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Keynote 695 is Phase 2 study of intratumoral tavokinogene telseplasmid (tavo; pIL-12) Electroporation (EP) plus IV Pembrolizumab. Eligible patients will be those with pathological diagnosis of unresectable or metastatic melanoma who are progressing or have progressed on either pembrolizumab or nivolumab.
Accepts Healthy Volunteers
Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms |
No |
Study Type
An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies. |
Interventional |
Eligible Ages | 18 Years and Over |
Gender | All |
Trial ID:
This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries. |
NCT03132675 |
Phase
Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use. |
Phase 2 |
Lead Sponsor
The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data. |
OncoSec Medical Incorporated |
Principal Investigator
The person who is responsible for the scientific and technical direction of the entire clinical study. |
Bridget O'Keeffe, PhD |
Principal Investigator Affiliation | OncoSec Medical Incorporated |
Agency Class
Category of organization(s) involved as sponsor (and collaborator) supporting the trial. |
Industry |
Overall Status | Recruiting |
Countries | Australia, Canada, Italy, Switzerland, United States |
Conditions
The disease, disorder, syndrome, illness, or injury that is being studied. |
Stage III/IV Melanoma |
The study will be comprised of a screening period, a treatment period (up to 2 years), a long term follow-up period, and a survival follow-up period. Eligible subjects will be treated with TAVO-EP to the accessible lesions on days 1, 5, and 8 every 6 weeks and with IV pembrolizumab (200 mg) on Day 1 of each 3-week cycle for up to 18 TAVO-EP cycles and 35 pembrolizumab cycles (from baseline) of continued treatment (approximately 2 years) or until disease progression. As many accessible lesions may be treated, as deemed feasible by the treating physician, as long as the size of each lesion is greater than 0.3 cm × 0.3 cm. Long-term Follow-up: All subjects will be followed after End of Treatment (EOT) visit for SAEs (through 90 days from last dose of study drug). Subjects who discontinue treatment will enter the long-term follow-up period unless they have started a new anti-cancer therapy (or other local anticancer immunotherapy) or have withdrawn consent for non-survival assessments. They will have scans, photographs, and investigator-assessed disease evaluation per RECIST v1.1 collected every 3 months until disease progression, or the subject receives a new systemic anti-cancer treatment (or other local anticancer immunotherapy). Survival Follow-up: Once a subject receives a new systemic anti-cancer treatment (or other local anticancer immunotherapy), they will move into survival follow-up. All subjects will be followed for survival and disease status, every 3 months up to a total duration of 5 years, withdrawal of consent, or until Sponsor terminates the study.
Experimental: tavo-EP plus IV pembrolizumab
Intratumoral Tavokinogene Telseplasmid (tavo, pIL 12) plus Electroporation (ImmunoPulse) in Combination with Intravenous Pembrolizumab
Biological: - tavokinogene telseplasmid
Intratumoral tavokinogene telseplasmid (tavo, pIL-12) delivered by electroporation every 6 weeks
Biological: - Pembrolizumab
Intravenous 3 weekly treatments
Device: - ImmunoPulse
Device that electroporates the tavokinogene telseplasmid
If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.
Status
Recruiting
Address
The University of Arizona Cancer Center
Tucson, Arizona, 85724
Status
Recruiting
Address
Yuma Regional Medical Center, Yuma Cancer Center
Yuma, Arizona, 85364
Status
Recruiting
Address
University of California, San Diego
La Jolla, California, 92093
Status
Recruiting
Address
UCSF Medical Center
San Francisco, California, 94115
Status
Recruiting
Address
University of Colorado Anschutz Medical Campus University of Colorado Cancer Center
Aurora, Colorado, 80045
Status
Recruiting
Address
University of Miami Sylvester Cancer Center
Miami, Florida, 33136
Status
Recruiting
Address
UF Health Cancer Center at Orlando Health
Orlando, Florida, 32806
Status
Completed
Address
Moffit Cancer Center
Tampa, Florida, 33612
Status
Withdrawn
Address
Northwestern University, Northwestern Medicine Feinger School of Medicine
Chicago, Illinois, 60611
Status
Recruiting
Address
Ochsner Cancer Institute
New Orleans, Louisiana, 70121
Status
Completed
Address
Dana-Farber Cancer Institute
Boston, Massachusetts, 02215
Status
Completed
Address
University of Michigan, Michigan Medicine Melanoma Oncology Clinic - Rogel Cancer Center
Ann Arbor, Michigan, 48109
Status
Withdrawn
Address
Health Partners Cancer Care Center
Saint Paul, Minnesota, 55101
Status
Recruiting
Address
Dartmouth Hitchcock Clinic
Lebanon, New Hampshire, 03756
Status
Completed
Address
Atlantic Health System
Morristown, New Jersey, 07860
Status
Completed
Address
Roswell Park Cancer Institute
Buffalo, New York, 14263
Status
Completed
Address
Health Quest Systems, Inc.
Poughkeepsie, New York, 12601
Status
Completed
Address
Duke University
Durham, North Carolina, 27710
Status
Completed
Address
Gabrail Cancer Center
Canton, Ohio, 44718
Status
Withdrawn
Address
University of Toledo
Toledo, Ohio, 43614
Status
Completed
Address
St. Luke's University Health Network
Bethlehem, Pennsylvania, 18015
Status
Completed
Address
Penn State Health Hershey Medical Center
Hershey, Pennsylvania, 17033
Status
Recruiting
Address
Fox Chase Cancer Center
Philadelphia, Pennsylvania, 19111
Status
Recruiting
Address
Texas Oncology/Baylor
Dallas, Texas, 75246
Status
Completed
Address
Houston Methodist Cancer Center
Houston, Texas, 77030
Status
Completed
Address
Huntsman Cancer Institute
Salt Lake City, Utah, 84107
Status
Completed
Address
Westmead Hospital
Westmead, New South Wales, 2145
Status
Completed
Address
Princess Alexandra Hospital
Woolloongabba, Queensland, 4102
Status
Completed
Address
Cavalry Central Districts Hospital
Elizabeth Vale, South Australia, 5112
Status
Completed
Address
Box Hill Hospital
Box Hill, Victoria, 3128
Status
Completed
Address
The Alfred Hospital
Melbourne, Victoria, 3004
Status
Withdrawn
Address
Affinity Clinical Research
Nedlands, Western Australia, 6009
Status
Completed
Address
St John of God Hospital
Subiaco, Western Australia, 6008
Status
Withdrawn
Address
The Moncton Hospital
Moncton, New Brunswick, E1C 6Z8
Status
Completed
Address
Princess Margaret Cancer Centre
Toronto, Ontario, M5G2M9
Status
Completed
Address
McGill University Health Centre
Montréal, Quebec, H4A 3J1
Status
Completed
Address
Istituto Nazionale Tumori IRCCS Fondazione G. Pascale
Napoli, , 80131
Status
Completed
Address
University of Zurich, Dermatology Clinic
Zürich, Canton Of Zurich,