Safety Immunogenicity and Preliminary Clinical Activity Study of PDC*lung01 Cancer Vaccine in NSCLC

  • STATUS
    Recruiting
  • End date
    Aug 30, 2024
  • participants needed
    64
  • sponsor
    PDC*line Pharma SAS
Updated on 30 April 2021

Summary

PDC-LUNG-101 trial is an open-label, dose-escalation, phase I/II study to assess the safety, the tolerability, the immunogenicity and the preliminary clinical activity of the therapeutic cancer vaccine, PDC*lung01, associated or not with anti-PD-1 treatment in patients with non-small-cell lung cancer.

Description

The therapeutic cancer vaccine, PDC*lung01 will be administered at two dose levels (low dose (LD) and high dose (HD)), as single agent or during maintenance treatment by pemetrexed (for adenocarcinomas in Cohorts A1 and A2) or added to the SoC (cohorts B1 and B2) i.e. anti-PD-1.

In cohorts A1 (low dose cohort) and A2 (high dose cohort), NSCLC patients will be treated at each of the six PDC*lung01 treatment visits with low dose/high dose administered successively by subcutaneous and then by intravenous route.

In cohort B1 and B2, the first PDClung01 injection will start within 48 hours after the first infusion of anti-PD-1. The fourth PDClung01 injection will occur within 48 hours after the infusion of the second cycle of anti-PD-1.

For each patient, the study will be divided into three consecutive parts:

  • Pre-screening (for HLA-A02:01 positivity), only patients with positive HLA-A02:01 status will be proposed to be screened.
  • Active period comprising a screening period, a treatment period (visits V1 to V6, during which the patient receives PDC*lung01 vaccine, at each visit) and an end-of-treatment (EoT) visit (V7, 4 weeks after the last injection),
  • Follow-up period which starts after the EoT visit and lasts up to two years after the first IMP administration.

