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Non Small Cell Lung CancerPhase 1/2NCT00923312

Trial of an RNActive®-Derived Cancer Vaccine in Stage IIIB/IV Non Small Cell Lung Cancer (NSCLC)

A Phase 1/2 study testing CV9201 in people with Non Small Cell Lung Cancer, run by CureVac at 14 sites in 2 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

This is a phase I/IIa open, uncontrolled, international, prospective clinical trial, in an out-patient setting, in patients with stage IIIB/IV NSCLC. The phase I part of the study consists of a dose escalation phase, in which the recommended dose (RD) for the phase IIa part of the study will be established based on… Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Non Small Cell Lung Cancer
What is being tested?
CV9201
Type of treatment
Vaccines
Could I receive a placebo?
No, everyone receives an active treatment
How many people
46 participants
Where
14 sitesin 2 countries
Study dates
May 2009to May 2014
Phase
Phase 1/2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Male or female and age ≥ 18 yrs and ≤ 75
  • Histologically or cytologically confirmed and documented stage IIIB /IV NSCLC
  • Documented stable disease or objective response according to RECIST criteria after initial chemotherapy or chemo-radiotherapy for advanced, unresectable disease:
  • Patients must have received a minimum of two cycles of standard chemotherapy, and adequate and effective radiotherapy if used in conjunction with chemotherapy (sequentially or concomitantly). Prophylactic brain radiation is allowed.
  • Surgery, radiotherapy and/ or chemotherapy can have been previously administered for non-advanced disease.
  • All therapies must be completed 4 weeks before start of study treatment.
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  • Performance status: Eastern Cooperative Oncology Group (ECOG) 0 - 1
  • Life expectancy > 6 months as assessed by the investigator
  • Adequate organ function:
  • Bone marrow function: hemoglobin ≥ 100 g/L; white blood cell count (WBC) ≥ 3.0 x 109/L; lymphocyte count ≥ 1.0 x 109/L; absolute neutrophil count (ANC) ≥ 1.5 x 109/L; platelet count ≥ 100 x 109/L
  • Hepatic: aspartate transaminase (AST) and alanine transaminase (ALT) ≤ 2.5 times upper limit of normal (ULN) (≤ 5 x ULN if hepatic metastases present); bilirubin ≤ 1.5 x ULN
  • Renal: Creatinine ≤ 2 mg/ dL and creatinine clearance ≥ 45 mL/ min
  • Patients of child-producing potential must agree to use contraception while enrolled in the study and for one month after the last immunization
  • Written informed consent must be obtained prior to conducting any study-specific procedures.

Who cannot join

  • History of anti-cancer therapy for advanced disease other than initial chemotherapy or chemo-radiotherapy or surgery
  • Immunotherapy within 4 weeks prior to study enrollment, including cytokines such as G-CSF, GM-CSF or interferons
  • Treatment with investigational anti-cancer agents during initial therapy for advanced disease or any investigational agents within 4 weeks prior to study enrollment
  • Concurrent anti-tumor therapy or concurrent immunotherapy such as lectins, unspecific immunostimulants, etc.
  • Previous anti-cancer immunotherapy comprising RNA-transfected dendritic cells or DNA vaccines targeting any tumor-associated antigens
  • Concurrent systemic steroids except topical (inhaled, topical, nasal) for the last 28 days, except replacement therapy
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  • Concurrent major surgery or planned surgery
  • Prior splenectomy
  • Documented history of active autoimmune disorders requiring systemic immunosuppressive therapy, (e.g., sarcoidosis, lupus erythematosus, rheumatoid arthritis, glomerulonephritis or systemic vasculitis), excepting autoimmune thyroiditis with only thyroid hormone replacement and stable disease > 1 year
  • Primary or secondary immune deficiency
  • Active allergy requiring continuous medication or active infections requiring anti-infectious therapy
  • Seropositive for HIV, HBV or HCV
  • History of other malignancies over the last 5 years (except basal cell carcinoma of the skin or carcinoma in situ of the cervix)
  • Uncontrolled medical condition considered as high risk for the treatment with an investigational drug including unstable diabetes mellitus, vena-cava-syndrome, known ascites and/or uncontrolled pleural effusion.
  • Brain metastases (symptomatic or asymptomatic) or leptomeningeal involvement
  • Symptomatic congestive heart failure (NYHA 3 and 4); unstable angina pectoris within 6 months prior to enrollment; significant cardiac arrhythmia, history of stroke or transient ischemic attack
  • History of seizures, encephalitis or multiple sclerosis
  • Gastric ulcer or inflammatory bowel disease or Crohn's disease or ulcerative colitis; no active diverticulitis
  • Active drug abuse or chronic alcoholism
  • Patients being committed to an institution by virtue of an order issued either by the judicial or the administrative authorities

Trial locations and contacts

14 sites in 2 countries.

