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Trial record 67 of 282 for:    Tumor infiltrating lymphocytes

Tecemotide (L-BLP25) in Rectal Cancer (SPRINT)

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ClinicalTrials.gov Identifier: NCT01507103
Recruitment Status : Completed
First Posted : January 10, 2012
Results First Posted : June 2, 2016
Last Update Posted : January 13, 2017
Sponsor:
Information provided by (Responsible Party):
Merck KGaA, Darmstadt, Germany

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Rectal Cancer
Interventions Biological: Tecemotide (L-BLP25)
Drug: cyclophosphamide (CPA)
Other: Chemoradiotherapy
Enrollment 124
Recruitment Details First/last participant (informed consent): Feb 2012/Dec 2013. Study completion date: Jun 2014.
Pre-assignment Details Enrolled: 140 screened for eligibility; 16 excluded (mainly due to non-fulfillment of inclusion or exclusion criteria), 124 subjects randomized.
Arm/Group Title Chemoradiotherapy+Tecemotide (L-BLP25)+CPA Chemoradiotherapy+Tecemotide (L-BLP25) Chemoradiotherapy
Hide Arm/Group Description Single dose of cyclophosphamide (300 mg/m^2 to a maximum of 600 mg) was administered intravenously, 3 days prior to the start of vaccination, followed by weekly subcutaneous vaccinations with tecemotide (L-BLP25) (actual delivered dose was 806 mcg) administered concomitantly with chemotherapy for 8 weeks, followed by a 9th subcutaneous vaccination 7 to 11 days prior to surgery. Weekly subcutaneous vaccinations with tecemotide (L-BLP25) (actual delivered dose was 806 mcg) administered concomitantly with chemotherapy for 8 weeks, followed by a 9th subcutaneous vaccination 7 to 11 days prior to surgery. Radiotherapy of 45-52 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-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.
Period Title: Overall Study
Started 41 41 42
Completed 41 41 42
Not Completed 0 0 0
Arm/Group Title Chemoradiotherapy+Tecemotide (L-BLP25)+CPA Chemoradiotherapy+Tecemotide (L-BLP25) Chemoradiotherapy Total
Hide Arm/Group Description Single dose of cyclophosphamide (300 mg/m^2 to a maximum of 600 mg) was administered intravenously, 3 days prior to the start of vaccination, followed by weekly subcutaneous vaccinations with tecemotide (L-BLP25) (actual delivered dose was 806 mcg) administered concomitantly with chemotherapy for 8 weeks, followed by a 9th subcutaneous vaccination 7 to 11 days prior to surgery. Weekly subcutaneous vaccinations with tecemotide (L-BLP25) (actual delivered dose was 806 mcg) administered concomitantly with chemotherapy for 8 weeks, followed by a 9th subcutaneous vaccination 7 to 11 days prior to surgery. Radiotherapy of 45-52 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-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. Total of all reporting groups
Overall Number of Baseline Participants 39 41 42 122
Hide Baseline Analysis Population Description
Safety analysis set included all subjects who received at least one dose of study treatment (tecemotide [L-BLP25] or CPA).
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 39 participants 41 participants 42 participants 122 participants
61.6  (10.74) 62.2  (10.12) 60.3  (8.77) 61.3  (9.84)
Gender  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 39 participants 41 participants 42 participants 122 participants
Female
9
  23.1%
14
  34.1%
10
  23.8%
33
  27.0%
Male
30
  76.9%
27
  65.9%
32
  76.2%
89
  73.0%
1.Primary Outcome
Title Change From Baseline in Tumor Immune Response Evaluated by Immunohistochemical (IHC) Analysis of Tumor Infiltrating Lymphocytes (TILs) at Week 14 (Post-surgery)
Hide Description Tumor biopsy samples were collected prior to baseline and after the surgery. The TILs were evaluated in 3 of the most abundant high-power fields (x40) per sample and the mean value considered (after excluding the lowest and the highest value). The tumor immune response was calculated as number of TILs divided by 100 tumor cells.
Time Frame Baseline and Week 14 (post-surgery)
Hide Outcome Measure Data
Hide Analysis Population Description
Immunomonitoring analysis set included all subjects for whom at least the baseline ELISpot blood and tumor sample, tumor sample at surgery and pre-surgery ELISpot blood drawing are available and whose tumor biopsy at baseline is MUC1-positive. Within the data table, n=number of subjects analyzed for each category.
Arm/Group Title Chemoradiotherapy+Tecemotide (L-BLP25)+Cyclophosphamide Chemoradiotherapy+Tecemotide (L-BLP25) Chemoradiotherapy
Hide Arm/Group Description:
Single dose of cyclophosphamide (300 mg/m^2 to a maximum of 600 mg) was administered intravenously, 3 days prior to the start of vaccination, followed by weekly subcutaneous vaccinations with tecemotide (L-BLP25) (actual delivered dose was 806 mcg) administered concomitantly with chemotherapy for 8 weeks, followed by a 9th subcutaneous vaccination 7 to 11 days prior to surgery.
Weekly subcutaneous vaccinations with tecemotide (L-BLP25) (actual delivered dose was 806 mcg) administered concomitantly with chemotherapy for 8 weeks, followed by a 9th subcutaneous vaccination 7 to 11 days prior to surgery.
Radiotherapy of 45-52 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-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.
