AzTrials
AzTrials

MelanomaPhase 1NCT02035956

IVAC MUTANOME Phase I Clinical Trial

A Phase 1 study testing IVAC MUTANOME, RBL001/RBL002 in people with Melanoma, run by BioNTech RNA Pharmaceuticals GmbH at 3 sites in 2 countries.

Completed

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

Official record
Search all trials

Trial summary

Clinical first-in-human study evaluating the safety, tolerability and immunogenicity of intra-nodal administration of a personalized vaccination with IVAC MUTANOME vaccine with or without initial treatment with RBL001/RBL002 vaccine in patients with advanced melanoma Read more about this study

Who is it for?
Ages 18 to 99 years
Conditions the study is for
Melanoma
What is being tested?
IVAC MUTANOME, RBL001/RBL002
Could I receive a placebo?
No, everyone receives an active treatment
How many people
15 participants
Where
3 sitesin 2 countries
Study dates
Dec 2013to Oct 2019
Phase
Phase 1
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 99 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Malignant Melanoma, resectable stage IIIA-C and IV (AJCC 2009 melanoma classification)
  • Patients with unresectable Malignant Melanoma stage IIIA-C in complete remission, partial remission or stable disease after treatment with vemurafenib or patients with slow progressive disease.
  • Malignant Melanoma, unresectable stage IV (AJCC 2009 melanoma classification) in complete remission, partial remission or stable disease after treatment with vemurafenib
  • All lines of treatment for malignant melanoma are accepted.
  • First line therapy for subjects not eligible or declining other first line therapies after all available treatment options have been transparently disclosed (to be documented in patient medical record).
  • ≥ 18 years of age
Show all 15Show fewer
  • Written informed consent
  • ECOG performance status (PS) 0-1 (appendix G)
  • Life expectancy > 6 months
  • WBC ≥ 3x109/L
  • Haemoglobin ≥ 10 g/dl
  • Platelet count ≥ 100,000/mm³
  • LDH level < 2.0 x ULN
  • Negative pregnancy test (measured by β-HCG) for females which are childbearing potential
  • Suitable lymph nodes for injection using ultrasound guidance

Who cannot join

  • Pregnancy or breastfeeding
  • Primary ocular melanoma
  • History (< 5 years) of a second malignancy other than squamous or basal cell carcinoma, non-active prostate cancer or cervical carcinoma in situ
  • Brain metastases
  • Known or symptomatic pleural effusions and/or ascites
  • Known hypersensitivity to the active substance or to any of the excipients
Show all 20Show fewer
  • A serious local infection (e.g. cellulitis, abscess) or systemic infection (e.g. pneumonia, septicemia) which requires systemic antibiotic treatment within 2 weeks prior to the first dose of study medication
  • Positive test for acute or chronic active hepatitis B or C infection, acute EBV or acute CMV injection
  • Clinically relevant autoimmune disease
  • Systemic immune suppression:
  • HIV disease
  • Use of chronic oral or systemic steroid medication (topical or inhalational steroids are permitted)
  • Other clinical relevant systemic immune suppression
  • Symptomatic congestive heart failure (NYHA 3 or 4)
  • Unstable angina pectoris
  • Radiotherapy within two weeks, myelosuppressive chemotherapy, ipilimumab and major surgery within 4 weeks/28 days before the first treatment. Interferon and approved BRAF inhibitors will be allowed as concurrent treatment.
  • Any investigational drug within 4 weeks/28 days or 5 half-lives depending on what gives the longer range before the first treatment of this study
  • Minor surgery within 14 days before the first treatment of this study
  • Fertile males and females who are unwilling to use a highly effective method of birth control (less than 1% per year, e.g. condom with spermicide, diaphragm with spermicide, birth control pills, injections, patches or intrauterine device) during study treatment and 28 days after the last dose of study treatment
  • Presence of a serious concurrent illness or other condition (e.g. psychological, family, sociological, or geographical circumstances) that does not permit adequate follow-up and compliance with the protocol

Trial locations and contacts

3 sites in 2 countries.

