Trial Outcomes & Findings for Tecemotide (L-BLP25) in Rectal Cancer (NCT NCT01507103)

Last Updated: 2017-01-13

Results Overview

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.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

124 participants

Primary outcome timeframe

Baseline and Week 14 (post-surgery)

Results posted on

2017-01-13

Participant Flow

First/last participant (informed consent): Feb 2012/Dec 2013. Study completion date: Jun 2014.

Enrolled: 140 screened for eligibility; 16 excluded (mainly due to non-fulfillment of inclusion or exclusion criteria), 124 subjects randomized.

Participant milestones

Participant milestones
Measure	Chemoradiotherapy+Tecemotide (L-BLP25)+CPA 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.	Chemoradiotherapy+Tecemotide (L-BLP25) 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.	Chemoradiotherapy 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 Study STARTED	41	41	42
Overall Study COMPLETED	41	41	42
Overall Study NOT COMPLETED	0	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Tecemotide (L-BLP25) in Rectal Cancer

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Chemoradiotherapy+Tecemotide (L-BLP25)+CPA n=39 Participants 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.	Chemoradiotherapy+Tecemotide (L-BLP25) n=41 Participants 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.	Chemoradiotherapy n=42 Participants 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 n=122 Participants Total of all reporting groups
Age, Continuous	61.6 years STANDARD_DEVIATION 10.74 • n=5 Participants	62.2 years STANDARD_DEVIATION 10.12 • n=7 Participants	60.3 years STANDARD_DEVIATION 8.77 • n=5 Participants	61.3 years STANDARD_DEVIATION 9.84 • n=4 Participants
Gender Female	9 Participants n=5 Participants	14 Participants n=7 Participants	10 Participants n=5 Participants	33 Participants n=4 Participants
Gender Male	30 Participants n=5 Participants	27 Participants n=7 Participants	32 Participants n=5 Participants	89 Participants n=4 Participants

PRIMARY outcome

Timeframe: Baseline and Week 14 (post-surgery)

Population: 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.

Outcome measures

Outcome measures
Measure	Chemoradiotherapy+Tecemotide (L-BLP25)+Cyclophosphamide n=27 Participants 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.	Chemoradiotherapy+Tecemotide (L-BLP25) n=33 Participants 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.	Chemoradiotherapy n=30 Participants 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.
Change From Baseline in Tumor Immune Response Evaluated by Immunohistochemical (IHC) Analysis of Tumor Infiltrating Lymphocytes (TILs) at Week 14 (Post-surgery) CD8+ (n=23, 27, 26)	0.609 TILs per 100 tumor cells Standard Deviation 5.4241	0.543 TILs per 100 tumor cells Standard Deviation 4.5009	1.538 TILs per 100 tumor cells Standard Deviation 3.9509
Change From Baseline in Tumor Immune Response Evaluated by Immunohistochemical (IHC) Analysis of Tumor Infiltrating Lymphocytes (TILs) at Week 14 (Post-surgery) CD8+/GrB+ (n=23, 27, 26)	0.565 TILs per 100 tumor cells Standard Deviation 3.1646	0.216 TILs per 100 tumor cells Standard Deviation 2.4187	0.936 TILs per 100 tumor cells Standard Deviation 2.7649

PRIMARY outcome

Timeframe: 18 weeks

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).

Outcome measures

Outcome measures
Measure	Chemoradiotherapy+Tecemotide (L-BLP25)+Cyclophosphamide n=27 Participants 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.	Chemoradiotherapy+Tecemotide (L-BLP25) n=33 Participants 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.	Chemoradiotherapy n=30 Participants 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.
Immunological Response to Treatment in Relation to Microsatellite Instability (MSI) Status: Number of Subjects Per MSI Category No	25 subjects	32 subjects	30 subjects
Immunological Response to Treatment in Relation to Microsatellite Instability (MSI) Status: Number of Subjects Per MSI Category Yes	2 subjects	1 subjects	0 subjects

PRIMARY outcome

Timeframe: Baseline, Week 5, Week 13 (pre-surgery), and Week 18 (end-of trial)

Population: Data were not analyzed as no acceptable ELISpot assay is available

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.

Outcome measures

Outcome data not reported

PRIMARY outcome

Timeframe: Baseline, Week 5, Week 13 (pre-surgery), and Week 18 (end-of trial)

Population: Data were not analyzed as no acceptable ELISpot assay is available

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.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Baseline and Week 14 (post-surgery)

Population: 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.

