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

Primary Purpose

Non-Small Cell Lung Cancer, Multiple Myeloma

Status
Terminated
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
Tecemotide
No intervention
Sponsored by
Merck KGaA, Darmstadt, Germany
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Non-Small Cell Lung Cancer focused on measuring Vaccine, Stimuvax, Tecemotide, L-BLP25, Non-Small Cell Lung Carcinoma, Multiple Myeloma

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Merck KGaA Communication Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Other

Arm Label

Tecemotide (L-BLP25)

Observational

Arm Description

Outcomes

Primary Outcome Measures

Number of Subjects With Adverse Events (AEs), Serious AEs, AEs Leading to Discontinuation and AEs Leading to Death
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)
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.

Full Information

First Posted
August 23, 2011
Last Updated
August 10, 2016
Sponsor
Merck KGaA, Darmstadt, Germany
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1. Study Identification

Unique Protocol Identification Number
NCT01423760
Brief Title
Common Safety Follow-up Trial of Tecemotide (L-BLP25)
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
Study Type
Interventional

2. Study Status

Record Verification Date
August 2016
Overall Recruitment Status
Terminated
Why Stopped
The study is terminated prematurely as the sponsor decided to discontinue program with Tecemotide in NSCLC.
Study Start Date
January 2012 (undefined)
Primary Completion Date
July 2015 (Actual)
Study Completion Date
August 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Merck KGaA, Darmstadt, Germany

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Non-Small Cell Lung Cancer, Multiple Myeloma
Keywords
Vaccine, Stimuvax, Tecemotide, L-BLP25, Non-Small Cell Lung Carcinoma, Multiple Myeloma

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
27 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Tecemotide (L-BLP25)
Arm Type
Experimental
Arm Title
Observational
Arm Type
Other
Intervention Type
Biological
Intervention Name(s)
Tecemotide
Other Intervention Name(s)
L-BLP25
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
No intervention
Intervention Description
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).
Primary Outcome Measure Information:
Title
Number of Subjects With Adverse Events (AEs), Serious AEs, AEs Leading to Discontinuation and AEs Leading to Death
Description
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.
Time Frame
Screening up to 42 days after last dose of study treatment with tecemotide (L-BLP25), assessed up to 3.6 years
Secondary Outcome Measure Information:
Title
Overall Survival (OS)
Description
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.
Time Frame
From randomization to death, assessed up to 3.6 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Medical Responsible
Organizational Affiliation
Merck KGaA, Darmstadt, Germany
Official's Role
Study Director
Facility Information:
Facility Name
Merck KGaA Communication Center
City
Darmstadt
Country
Germany

12. IPD Sharing Statement

Learn more about this trial

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

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