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EMD 640 744 in Montanide ISA 51 VG Administered in Subjects With Advanced Solid Tumors

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Merck KGaA
ClinicalTrials.gov Identifier:
NCT01012102
First received: October 20, 2009
Last updated: February 19, 2014
Last verified: October 2011
  Purpose

To compare 3 doses of EMD 640744 administered by subcutaneous injection in combination with Montanide® ISA 51 VG with regard to immunological efficacy.

The primary target variable is the immune response as assessed by ELISPOT before and until week 17 after vaccination with EMD 640744 in Montanide® ISA 51 VG.


Condition Intervention Phase
Advanced Solid Tumors
Biological: EMD 640744
Other: Montanide ISA 51 VG
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: An Open Label, Parallel Group, Randomized Phase I Study of Biological Activity, Safety, Tolerability, and Clinical Activity of Different Dose Levels of EMD 640 744 in Montanide ISA 51 VG Administered in Subjects With Advanced Solid Tumors

Resource links provided by NLM:


Further study details as provided by Merck KGaA:

Primary Outcome Measures:
  • To compare 3 doses of EMD 640744 administered by subcutaneous injection in combination with Montanide® ISA 51 VG with regard to immunological efficacy [ Time Frame: 1-4 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • To assess the safety and tolerability of different doses of EMD 640744 in Montanide® ISA 51 VG in terms of laboratory parameters and adverse event profile. [ Time Frame: 3 months ] [ Designated as safety issue: Yes ]
  • To assess the clinical efficacy in terms of the overall response, progression-free survival time, and survival time. [ Time Frame: 3 months ] [ Designated as safety issue: Yes ]

Enrollment: 104
Study Start Date: April 2008
Study Completion Date: September 2011
Primary Completion Date: October 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Group 1
EMD 640744 30μg and Montanide® ISA 51 VG
Biological: EMD 640744
EMD 640744 30μg, weekly in initiation phase and monthly in maintenance phase (in combination with Montanide® ISA 51 VG)
Other: Montanide ISA 51 VG
Adjuvant. Montanide® ISA 51 VG, weekly in initiation phase and monthly in maintenance phase (in combination with EMD 640744 30ug)
Experimental: Group 2
EMD 640744 100μg and Montanide® ISA 51 VG
Biological: EMD 640744
EMD 640744 100μg, weekly in initiation phase and monthly in maintenance phase (in combination with Montanide® ISA 51 VG)
Other: Montanide ISA 51 VG
Adjuvant. Montanide® ISA 51 VG, weekly in initiation phase and monthly in maintenance phase (in combination with EMD 640744 100ug)
Experimental: Group 3
EMD 640744 300μg and Montanide® ISA 51 VG
Biological: EMD 640744
EMD 640744 300μg, weekly in initiation phase and monthly in maintenance phase (in combination with Montanide® ISA 51 VG)
Other: Montanide ISA 51 VG
Adjuvant. Montanide® ISA 51 VG, weekly in initiation phase and monthly in maintenance phase (in combination with EMD 640744 300ug)

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Male and female subjects ≥18 years of age
  • Signed written informed consent
  • Histologically or cytologically documented metastatic or locally advanced survivin-expressing solid tumor for which no established therapy exists
  • Disease must be measurable by RECIST criteria or evaluable by clinical, radiographic, or laboratory criteria established for the given tumor entity
  • Expressing at least one of the following HLA alleles:HLA-A1,-A2,-A3,-A24, and -B7 assessed by HLAgenotyping
  • ECOG performance status of ≤1, estimated life expectancy of at least 3 months
  • Adequate hematological function defined by WBC ≥3 x 10x9/L, lymphocyte count ≥0.5 x 10x9/L, hemoglobin ≥10 g/dL, platelet count ≥100 x 10x9/L
  • Adequate blood coagulation parameters defined as aPTT and INR ≤ 1.5 x ULN
  • Adequate renal function defined by a serum creatinine ≤2 x ULN
  • Adequate hepatic function defined by total bilirubin ≤2 x ULN and AST and ALT levels ≤2.5 x ULN (in subjects with liver metastases ≤5 x ULN)
  • Effective contraception for female and male subjects if the risk of conception exists

Exclusion Criteria:

  • Treatment in another clinical study within the past 30 days prior to the first administration of study treatment
  • Previous treatment with an investigational anticancer vaccine
  • Requirement of concurrent treatment with a nonpermitted drug
  • Active significant autoimmune disease (with the exception of vitiligo)
  • Receipt of allogeneic stem cell transplantation
  • Significant acute or chronic infections (e.g. viral hepatitis, HIV)
  • Primary brain tumors and brain metastases (with the exception of brain metastases that are stable after irradiation or surgically resected brain metastases if subjects have been asymptomatic for ≥6 months)
  • Rapidly progressive disease (e.g. tumor lysis syndrome)
  • Radiotherapy, chemotherapy, surgery (excluding prior diagnostic biopsy), immunotherapy or any investigational drug within 30 days before the start of study treatment
  • Pregnancy or lactation
  • Active drug or alcohol abuse
  • Known hypersensitivity to the study treatment or any of its components
  • Any significant disease that, in the Investigator's opinion, should exclude the subject from the study; for questions about this criterion, the Investigator should contact the sponsor.
  • Persisting toxicity related to prior therapy ≥grade 2 National Cancer Institute-Common Terminology Criteria For Adverse Events version 3.0
  • Legal incapacity or limited legal capacity
  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: NCT01012102

Sponsors and Collaborators
Merck KGaA
Investigators
Study Director: Jens-Peter Marschner, MD Merck KGaA, Darmstadt
  More Information

Publications:
Responsible Party: Merck KGaA
ClinicalTrials.gov Identifier: NCT01012102     History of Changes
Other Study ID Numbers: EMR 200032-001
Study First Received: October 20, 2009
Last Updated: February 19, 2014
Health Authority: Switzerland: Swissmedic

Keywords provided by Merck KGaA:
EMD 640744
Montanide
Advanced solid tumours

Additional relevant MeSH terms:
Neoplasms
Freund's Adjuvant
Adjuvants, Immunologic
Immunologic Factors
Pharmacologic Actions
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on November 27, 2014