3 sites in 2 countries

Germany2 sites

  • Hautklinik und Poliklinik Universitätsmedizin der Johannes-Gutenberg Universität Mainz

    Mainz, 55131

  • Klinik für Dermatologie, Venerologie und Allergologie UMM - Universitätsmedizin Mannheim Medizinische Fakultät Mannheim der Ruprecht-Karls-Universität Heidelberg

    Mannheim, 68167

Other trials in Germany

Austria1 site

  • Medizinische Universität Wien

    Vienna, AT-Wien, 1090

Other trials in Austria

About this study

Official title: First-in-human Study Evaluating the Safety, Tolerability and Immunogenicity of i.n. Administration of a Personalized Vaccination With IVAC MUTANOME Vaccine w/o Initial Treatment With RBL001/RBL002 Vaccine in Patients With Advanced Melanoma

Clinical first-in-human study evaluating the safety, tolerability and immunogenicity of intra-nodal administration of a personalized vaccination with IVAC MUTANOME vaccine with or without initial treatment with RBL001/RBL002 vaccine in patients with advanced melanoma

Read the detailed description

IVAC MUTANOME is a poly-neo-epitopic coding RNA vaccine targeting the unique mutation signature of an individual patient. It is engineered on demand, provided as two patient-specific RNA drug products and administered as an individual treatment.

RBL001/RBL002 and IVAC MUTANOME are naked ribonucleic acid (RNA) based recombinant vaccines optimized to induce antigen-specific CD8+ and CD4+ T cell responses against melanoma associated target antigens.

The two antigens are well characterized antigens in melanoma that have been previously utilized with excellent safety and proven immunogenicity as vaccine targets in a number of independent clinical trials.

The overall rationale of the study is to determine safety of the novel RNA-based vaccine strategy and determine the number and function of vaccine-induced antigen-specific immune-responses as early biomarkers for the clinical mode of action.

The IVAC MUTANOME vaccine approach is based on targeting multiple immunogenic tumour mutations unique to a given patient's tumour using a poly-epitopic RNA-based vaccine manufactured for use in a single patient only. Parallel to the target discovery process and on demand manufacturing of IVAC MUTANOME vaccine patients with RBL001 and/ or RBL002 positive-tumours will receive the RBL001/RBL002 vaccine. Patients which tumours that are RBL001 and RBL002 negative can also be included into the clinical study but will not receive RBL001/RBL002 prior to IVAC MUTANOME. Applying this approach the RBL001/RBL002 vaccine and the IVAC MUTANOME vaccine administration is expected to lead to several effects contributing to their immunological (therapeutic) effects.

Conditions
Melanoma
Being tested
IVAC MUTANOME, RBL001/RBL002
Keywords
IVAC MUTANOME, IVAC, personalized therapy, personalized immuno therapy, RB_0004-01, Ribological, Melanoma, cancer vaccine
Medical subject headings
Melanoma

What participants receive

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

  • IVAC MUTANOME, RBL001/RBL002Biological

    Also called cancer vaccine

    Each patient will receive multiple repeated intranodal injections of IVAC MUTANOME vaccine with or without initial treatment with RBL001/RBL002.

Study groups in NCT02035956
Study groupRoleWhat they receive
IVAC MUTANOME RBL001/RBL002ExperimentalAll participants will be treated with the personalized IVAC MUTANOME vaccine with or without prior treatment with RBL001/RBL002 vaccine depending on expression of these two antigens. Vaccines will be administered intra-nodally.
Receives: Biological: IVAC MUTANOME, RBL001/RBL002

What is being measured

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

  1. Safety and tolerability of repetitive doses

    Number of Patients with adverse events, total number of adverse events

    Measured: up to a maximum of 189 days

Secondary outcomes (1)

  1. Monitoring of vaccine-induced cellular immune response,

    Determination of pharmacodynamic activity

    Measured: 161 days

Timeline

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

  1. First posted14 Jan 2014 (estimated)
  2. Study startDec 2013
  3. Primary completion14 Feb 2017
  4. Study completionOct 2019

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
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
15 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02035956
Sponsor's protocol ID
RB_0004-01
Status last verified
Jan 2020
First submitted
10 Jan 2014
Last updated
18 Jan 2020
Results posted
No
Data monitoring committee
Yes

Publications

  • Weber D, Ibn-Salem J, Sorn P, Suchan M, Holtstrater C, Lahrmann U, Vogler I, Schmoldt K, Lang F, Schrors B, Lower M, Sahin U. Accurate detection of tumor-specific gene fusions reveals strongly immunogenic personal neo-antigens. Nat Biotechnol. 2022 Aug;40(8):1276-1284. doi: 10.1038/s41587-022-01247-9. Epub 2022 Apr 4.

    PubMed 35379963

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing IVAC MUTANOME, RBL001/RBL002 in people with Melanoma, run by BioNTech RNA Pharmaceuticals GmbH at 3 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 15 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 18 Jan 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in Germany, Austria. 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 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.

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?

Safety and tolerability of repetitive doses (time frame: up to a maximum of 189 days). 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 NCT02035956, 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 18 Jan 2020.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in
IVAC MUTANOME Phase I Clinical Trial (NCT02035956) | AzTrials