A Phase 2, Multi-Center, Open-Label Study of a Conditionally Replicative Adenovirus, DNX-2401, with Pembrolizumab for Recurrent Glioblastoma or Gliosarcoma (CAPTIVE/KEYNOTE-192)

THIS CLINICAL RESEARCH STUDY IS NOW ENROLLING

DNX-2401 (tasadenoturev) and pembrolizumab (MK3475) are investigational drugs for recurrent malignant brain cancers called glioblastoma and gliosarcoma. An investigational drug is one that the FDA and other health authorities have not approved to be safe and effective for the use being studied.

What is CAPTIVE?

CAPTIVE is a clinical study designed to investigate the efficacy and safety of DNX-2401 with pembrolizumab as a potential treatment for recurrent glioblastoma. Investigational study sites are currently screening patients in the US and Canada for participation in the CAPTIVE/KEYNOTE-192 study.

What is DNX-2401?

DNX-2401 is an investigational drug that is a modified adenovirus (common cold virus), which has been designed to specifically and selectively infect and attack cancer cells, but not normal cells.

DNX-2401 has been studied in over 150 patients in 6 clinical trials for cancer.

How does it work?

After DNX-2401 infects tumor cells, it multiplies and causes tumor cell death. The dying tumor cell releases signals that stimulate the immune system to attack and kill additional tumor cells. The new copies of DNX-2401 infect more tumor cells, leading to a chain reaction of tumor cell killing.

What is pembrolizumab?

Pembrolizumab, also known as KEYTRUDA,® is a monoclonal antibody that has already been approved by the FDA for use in some patients with advanced melanoma and certain patients with non-small cell lung cancer. Monoclonal antibodies are a type of targeted cancer therapy. Pembrolizumab is developed by Merck & Co., Inc.

How does it work?

Pembrolizumab is a selective antibody directed against the PD-1 receptor, a protein on the cell surface. Pembrolizumab blocks the PD-1 receptor and prevents the activation of proteins PD-L1 and PD-L2, which causes activation of an immune response against tumor cells.

CAPTIVE study

The purpose of this study is to investigate the safety and efficacy of using DNX-2401 and pembrolizumab together for the treatment of recurrent glioblastoma.

You may qualify for the CAPTIVE study if you:

  • Are at least 18 years old
  • Have been diagnosed with a first or second recurrence of glioblastoma or gliosarcoma
  • Have a tumor that measures between 1-4 cm (up to 1½ inches) in longest diameter
  • Have a tumor for which resection (brain surgery) is not possible or planned

Additional study entry criteria also apply. Contact any of the study sites listed below for more information or visit the clinical trials website: https://clinicaltrials.gov/show/NCT02798406

Trial Sites Currently Screening and Enrolling Patients

Country State/Prov. City Physician Institution Contact
USA AR Little Rock Shirley S. Ong, MD University of Arkansas
for Medical Sciences
Candi Langmaid (501-686-8274)
Kacie Simpson (501-686-8274)
USA CA Los Angeles Timothy Cloughesy, MD UCLA Medical Center Emese Filka (310-794-3521)
Stacy Green, NP (310-825-0644)
USA IL Chicago Priya Kumthekar, MD Northwestern University Rachel Lukas (312-695-1371)
Lauren Kloeppinger (312-926-6585)
USA MN Minneapolis Clark Chen, MD, PhD University of Minnesota Clark Chen, MD, PhD (612-624-1207)
Felicia O'Neill, RN, MPH (612-626-2569)
USA NC Chapel Hill Simon Khagi, MD UNC Lineberger Comprehensive
Cancer Center
Lisa A Brett, RN, CCRC (984-974-8253)
Correai Moore (984-974-8672)
USA NJ New Brunswick Robert D. Aiken, MD Rutgers Cancer Institute  
of New Jersey
Celeste Jackson, BS (732-235-9427) 
Karen Jackson (732-235-9835)
USA NY New York Mariza Daras, MD Memorial Sloan Kettering
Cancer Center
Mariza Daras, MD (212-610-0239)
Brain Tumor Line (212-639-2848)
USA NY New York Rohan Ramakrishna, MD Weill-Cornell Medicine
New York - Presbyterian
Alyson Hignight (212-746-1788)
Mary O’Hehir (212-746-7373)
USA OH Cleveland Michael Vogelbaum, MD, PhD Cleveland Clinic Cathy Schilero (216-636-9410)
Teresa Allison (216-444-6459)
USA OH Columbus Vinay Puduvalli, MBBS Ohio State University
James Cancer Center
Nadia Osman (614-685-2435)
Barb Kleiber (614-293-1815)
USA PA Allentown Suresh Nair, MD Lehigh Valley Health Network Yasmin Candelo, RN, BSN (610-402-0636)
Dana E. Clark (610-402-9543)
USA TX Austin Morris Groves, MD Texas Oncology Austin-Midtown Kristen K Brueggemann, RN, BSN (512-421-4108)
Kaelyn Kappeler, CCRC (512-421-4234)
USA TX Houston Frederick F. Lang, MD, 
FACS, FAANS
University of Texas
MD Anderson Cancer Center
Sharon Ji, MD, MS (713-792-2400)
Carmen Jacobs, BS, RN (713-792-2400)
USA UT Salt Lake City Howard Colman, MD, PhD Huntsman Cancer Institute Karthik Sonty (801-587-5562)
Brett Johnson (801-587-4429)
Canada Ontario Toronto Gelareh Zadeh, MD,
PhD, FRCSC
University Health Network Takyee Tung (416-603-5800 ext 5578)
Mariya Bakalets (416-946-4603)


2450 Holcombe Blvd Suite X+ 200
Houston, TX 77021
USA


2000 Galloping Hill Rd
Kenilworth, NJ 07033
USA

Disclaimer: The information in this website is not intended to promote DNX-2401, pembrolizumab (MK-3475), or any product and makes no representations or warranties. Potential patients should not make any healthcare decisions based solely on the information presented here.