Tavo and Pembrolizumab in Patients With Stage III/IV Melanoma Progressing on Pembrolizumab or Nivolumab Treatment (Keynote695)
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|ClinicalTrials.gov Identifier: NCT03132675|
Recruitment Status : Recruiting
First Posted : April 28, 2017
Last Update Posted : April 29, 2021
|Condition or disease||Intervention/treatment||Phase|
|Stage III/IV Melanoma||Biological: tavokinogene telseplasmid Biological: Pembrolizumab Device: ImmunoPulse||Phase 2|
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 patients will be treated with intratumoral tavo-EP to the accessible lesions on Days 1, 5 and 8 every 6 weeks and with IV pembrolizumab (200mg) on Day 1 of each 3-week cycle for 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 assuming the size of each lesion is greater than 0.3 cm x 0.3 cm.
Long-term Follow-up: All subjects will be followed after End of Study (EOS) Treatment visit for SAEs (through 90 days from last dose of study drug). Subjects who discontinue treatment due to disease progression will directly enter the survival follow-up period following the End of Study Treatment visit. Subjects who discontinue treatment for any reason other than disease progression or withdrawal of consent enter the long-term follow-up period. They will have scans, photographs, and investigator-assessed disease evaluation per RECIST v1.1 collected every 3 months until disease progression, subject receives a new anti-cancer treatment (with the exception of maintenance pembrolizumab).
Information on all subjects' first new anti-cancer therapy will also be collected.
Survival Follow-up: Once a subject receives a new anti-cancer treatment or progresses during long-term follow-up, they will move into survival follow-up. All subjects will be followed for survival and disease status-, every 3 months until treatment period, long-term follow-up period, and survival follow-up period reaches a total duration of 5 years, withdrawal of consent, or until Sponsor terminates the study.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||152 participants|
|Intervention Model:||Single Group Assignment|
|Intervention Model Description:||
Phase 2, non-comparative, open-label, single-arm, multicenter study of intatrumoral tavo-EP plus IV pembrolizumab.
Cohort 1 Locally advanced or metastatic melanoma:
Approximatey 100 evaluable subjects will be enrolled into this cohort. The sample site may increase by up to an additional 25 subjects in order to collect clinical experience with the GenPulse OMS electroporation device.
Cohort 2 Locally advanced or metastatic melanoma with prior exposure to ipilimumab in combination with nivolumab:
Approximately 27 subjects will be enrolled into the cohort. Eligible subjects will be those with pathological diagnosis of unresectable or metastatic melanoma who are progressing or have progressed on ipilimumab combined with nivolumab.
|Masking:||None (Open Label)|
|Masking Description:||Blinded Independent Central Review|
|Official Title:||A Multicenter Phase 2, Open Label Study of Intratumoral Tavokinogene Telseplasmid (Tavo, pIL-12) Plus Electroporation in Combination With Intravenous Pembrolizumab in Patients With Stage III/IV Melanoma Who Are Progressing on Either Pembrolizumab or Nivolumab Treatment (Keynote 695)|
|Actual Study Start Date :||October 3, 2017|
|Estimated Primary Completion Date :||December 31, 2022|
|Estimated Study Completion Date :||July 31, 2023|
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
Intravenous 3 weekly treatments
Other Name: Keytruda
Device that electroporates the tavokinogene telseplasmid
Other Name: tavo-EP
- Overall Response Rate (ORR) [ Time Frame: approximately 2 years ]ORR by blinded independent central review (BICR) based on RECIST v1.1
- Objective Response rate (ORR) [ Time Frame: approximately 2 years ]ORR by investigator assessment based on RECIST v1.1
- Duration of Response (DOR) [ Time Frame: approximately 2 years ]DOR by Investigator assessment and BICR based on RECIST v1.1
- Progression free survival (PFS) [ Time Frame: approximately 2 years ]PFS by investigator assessment and BICR based on RECIST v1.1
- Immune Progression Free Survival (iPFS) [ Time Frame: approximately 2 years ]iPFS by Investigator assessment and BICR based on iRECIST
- Immune Overall Response Rate (iORR) [ Time Frame: approximately 2 years ]iORR by Investigator assessment and BICR based on iRECIST
- Overall survival (OS) [ Time Frame: approximately 2 years ]Overall survival
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): NCT03132675
|Contact: Chris Bakerfirstname.lastname@example.org|
|Contact: Jendy Sellemail@example.com|
|Study Director:||Jendy Sell||OncoSec Medical Incorporated|