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Study of a New Immunotherapy Treatment Called NC410 in People with Different Types of Advanced or Metastatic Cancers

Clinicaltrials.gov identifier:
NCT05572684

Treatment
People with advanced or metastatic colorectal, endometrial, ovarian, stomach, esophageal or other cancers

Study Contact Information:

For additional information, please contact:

Associate Director Clinical Operations at NextCure Inc. by phone (859)468-8632 or email [email protected]

Director of Clinical Research  by phone (240)399-4900 or email [email protected]

 

Study of a New Immunotherapy Treatment Called NC410 in People with Different Types of Advanced or Metastatic Cancers

About the Study

This study will test the safety and effectiveness of a new drug called NC410 used in combination with the agent Keytruda (pembrolizumab) in people with advanced or cancers that cannot be removed by surgery. The study is open to people with colorectal, endometrial, ovarian, stomach, esophageal, head and neck and other cancers that:

  • have a tumor marker known as microsatellite stable (MSS), OR
  • have been treated with and no longer respond to treatment with  drugs known as immune checkpoint inhibitors.

What the Study Involves

All participants will receive the study drug NC410 injected by IV every 2 weeks and Keytruda injected IV every 6 weeks until the treatment stops working or causes serious side effects.

Study Sites

Arizona

Colorado

Kentucky

Maryland

New Jersey

  • Hackensack
    Hackensack Meridian Health University Medical Center - John Theurer Cancer Center
    Contact: Chelsea McCabe (551)996-4725 [email protected]

Ohio

  • Cincinnati
    University of Cincinnati Cancer Center
    Contact: Christine Vollmer (513)213-3203 [email protected]

Texas

  • Dallas
    Texas Oncology - Baylor Charles A. Sammons Cancer Center
    Contact: Jonathan B. Huntzinger [email protected]
  • Houston
    MD Anderson Cancer Center
    Contact: Siqing Fu (713)792-4318 [email protected]
  • San Antonio
    UT Health San Antonio
    Contact: Epp Goodwin (210)450-5798 [email protected]
  • San Antonio
    Texas Oncology - San Antonio
    Contact: Debora E. Lind [email protected]

Virginia

  • Fairfax
    Inova Schar Cancer Institute
    Contact: Stephanie Van Bebber (571)472-0213 [email protected]
  • Fairfax
    Virginia Cancer Specialist
    Contact: Carrie Friedman [email protected]

Washington

This Study is Open To:

Patients 18 years or older who have advanced or colorectal, endometrial, ovarian, stomach, esophageal, head and neck, lung or cervical cancer, and:

  • cancer has tumor marker microsatellite stable (MSS) or tumor is but has progressed after treatment with
  • are not pregnant or breastfeeding, and agree to use birth control until 120 days after the final treatment
  • have a life expectancy of at least 12 weeks
  • have adequate organ function
  • have a tumor that can be measured in size as assessed by the research team
  • are able to provide a tumor sample either from a previous biopsy that was taken within the last 5 years, or through a new biopsy
This Study is Not Open To:

Patients who:

  • are pregnant
  • have received  treatment in the last 4 weeks
  • have received radiation therapy within the last 2 weeks of beginning the treatment
  • have received a live vaccine within 30 days of beginning the treatment or a COVID-19 vaccine within the last 2 weeks
  • is currently participating in or previously participated in a treatment research study within the last 4 weeks
  • have had a tissue, stem cell, or organ transplant
  • has a decreased ability to fight infections and other diseases 
  • has an active infection requiring
  • has a known history of HIV infection