Overall Number of Participants Analyzed 27 33 30
Mean (Standard Deviation)
Unit of Measure: TILs per 100 tumor cells
CD8+ (n=23, 27, 26) 0.609  (5.4241) 0.543  (4.5009) 1.538  (3.9509)
CD8+/GrB+ (n=23, 27, 26) 0.565  (3.1646) 0.216  (2.4187) 0.936  (2.7649)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Chemoradiotherapy+Tecemotide (L-BLP25)+Cyclophosphamide, Chemoradiotherapy
Comments Category: CD8+ The difference between baseline and surgical tumor samples was analysed and compared across the 3 treatment arms (effect estimate for Arm A vs Arm C) based on an analysis of covariance (ANCOVA) model. Difference from baseline = Surgery value-Baseline value. Adjustment was based on ANCOVA model with treatment arm as factor and baseline value as covariate. No interaction included. Pairwise tests have been performed to compare Arm A with Arm C, Arm B with Arm C, and Arm A with Arm B
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.794
Comments Arm effect
Method type III SS F-test
Comments [Not Specified]
Method of Estimation Estimation Parameter Effect estimate
Estimated Value -0.04
Confidence Interval (2-Sided) 95%
-0.72 to 0.65
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Chemoradiotherapy+Tecemotide (L-BLP25), Chemoradiotherapy
Comments Category: CD8+ The difference between baseline and surgical tumor samples was analysed and compared across the 3 treatment arms (effect estimate for Arm B vs Arm C) based on an ANCOVA model. Difference from baseline = Surgery value-Baseline value. Adjustment was based on ANCOVA model with treatment arm as factor and baseline value as covariate. No interaction included. Pairwise tests have been performed to compare Arm A with Arm C, Arm B with Arm C, and Arm A with Arm B
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.794
Comments Arm effect
Method type III SS F-test
Comments [Not Specified]
Method of Estimation Estimation Parameter Effect estimate
Estimated Value -0.20
Confidence Interval (2-Sided) 95%
-0.82 to 0.43
Estimation Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Chemoradiotherapy+Tecemotide (L-BLP25)+Cyclophosphamide, Chemoradiotherapy+Tecemotide (L-BLP25)
Comments Category: CD8+ The difference between baseline and surgical tumor samples was analysed and compared across the 3 treatment arms (effect estimate for Arm A vs Arm B) based on an ANCOVA model. Difference from baseline = Surgery value-Baseline value. Adjustment was based on ANCOVA model with treatment arm as factor and baseline value as covariate. No interaction included. Pairwise tests have been performed to compare Arm A with Arm C, Arm B with Arm C, and Arm A with Arm B
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.794
Comments Arm effect
Method type III SS F-test
Comments [Not Specified]
Method of Estimation Estimation Parameter Effect estimate
Estimated Value 0.16
Confidence Interval (2-Sided) 95%
-0.49 to 0.82
Estimation Comments [Not Specified]
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Chemoradiotherapy+Tecemotide (L-BLP25)+Cyclophosphamide, Chemoradiotherapy
Comments Category: CD8+/GrB+ The difference between baseline and surgical tumor samples was analysed and compared across the 3 treatment arms (effect estimate for Arm A vs Arm C) based on an ANCOVA model. Difference from baseline = Surgery value-Baseline value. Adjustment was based on ANCOVA model with treatment arm as factor and baseline value as covariate. No interaction included. Pairwise tests have been performed to compare Arm A with Arm C, Arm B with Arm C, and Arm A with Arm B
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.654
Comments Arm effect
Method type III SS F-test
Comments [Not Specified]
Method of Estimation Estimation Parameter Effect estimate
Estimated Value 0.02
Confidence Interval (2-Sided) 95%
-0.52 to 0.57
Estimation Comments [Not Specified]
Show Statistical Analysis 5 Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection Chemoradiotherapy+Tecemotide (L-BLP25), Chemoradiotherapy
Comments Category: CD8+/GrB+ The difference between baseline and surgical tumor samples was analysed and compared across the 3 treatment arms (effect estimate for Arm B vs Arm C) based on an ANCOVA model. Difference from baseline = Surgery value-Baseline value. Adjustment was based on ANCOVA model with treatment arm as factor and baseline value as covariate. No interaction included. Pairwise tests have been performed to compare Arm A with Arm C, Arm B with Arm C, and Arm A with Arm B
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.654
Comments Arm effect
Method type III SS F-test
Comments [Not Specified]
Method of Estimation Estimation Parameter Effect estimate
Estimated Value -0.19
Confidence Interval (2-Sided) 95%
-0.69 to 0.31
Estimation Comments [Not Specified]
Show Statistical Analysis 6 Hide Statistical Analysis 6
Statistical Analysis Overview Comparison Group Selection Chemoradiotherapy+Tecemotide (L-BLP25)+Cyclophosphamide, Chemoradiotherapy+Tecemotide (L-BLP25)
Comments Category: CD8+/GrB+ The difference between baseline and surgical tumor samples was analysed and compared across the 3 treatment arms (effect estimate for Arm A vs Arm B) based on an ANCOVA model. Difference from baseline = Surgery value-Baseline value. Adjustment was based on ANCOVA model with treatment arm as factor and baseline value as covariate. No interaction included. Pairwise tests have been performed to compare Arm A with Arm C, Arm B with Arm C, and Arm A with Arm B
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.654
Comments Arm effect
Method type III SS F-test
Comments [Not Specified]
Method of Estimation Estimation Parameter Effect estimate
Estimated Value 0.21
Confidence Interval (2-Sided) 95%
-0.31 to 0.74
Estimation Comments [Not Specified]
2.Primary Outcome
Title Immunological Response to Treatment in Relation to Microsatellite Instability (MSI) Status: Number of Subjects Per MSI Category
Hide Description A potential association between MSI status (present or absent) and the primary endpoints (difference from baseline to surgery in CD8+ and CD8+/GrB+ T cell infiltration) was evaluated. Determination of mismatch repair protein (MRP)-expression (hMLH1, hMSH2, hMSH6 and hPMS2) was performed for the detection of the MSI-H-phenotype by IHC and/or on tumor deoxyribonucleic acid (DNA) sample using 5 microsatellite markers (BAT-25, BAT-26, NR-21, NR-24 and MONO-27).