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).

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Baseline and Week 18 (follow-up / end-of trial)

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.

Outcome measures

Adverse Events

Chemoradiotherapy+Tecemotide (L-BLP25)+CPA

Serious events: 10 serious events

Other events: 38 other events

Deaths: 0 deaths

Chemoradiotherapy+Tecemotide (L-BLP25)

Serious events: 10 serious events

Other events: 41 other events

Deaths: 0 deaths

Chemoradiotherapy

Serious events: 12 serious events

Other events: 41 other events

Deaths: 0 deaths

Serious adverse events

Other adverse events

Additional Information

Merck KGaA Communication Center

Merck Serono, a division of Merck KGaA

Phone: +49-6151-72-5200

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee 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.
Publication restrictions are in place

Restriction type: OTHER

Measure	Chemoradiotherapy+Tecemotide (L-BLP25)+Cyclophosphamide n=27 Participants 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.	Chemoradiotherapy+Tecemotide (L-BLP25) n=33 Participants 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.	Chemoradiotherapy n=30 Participants 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.
Change From Baseline in Immunological Response in Peripheral Blood at Week 18 (Follow-up / end-of Trial) CD3+CD56+CD16+Granzyme B+/LY (n=26,30,24)	0.243 log2 (percentage of T cells) Standard Deviation 0.6969	-0.201 log2 (percentage of T cells) Standard Deviation 1.0731	0.131 log2 (percentage of T cells) Standard Deviation 0.7652
Change From Baseline in Immunological Response in Peripheral Blood at Week 18 (Follow-up / end-of Trial) CD3-CD56+CD16+GranzymeB+ (n=26,30,24)	-0.013 log2 (percentage of T cells) Standard Deviation 0.1051	-0.046 log2 (percentage of T cells) Standard Deviation 0.1259	-0.081 log2 (percentage of T cells) Standard Deviation 0.2238
Change From Baseline in Immunological Response in Peripheral Blood at Week 18 (Follow-up / end-of Trial) CD3-CD56+CD16+Perforin+ (n=26,30,24)	-0.050 log2 (percentage of T cells) Standard Deviation 0.0769	-0.033 log2 (percentage of T cells) Standard Deviation 0.1868	-0.088 log2 (percentage of T cells) Standard Deviation 0.2282
Change From Baseline in Immunological Response in Peripheral Blood at Week 18 (Follow-up / end-of Trial) CD3+CD4+CD27+ (n=26,30,24)	-0.181 log2 (percentage of T cells) Standard Deviation 0.1848	-0.135 log2 (percentage of T cells) Standard Deviation 0.1521	-0.099 log2 (percentage of T cells) Standard Deviation 0.1913
Change From Baseline in Immunological Response in Peripheral Blood at Week 18 (Follow-up / end-of Trial) CD3-CD56+CD16+Granzyme B+/LY (n=26,30,24)	0.264 log2 (percentage of T cells) Standard Deviation 0.5885	0.047 log2 (percentage of T cells) Standard Deviation 1.2787	0.415 log2 (percentage of T cells) Standard Deviation 0.6040
Change From Baseline in Immunological Response in Peripheral Blood at Week 18 (Follow-up / end-of Trial) CD3-CD56+CD16+Perforin+/LY (n=26,30,24)	0.226 log2 (percentage of T cells) Standard Deviation 0.5669	0.058 log2 (percentage of T cells) Standard Deviation 1.2902	0.411 log2 (percentage of T cells) Standard Deviation 0.6019
Change From Baseline in Immunological Response in Peripheral Blood at Week 18 (Follow-up / end-of Trial) CD3-CD56+CD16-CD107a+ (n=26,30,24)	0.216 log2 (percentage of T cells) Standard Deviation 1.2010	-0.318 log2 (percentage of T cells) Standard Deviation 1.5863	0.037 log2 (percentage of T cells) Standard Deviation 1.0191
Change From Baseline in Immunological Response in Peripheral Blood at Week 18 (Follow-up / end-of Trial) CD3+CD8+CD127-FoxP3-CD45RA-CD25+CTLA4+(n=27,29,24)	0.050 log2 (percentage of T cells) Standard Deviation 0.3933	0.152 log2 (percentage of T cells) Standard Deviation 0.5386	-0.012 log2 (percentage of T cells) Standard Deviation 0.5202
