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

NCT ID: NCT01012102

Last Updated: 2014-02-20

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 104 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-04-30
• Study Completion Date: 2011-09-30

Brief Summary

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.

Conditions

Advanced Solid Tumors

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Group 1

EMD 640744 30μg and Montanide® ISA 51 VG

Group Type: EXPERIMENTAL

EMD 640744

Intervention Type: BIOLOGICAL

EMD 640744 30μg, weekly in initiation phase and monthly in maintenance phase (in combination with Montanide® ISA 51 VG)

Montanide ISA 51 VG

Intervention Type: OTHER

Adjuvant. Montanide® ISA 51 VG, weekly in initiation phase and monthly in maintenance phase (in combination with EMD 640744 30ug)

Group 2

EMD 640744 100μg and Montanide® ISA 51 VG

Group Type: EXPERIMENTAL

EMD 640744

Intervention Type: BIOLOGICAL

EMD 640744 100μg, weekly in initiation phase and monthly in maintenance phase (in combination with Montanide® ISA 51 VG)

Montanide ISA 51 VG

Intervention Type: OTHER

Adjuvant. Montanide® ISA 51 VG, weekly in initiation phase and monthly in maintenance phase (in combination with EMD 640744 100ug)

Group 3

EMD 640744 300μg and Montanide® ISA 51 VG

Group Type: EXPERIMENTAL

EMD 640744

Intervention Type: BIOLOGICAL

EMD 640744 300μg, weekly in initiation phase and monthly in maintenance phase (in combination with Montanide® ISA 51 VG)

Montanide ISA 51 VG

Intervention Type: OTHER

Adjuvant. Montanide® ISA 51 VG, weekly in initiation phase and monthly in maintenance phase (in combination with EMD 640744 300ug)

Interventions

EMD 640744

EMD 640744 30μg, weekly in initiation phase and monthly in maintenance phase (in combination with Montanide® ISA 51 VG)

Intervention Type: BIOLOGICAL

EMD 640744

EMD 640744 100μg, weekly in initiation phase and monthly in maintenance phase (in combination with Montanide® ISA 51 VG)

Intervention Type: BIOLOGICAL

EMD 640744

EMD 640744 300μg, weekly in initiation phase and monthly in maintenance phase (in combination with Montanide® ISA 51 VG)

Intervention Type: BIOLOGICAL

Montanide ISA 51 VG

Adjuvant. Montanide® ISA 51 VG, weekly in initiation phase and monthly in maintenance phase (in combination with EMD 640744 30ug)

Intervention Type: 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)

Intervention Type: 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)

Intervention Type: OTHER

Eligibility 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Merck KGaA, Darmstadt, Germany

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jens-Peter Marschner, MD

Role: STUDY_DIRECTOR

Merck KGaA, Darmstadt

References

Lennerz V, Gross S, Gallerani E, Sessa C, Mach N, Boehm S, Hess D, von Boehmer L, Knuth A, Ochsenbein AF, Gnad-Vogt U, Zieschang J, Forssmann U, Woelfel T, Kaempgen E. Immunologic response to the survivin-derived multi-epitope vaccine EMD640744 in patients with advanced solid tumors. Cancer Immunol Immunother. 2014 Apr;63(4):381-94. doi: 10.1007/s00262-013-1516-5. Epub 2014 Feb 2.

Reference Type: RESULT

PMID: 24487961 (View on PubMed)

Other Identifiers

EMR 200032-001

Identifier Type: -

Identifier Source: org_study_id