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Lipo-MERIT

Phase 1

Melanoma | Monoclonal antibody | Oncology |BioNTech SE|Last Updated: Mar 12, 2026

Success Probability

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Market & Valuation

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Trial Design

UNCONTROLLEDDMC
Total Trials1
Total Enrollment119

FDA Designations

No designations recorded

Clinical trial landscape

Lipo-MERIT · 1 trial · 1 indication

Phase 1 1
NCT02410733Evaluation of the Safety and Tolerability of i.v. Administration of a Cancer Vaccine in Patients With Advanced MelanomaMelanoma
COMPLETED119 Analytics
PHASE1COMPLETED
Evaluation of the Safety and Tolerability of i.v. Administration of a Cancer Vaccine in Patients With Advanced Melanoma
MelanomaUnlock trial analytics

Study Endpoints

Primary Endpoints

Number of Adverse Events as a Measure of safety and tolerability
up to 8 years

Number of patients with adverse events, total number of adverse events, dose limiting toxicities

Secondary Endpoints

Objective response rate (ORR)
up to 8 years
Disease control rate (DCR)
up to 8 years
Duration of response (DoR)
up to 8 years
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Study Design & Arms

AllocationNA
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Lipo-MERITEXPERIMENTAL7 dose escalation cohorts (3 +3 design) and 3 expanded cohorts

Interventions

NameTypeDescription
Lipo-MERITBIOLOGICALvaccination
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Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites4

Inclusion Criteria: * Cohort I: stage IV malignant melanoma (American joint committee on cancer (AJCC) 2009 melanoma classification) * Cohorts II-VII and expanded cohorts: stage IIIB-C, or stage IV of malignant melanoma (AJCC 2009 melanoma classification) \[only applicable until approval of protoco...

Countries:Germany
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Frequently asked questions about Lipo-MERIT

What is Lipo-MERIT used for?

Lipo-MERIT is an investigational cancer vaccine being studied for the treatment of advanced melanoma. It is administered intravenously and is currently in clinical development for patients with this type of skin cancer.

Who makes Lipo-MERIT?

Lipo-MERIT is being developed by BioNTech SE, a biotechnology company traded on the NASDAQ under the ticker symbol BNTX. The company is conducting clinical trials to evaluate the safety and tolerability of this investigational therapy.

What phase is Lipo-MERIT in?

Lipo-MERIT is in Phase 1 clinical development. It is an investigational drug and has not been approved by regulatory authorities. A Phase 1 trial has been completed to assess its safety and tolerability in patients with advanced melanoma.

What clinical trials is Lipo-MERIT in?

Lipo-MERIT has been studied in one clinical trial, identified as NCT02410733. This Phase 1 trial, titled 'Evaluation of the Safety and Tolerability of i.v. Administration of a Cancer Vaccine in Patients With Advanced Melanoma,' was completed and enrolled 119 participants in Germany.

Is Lipo-MERIT a monoclonal antibody?

Yes, Lipo-MERIT is classified as a monoclonal antibody. It is being developed as a cancer vaccine for melanoma and is administered intravenously. The drug is still in clinical development and has not been approved for commercial use.