Nous-209 Genetic Vaccine for the Treatment of Microsatellite Unstable Solid Tumors
Last updated on July 2021Recruitment
- Recruitment Status
- Recruiting
- Estimated Enrollment
- Same as current
Summary
- Conditions
- Solid Tumor, Adult
- Type
- Interventional
- Phase
- Phase 1
- Design
- Allocation: Non-RandomizedIntervention Model: Sequential AssignmentIntervention Model Description: Cohort A - Dose escalation. Patients treated to evaluate safety and tolerability of two heterologous prime/boost vaccine regimen doses (low/low or high/high) in combo with pembrolizumab, and to define Recommended Phase 2 Dose (RP2D). Cohort B - Dose Expansion. This Cohort will test the RP2D vaccination schedule in combination with pembrolizumab.Masking: None (Open Label)Primary Purpose: Treatment
Participation Requirements
- Age
- Between 18 years and 85 years
- Gender
- Both males and females
Description
Ref. Protocol v4.0, dated 14Apr20. Both FrameShift Peptides (FSP) neoantigen-encoding genetic vaccines are administered intramuscularly using 1 prime with the GAd20-209-FSP and 3 boosts with MVA-209-FSP in combination with the licensed programmed death receptor-1 (PD-1)-blocking antibody pembrolizum...
Ref. Protocol v4.0, dated 14Apr20. Both FrameShift Peptides (FSP) neoantigen-encoding genetic vaccines are administered intramuscularly using 1 prime with the GAd20-209-FSP and 3 boosts with MVA-209-FSP in combination with the licensed programmed death receptor-1 (PD-1)-blocking antibody pembrolizumab in adult patients with unresectable or metastatic dMMR or MSI-H CRC, gastric, or G-E junction tumors. GAd20-209-FSP prime will be administered on the day of 2nd pembrolizumab infusion (week 4); MVA-209-FSP boosts will be administered on the day of 3rd, 4th and 5th pembrolizumab infusion (weeks 7 and 10 and 13). The study (as per Protocol v4.0 dated 14 April 2020) is composed of a Main Study lasting 26 weeks and an Extended Follow-up from week 27 to week 106 of anti-PD-1 checkpoint inhibitor pembrolizumab SOC treatment and further 4 weeks following cessation of pembrolizumab treatment for safety follow-up until week 110. Main Study: The Main Study (26 weeks duration) is composed of two sequential cohorts. Cohort A (dose escalation cohort) will determine the recommended phase 2 dose (RP2D) for IP in combination with the anti-PD-1 checkpoint inhibitor pembrolizumab in patients with unresectable or metastatic dMMR or MSI-H CRC, gastric, or G-E junction tumors. Cohort B will expand the Cohort A in the same patients' population at the RP2D of IP in combination with pembrolizumab. Extended Follow-up: After week 26, treatment with pembrolizumab will continue up to week 106, unless there is documented disease progression (investigators may decide to continue pembrolizumab treatment beyond progression in specific circumstances), unacceptable adverse event(s), intercurrent illness that prevents further administration of treatment, Investigator's decision to withdraw the subject, subject withdraws consent, pregnancy of the subject, noncompliance with trial treatment or procedure requirements, or administrative reasons. At the end of Extended Follow-Up (week 106), or before, if pembrolizumab treatment was prematurely discontinued, each subject will be followed for 4 additional weeks (up to week 110) for adverse event monitoring.
Tracking Information
- NCT #
- NCT04041310
- Collaborators
- Not Provided
- Investigators
- Study Director: Patricia Delaite, MD Nouscom SRL
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