Study of a New Immunotherapy Treatment Called NC410 in People with Different Types of Advanced or Metastatic Cancers
https://www.facingourrisk.org/research-clinical-trials/study/251/study-of-an-immunotherapy-treatment-in-individuals-with-advanced-or-metastatic-solid-tumors
Clinicaltrials.gov identifier:
NCT05572684 (https://clinicaltrials.gov/show/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]
About the Study
This study will test the safety and effectiveness of a new immunotherapy drug called NC410 used in combination with the immunotherapy agent Keytruda (pembrolizumab) in people with advanced or metastatic 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 immunotherapy 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
- Tucson
Arizona Oncology Associates
Contact: Julie A. Klinker [email protected]
Colorado
- Aurora
Rocky Mountain Cancer Centers
Contact: Jennifer R. Hege [email protected]
Kentucky
- Edgewood
St. Elizabeth Edgewood Hospital
Contact: Amy Pajik [email protected]
Maryland
- Baltimore
Johns Hopkins Sidney Kimmel Comprehensive Cancer Center
Contact: Research Referral Office [email protected] or Eric Christenson [email protected]
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
- Vancouver
Northwest Cancer Specialist
Contact: Susan Papenfuse [email protected]
This Study is Open To:
Patients 18 years or older who have advanced or metastatic colorectal, endometrial, ovarian, stomach, esophageal, head and neck, lung or cervical cancer, and:
- cancer has tumor marker microsatellite stable (MSS) or tumor is MSI-High but has progressed after treatment with immunotherapy
- 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 immunotherapy 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 immunotherapy
- has a known history of HIV infection
About FORCE
FORCE is a national nonprofit organization, established in 1999. Our mission is to improve the lives of individuals and families affected by adult hereditary cancers.