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IVAC MUTANOME, RBL001/RBL002

Phase 1

Melanoma | Monoclonal antibody | Oncology |BioNTech SE|Last Updated: Jan 18, 2020

Success Probability

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Market & Valuation

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Trial Design

UNCONTROLLEDDMC
Total Trials1
Total Enrollment15

FDA Designations

No designations recorded

Clinical trial landscape

IVAC MUTANOME, RBL001/RBL002 · 1 trial · 1 indication

Phase 1 1
NCT02035956IVAC MUTANOME Phase I Clinical TrialMelanoma
COMPLETED15 Analytics
PHASE1COMPLETED
IVAC MUTANOME Phase I Clinical Trial
MelanomaUnlock trial analytics

Study Endpoints

Primary Endpoints

Safety and tolerability of repetitive doses
up to a maximum of 189 days

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

Secondary Endpoints

Monitoring of vaccine-induced cellular immune response,
161 days
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Study Design & Arms

AllocationNA
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
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.

Interventions

NameTypeDescription
IVAC MUTANOME, RBL001/RBL002BIOLOGICALEach patient will receive multiple repeated intranodal injections of IVAC MUTANOME vaccine with or without initial treatment with RBL001/RBL002.
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Eligibility Criteria

Age Range18 Years to 99 Years
SexALL
Healthy VolunteersNo
Study Sites3

Inclusion Criteria: * 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 dis...

Countries:AustriaGermany
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Frequently asked questions about IVAC MUTANOME, RBL001/RBL002

What is IVAC MUTANOME used for?

IVAC MUTANOME is an investigational cancer immunotherapy being studied for the treatment of melanoma. It is a personalized vaccine designed to target specific mutations in a patient's tumor. The drug is currently in Phase 1 clinical development and has completed a clinical trial in patients with melanoma.

What does IVAC MUTANOME target?

IVAC MUTANOME is a personalized cancer vaccine that targets neoantigens, which are unique mutations present on a patient's tumor cells. By targeting these specific mutations, the vaccine aims to stimulate the immune system to recognize and attack cancer cells. This approach is tailored to each individual patient's tumor profile.

Who is developing IVAC MUTANOME?

IVAC MUTANOME is being developed by BioNTech SE, a biotechnology company focused on immunotherapies. BioNTech is publicly traded on the NASDAQ under the ticker symbol BNTX. The company is conducting clinical trials to evaluate the safety and efficacy of this personalized cancer vaccine in melanoma patients.

What phase is IVAC MUTANOME in?

IVAC MUTANOME is currently in Phase 1 clinical development. A Phase 1 trial has been completed, which was designed to assess the safety, tolerability, and preliminary efficacy of the vaccine in patients with melanoma. The drug is still investigational and has not been approved by regulatory authorities.

What clinical trials is IVAC MUTANOME in?

IVAC MUTANOME has been studied in a Phase 1 clinical trial with the identifier NCT02035956. This completed trial enrolled 15 patients with melanoma and was conducted in Austria and Germany. The study was uncontrolled, meaning there was no comparison group, and it included adult patients aged 18 years and older.

Is IVAC MUTANOME the same as RBL001/RBL002?

Yes, IVAC MUTANOME is also known as RBL001/RBL002. These names refer to the same investigational personalized cancer vaccine being developed by BioNTech SE for the treatment of melanoma. The drug is in Phase 1 clinical development and has completed a clinical trial in patients with this condition.