Tecemotide (L-BLP25) in Rectal Cancer

PHASE2CompletedINTERVENTIONAL
Enrollment

124

Participants

Timeline

Start Date

February 29, 2012

Primary Completion Date

June 30, 2014

Study Completion Date

June 30, 2014

Conditions
Rectal Cancer
Interventions
BIOLOGICAL

Tecemotide (L-BLP25)

Subjects will receive 8 consecutive weekly subcutaneous vaccinations with 806 microgram (mcg) of tecemotide (L-BLP25) at Weeks 1, 2, 3, 4, 5, 6, 7 and 8, which will be administered concomitantly with the chemoradiotherapy, followed by a 9th subcutaneous injection 7 to 11 days prior to surgery.

DRUG

cyclophosphamide (CPA)

A single intravenous infusion of 300 milligram per square meter (mg/m\^2) (to a maximum 600 mg) of CPA will be given 3 days before the first tecemotide (L-BLP25) administration.

OTHER

Chemoradiotherapy

Radiotherapy of 45-52 grays (Gy) will be applied 5 times per week, over a minimum period of 5 weeks. Capecitabine at a dose of 825 mg/m\^2, twice daily or equivalent dose of 5-fluorouracil (5-FU) will be given orally, starting at the first day of radiotherapy and given 5 to 7 days per week during the time of radiotherapy.

Trial Locations (1)

Unknown

NKI (Nederlands Kanker Instituut), Amsterdam

All Listed Sponsors
lead

Merck KGaA, Darmstadt, Germany

INDUSTRY

NCT01507103 - Tecemotide (L-BLP25) in Rectal Cancer | Biotech Hunter | Biotech Hunter