Status:
COMPLETED
Tecemotide (L-BLP25) in Rectal Cancer
Lead Sponsor:
Merck KGaA, Darmstadt, Germany
Conditions:
Rectal Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
The objective of this mechanistic study is to determine the impact of tecemotide (L-BLP25) administration on the mucinous glycoprotein 1 - (MUC1) specific immune response in subjects with newly diagno...
Eligibility Criteria
Inclusion
- Male and female subjects with histologically documented resectable rectal adenocarcinoma in Stage 2-4
- Availability of tumor biopsy sufficient for immunological analysis
- Indication to receive neoadjuvant concomitant chemoradiotherapy consisting of a radiation dose of 45-52 Gy and capecitabine 825 mg/m\^2 orally twice daily. The use of an equivalent schedule based on 5-FU is acceptable
- Magnetic resonance imaging small pelvis / computed tomography thorax/abdomen (or X-ray thorax) to document absence of metastatic disease. Imaging must not be older than 6 weeks prior to randomization
- Eastern Cooperative Oncology Group performance status of 0 or 1
- Written informed consent
- Greater than or equal to (\>=) 18 years of age
Exclusion
- Previous chemotherapy and/or previous radiotherapy of the pelvic region
- Relapsing disease
- Previous vaccination with any MUC1 vaccine and other therapeutic cancer vaccines
- Previous organ transplantation (bone marrow or solid organs)
- Subjects with metastatic disease (except for solitary, resectable liver or lung metastases)
- Inadequate hematological function (that is, platelet count less than 140\*10\^9 per liter \[/L\], or white blood cell less than 2.5\*10\^9/L, or hemoglobin less than 90 gram per liter). Clinically significant hepatic dysfunction (that is alanine aminotransferase greater than 2.5\*upper limit of normal \[ULN\], or aspartate aminotransferase greater than 2.5\*ULN, or bilirubin greater than 1.5\*ULN). Inadequate renal function (that is serum creatinine greater than 1.5\*ULN)
- Autoimmune diseases
- Recognized immunodeficiency disease including cellular immunodeficiencies, hypogammaglobulinemia or dysgammaglobulinemia; subjects who have hereditary or congenital immunodeficiencies
- Clinically significant cardiac disease, for example, New York Heart Association Classes III-IV; uncontrolled angina, uncontrolled arrhythmia or uncontrolled hypertension, myocardial infarction in the previous 6 months as confirmed by medical history and an electrocardiogram
- Other protocol defined exclusion criteria could apply
Key Trial Info
Start Date :
February 1 2012
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2014
Estimated Enrollment :
124 Patients enrolled
Trial Details
Trial ID
NCT01507103
Start Date
February 1 2012
End Date
June 1 2014
Last Update
January 13 2017
Active Locations (1)
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1
NKI (Nederlands Kanker Instituut)
Amsterdam, Netherlands