14 sites in 2 countries

Germany12 sites

  • RWTH Aachen

    Aachen, 52074

  • Medizinische Klinik III, Universitätsklinikum Bonn

    Bonn, 53111

  • Medizinische Klinik V, Klinikum Darmstadt

    Darmstadt, 64283

  • Medizinische Klinik I, Universitätsklinikum Dresden

    Dresden, 01304

  • Nordwest Krankenhaus

    Frankfurt, 60488

  • Krankenhaus Großhansdorf

    Großhansdorf, 22927

  • Universitätsklinikum Hamburg Eppendorf, Medizinische Klinik II

    Hamburg, 20246

  • Thoraxklinik am Universitätsklinikum Heidelberg

    Heidelberg, 69126

  • Universitätsklinikum des Saarlandes

    Homburg, 66421

  • III. Medizinische Klinik und Poliklinik, Universitätsmedizin Mainz

    Mainz, 55131

  • III. Medizinische Klinik, Klinikum rechts der Isar

    München, 81675

  • Medizinische Klinik II, Universität Tübingen

    Tübingen, 72074

Other trials in Germany

Switzerland2 sites

  • UniversitätsSpital Basel

    Basel, 4031

  • UniversitätsSpital Zürich

    Zurich, 8091

Other trials in Switzerland

About this study

Official title: Safety and Efficacy Phase I/IIa Trial of an RNActive®-Derived Cancer Vaccine in Stage IIIB/IV Non Small Cell Lung Cancer (NSCLC)

This is a phase I/IIa open, uncontrolled, international, prospective clinical trial, in an out-patient setting, in patients with stage IIIB/IV NSCLC.

The phase I part of the study consists of a dose escalation phase, in which the recommended dose (RD) for the phase IIa part of the study will be established based on the incidence of dose-limiting toxicities (DLT). In the phase IIa part of the study, additional patients will be included at the RD, to confirm the safety and explore the activity of that dose.

This study will take place in Switzerland (2 sites) and Germany (11 sites).

Read the detailed description

Medical Need:

Lung cancer is the leading cause of cancer mortality in developed countries; about 87% of lung cancers are of the NSCLC type. Patients with more advanced but non-metastatic disease (IIIA or IIIB) usually undergo chemotherapy and/or radiation therapy, with or without secondary surgical resection. Patients with progression after chemotherapy and/or radiotherapy may receive second-line treatment with targeted therapies. Despite these aggressive treatments, only about 5% of patients with metastatic disease survive for 5 or more years. Given these dismal statistics, it is clear that new therapeutic approaches for treatment of NSCLC are urgently needed.

Potential Benefits:

CV9201 is an mRNA-based vaccine for the treatment of human NSCLC that is based on CureVac's RNActive® technology.

As an mRNA-based vaccine, CV9201 features several advantages over other approaches: it is highly specific, there is no restriction to the patient's MHC genotype, and it does not need to cross the nuclear membrane to be active. Finally, in the absence of reverse transcriptase, RNA can not be integrated into the genome.

For the planned first-in-man study, CV9201 will be administered in 5 doses. The phase I part of this phase I/IIa study is a dose finding study, to determine the RD for the phase IIa part.

Being tested
CV9201
Medical subject headings
Carcinoma, Non-Small-Cell Lung

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • CV9201Biological

    CV9201 is a vaccine consisting of five drug product components. Treatment will be administered on 5 timepoints.

Study groups in NCT00923312
Study groupRoleWhat they receive
CV9201ExperimentalCV9201 is composed of five formulated mRNAs (drug product components) encoding antigens that are overexpressed or exclusively expressed in NSCLC cells.
Receives: Biological: CV9201

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Phase I: Determination of the recommended dose (RD) for exploration in the phase IIa part of the study

    Measured: During the first 2-3 month of Phase I

  2. Phase II: Assessment of safety and tolerability of the treatment regimen

    Measured: Complete duration of Phase II

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted18 Jun 2009 (estimated)
  2. Study startMay 2009
  3. Primary completionFeb 2012
  4. Study completionMay 2014

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1/2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
46 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00923312
Sponsor's protocol ID
CV-9201-003
Status last verified
Oct 2013
First submitted
16 Jun 2009
Last updated
20 Mar 2018
Results posted
No
Data monitoring committee
Yes

Publications

  • Fotin-Mleczek M, Duchardt KM, Lorenz C, Pfeiffer R, Ojkic-Zrna S, Probst J, Kallen KJ. Messenger RNA-based vaccines with dual activity induce balanced TLR-7 dependent adaptive immune responses and provide antitumor activity. J Immunother. 2011 Jan;34(1):1-15. doi: 10.1097/CJI.0b013e3181f7dbe8.

    PubMed 21150709

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing CV9201 in people with Non Small Cell Lung Cancer, run by CureVac at 14 sites in 2 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 14 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 20 Mar 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 14 sites in Germany, Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Phase I: Determination of the recommended dose (RD) for exploration in the phase IIa part of the study (time frame: During the first 2-3 month of Phase I). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00923312, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Mar 2018.

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