Memorial Sloan Kettering Basking Ridge - Basking Ridge, New Jersey

  • Memorial Sloan Kettering Monmouth - Middletown, New Jersey

  • Memorial Sloan Kettering Bergen - Montvale, New Jersey

  • Memorial Sloan Kettering Commack - Commack, New York

  • Memoral Sloan Kettering Westchester - Harrison, New York

  • Memorial Sloan Kettering Cancer Center - New York, New York

  • Memorial Sloan Kettering Nassau - Uniondale, New York

The purpose of this study is to find out whether the study drug, TSR-042 as a single agent, can provide an effective treatment for locally advanced mismatch repair deficient cancer instead of the standard treatment of chemoradiation and surgery. Early results in the first 11 evaluable patients had a complete clinical response 12 months after finishing treatment, though the durability of response requires long term follow up. This phase of the trail will ultimately enroll 30 patients.


Cancer Preventive Vaccine Nous-209 for Lynch Syndrome Patients - Currently not yet recruiting participants. Estimated Study Start Date: June 2022

  • MD Anderson Cancer Center - Houston, Texas

  • City of Hope Comprehensive Cancer Center - Duarte, California

  • Fox Chase Cancer Center - Philadelphia, Pennsylvania

  • University of Puerto Rico - San Juan, Puerto Rico

This phase Ib/II trial evaluates the safety and effect of the Nous-209 vaccine in Lynch syndrome patients. Lynch syndrome is an inherited disorder in which affected individuals have a higher-than-normal chance of developing colorectal cancer and certain other types of cancer, often before the age of 50. In Lynch syndrome, errors in the genetic information inside cells are not properly corrected. When that happens, the cells produce new proteins called neoantigens. Neoantigens are recognized by the body's immune system as foreign, and the body tries to get rid of them. Nous-209 is a vaccine made with man-made copies of some of those neoantigens. This trial aims to see whether the Nous-209 vaccine is safe to give to patients with Lynch syndrome, whether people are able to take the Nous-209 vaccine without becoming too uncomfortable, and how the immune system of patients with Lynch syndrome respond to the Nous-209 vaccine. This trial may help researchers determine whether receiving Nous-209 has an effect on the development of polyps or tumors in the colon.

Additional Information
To learn more about the Lynch Syndrome Preventive Vaccine Trial and Lynch Syndrome vaccine research: https://prevention.cancer.gov/news-and-events/blog/vaccine-prevent-hereditary#.YPnThQHKzHE.facebook

Although still in the design phase, the study will test a neoantigen-based vaccine against Lynch syndrome, a common hereditary condition that carries a 70-80% lifetime risk for colorectal cancer. The syndrome also raises the risk for developing endometrial cancer and several other cancers, often before age 50 years.


Nous-209 Genetic Vaccine for the Treatment of Microsatellite Unstable Solid Tumors - currently recruiting participants

  • City of Hope Comprehensive Cancer Center - Duarte, California (Active, not recruiting)

  • Johns Hopkins University - Baltimore, Maryland (Active, not recruiting)

  • Washington University School of Medicine, Division of Oncology - St. Louis, Missouri (Active, not recruiting)

  • Roswell Park Comprehensive Cancer Center - Buffalo, New York (Active, not recruiting)

  • NYU Langone Medical Center - New York, New York (Recruiting)

  • Weill Cornell Medicine / New York-Presbyterian Hospital - New York, New York (Active, not recruiting)

  • MD Anderson Cancer Center (MDACC) - Houston, Texas (Active, not recruiting)

This phase 1 trial is evaluating the safety, tolerability, ability to cause an immune response to the vaccine, and to detect preliminary evidence of anti tumor activity.

This is the First in Humans clinical study of Nous-209 genetic vaccine in patients with inoperable or metastatic Mismatch Repair Deficient (dMMR) or Microsatellite Instability High (MSI-H) colorectal, gastric, gastro-esophageal junction and endometrial tumors in hereditary or sporadic (not caused by an inherited gene mutation) forms of the diseases. This vaccine is being used in combination with the immunotherapy drug pembrolizumab (Keytruda).

Most tumors caused by Lynch Syndrome are dMMR and/or MSI-H


Metagenic Evaluation of the Gut Microbiome in Participants With Lynch Syndrome and Other Hereditary Colonic Polyposis Syndromes - currently recruiting participants

  • Memorial Sloan Kettering Cancer Center, New York, New York

  • This trial’s purpose is to understand the role bacteria may play in colorectal cancer risk.


Investigating whether Lipitor (a cholesterol lowering drug) alone or with aspirin would reduce the risk of colorectal cancer in individuals with Lynch Syndrome - currently recruiting participants

  • Fox Chase Cancer Center, Philadelphia, PA

  • This is an exploratory biomarker trial to assess the ability of atorvastatin (common cholesterol lowering agent) alone or combining with aspirin (a nonsteroidal anti-inflammatory drug) to reduce the risk of colorectal cancer in high-risk individuals with Lynch Syndrome. Subjects will be stratified based on their prior history of polyps/cancer to receive atorvastatin without or with aspirin for 6 weeks. Blood and normal colon biopsies will be obtained at Day 0 and at 6 weeks on study. Tissue endpoints for analysis include cell proliferation, apoptosis and changes in gene expression. Circulating lipid profiles and metabolic function, and post-treatment questionnaires will be used to assess the acceptability of the study.


Investigating whether Omega 3 fatty acids in colorectal cancer prevention in individuals with Lynch Syndrome - currently recruiting participants

  • University of Kansas Cancer Center, Kansas City, KS

  • This is a pilot study aimed at assessing the effects of moderate dose omega-3-acid ethyl esters capsules (generic Lovaza) on molecular, and intestinal microbiota changes in participants at high risk for colorectal cancer. The study will be a single arm, open label study.


Investigating Pembrolizumab (Keytruda) an immunotherapy drug in the treatment of younger patients with certain brain cancers in Individuals with Lynch Syndrome and Constitutional Mismatch Repair Deficiency Syndrome - currently recruiting participants

  • Children’s Hospital Los Angeles, Los Angeles, CA 

  • Lucile Packers Children’s Hospital Stanford University, Palo Alto, CA

  • St. Jude’s Children’s Research Hospital, Memphis, TN

  • Children’s Hospital of Pittsburgh of UPMC, Pittsburgh, PA

  • Memorial Sloan Kettering Cancer Center, New York, NY

  • Children’s National Medical Center, Washington, DC

  • Plus 5 more hospitals across the US

  • This phase I trial studies the side effects and best dose of pembrolizumab and to see how well it works in treating younger patients with high-grade gliomas (brain tumors that are generally expected to be fast growing and aggressive), diffuse intrinsic pontine gliomas (brain stem tumors), brain tumors with a high number of genetic mutations, ependymoma or medulloblastoma that have come back (recurrent), progressed, or have not responded to previous treatment (refractory). Immunotherapy with monoclonal antibodies, such as pembrolizumab, may induce changes in the body's immune system, and may interfere with the ability of tumor cells to grow and spread.


To study men at high genetic risk for prostate cancer and determine if certain genetic changes and family history can help prevent or treat prostate cancer - currently recruiting participants

  • National Institutes of Health Clinical Center, Bethesda, MD

  • Research studies have shown that genetic changes and family history may increase a man’s risk for prostate cancer. Researchers want to follow the prostate health of men who have specific genetic changes associated with prostate cancer to help them learn more about which men are at higher risk for prostate cancer.