Time Frame 18 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Immunomonitoring analysis set included all subjects for whom at least the baseline ELISpot blood and tumor sample, tumor sample at surgery and pre-surgery ELISpot blood drawing are available and whose tumor biopsy at baseline is MUC1-positive.
Arm/Group Title Chemoradiotherapy+Tecemotide (L-BLP25)+Cyclophosphamide Chemoradiotherapy+Tecemotide (L-BLP25) Chemoradiotherapy
Hide Arm/Group Description:
Single dose of cyclophosphamide (300 mg/m^2 to a maximum of 600 mg) was administered intravenously, 3 days prior to the start of vaccination, followed by weekly subcutaneous vaccinations with tecemotide (L-BLP25) (actual delivered dose was 806 mcg) administered concomitantly with chemotherapy for 8 weeks, followed by a 9th subcutaneous vaccination 7 to 11 days prior to surgery.
Weekly subcutaneous vaccinations with tecemotide (L-BLP25) (actual delivered dose was 806 mcg) administered concomitantly with chemotherapy for 8 weeks, followed by a 9th subcutaneous vaccination 7 to 11 days prior to surgery.
Radiotherapy of 45-52 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-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.
Overall Number of Participants Analyzed 27 33 30
Measure Type: Number
Unit of Measure: subjects
No 25 32 30
Yes 2 1 0
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Chemoradiotherapy+Tecemotide (L-BLP25)+Cyclophosphamide, Chemoradiotherapy
Comments Category: CD8+ The difference in T cell infiltration from baseline to surgery was analysed and compared across the 3 treatment arms (effect estimate for Arm A vs Arm C) based on an ANCOVA model. Difference from baseline = Surgery value-Baseline value. Adjustment was based on ANCOVA model with treatment arm as factor and baseline value and MSI category as covariates. No interaction included. Pairwise tests have been performed to compare Arm A with Arm C, Arm B with Arm C, and Arm A with Arm B.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.921
Comments [Not Specified]
Method type III SS F-test
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Means estimate
Estimated Value -0.03
Confidence Interval (2-Sided) 95%
-0.73 to 0.67
Estimation Comments Difference between Means adjusted on covariates baseline value and MSI category.
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Chemoradiotherapy+Tecemotide (L-BLP25), Chemoradiotherapy
Comments Category: CD8+ The difference in T cell infiltration from baseline to surgery was analysed and compared across the 3 treatment arms (effect estimate for Arm B vs Arm C) based on an ANCOVA model. Difference from baseline = Surgery value-Baseline value. Adjustment was based on ANCOVA model with treatment arm as factor and baseline value and MSI category as covariates. No interaction included. Pairwise tests have been performed to compare Arm A with Arm C, Arm B with Arm C, and Arm A with Arm B.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.921
Comments [Not Specified]
Method type III SS F-test
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Means estimate
Estimated Value -0.20
Confidence Interval (2-Sided) 95%
-0.83 to 0.44
Estimation Comments Difference between Means adjusted on covariates baseline value and MSI category.
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Chemoradiotherapy+Tecemotide (L-BLP25)+Cyclophosphamide, Chemoradiotherapy+Tecemotide (L-BLP25)
Comments Category: CD8+ The difference in T cell infiltration from baseline to surgery was analysed and compared across the 3 treatment arms (effect estimate for Arm A vs Arm B) based on an ANCOVA model. Difference from baseline = Surgery value-Baseline value. Adjustment was based on ANCOVA model with treatment arm as factor and baseline value and MSI category as covariates. No interaction included. Pairwise tests have been performed to compare Arm A with Arm C, Arm B with Arm C, and Arm A with Arm B.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.921
Comments [Not Specified]
Method type III SS F-test
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Means estimate
Estimated Value 0.17
Confidence Interval (2-Sided) 95%
-0.50 to 0.83
Estimation Comments Difference between Means adjusted on covariates baseline value and MSI category.
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Chemoradiotherapy+Tecemotide (L-BLP25)+Cyclophosphamide, Chemoradiotherapy
Comments Category:CD8+/GrB+ The difference in T cell infiltration from baseline to surgery was analysed and compared across the 3 treatment arms (effect estimate for Arm A vs Arm C) based on an ANCOVA model. Difference from baseline=Surgery value-Baseline value. Adjustment was based on ANCOVA model with treatment arm as factor and baseline value and MSI category as covariates. No interaction included. Pairwise tests have been performed to compare Arm A with Arm C, Arm B with Arm C, and Arm A with Arm B.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.890
Comments [Not Specified]
Method type III SS F-test
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Means estimate
Estimated Value 0.02
Confidence Interval (2-Sided) 95%
-0.54 to 0.58
Estimation Comments Difference between Means adjusted on covariates baseline value and MSI category.
Show Statistical Analysis 5 Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection Chemoradiotherapy+Tecemotide (L-BLP25), Chemoradiotherapy
Comments Category:CD8+/GrB+ The difference in T cell infiltration from baseline to surgery was analysed and compared across the 3 treatment arms (effect estimate for Arm B vs Arm C) based on an ANCOVA model. Difference from baseline=Surgery value-Baseline value. Adjustment was based on ANCOVA model with treatment arm as factor and baseline value and MSI category as covariates. No interaction included. Pairwise tests have been performed to compare Arm A with Arm C, Arm B with Arm C, and Arm A with Arm B.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.890
Comments [Not Specified]
Method type III SS F-test
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Means estimate
Estimated Value -0.19
Confidence Interval (2-Sided) 95%
-0.70 to 0.31
Estimation Comments Difference between Means adjusted on covariates baseline value and MSI category.
