INVAC-1 Anti-Cancer hTERT DNA Immunotherapy
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|ClinicalTrials.gov Identifier: NCT02301754|
Recruitment Status : Completed
First Posted : November 26, 2014
Last Update Posted : February 26, 2019
|Condition or disease||Intervention/treatment||Phase|
|Solid Tumors||Biological: INVAC-1||Phase 1|
This is the first-in-patient study of INVAC-1, a DNA vaccine encoding human telomerase reverse transcriptase (hTERT). hTERT is the catalytic subunit of the telomerase complex which synthesizes telomeric DNA at the chromosome ends. hTERT is overexpressed in most human tumors and virtually all types of cancers.
INVAC-1 is developed for cancer therapy. Stimulation of the immune system directed against telomerase expressing cancer cells has the potential to generate tumor responses.
The study is designed to evaluate the safety and pharmacodynamics (PD) of INVAC-1 administered alone by intradermal route to adults with solid tumor malignancies.
As shown in non-clinical studies, the efficacy of the vaccine is enhanced by electroporation, which thus will be combined with the vaccination in the present study.
The general clinical plan includes development of INVAC-1 in both hematologic malignancies and solid tumors, as a single agent and in combination with other targeted anticancer agents such as check-points inhibitors, radiotherapy or chemotherapies.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||26 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A First in Human Phase I Study of INVAC-1 as a Single Agent in Patients With Advanced Cancer|
|Study Start Date :||November 2014|
|Actual Primary Completion Date :||February 2018|
|Actual Study Completion Date :||June 1, 2018|
INVAC-1 at escalating doses of 100, 400 and 800 µg will be given as a single agent by intradermal injection (Q 4 weeks x 3 cycles), always combined with electroporation.
Each patient will receive 3 cycles, unless motivated treatment interruption.
intradermal injection combined with electroporation
- Dose Limiting Toxicities (DLTs) of INVAC-1 as single agent in combination with electroporation [ Time Frame: up to 28 days after last injection ]
- Adverse Events as characterized by type, frequency, severity (as graded by NCI Common Toxicity Criteria for Adverse Effects (CTCAE) v.4.03), timing, seriousness and relationship to study therapy INVAC-1 + electroporation; [ Time Frame: up to 28 days after last injection ]
- Routine laboratory abnormalities as characterized by type, frequency, severity (as graded by NCI CTCAE v.4.03) and timing [ Time Frame: up to 28 days after last injection ]
- Tumor Necrosis Factor-α, Interleukine (IL)-17, IL-8, IL-6, IL-1β measured in serum [ Time Frame: up to 28 days after last injection ]
- anti-nuclear antibodies (ANA), anti-DNA, anti-TPO measured in serum [ Time Frame: up to 28 days after last injection ]
- Elispot Interferon gamma [ Time Frame: every 4 weeks up to 3 months ]
- Absolute cell counts and phenotype for circulating T and Natural Killer cells [ Time Frame: every 2 weeks up to 3 months ]
- circulating tumor DNA assessed by quantification of the allelic fraction of the DNA mutations; circulating DNA is extracted from plasma [ Time Frame: before treatment; at day 15 of cycle 3 ]
- Objective response assessed by immune-related Response Criteria (ir-RC); [ Time Frame: every 8 weeks during treatement and every 2 to 4 months during one-year follow-up ]
- Duration of response [ Time Frame: every 8 weeks during treatement and every 2 to 4 months during one-year follow-up ]
- Progression free survival [ Time Frame: approximately 15 months ]
- Overall survival [ Time Frame: approximately 15 months ]
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): NCT02301754
|Hôpital Saint Louis|
|Paris, France, 75010|
|Hôpital Européen Georges Pompidou|
|Paris, France, 75015|
|Principal Investigator:||Stéphane Culine, MD||Hopital St Louis - Paris - France|