Details
Condition Non-Small Cell Lung Cancer, nsclc
Treatment PDC*lung01, Keytruda Injectable Product, Alimta Injectable Product
Clinical Study IdentifierNCT03970746
SponsorPDC*line Pharma SAS
Last Modified on30 April 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Pre-screening
Documented HLA-A02:01 positivity after the patient has provided written
informed consent
Only patients showing a documented positive result in pre-screening will be
allowed to enter the screening period
Screening
Patients with histologically proven, or cytologically proven (allowed only for patients recruited in cohorts A1/A2), non-small-cell lung cancer (NSCLC). The stage of the disease is evaluated according to the classification of the American Joint Committee on Cancer, 8th edition (see Section 25.1)
For the dose-escalation phase (Cohorts A1 and A2): a wash-out period of at least 4 weeks after administration of the last cycle of platinum-based chemotherapy is required
(i) Stage IIa/IIb/IIIa NSCLC following surgery and, if applicable, following
adjuvant platinum-based chemotherapy, or (ii) Stage IV histologically or
cytologically confirmed case of epidermoid (squamous) NSCLC following 4
courses of platinum-based therapy, if targeted treatment options were not
indicated or (iii) Stage IV histologically or cytologically confirmed case of
adenocarcinoma (non-squamous) lung cancer NSCLC following 4 to 6 courses
cycles of pemetrexed and platinum combination if targeted treatment options
were not indicated, (iv) Populations (ii) and (iii) who have stopped
prematurely chemotherapy, after at least 2 cycles of platinum-based therapy
for any reason, AND do present with a documented stable disease or complete
response
b. For the anti-PD-1 immunotherapy (Cohorts B1 and B2): The patient has first-
line metastatic stage IV NSCLC measurable disease and is starting anti-PD-1
The intention and decision to prescribe the anti-PD-1 monotherapy as SoC
(TPS50%), assuming no targeted mutation detected, following standard NGS
testing, if applicable, and thus no targeted treatment option is indicated
must have been made by the investigator before and regardless of the patient's
participation in the study
\. ECOG performance status 0 or 1
\. Adequate renal and hepatic function as defined below
Serum creatinine clearance > 50 mL/min (Cockcroft-Gault formula)
Bilirubin 1.5 times upper limit of normal (ULN)
Aspartate transaminase (AST) and alanine transaminase (ALT) 2.5 times ULN (up to 5 times ULN are allowed in case of presence of liver metastases). 4. Adequate haematological function as defined below
Platelet count 70 x 10/L
White blood cell count 2.5 x 10/L with
lymphocytes 1 x 10/L, among which 10 % of CD8+ T cells and
absolute neutrophil count 1.5 x 10/L
Haemoglobin 90 g/L 5. Patient willing and able to provide a baseline blood sample for leucocyte enumeration, cellular allogeneic response and immune-monitoring of 100 ml in total (in one or two samplings). 6. For patients with brain metastases
Central nervous system metastases are not symptomatic and have been treated
In addition, subjects must be either off corticosteroids, or on a stable or decreasing dose of 10mg daily prednisone (or equivalent) during at least 2 weeks before baseline. 7. For female patients without child-bearing potential: a documentation of tubal ligation or hysterectomy, ovariectomy or a post-menopausal status is available
For female patients of child-bearing potential: a negative serum pregnancy
test at screening is required. The patient agrees to practiceuse a "dual
method"highly effective contraception method from signing informed consent
form (screening), throughout the study treatment period with PDC _lung01 and
for at least 28 days after the last administration of PDC_ lung01
For female patients receiving Pemetrexed in cohorts A1/A2 concomitantly with
PDClung01, according to corresponding SmPC, it is required to use effective
contraception during treatment with pemetrexed
For female patients receiving Pembrolizumab in cohorts B1/B2 concomitantly
with PDClung01, according to corresponding SmPC, it is required to use an
effective method of contraception up to 4 months thereafter
A woman is considered of childbearing potential (WOCBP), i.e. fertile
following menarche and until becoming post-menopausal unless permanently
sterile. Permanent sterilisation methods include hysterectomy, bilateral
salpingectomy and bilateral oophorectomy
A postmenopausal state is defined as no menses for 12 months without an
alternative medical cause
Highly effective" contraceptive measures acceptable for the whole duration of
the study have been defined based on the CTFGs recommendations on
contraception and are the following
Combined (estrogen and progestogen containing) hormonal contraception associated with inhibition of ovulation (oral, intravaginal, transdermal)
Progestogen-only hormonal contraception associated with inhibition of ovulation (oral, injectable, implantable)
Intrauterine device (IUD)
Intrauterine hormone-releasing system (IUS)
Monogamous relationship with a vasectomized partner. Partner must have been vasectomized for at least 6 months before the participant entered into the study
Abstinence or absence of sexual relations with men. 8. Males with reproductive potential should use barrier method of contraception (condom) from signing informed consent form (screening) up to at least 28 days after the last dose of PDClung01
For male patients receiving Pemetrexed in cohorts A1/A2 concomitantly with
PDClung01, according to corresponding SmPC, it is required to use barrier
method of contraception up to 6 months thereafter
\. In the Investigator's opinion, the patient is able and willing to comply
with the requirements of the study
\. Patient willing and able to sign the study informed consent form before
any study-specific procedures are conducted
\. Patient (male or female) is aged 18 years or above
\. Specific for patients enrolled in France : Patient is affiliated to a
health insurance system

Exclusion Criteria

Mixed small-cell and non-small-cell histological features
Patient has documented evidence of EGFR mutation, ALK fusion or ROS1 fusion (according to current ESMO clinical practice guidelines) or any mutation for which targeted treatment options would be indicated, as per SoC
Patient has received immunotherapy or any investigational drugs within 4 weeks before the first PDClung01 dose
Patient without brain metastasis is receiving systemic corticosteroids at a dose level exceeding 10 mg/day (prednisone or equivalent) during the screening period (administration by nasal spray, topical solution or oral inhaler is non-systemic and is therefore allowed)
Patient has a medical history of cancer other than NSCLC, except the following: (i) non-melanoma skin cancer with complete resection, (ii) in situ carcinoma of the cervix, (iii) other cancer treated with no evidence of disease for at least five years
Patient presents at screening anti-HLA antibodies against HLA molecules expressed by the PDCline
Known hepatitis B and/or C infection (testing not required)
Known positive for human immunodeficiency virus (HIV; testing not required)
Uncontrolled congestive heart failure or hypertension, unstable heart disease (coronary artery disease with unstable angina or myocardial infarction within 6 months of baseline) or uncontrolled ventricular arrhythmias at the time of enrolment in the study (atrial fibrillation or flutter is acceptable)
Any history of splenectomy or splenic irradiation
For female patients: pregnancy or lactation
Any condition, including autoimmune or immunodeficiency active disease that, in the opinion of the Investigator, would jeopardise patient's safety, or might compromise the effect of the study drug or the assessment of the study result
Specific for patients enrolled in France: Patient is under legal protection
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