Show Statistical Analysis 6 Hide Statistical Analysis 6
Statistical Analysis Overview Comparison Group Selection Chemoradiotherapy+Tecemotide (L-BLP25)+Cyclophosphamide, Chemoradiotherapy+Tecemotide (L-BLP25)
Comments Category:CD8+/GrB+ The difference in T cell infiltration from baseline to surgery was analysed and compared across the 3 treatment arms (effect estimate for Arm A vs Arm B) based on an ANCOVA model. Difference from baseline=Surgery value-Baseline value. Adjustment was based on ANCOVA model with treatment arm as factor and baseline value and MSI category as covariates. No interaction included. Pairwise tests have been performed to compare Arm A with Arm C, Arm B with Arm C, and Arm A with Arm B.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.890
Comments [Not Specified]
Method type III SS F-test
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Means estimate
Estimated Value 0.21
Confidence Interval (2-Sided) 95%
-0.32 to 0.74
Estimation Comments Difference between Means adjusted on covariates baseline value and MSI category.
3.Primary Outcome
Title Change From Baseline in Interferon (IFN)-Gamma Secretion of Mononuclear Cells in Response to MUC1 by Enzyme-linked Immunosorbent Spot (ELISpot) at Post-baseline
Hide Description IFN-gamma secretion of mononuclear cells in response to MUC1 was to be measured by ELISpot. The maximal post-baseline value out of Week 5, Week 11-13 (pre-surgery), and Week 16-18 (follow-up / end-of trial) was evaluated in comparison to Baseline.
Time Frame Baseline, Week 5, Week 13 (pre-surgery), and Week 18 (end-of trial)
Hide Outcome Measure Data
Hide Analysis Population Description
Data were not analyzed as no acceptable ELISpot assay is available
Arm/Group Title Chemoradiotherapy+Tecemotide (L-BLP25)+Cyclophosphamide Chemoradiotherapy+Tecemotide (L-BLP25) Chemoradiotherapy
Hide Arm/Group Description:
Single dose of cyclophosphamide (300 mg/m^2 to a maximum of 600 mg) was administered intravenously, 3 days prior to the start of vaccination, followed by weekly subcutaneous vaccinations with tecemotide (L-BLP25) (actual delivered dose was 806 mcg) administered concomitantly with chemotherapy for 8 weeks, followed by a 9th subcutaneous vaccination 7 to 11 days prior to surgery.
Weekly subcutaneous vaccinations with tecemotide (L-BLP25) (actual delivered dose was 806 mcg) administered concomitantly with chemotherapy for 8 weeks, followed by a 9th subcutaneous vaccination 7 to 11 days prior to surgery.
Radiotherapy of 45-52 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-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.
Overall Number of Participants Analyzed 0 0 0
No data displayed because Outcome Measure has zero total analyzed.
4.Primary Outcome
Title Change From Baseline in IFN-gamma Secretion of Mononuclear Cells in Response to Carcinoembryonic Antigen (CEA) by ELISpot at Post-baseline
Hide Description IFN-gamma secretion of mononuclear cells in response to CEA was to be measured by ELISpot. The maximal post-baseline value out of Week 5, Week 11-13 (pre-surgery), and Week 16-18 (follow-up / end-of trial) was evaluated in comparison to Baseline.
Time Frame Baseline, Week 5, Week 13 (pre-surgery), and Week 18 (end-of trial)
Hide Outcome Measure Data
Hide Analysis Population Description
Data were not analyzed as no acceptable ELISpot assay is available
Arm/Group Title Chemoradiotherapy+Tecemotide (L-BLP25)+Cyclophosphamide Chemoradiotherapy+Tecemotide (L-BLP25) Chemoradiotherapy
Hide Arm/Group Description:
Single dose of cyclophosphamide (300 mg/m^2 to a maximum of 600 mg) was administered intravenously, 3 days prior to the start of vaccination, followed by weekly subcutaneous vaccinations with tecemotide (L-BLP25) (actual delivered dose was 806 mcg) administered concomitantly with chemotherapy for 8 weeks, followed by a 9th subcutaneous vaccination 7 to 11 days prior to surgery.
Weekly subcutaneous vaccinations with tecemotide (L-BLP25) (actual delivered dose was 806 mcg) administered concomitantly with chemotherapy for 8 weeks, followed by a 9th subcutaneous vaccination 7 to 11 days prior to surgery.
Radiotherapy of 45-52 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-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.
Overall Number of Participants Analyzed 0 0 0
No data displayed because Outcome Measure has zero total analyzed.
5.Secondary Outcome
Title Change From Baseline in Peritumoral Immune Response at Week 14 (Post-surgery)
Hide Description Immunological changes in the tumor microenvironment were evaluated based on IHC expression of CD3+, CD4+, and Ki67+CD3+ T cells; regulatory T cells (FOXP3+) and myeloid-derived suppressor cells (CD33+CD14-); other immune cells such as NK cells (CD3-CD57+), B cells (CD20+), macrophages (CD68+), and dendritic cells (S100+). Peritumoral immune response was calculated as number of lymphoid cells at the margin of the tumor or in the tumor bed (if there is complete pathological response).
Time Frame Baseline and Week 14 (post-surgery)
Hide Outcome Measure Data
Hide Analysis Population Description
The pre-specified statistical threshold for reporting of results of planned analysis for either arm or interaction effect was not met in the analysis population. Hence the data was not assessed for the outcome measure.
Arm/Group Title Chemoradiotherapy+Tecemotide (L-BLP25)+Cyclophosphamide Chemoradiotherapy+Tecemotide (L-BLP25) Chemoradiotherapy
Hide Arm/Group Description:
Single dose of cyclophosphamide (300 mg/m^2 to a maximum of 600 mg) was administered intravenously, 3 days prior to the start of vaccination, followed by weekly subcutaneous vaccinations with tecemotide (L-BLP25) (actual delivered dose was 806 mcg) administered concomitantly with chemotherapy for 8 weeks, followed by a 9th subcutaneous vaccination 7 to 11 days prior to surgery.