Change From Baseline in Immunological Response in Peripheral Blood at Week 18 (Follow-up / end-of Trial) CD3+CD56+CD16-Granzyme B+ (n=26,30,24)	0.479 log2 (percentage of T cells) Standard Deviation 1.6943	-0.241 log2 (percentage of T cells) Standard Deviation 0.9628	-0.024 log2 (percentage of T cells) Standard Deviation 0.6623
Change From Baseline in Immunological Response in Peripheral Blood at Week 18 (Follow-up / end-of Trial) CD3-CD56+CD16+/LY (n=26,30,24)	0.277 log2 (percentage of T cells) Standard Deviation 0.5448	0.090 log2 (percentage of T cells) Standard Deviation 1.2968	0.497 log2 (percentage of T cells) Standard Deviation 0.6119
Change From Baseline in Immunological Response in Peripheral Blood at Week 18 (Follow-up / end-of Trial) CD3-CD19+BTLA4+ (n=27,29,23)	-0.030 log2 (percentage of T cells) Standard Deviation 0.0489	-0.028 log2 (percentage of T cells) Standard Deviation 0.0550	-0.017 log2 (percentage of T cells) Standard Deviation 0.0352
Change From Baseline in Immunological Response in Peripheral Blood at Week 18 (Follow-up / end-of Trial) Lymphs Tube 2 (n=27,30,25)	-1.024 log2 (percentage of T cells) Standard Deviation 0.4392	-0.941 log2 (percentage of T cells) Standard Deviation 0.6080	-0.952 log2 (percentage of T cells) Standard Deviation 0.4761
Change From Baseline in Immunological Response in Peripheral Blood at Week 18 (Follow-up / end-of Trial) CD3+CD56+CD16+CD107a+ (n=26,30,24)	-1.216 log2 (percentage of T cells) Standard Deviation 4.5484	1.966 log2 (percentage of T cells) Standard Deviation 6.6322	-2.752 log2 (percentage of T cells) Standard Deviation 6.4790
Change From Baseline in Immunological Response in Peripheral Blood at Week 18 (Follow-up / end-of Trial) CD3+CD4+BTLA4+ (n=26,30,24)	0.063 log2 (percentage of T cells) Standard Deviation 1.4413	0.122 log2 (percentage of T cells) Standard Deviation 0.4833	-0.035 log2 (percentage of T cells) Standard Deviation 0.4117
Change From Baseline in Immunological Response in Peripheral Blood at Week 18 (Follow-up / end-of Trial) Lymphs Tube 3 (n=27,30,25)	-0.994 log2 (percentage of T cells) Standard Deviation 0.4545	-0.920 log2 (percentage of T cells) Standard Deviation 0.5923	-0.936 log2 (percentage of T cells) Standard Deviation 0.4746
Change From Baseline in Immunological Response in Peripheral Blood at Week 18 (Follow-up / end-of Trial) CD3+CD56+CD16+CCR7+ (n=26,30,24)	-1.341 log2 (percentage of T cells) Standard Deviation 4.1442	0.541 log2 (percentage of T cells) Standard Deviation 6.3502	-3.390 log2 (percentage of T cells) Standard Deviation 5.1877
Change From Baseline in Immunological Response in Peripheral Blood at Week 18 (Follow-up / end-of Trial) CD3+CD8+CD127+FoxP3-CD25-CD45RA+CTLA4-(n=27,29,24)	-0.604 log2 (percentage of T cells) Standard Deviation 0.8102	-1.062 log2 (percentage of T cells) Standard Deviation 1.1436	-0.940 log2 (percentage of T cells) Standard Deviation 1.2678
Change From Baseline in Immunological Response in Peripheral Blood at Week 18 (Follow-up / end-of Trial) Background corrected CD3+CD4+IFNg+ (n=21,27,21)	0.058 log2 (percentage of T cells) Standard Deviation 0.9767	0.544 log2 (percentage of T cells) Standard Deviation 0.9521	0.359 log2 (percentage of T cells) Standard Deviation 1.3187
Change From Baseline in Immunological Response in Peripheral Blood at Week 18 (Follow-up / end-of Trial) CD3+CD56+CD16+Perforin+/LY (n=26,30,24)	0.240 log2 (percentage of T cells) Standard Deviation 0.6997	-0.177 log2 (percentage of T cells) Standard Deviation 0.9920	0.101 log2 (percentage of T cells) Standard Deviation 0.7617
Change From Baseline in Immunological Response in Peripheral Blood at Week 18 (Follow-up / end-of Trial) CD3+CD4+CD127+FoxP3-CD45RA-CD25+CTLA4+(n=27,29,24)	0.711 log2 (percentage of T cells) Standard Deviation 1.3825	0.674 log2 (percentage of T cells) Standard Deviation 1.2689	1.035 log2 (percentage of T cells) Standard Deviation 1.4996

