Study of Ad-RTS-hIL-12 + Veledimex in Combination With Cemiplimab in Subjects With Recurrent or Progressive Glioblastoma
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|ClinicalTrials.gov Identifier: NCT04006119|
Recruitment Status : Active, not recruiting
First Posted : July 2, 2019
Last Update Posted : June 26, 2020
This research study involves an investigational product: Ad-RTS-hIL-12 given with veledimex for production of human IL-12. IL-12 is a protein that can improve the body's natural response to disease by enhancing the ability of the immune system to kill tumor cells and may interfere with blood flow to the tumor.
Cemiplimab-rwlc (Libtayo) is an antibody (a kind of human protein) that is being tested to see if it will allow the body's immune system to work against glioblastoma tumors. Libtayo (cemiplimab-rwlc) is currently FDA approved in the United States for metastatic cutaneous cell carcinoma (CSCC), but is not approved in glioblastoma. Cemiplimab-rwlc may help your immune system detect and attack cancer cells. Ad-RTS-hIL-12 and veledimex will be given in combination with cemiplimab-rwlc to enhance the IL-12 mediated effect observed to date.
The main purpose of this study is to evaluate the safety and efficacy of a single tumoral injection of Ad-RTS-hIL-12 given with oral veledimex in combination with cemiplimab-rwlc.
|Condition or disease||Intervention/treatment||Phase|
|Glioblastoma||Biological: Ad-RTS-hIL-12 Drug: Veledimex Drug: Cemiplimab-Rwlc||Phase 2|
Eligible patients will receive one dose of cemiplimab-rwlc, via infusion, one week prior to standard of care craniotomy and tumor resection (subtotal or total). On the day of surgery, patients will receive one dose of veledimex before the resection procedure. Ad-RTS-hIL-12 will be administered by free-hand injection. Patients will continue on oral veledimex for 14 days. Following veledimex, patients will receive cemiplimab-rwlc via infusion every three weeks.
The study is divided into three periods: the screening period, the treatment period and the follow-up period.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||36 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase II Study of Ad-RTS-hIL-12 + Veledimex in Combination With Cemiplimab-rwlc (Libtayo®) in Subjects With Recurrent or Progressive Glioblastoma|
|Actual Study Start Date :||August 1, 2019|
|Estimated Primary Completion Date :||June 2022|
|Estimated Study Completion Date :||August 2022|
Experimental: Ad-RTS-hIL-12 + veledimex in combination with cemiplimab-rwlc
Intratumoral Ad-RTS-hIL-12 and oral veledimex (activator ligand, 20mg) given in combination with cemiplimab-rwlc via infusion.
20mg/day 15 oral daily doses of veledimex
Infusion every 3 weeks (350mg)
- Safety of intratumoral Ad-RTS-hIL-12 and oral veledimex in combination with cemiplimab-rwlc in subjects with recurrent or progressive glioblastoma. [ Time Frame: 3.5yrs ]Evaluation of adverse events as assessed by CTCAE v5.0 will be based on the incidence, intensity and type of adverse event.
- Efficacy of intratumoral Ad-RTS-hIL-12 and oral veledimex in combination with cemiplimab-rwlc in subjects with recurrent or progressive glioblastoma. [ Time Frame: 3.5yrs ]Overall Survival
- To determine the survival rates at 6, 12, 18 and 24 months [ Time Frame: 6, 12, 18 and 24 months after completion of enrollment ]
- To determine the progression free survival (PFS) [ Time Frame: 3.5yrs ]
- To determine the rate of pseudoprogression (PSP) at 6, 12, 18 and 24 months [ Time Frame: 6, 12, 18 and 24 months after completion of enrollment ]
- To determine the Investigator's assessment of response, including tumor objective response rate (ORR) at 6, 12, 18 and 24 months [ Time Frame: 6, 12, 18 and 24 months after completion of enrollment ]
- To determine the tumor response rates at 6, 12, 18 and 24 months [ Time Frame: 6, 12, 18 and 24 months after completion of enrollment ]
- Changes from baseline in cellular responses elicited by Ad-RTS-hIL-12 and veledimex in combination with cemiplimab-rwlc [ Time Frame: 3.5yrs ]
- Changes from baseline in humoral immune responses elicited by Ad-RTS-hIL-12 and veledimex in combination with cemiplimab-rwlc [ Time Frame: 3.5yrs ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04006119
|United States, California|
|Los Angeles, California, United States, 90048|
|University of California - San Francisco|
|San Francisco, California, United States, 94158|
|United States, Florida|
|Baptist MD Anderson Cancer Center|
|Jacksonville, Florida, United States, 32207|
|United States, Illinois|
|Northwestern Memorial Hospital|
|Chicago, Illinois, United States, 60611|
|United States, Massachusetts|
|Brigham and Women's|
|Boston, Massachusetts, United States, 02115|
|United States, New Jersey|
|JFK Medical Center|
|Edison, New Jersey, United States, 08820|
|United States, New York|
|NYU Langone Health|
|New York, New York, United States, 10016|
|Study Director:||Arnold Gelb, M.D.||Ziopharm|