Weekly subcutaneous vaccinations with tecemotide (L-BLP25) (actual delivered dose was 806 mcg) administered concomitantly with chemotherapy for 8 weeks, followed by a 9th subcutaneous vaccination 7 to 11 days prior to surgery.
Radiotherapy of 45-52 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-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.
Overall Number of Participants Analyzed 0 0 0
No data displayed because Outcome Measure has zero total analyzed.
6.Secondary Outcome
Title Change From Baseline in Immunological Response in Peripheral Blood at Week 18 (Follow-up / end-of Trial)
Hide Description Immunological changes in peripheral blood were evaluated based on fluorescence analysis cell sorter phenotypic characterization of T cells (CD3+CD4+ and CD3+CD8+) and of markers of activation and proliferation (CD27, BTLA); and regulatory cells such as CD3+CD4+ (or CD8+) CD45RA+CD25+FoxP3+CD127 T cells. Immunological Response in peripheral blood was measured on a continuous scale.
Time Frame Baseline and Week 18 (follow-up / end-of trial)
Hide Outcome Measure Data
Hide Analysis Population Description
Immunomonitoring analysis set included all subjects for whom at least the baseline ELISpot blood and tumor sample, tumor sample at surgery and pre-surgery ELISpot blood drawing are available and whose tumor biopsy at baseline is MUC1-positive. Within the data table, n=number of subjects analysed for each category.
Arm/Group Title Chemoradiotherapy+Tecemotide (L-BLP25)+Cyclophosphamide Chemoradiotherapy+Tecemotide (L-BLP25) Chemoradiotherapy
Hide Arm/Group Description:
Single dose of cyclophosphamide (300 mg/m^2 to a maximum of 600 mg) was administered intravenously, 3 days prior to the start of vaccination, followed by weekly subcutaneous vaccinations with tecemotide (L-BLP25) (actual delivered dose was 806 mcg) administered concomitantly with chemotherapy for 8 weeks, followed by a 9th subcutaneous vaccination 7 to 11 days prior to surgery.
Weekly subcutaneous vaccinations with tecemotide (L-BLP25) (actual delivered dose was 806 mcg) administered concomitantly with chemotherapy for 8 weeks, followed by a 9th subcutaneous vaccination 7 to 11 days prior to surgery.
Radiotherapy of 45-52 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-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.
Overall Number of Participants Analyzed 27 33 30
Mean (Standard Deviation)
Unit of Measure: log2 (percentage of T cells)
CD3-CD56+CD16+GranzymeB+ (n=26,30,24) -0.013  (0.1051) -0.046  (0.1259) -0.081  (0.2238)
CD3-CD56+CD16+Perforin+ (n=26,30,24) -0.050  (0.0769) -0.033  (0.1868) -0.088  (0.2282)
CD3+CD4+CD27+ (n=26,30,24) -0.181  (0.1848) -0.135  (0.1521) -0.099  (0.1913)
CD3-CD56+CD16+Granzyme B+/LY (n=26,30,24) 0.264  (0.5885) 0.047  (1.2787) 0.415  (0.6040)
CD3-CD56+CD16+Perforin+/LY (n=26,30,24) 0.226  (0.5669) 0.058  (1.2902) 0.411  (0.6019)
CD3-CD56+CD16-CD107a+ (n=26,30,24) 0.216  (1.2010) -0.318  (1.5863) 0.037  (1.0191)
CD3+CD8+CD127-FoxP3-CD45RA-CD25+CTLA4+(n=27,29,24) 0.050  (0.3933) 0.152  (0.5386) -0.012  (0.5202)
CD3+CD56+CD16-Granzyme B+ (n=26,30,24) 0.479  (1.6943) -0.241  (0.9628) -0.024  (0.6623)
CD3-CD56+CD16+/LY (n=26,30,24) 0.277  (0.5448) 0.090  (1.2968) 0.497  (0.6119)
CD3-CD19+BTLA4+ (n=27,29,23) -0.030  (0.0489) -0.028  (0.0550) -0.017  (0.0352)
Lymphs Tube 2 (n=27,30,25) -1.024  (0.4392) -0.941  (0.6080) -0.952  (0.4761)
CD3+CD56+CD16+CD107a+ (n=26,30,24) -1.216  (4.5484) 1.966  (6.6322) -2.752  (6.4790)
CD3+CD4+BTLA4+ (n=26,30,24) 0.063  (1.4413) 0.122  (0.4833) -0.035  (0.4117)
Lymphs Tube 3 (n=27,30,25) -0.994  (0.4545) -0.920  (0.5923) -0.936  (0.4746)
CD3+CD56+CD16+CCR7+ (n=26,30,24) -1.341  (4.1442) 0.541  (6.3502) -3.390  (5.1877)
CD3+CD8+CD127+FoxP3-CD25-CD45RA+CTLA4-(n=27,29,24) -0.604  (0.8102) -1.062  (1.1436) -0.940  (1.2678)
Background corrected CD3+CD4+IFNg+ (n=21,27,21) 0.058  (0.9767) 0.544  (0.9521) 0.359  (1.3187)
CD3+CD56+CD16+Granzyme B+/LY (n=26,30,24) 0.243  (0.6969) -0.201  (1.0731) 0.131  (0.7652)
CD3+CD56+CD16+Perforin+/LY (n=26,30,24) 0.240  (0.6997) -0.177  (0.9920) 0.101  (0.7617)
CD3+CD4+CD127+FoxP3-CD45RA-CD25+CTLA4+(n=27,29,24) 0.711  (1.3825) 0.674  (1.2689) 1.035  (1.4996)
Time Frame Date of first signature of informed consent until the Follow-up/End-of-Trial visit (Week 18).