Serious adverse events
Measure	Chemoradiotherapy+Tecemotide (L-BLP25)+CPA n=39 participants at risk 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.	Chemoradiotherapy+Tecemotide (L-BLP25) n=41 participants at risk 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.	Chemoradiotherapy n=42 participants at risk 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.
Blood and lymphatic system disorders Anaemia	0.00% 0/39 • Date of first signature of informed consent until the Follow-up/End-of-Trial visit (Week 18). 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).	0.00% 0/41 • Date of first signature of informed consent until the Follow-up/End-of-Trial visit (Week 18). 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).	2.4% 1/42 • Number of events 1 • Date of first signature of informed consent until the Follow-up/End-of-Trial visit (Week 18). 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).
Blood and lymphatic system disorders Coagulopathy	0.00% 0/39 • Date of first signature of informed consent until the Follow-up/End-of-Trial visit (Week 18). 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).	0.00% 0/41 • Date of first signature of informed consent until the Follow-up/End-of-Trial visit (Week 18). 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).	2.4% 1/42 • Number of events 1 • Date of first signature of informed consent until the Follow-up/End-of-Trial visit (Week 18). 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).
Blood and lymphatic system disorders Thrombocytopenia	0.00% 0/39 • Date of first signature of informed consent until the Follow-up/End-of-Trial visit (Week 18). 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).	0.00% 0/41 • Date of first signature of informed consent until the Follow-up/End-of-Trial visit (Week 18). 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).	2.4% 1/42 • Number of events 1 • Date of first signature of informed consent until the Follow-up/End-of-Trial visit (Week 18). 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).
Gastrointestinal disorders Gastrointestinal necrosis	2.6% 1/39 • Number of events 1 • Date of first signature of informed consent until the Follow-up/End-of-Trial visit (Week 18). 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).	0.00% 0/41 • Date of first signature of informed consent until the Follow-up/End-of-Trial visit (Week 18). 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).	0.00% 0/42 • Date of first signature of informed consent until the Follow-up/End-of-Trial visit (Week 18). 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).
Gastrointestinal disorders Ileus	2.6% 1/39 • Number of events 1 • Date of first signature of informed consent until the Follow-up/End-of-Trial visit (Week 18). 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).	0.00% 0/41 • Date of first signature of informed consent until the Follow-up/End-of-Trial visit (Week 18). 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).	0.00% 0/42 • Date of first signature of informed consent until the Follow-up/End-of-Trial visit (Week 18). 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).
Gastrointestinal disorders Intestinal obstruction	2.6% 1/39 • Number of events 1 • Date of first signature of informed consent until the Follow-up/End-of-Trial visit (Week 18). 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).	0.00% 0/41 • Date of first signature of informed consent until the Follow-up/End-of-Trial visit (Week 18). 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).	0.00% 0/42 • Date of first signature of informed consent until the Follow-up/End-of-Trial visit (Week 18). 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).
Gastrointestinal disorders Peritoneal haemorrhage	2.6% 1/39 • Number of events 1 • Date of first signature of informed consent until the Follow-up/End-of-Trial visit (Week 18). 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).	0.00% 0/41 • Date of first signature of informed consent until the Follow-up/End-of-Trial visit (Week 18). 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).	0.00% 0/42 • Date of first signature of informed consent until the Follow-up/End-of-Trial visit (Week 18). 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).
General disorders Asthenia	0.00% 0/39 • Date of first signature of informed consent until the Follow-up/End-of-Trial visit (Week 18). 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).	2.4% 1/41 • Number of events 1 • Date of first signature of informed consent until the Follow-up/End-of-Trial visit (Week 18). 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).	0.00% 0/42 • Date of first signature of informed consent until the Follow-up/End-of-Trial visit (Week 18). 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).
General disorders Impaired healing	0.00% 0/39 • Date of first signature of informed consent until the Follow-up/End-of-Trial visit (Week 18). 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).	0.00% 0/41 • Date of first signature of informed consent until the Follow-up/End-of-Trial visit (Week 18). 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).	2.4% 1/42 • Number of events 1 • Date of first signature of informed consent until the Follow-up/End-of-Trial visit (Week 18). 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).
