A Phase I Dose-Finding Study to Evaluate Safety and Tolerability of CVHNLC Plus Pembrolizumab in Patients With Squamous Non Small-Cell Lung Cancer (sqNSCLC)
CureVac
Summary
This is an open-label, first-in-human, dose escalation study of CV09070101 mRNA (CVHNLC) in patients with metastatic Squamous Non-Small-Cell Lung Cancer (sqNSCLC). The study will evaluate the safety and tolerability of CVHNLC plus pembrolizumab in an Dose Escalation Part and, once the safety of this combination is established, CVHNLC plus prembrolizumab and chemotherapy (carboplatin and paclitaxel) will be evaluated in an Dose Expansion Part with the recommended dose selected from the Dose Escalation Part.
Description
Dose Escalation (Metastatic 1L Maintenance sqNSCLC) The Dose Escalation Part will be comprised of 3 dose cohorts with a starting dose of 100 μg (dose level 1). Once the starting dose is established as safe, further dose levels of 200 μg and 400 μg may be explored. Depending on safety assessment guided by a Bayesian Logistic Regression Model (BLRM) design intermediate dose levels may be explored. In case the HTD is exceeded at 100 μg, a lower dose level of 50 μg may be explored. Approximately 3 to 6 patients will be enrolled per dose level/cohort. To better understand the safety and tolerabili…
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: Dose Escalation Part (Metastatic 1L Maintenance sqNSCLC) 1. Patients with histologically confirmed metastatic Stage IV (per American Joint Commission on Cancer (AJCC) Staging Manual, Eighth Edition) sqNSCLC not amenable for surgical or locoregional therapy. 2. Patients who have received pembrolizumab for 3 months but no longer than 6 months from start of pembrolizumab treatment (at least 3 cycles with a total dose of 600 mg), either as monotherapy or in combination with at least 2 cycles of chemotherapy with carboplatin and (nab-)paclitaxel as first-line treatment with no…
Interventions
- BiologicalCV09070101 mRNA vaccine (CVHNLC) 50 µg
CVHNLC will be administered as in IM injection (4x in induction treatment period, than during main treatment period every 3 weeks) plus pembrolizumab (3-weekly)
- BiologicalCV09070101 mRNA vaccine (CVHNLC) 100 µg
CVHNLC will be administered as in IM injection (4x in induction treatment period, than during main treatment period every 3 weeks) plus pembrolizumab (3-weekly)
- BiologicalCV09070101 mRNA vaccine (CVHNLC) 200 µg
CVHNLC will be administered as in IM injection (4x in induction treatment period, than during main treatment period every 3 weeks) plus pembrolizumab (3-weekly)
- BiologicalCV09070101 mRNA vaccine (CVHNLC) 400 µg
CVHNLC will be administered as in IM injection (4x in induction treatment period, than during main treatment period every 3 weeks) plus pembrolizumab (3-weekly)
- BiologicalCV09070101 mRNA vaccine (CVHNLC) 400 µg
CVHNLC will be administered as in IM injection (4x in induction treatment period, than during main treatment period every 3 weeks) plus pembrolizumab (3-weekly) and carboplatin/paclitaxel (3-weekly)
Locations (13)
- Virginia Cancer CenterFairfax, Virginia
- Virginia Commonwealth University, Massey Comprehensive Cancer Center, McGlothlin Medical Education CenterRichmond, Virginia
- AP-HM - Hôpital NordMarseille
- Institut Curie - Hôpital de ParisParis
- CHU de Rennes - Hôpital PontchaillouRennes
- Institut de Cancerologie de l'Ouest - Hôpital Saint Herblain - PPDSSaint-Herblain