Adverse Event Reporting Description TEAEs: AE's during treatment; absent pre-treatment (PT)/worsened relative to PT & onset dates occurring from first trial treatment till the Follow-up/EOT. Safety Analysis Set included all randomized subjects; received at least 1 dose of treatment (arm A:one dose of CPA, arm B:one s.c. injection of tecemotide, arm C:neo-adjuvant chemoradiotherapy).
 
Arm/Group Title Chemoradiotherapy+Tecemotide (L-BLP25)+CPA Chemoradiotherapy+Tecemotide (L-BLP25) Chemoradiotherapy
Hide Arm/Group Description Single dose of cyclophosphamide (300 mg/m^2 to a maximum of 600 mg) was administered intravenously, 3 days prior to the start of vaccination, followed by weekly subcutaneous vaccinations with tecemotide (L-BLP25) (actual delivered dose was 806 mcg) administered concomitantly with chemotherapy for 8 weeks, followed by a 9th subcutaneous vaccination 7 to 11 days prior to surgery. Weekly subcutaneous vaccinations with tecemotide (L-BLP25) (actual delivered dose was 806 mcg) administered concomitantly with chemotherapy for 8 weeks, followed by a 9th subcutaneous vaccination 7 to 11 days prior to surgery. Radiotherapy of 45-52 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-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.
All-Cause Mortality
Chemoradiotherapy+Tecemotide (L-BLP25)+CPA Chemoradiotherapy+Tecemotide (L-BLP25) Chemoradiotherapy
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Chemoradiotherapy+Tecemotide (L-BLP25)+CPA Chemoradiotherapy+Tecemotide (L-BLP25) Chemoradiotherapy
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   10/39 (25.64%)      10/41 (24.39%)      12/42 (28.57%)    
Blood and lymphatic system disorders       
Anaemia * 1  0/39 (0.00%)  0 0/41 (0.00%)  0 1/42 (2.38%)  1
Coagulopathy * 1  0/39 (0.00%)  0 0/41 (0.00%)  0 1/42 (2.38%)  1
Thrombocytopenia * 1  0/39 (0.00%)  0 0/41 (0.00%)  0 1/42 (2.38%)  1
Gastrointestinal disorders       
Gastrointestinal necrosis * 1  1/39 (2.56%)  1 0/41 (0.00%)  0 0/42 (0.00%)  0
Ileus * 1  1/39 (2.56%)  1 0/41 (0.00%)  0 0/42 (0.00%)  0
Intestinal obstruction * 1  1/39 (2.56%)  1 0/41 (0.00%)  0 0/42 (0.00%)  0
Peritoneal haemorrhage * 1  1/39 (2.56%)  1 0/41 (0.00%)  0 0/42 (0.00%)  0
General disorders       
Asthenia * 1  0/39 (0.00%)  0 1/41 (2.44%)  1 0/42 (0.00%)  0
Impaired healing * 1  0/39 (0.00%)  0 0/41 (0.00%)  0 1/42 (2.38%)  1
Injection site reaction * 1  1/39 (2.56%)  1 0/41 (0.00%)  0 0/42 (0.00%)  0
Infections and infestations       
Abdominal abscess * 1  0/39 (0.00%)  0 0/41 (0.00%)  0 1/42 (2.38%)  1
Anal abscess * 1  0/39 (0.00%)  0 0/41 (0.00%)  0 1/42 (2.38%)  1
Catheter site infection * 1  0/39 (0.00%)  0 0/41 (0.00%)  0 1/42 (2.38%)  1
Gastrointestinal infection * 1  0/39 (0.00%)  0 1/41 (2.44%)  1 0/42 (0.00%)  0
Pelvic infection * 1  1/39 (2.56%)  1 0/41 (0.00%)  0 0/42 (0.00%)  0
Peritonitis * 1  0/39 (0.00%)  0 1/41 (2.44%)  1 0/42 (0.00%)  0
Skin infection * 1  0/39 (0.00%)  0 0/41 (0.00%)  0 1/42 (2.38%)  1
Urinary tract infection * 1  0/39 (0.00%)  0 1/41 (2.44%)  1 0/42 (0.00%)  0
Wound infection bacterial * 1  0/39 (0.00%)  0 1/41 (2.44%)  1 0/42 (0.00%)  0
Injury, poisoning and procedural complications       
Accidental overdose * 1  1/39 (2.56%)  1 0/41 (0.00%)  0 0/42 (0.00%)  0
Anastomotic leak * 1  0/39 (0.00%)  0 1/41 (2.44%)  1 0/42 (0.00%)  0
Gastrointestinal anastomotic leak * 1  1/39 (2.56%)  1 0/41 (0.00%)  0 0/42 (0.00%)  0
Gastrointestinal stoma complication * 1  2/39 (5.13%)  2 0/41 (0.00%)  0 0/42 (0.00%)  0
Post procedural complication * 1  0/39 (0.00%)  0 0/41 (0.00%)  0 1/42 (2.38%)  1
Procedural intestinal perforation * 1  0/39 (0.00%)  0 0/41 (0.00%)  0 1/42 (2.38%)  1
Radiation skin injury * 1  0/39 (0.00%)  0 0/41 (0.00%)  0 1/42 (2.38%)  1
Investigations       
Gamma-glutamyltransferase increased * 1  0/39 (0.00%)  0 0/41 (0.00%)  0 1/42 (2.38%)  1
Metabolism and nutrition disorders       
Dehydration * 1  0/39 (0.00%)  0 2/41 (4.88%)  2 1/42 (2.38%)  1
