NCT01684241

Brief Summary

Clinical first-in-human dose escalation study evaluating the safety and tolerability of intranodal administration of an RNA-based cancer vaccine targeting two tumor-associated antigens in patients with advanced melanoma

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
29

participants targeted

Target at P25-P50 for phase_1

Timeline
Completed

Started Jun 2012

Typical duration for phase_1

Geographic Reach
2 countries

4 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2012

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

September 10, 2012

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 12, 2012

Completed
2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2015

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2015

Completed
Last Updated

January 18, 2020

Status Verified

January 1, 2020

Enrollment Period

2.9 years

First QC Date

September 10, 2012

Last Update Submit

January 14, 2020

Conditions

Melanoma

Keywords

BiontechBiontech RNA Pharmaceuticals GmbHBiontech RNAMERITRNAImmuno TherapyRB_0001-01RibologicalMelanomaRBL001RBL002cancer vaccine

Outcome Measures

Primary Outcomes (1)

  • Number of adverse events

    Number of Patients with adverse events, total number of adverse events, dose-limiting toxicities

    90 days

Secondary Outcomes (2)

  • Determination of antitumoral immune responses

    90 days

  • Clinical Monitoring of Tumor Lesions

    90 days

Study Arms (1)

RBL001/RBL002 intranodal administration

EXPERIMENTAL

All participants will be treated with RBL001/RBL002 after allocation to one of the four escalating dose cohorts: * Cohort-1 50 µg RBL001 and 50 µg RBL002 * Cohort-2 100 µg RBL001 and 100 µg RBL002 * Cohort-3 300 µg RBL001 and 300 µg RBL002 * Cohort-4 600 µg RBL001 and 600 µg RBL002

Biological: RBL001/RBL002

Interventions

RBL001/RBL002BIOLOGICAL

Each participant will receive 8 repeated intranodal administrations of RBL001 and RBL002 during a time frame of 43 to 51 days.

Also known as: cancer vaccine
RBL001/RBL002 intranodal administration

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Stage IIC, IIIA-C or unresectable stage IV of cutaneous melanoma (AJCC 2009 melanoma classification)
  • 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!)
  • Antigen expression confirmed by RT-PCR analysis from FFPE
  • ≥ 18 years of age
  • Written informed consent (part I and part II)
  • ECOG performance status (PS) 0-1 or Karnofsky Index 70-100 %
  • Life expectancy \> 3 months
  • WBC ≥ 3x109/L
  • Hemoglobin ≥ 10 g/dl
  • Platelet count ≥ 100,000/mm³
  • LDH level \< 2.0 x ULN
  • Negative pregnancy test (measured by β-HCG) for females of childbearing age
  • Suitable lymph nodes for injection using ultrasound guidance

You may not qualify if:

  • Pregnancy or breastfeeding
  • Primary ocular melanoma
  • Presence of 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
  • Acute or chronic active hepatitis B or C infection, EBV or CMV
  • Receipt of allogenic stem cell transplantation
  • 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
  • +5 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

Medizinische Universität Wien, Abteilung für Dermatologie

Vienna, A-1090, Austria

Location

Medizinische Fakultät der Universität Duisburg-Essen

Essen, 45122, Germany

Location

Universtitätsmedizin der Johannes-Gutenberg Universtität

Mainz, 55131, Germany

Location

Universitätsklinik Mannheim

Mannheim, Germany

Location

MeSH Terms

Conditions

Melanoma

Interventions

Cancer Vaccines

Condition Hierarchy (Ancestors)

Neuroendocrine TumorsNeuroectodermal TumorsNeoplasms, Germ Cell and EmbryonalNeoplasms by Histologic TypeNeoplasmsNeoplasms, Nerve TissueNevi and MelanomasSkin NeoplasmsNeoplasms by SiteSkin DiseasesSkin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

VaccinesBiological ProductsComplex Mixtures

Study Officials

  • Ugur Sahin, Prof. Dr.

    Ribological 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

September 10, 2012

First Posted

September 12, 2012

Study Start

June 1, 2012

Primary Completion

May 1, 2015

Study Completion

July 1, 2015

Last Updated

January 18, 2020

Record last verified: 2020-01

Locations

AU(1)DE(3)