Safety and Tolerability of CVHNLC Plus Pembrolizumab in Patients With Squamous Non Small-Cell Lun… (NCT07073183) | Clinical Trial Compass
WithdrawnPhase 1
Safety and Tolerability of CVHNLC Plus Pembrolizumab in Patients With Squamous Non Small-Cell Lung Cancer (sqNSCLC)
Stopped: In accordance with 21 CFR 312.38, CureVac is herewith withdrawing IND No. 031346 for CV09070101 (referred to as CVHNLC) for the indication of squamous Non-Small-Cell Lung Cancer (sqNSCLC), following the strategic decision to not pursue the CVHNL
United States, France, Spain0Started 2025-07-30
Plain-language 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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. 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.
. 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 documented disease progression and who are indicated for maintenance therapy with pembrolizumab.
. Patients able to tolerate further anti-PD-1 therapy i.e., no criteria for permanent discontinuation of pembrolizumab due to toxicity have been met during previous treatment.
. No known targetable molecular aberration.
. Patients having measurable disease according to RECIST 1.1.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Incidence of treatment-related adverse events (TRAEs)
Timeframe: 1 year
2
Incidence of treatment-emergent adverse events (TEAEs)
Timeframe: 1 year
3
Incidence of serious adverse events (SAEs)
Timeframe: 1 year
4
Incidence of adverse events of special interest (AESIs)
Timeframe: 1 year
5
Incidence of immune-related adverse events (irAEs)
Timeframe: 1 year
6
Incidence of injection site reactions (ISRs)
Timeframe: 1 year
7
Incidence of medical attended adverse events (MAEs) treatment-emergent adverse events leading to treatment discontinuation
. Available formalin-fixed paraffin-embedded (FFPE) tumor tissue samples from non- irradiated lesions that are not older than 6 months for retrospective assessment of antigen expression and potential other biomarker analyses (in total 15 slides of at least 5 μm thickness or equivalent amount provided as a single block).
. Recovered from all AEs related to prior therapies including anti-PD-(L)1 inhibitor treatment-related AEs to CTCAE Grade ≤ 1 or baseline (except for alopecia areata, vitiligo, chemotherapy induced polyneuropathy or endocrinopathies that are compensated by hormone replacement and Grade 2 lymphopenia).
. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
Exclusion criteria
. Disease progression on or within 12 months after the last dose of (neo-)adjuvant anti PD-(L)1 treatment before start of first-line treatment.
. Prior radiotherapy within 2 weeks before start of trial treatment.
. History of other malignancies unless the patient has undergone potentially curative treatment without evidence of recurrence within the last 3 years. Exception is BCC or carcinoma in situ of any site that has been adequately treated (with the exception of systemic therapy).
. Previous anaphylactic or severe allergic reaction to LNP-formulated drug or (mRNA) vaccine (or known allergy to any other component of CVHNLC).
. Allergy to aminoglycoside or beta-lactam antibiotics.
. History of previous permanent discontinuation of anti-PD-(L)1 therapy due to toxicity or any other contraindications to treatment with pembrolizumab, including severe hypersensitivity to anti-PD-1 checkpoint inhibitors, its active substance, or one of its excipients.
Incidence of clinically significant laboratory abnormalities per National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) v.5.0.
Timeframe: 1 year
9
Number of patients with dose-limiting toxicities (DLTs) evaluated during the first 4 weeks of treatment (Dose Escalation Part only)