Hyponatraemia * 1  0/39 (0.00%)  0 0/41 (0.00%)  0 1/42 (2.38%)  1
Hypovolaemia * 1  0/39 (0.00%)  0 1/41 (2.44%)  1 0/42 (0.00%)  0
Musculoskeletal and connective tissue disorders       
Coccydynia * 1  0/39 (0.00%)  0 1/41 (2.44%)  1 0/42 (0.00%)  0
Neoplasms benign, malignant and unspecified (incl cysts and polyps)       
Peritumoural oedema * 1  0/39 (0.00%)  0 1/41 (2.44%)  1 0/42 (0.00%)  0
Nervous system disorders       
Central nervous system lesion * 1  0/39 (0.00%)  0 1/41 (2.44%)  1 0/42 (0.00%)  0
Hemiplegia * 1  0/39 (0.00%)  0 1/41 (2.44%)  1 1/42 (2.38%)  1
Ischaemic stroke * 1  0/39 (0.00%)  0 0/41 (0.00%)  0 1/42 (2.38%)  1
Syncope * 1  0/39 (0.00%)  0 0/41 (0.00%)  0 1/42 (2.38%)  1
Renal and urinary disorders       
Renal colic * 1  0/39 (0.00%)  0 1/41 (2.44%)  1 0/42 (0.00%)  0
Renal failure * 1  0/39 (0.00%)  0 1/41 (2.44%)  1 1/42 (2.38%)  1
Urinary retention * 1  0/39 (0.00%)  0 0/41 (0.00%)  0 1/42 (2.38%)  1
Reproductive system and breast disorders       
Female genital tract fistula * 1  1/39 (2.56%)  1 0/41 (0.00%)  0 0/42 (0.00%)  0
Respiratory, thoracic and mediastinal disorders       
Pneumothorax * 1  0/39 (0.00%)  0 0/41 (0.00%)  0 1/42 (2.38%)  1
Respiratory failure * 1  0/39 (0.00%)  0 1/41 (2.44%)  1 0/42 (0.00%)  0
Vascular disorders       
Aortic thrombosis * 1  0/39 (0.00%)  0 0/41 (0.00%)  0 1/42 (2.38%)  1
Hypotension * 1  0/39 (0.00%)  0 0/41 (0.00%)  0 1/42 (2.38%)  1
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA Version17.0
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Chemoradiotherapy+Tecemotide (L-BLP25)+CPA Chemoradiotherapy+Tecemotide (L-BLP25) Chemoradiotherapy
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   38/39 (97.44%)      41/41 (100.00%)      41/42 (97.62%)    
Blood and lymphatic system disorders       
Anaemia * 1  5/39 (12.82%)  5 4/41 (9.76%)  4 6/42 (14.29%)  6
Leukopenia * 1  4/39 (10.26%)  4 5/41 (12.20%)  5 5/42 (11.90%)  5
Neutropenia * 1  2/39 (5.13%)  2 1/41 (2.44%)  1 2/42 (4.76%)  2
Thrombocytopenia * 1  1/39 (2.56%)  1 0/41 (0.00%)  0 4/42 (9.52%)  4
Gastrointestinal disorders       
Abdominal distension * 1  1/39 (2.56%)  1 3/41 (7.32%)  3 3/42 (7.14%)  3
Abdominal pain * 1  5/39 (12.82%)  5 8/41 (19.51%)  8 8/42 (19.05%)  8
Abdominal pain upper * 1  2/39 (5.13%)  2 5/41 (12.20%)  5 0/42 (0.00%)  0
Anorectal discomfort * 1  5/39 (12.82%)  5 3/41 (7.32%)  3 7/42 (16.67%)  7
Constipation * 1  6/39 (15.38%)  6 4/41 (9.76%)  4 7/42 (16.67%)  7
Defaecation urgency * 1  2/39 (5.13%)  2 1/41 (2.44%)  1 1/42 (2.38%)  1
Diarrhoea * 1  15/39 (38.46%)  15 18/41 (43.90%)  18 21/42 (50.00%)  21
Dyspepsia * 1  2/39 (5.13%)  2 1/41 (2.44%)  1 3/42 (7.14%)  3
Faecal incontinence * 1  2/39 (5.13%)  2 1/41 (2.44%)  1 0/42 (0.00%)  0
Flatulence * 1  2/39 (5.13%)  2 3/41 (7.32%)  3 3/42 (7.14%)  3
Gastrointestinal pain * 1  2/39 (5.13%)  2 0/41 (0.00%)  0 0/42 (0.00%)  0
Nausea * 1  8/39 (20.51%)  8 12/41 (29.27%)  12 13/42 (30.95%)  13
Painful defaecation * 1  3/39 (7.69%)  3 1/41 (2.44%)  1 4/42 (9.52%)  4
Proctalgia * 1  10/39 (25.64%)  10 14/41 (34.15%)  14 12/42 (28.57%)  12
Rectal haemorrhage * 1  5/39 (12.82%)  5 2/41 (4.88%)  2 4/42 (9.52%)  4
Rectal tenesmus * 1  2/39 (5.13%)  2 2/41 (4.88%)  2 0/42 (0.00%)  0
Toothache * 1  1/39 (2.56%)  1 3/41 (7.32%)  3 0/42 (0.00%)  0
Vomiting * 1  6/39 (15.38%)  6 4/41 (9.76%)  4 2/42 (4.76%)  2
General disorders       
Asthenia * 1  9/39 (23.08%)  9 7/41 (17.07%)  7 6/42 (14.29%)  6
Chills * 1  4/39 (10.26%)  4 2/41 (4.88%)  2 1/42 (2.38%)  1
Fatigue * 1  12/39 (30.77%)  12 9/41 (21.95%)  9 12/42 (28.57%)  12
Influenza like illness * 1  4/39 (10.26%)  4 0/41 (0.00%)  0 0/42 (0.00%)  0
Injection site erythema * 1  3/39 (7.69%)  3 11/41 (26.83%)  11 0/42 (0.00%)  0
Injection site haematoma * 1  2/39 (5.13%)  2 1/41 (2.44%)  1 0/42 (0.00%)  0
Injection site induration * 1  4/39 (10.26%)  4 2/41 (4.88%)  2 0/42 (0.00%)  0
