Evaluation of the Safety and Tolerability of i.v. Administration of a Cancer Vaccine in Patients With Advanced Melanoma

NCT02410733 | Completed Phase 1 DMC

• 2 other identifiers: RB_0003-012013-001646-33
• Study Type: interventional
• Target: 119
• Locations: 1 country
• Sites: 4

Brief Summary

The purpose of this study is to determine the safety and tolerability of intravenous administration of a tetravalent RNA-lipoplex cancer vaccine targeting four tumor-associated antigens in patients with advanced melanoma.

Conditions

Melanoma

Keywords

melanoma; Lipo-MERIT; cancer vaccine; RB_0003-01; BioNTech; BioNTech SE; BioNTech RNA; RNA; RNA vaccine; BNT111

Outcome Measures

Primary Outcomes (1)

• Number of Adverse Events as a Measure of safety and tolerability

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

  up to 8 years

Secondary Outcomes (6)

• Objective response rate (ORR)

  up to 8 years

• Disease control rate (DCR)

  up to 8 years

• Duration of response (DoR)

  up to 8 years

• Progression Free Survival (PFS)

  up to 8 years

• Overall survival (OS)

  up to 8 years

Study Arms (1)

Lipo-MERIT

EXPERIMENTAL

7 dose escalation cohorts (3 +3 design) and 3 expanded cohorts

Biological: Lipo-MERIT

Interventions

Lipo-MERIT BIOLOGICAL

vaccination

Lipo-MERIT

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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) \[only applicable until approval of protocol version 10.0\] Expanded cohort C only patients with stage IV melanoma (AJCC 2009 melanoma classification) with measurable disease (at least one target lesion according irRECIST) \[applicable for all patients included after approval of protocol version 10.0 and higher\] and with disease progression at the time of first treatment with Investigational medicinal product (IMP) \[applicable for all patients included after approval of protocol version 11.0\]
• Therapy only for subjects not eligible or declining any other available approved therapy after all available treatment options have been transparently disclosed (to be documented!)
• Expression of either NY-ESO-1, tyrosinase, MAGE-A3, and/or TPTE confirmed by RT-qPCR analysis from formalin-fixed paraffin-embedded (FFPE)
• ≥ 18 years of age
• Written informed consent
• Eastern cooperative oncology group (ECOG) performance status (PS) 0-1
• Life expectancy ≥ 6 months
• White blood cell (WBC) ≥ 3x10\^9/L
• Hemoglobin ≥ 9 g/dL
• Platelet count ≥ 100,000/mm\^3
• Alanine aminotransferase/Aspartate aminotransferase (ALT/AST) \< 3 x upper limit of normal (ULN) (except patients with liver metastasis)
• Negative pregnancy test (measured by Human chorionic gonadotropin \[β-HCG\]) for females with childbearing age

You may not qualify if:

• Pregnancy or breastfeeding
• Primary ocular melanoma
• Concurrence of a second malignancy other than squamous or basal cell carcinoma, non-active prostate cancer, or cervical carcinoma in situ or non-active treated urothelial carcinoma
• Brain metastases
• Patients with history of treated or inactive brain metastasis are eligible for treatment in expanded cohort C, provided they meet all of the following criteria:
• measurable disease outside of the brain (in addition to inactive brain metastasis);
• no ongoing requirement of corticosteroids as therapy for brain metastases,
• with corticosteroids discontinued ≥1 week prior to visit 2 (day 1) with no ongoing symptoms attributable to brain metastasis;
• the screening brain radiographic imaging is ≥ 4 weeks since completion of radiotherapy
• Post-splenectomy Patients
• Known hypersensitivity to the active substance or to any of the excipients
• 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
• Clinically relevant active autoimmune disease
• Systemic immune suppression:

Sponsors & Collaborators

• BioNTech SE: lead

Study Sites (4)

Johann Wolfgang Goethe Universität Frankfurt, Klinik für Dermatologie, Venerologie und Allergologie

Frankfurt, 60590, Germany

Location

Universität Heidelberg, Dermatologie und NCT

Heidelberg, 69120, Germany

Location

Universitätsmedizin Mainz, Hautklinik und Poliklinik

Mainz, 55131, Germany

Location

Universitätsmedizin Mannheim, Klinik für Dermatologie, Venerologie und Allergologie

Mannheim, 68167, Germany

Location

Related Publications (1)

• Sahin U, Oehm P, Derhovanessian E, Jabulowsky RA, Vormehr M, Gold M, Maurus D, Schwarck-Kokarakis D, Kuhn AN, Omokoko T, Kranz LM, Diken M, Kreiter S, Haas H, Attig S, Rae R, Cuk K, Kemmer-Bruck A, Breitkreuz A, Tolliver C, Caspar J, Quinkhardt J, Hebich L, Stein M, Hohberger A, Vogler I, Liebig I, Renken S, Sikorski J, Leierer M, Muller V, Mitzel-Rink H, Miederer M, Huber C, Grabbe S, Utikal J, Pinter A, Kaufmann R, Hassel JC, Loquai C, Tureci O. An RNA vaccine drives immunity in checkpoint-inhibitor-treated melanoma. Nature. 2020 Sep;585(7823):107-112. doi: 10.1038/s41586-020-2537-9. Epub 2020 Jul 29.

  PMID: 32728218 DERIVED

MeSH Terms

Conditions

Melanoma

Condition Hierarchy (Ancestors)

Neuroendocrine Tumors; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Nerve Tissue; Nevi and Melanomas; Skin Neoplasms; Neoplasms by Site; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• BioNTech Responsible Person

  BioNTech SE

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 24, 2015
• First Posted: April 8, 2015
• Study Start: March 1, 2015
• Primary Completion: June 20, 2023
• Study Completion: June 20, 2023
• Last Updated: March 12, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

DE (4)