IVAC MUTANOME Phase I Clinical Trial

NCT02035956 | Completed Phase 1 DMC

• 1 other identifier: RB_0004-01
• Study Type: interventional
• Target: 15
• Locations: 2 countries
• Sites: 3

Brief 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

Conditions

Melanoma

Keywords

IVAC MUTANOME; IVAC; personalized therapy; personalized immuno therapy; RB_0004-01; Ribological; Melanoma; cancer vaccine

Outcome Measures

Primary Outcomes (1)

• Safety and tolerability of repetitive doses

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

  up to a maximum of 189 days

Secondary Outcomes (1)

• Monitoring of vaccine-induced cellular immune response,

  161 days

Study Arms (1)

IVAC MUTANOME RBL001/RBL002

EXPERIMENTAL

All 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.

Biological: IVAC MUTANOME, RBL001/RBL002

Interventions

IVAC MUTANOME, RBL001/RBL002 BIOLOGICAL

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

Also known as: cancer vaccine

IVAC MUTANOME RBL001/RBL002

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• 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

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• BioNTech RNA Pharmaceuticals GmbH: lead

Study Sites (3)

Medizinische Universität Wien

Vienna, AT-Wien, 1090, Austria

Location

Hautklinik und Poliklinik Universitätsmedizin der Johannes-Gutenberg Universität Mainz

Mainz, 55131, Germany

Location

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

Mannheim, 68167, Germany

Location

Related Publications (1)

• 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.

  PMID: 35379963 DERIVED

MeSH Terms

Conditions

Melanoma

Interventions

Cancer Vaccines

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

Intervention Hierarchy (Ancestors)

Vaccines; Biological Products; Complex Mixtures

Study Officials

• Ugur Sahin, Prof. Dr.

  BioNTech RNA Pharmaceuticals GmbH

  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: January 10, 2014
• First Posted: January 14, 2014
• Study Start: December 1, 2013
• Primary Completion: February 14, 2017
• Study Completion: October 1, 2019
• Last Updated: January 18, 2020

Record last verified: 2020-01

Locations

AU (1); DE (2)