Injection site nodule * 1  5/39 (12.82%)  5 11/41 (26.83%)  11 0/42 (0.00%)  0
Injection site pain * 1  0/39 (0.00%)  0 3/41 (7.32%)  3 0/42 (0.00%)  0
Injection site reaction * 1  7/39 (17.95%)  7 7/41 (17.07%)  7 3/42 (7.14%)  3
Pyrexia * 1  2/39 (5.13%)  2 1/41 (2.44%)  1 1/42 (2.38%)  1
Infections and infestations       
Cystitis * 1  3/39 (7.69%)  3 2/41 (4.88%)  2 2/42 (4.76%)  2
Nasopharyngitis * 1  0/39 (0.00%)  0 2/41 (4.88%)  2 3/42 (7.14%)  3
Urinary tract infection * 1  2/39 (5.13%)  2 4/41 (9.76%)  4 3/42 (7.14%)  3
Injury, poisoning and procedural complications       
Procedural nausea * 1  1/39 (2.56%)  1 2/41 (4.88%)  2 3/42 (7.14%)  3
Procedural pain * 1  8/39 (20.51%)  8 3/41 (7.32%)  3 7/42 (16.67%)  7
Radiation skin injury * 1  2/39 (5.13%)  2 9/41 (21.95%)  9 2/42 (4.76%)  2
Investigations       
Antinuclear antibody increased * 1  4/39 (10.26%)  4 3/41 (7.32%)  3 0/42 (0.00%)  0
Weight decreased * 1  3/39 (7.69%)  3 2/41 (4.88%)  2 5/42 (11.90%)  5
Metabolism and nutrition disorders       
Decreased appetite * 1  7/39 (17.95%)  7 6/41 (14.63%)  6 13/42 (30.95%)  13
Hypokalaemia * 1  2/39 (5.13%)  2 1/41 (2.44%)  1 1/42 (2.38%)  1
Hyponatraemia * 1  2/39 (5.13%)  2 1/41 (2.44%)  1 0/42 (0.00%)  0
Musculoskeletal and connective tissue disorders       
Back pain * 1  0/39 (0.00%)  0 0/41 (0.00%)  0 4/42 (9.52%)  4
Nervous system disorders       
Dizziness * 1  2/39 (5.13%)  2 3/41 (7.32%)  3 0/42 (0.00%)  0
Dysgeusia * 1  3/39 (7.69%)  3 2/41 (4.88%)  2 1/42 (2.38%)  1
Headache * 1  6/39 (15.38%)  6 1/41 (2.44%)  1 4/42 (9.52%)  4
Psychiatric disorders       
Anxiety * 1  1/39 (2.56%)  1 1/41 (2.44%)  1 4/42 (9.52%)  4
Insomnia * 1  2/39 (5.13%)  2 4/41 (9.76%)  4 2/42 (4.76%)  2
Renal and urinary disorders       
Dysuria * 1  10/39 (25.64%)  10 8/41 (19.51%)  8 5/42 (11.90%)  5
Haematuria * 1  2/39 (5.13%)  2 1/41 (2.44%)  1 1/42 (2.38%)  1
Pollakiuria * 1  3/39 (7.69%)  3 5/41 (12.20%)  5 1/42 (2.38%)  1
Urinary tract pain * 1  2/39 (5.13%)  2 2/41 (4.88%)  2 1/42 (2.38%)  1
Respiratory, thoracic and mediastinal disorders       
Cough * 1  2/39 (5.13%)  2 2/41 (4.88%)  2 2/42 (4.76%)  2
Skin and subcutaneous tissue disorders       
Dermatitis * 1  2/39 (5.13%)  2 1/41 (2.44%)  1 0/42 (0.00%)  0
Dry skin * 1  2/39 (5.13%)  2 2/41 (4.88%)  2 1/42 (2.38%)  1
Erythema * 1  5/39 (12.82%)  5 5/41 (12.20%)  5 1/42 (2.38%)  1
Palmar-plantar erythrodysaesthesia syndrome * 1  3/39 (7.69%)  3 4/41 (9.76%)  4 3/42 (7.14%)  3
Pruritus * 1  2/39 (5.13%)  2 1/41 (2.44%)  1 0/42 (0.00%)  0
Rash * 1  5/39 (12.82%)  5 4/41 (9.76%)  4 0/42 (0.00%)  0
Vascular disorders       
Hypertension * 1  1/39 (2.56%)  1 1/41 (2.44%)  1 3/42 (7.14%)  3
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA Version17.0
Not all efficacy data were analyzed as no acceptable ELISpot assay is available. The Sponsor decided to discontinue the development of tecemotide (L-BLP25) in September 2014
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

The Investigator will inform the Sponsor in advance about any plans to publish or present data from the trial. Any publications and presentations of the results (abstracts in journals or newspapers, oral presentations, etc.), either in whole or in part, by Investigators or their representatives will require pre-submission review by the Sponsor.

The Sponsor will not suppress or veto publications, but maintains the right to delay publication in order to protect intellectual property rights.

Results Point of Contact
Name/Title: Merck KGaA Communication Center
Organization: Merck Serono, a division of Merck KGaA
Phone: +49-6151-72-5200
Responsible Party: Merck KGaA, Darmstadt, Germany
ClinicalTrials.gov Identifier: NCT01507103     History of Changes
Other Study ID Numbers: EMR 63325-013
2011-000847-25 ( EudraCT Number )
First Submitted: January 6, 2012
First Posted: January 10, 2012
Results First Submitted: September 21, 2015
Results First Posted: June 2, 2016
Last Update Posted: January 13, 2017