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Common Safety Follow-up Trial of Tecemotide (L-BLP25)

This study has been terminated.
(The study is terminated prematurely as the sponsor decided to discontinue program with Tecemotide in NSCLC.)
Sponsor:
Information provided by (Responsible Party):
Merck KGaA
ClinicalTrials.gov Identifier:
NCT01423760
First received: August 23, 2011
Last updated: August 10, 2016
Last verified: August 2016
  Purpose
This is an open-label, common follow-up trial. Subjects who were enrolled in a Merck KGaA, EMD Serono or Merck Serono Japan sponsored trial with tecemotide (L-BLP25) were enrolled in this follow-up trial to continue their maintenance treatment with tecemotide (L-BLP25). Subjects were transferred once the feeder trial (EMR 63325-005 [NCT00157209], EMR 63325-006 [NCT00157196] and EMR 63325-008 [NCT01094548]) objectives were met. Subjects who received tecemotide (L-BLP25) in a feeder trial continued tecemotide (L-BLP25) treatment in this follow-up trial and have safety assessments performed as well as were observed for progressive disease (PD) and survival in 6- month intervals. Subjects who had not received tecemotide (L-BLP25) in feeder trials, or discontinued treatment were only observed for PD and survival in 6-month intervals and were not provided treatment with tecemotide (L-BLP25).

Condition Intervention
Non-Small Cell Lung Cancer
Multiple Myeloma
Biological: Tecemotide
Other: No intervention

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: An Open-label Trial to Collect Long-term Data on Subjects Following Participation in Previous EMD 531444 (L-BLP25 or BLP25 Liposome Vaccine) Clinical Trials

Resource links provided by NLM:


Further study details as provided by Merck KGaA:

Primary Outcome Measures:
  • Number of Subjects With Adverse Events (AEs), Serious AEs, AEs Leading to Discontinuation and AEs Leading to Death [ Time Frame: Screening up to 42 days after last dose of study treatment with tecemotide (L-BLP25), assessed up to 3.6 years ]
    An Adverse Event (AE) is defined as any new untoward medical occurrences/worsening of pre-existing medical condition without regard to possibility of causal relationship. A Serious AE is an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect, AEs leading to discontinuation and AEs leading to death.


Secondary Outcome Measures:
  • Overall Survival (OS) [ Time Frame: From randomization to death, assessed up to 3.6 years ]
    Overall survival time was defined as the time from randomization to death. Subjects without events were censored at the last date they were known to be alive.


Enrollment: 27
Study Start Date: January 2012
Study Completion Date: August 2015
Primary Completion Date: July 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Tecemotide (L-BLP25) Biological: Tecemotide
Subjects who received tecemotide (L-BLP25) for the treatment of non-small cell lung cancer (NSCLC) or multiple myeloma in a feeder trial will continue to be treated with tecemotide (L-BLP25) and have safety assessments performed until the discontinuation criteria in the respective feeder trial protocol are met.
Other Name: L-BLP25
Observational Other: No intervention
Subjects who had not received tecemotide in the feeder study, or who had discontinued treatment with tecemotide (L-BLP25), will only be observed for progressive disease (PD) (if applicable) and survival in 6-month intervals and will not be provided treatment with tecemotide (L-BLP25).

  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Signed written informed consent.
  • Registration and treatment in a clinical trial with tecemotide (L-BLP25) under sponsorship of Merck KGaA/EMD Serono/Merck Serono Japan (feeder trial). [Note, subjects who have been allocated to treatments not containing tecemotide (L BLP25) in the feeder trial are eligible for this trial and will be followed-up for progressive disease (PD) (if applicable) and survival.]
  • End of Treatment procedures have been performed in the feeder trial.
  • Other protocol defined inclusion criteria could apply

Exclusion Criteria

  • Pregnancy and lactation period; women of childbearing potential, unless using effective contraception as determined by the Investigator. Subjects whom the Investigator considers may be at risk of pregnancy will have a pregnancy test performed per institutional standard
  • Known hypersensitivity to any of the trial treatment ingredients (if applicable)
  • Legal incapacity or limited legal capacity
  • Any other reason that, in the opinion of the Investigator, precludes the subject from participating in the trial
  • Other protocol defined exclusion criteria could apply
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01423760

Locations
Germany
Merck KGaA Communication Center
Darmstadt, Germany
Sponsors and Collaborators
Merck KGaA
Investigators
Study Director: Medical Responsible Merck KGaA
  More Information

Responsible Party: Merck KGaA
ClinicalTrials.gov Identifier: NCT01423760     History of Changes
Other Study ID Numbers: EMR 63325-011 
Study First Received: August 23, 2011
Results First Received: June 2, 2016
Last Updated: August 10, 2016

Keywords provided by Merck KGaA:
Vaccine
Stimuvax
Tecemotide
L-BLP25
Non-Small Cell Lung Carcinoma
Multiple Myeloma

Additional relevant MeSH terms:
Multiple Myeloma
Neoplasms, Plasma Cell
Carcinoma, Non-Small-Cell Lung
Neoplasms by Histologic Type
Neoplasms
Hemostatic Disorders
Vascular Diseases
Cardiovascular Diseases
Paraproteinemias
Blood Protein Disorders
Hematologic Diseases
Hemorrhagic Disorders
Lymphoproliferative Disorders
Immunoproliferative Disorders
Immune System Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms
Lung Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Lung Diseases
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on February 24, 2017