General disorders Injection site reaction	2.6% 1/39 • Number of events 1 • Date of first signature of informed consent until the Follow-up/End-of-Trial visit (Week 18). 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).	0.00% 0/41 • Date of first signature of informed consent until the Follow-up/End-of-Trial visit (Week 18). 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).	0.00% 0/42 • Date of first signature of informed consent until the Follow-up/End-of-Trial visit (Week 18). 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).
Infections and infestations Abdominal abscess	0.00% 0/39 • Date of first signature of informed consent until the Follow-up/End-of-Trial visit (Week 18). 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).	0.00% 0/41 • Date of first signature of informed consent until the Follow-up/End-of-Trial visit (Week 18). 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).	2.4% 1/42 • Number of events 1 • Date of first signature of informed consent until the Follow-up/End-of-Trial visit (Week 18). 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).
Infections and infestations Anal abscess	0.00% 0/39 • Date of first signature of informed consent until the Follow-up/End-of-Trial visit (Week 18). 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).	0.00% 0/41 • Date of first signature of informed consent until the Follow-up/End-of-Trial visit (Week 18). 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).	2.4% 1/42 • Number of events 1 • Date of first signature of informed consent until the Follow-up/End-of-Trial visit (Week 18). 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).
Infections and infestations Catheter site infection	0.00% 0/39 • Date of first signature of informed consent until the Follow-up/End-of-Trial visit (Week 18). 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).	0.00% 0/41 • Date of first signature of informed consent until the Follow-up/End-of-Trial visit (Week 18). 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).	2.4% 1/42 • Number of events 1 • Date of first signature of informed consent until the Follow-up/End-of-Trial visit (Week 18). 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).
Infections and infestations Gastrointestinal infection	0.00% 0/39 • Date of first signature of informed consent until the Follow-up/End-of-Trial visit (Week 18). 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).	2.4% 1/41 • Number of events 1 • Date of first signature of informed consent until the Follow-up/End-of-Trial visit (Week 18). 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).	0.00% 0/42 • Date of first signature of informed consent until the Follow-up/End-of-Trial visit (Week 18). 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).
Infections and infestations Pelvic infection	2.6% 1/39 • Number of events 1 • Date of first signature of informed consent until the Follow-up/End-of-Trial visit (Week 18). 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).	0.00% 0/41 • Date of first signature of informed consent until the Follow-up/End-of-Trial visit (Week 18). 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).	0.00% 0/42 • Date of first signature of informed consent until the Follow-up/End-of-Trial visit (Week 18). 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).
Infections and infestations Peritonitis	0.00% 0/39 • Date of first signature of informed consent until the Follow-up/End-of-Trial visit (Week 18). 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).	2.4% 1/41 • Number of events 1 • Date of first signature of informed consent until the Follow-up/End-of-Trial visit (Week 18). 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).	0.00% 0/42 • Date of first signature of informed consent until the Follow-up/End-of-Trial visit (Week 18). 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).
Infections and infestations Skin infection	0.00% 0/39 • Date of first signature of informed consent until the Follow-up/End-of-Trial visit (Week 18). 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).	0.00% 0/41 • Date of first signature of informed consent until the Follow-up/End-of-Trial visit (Week 18). 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).	2.4% 1/42 • Number of events 1 • Date of first signature of informed consent until the Follow-up/End-of-Trial visit (Week 18). 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).
Infections and infestations Urinary tract infection	0.00% 0/39 • Date of first signature of informed consent until the Follow-up/End-of-Trial visit (Week 18). 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).	2.4% 1/41 • Number of events 1 • Date of first signature of informed consent until the Follow-up/End-of-Trial visit (Week 18). 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).	0.00% 0/42 • Date of first signature of informed consent until the Follow-up/End-of-Trial visit (Week 18). 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).
Infections and infestations Wound infection bacterial	0.00% 0/39 • Date of first signature of informed consent until the Follow-up/End-of-Trial visit (Week 18). 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).	2.4% 1/41 • Number of events 1 • Date of first signature of informed consent until the Follow-up/End-of-Trial visit (Week 18). 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).	0.00% 0/42 • Date of first signature of informed consent until the Follow-up/End-of-Trial visit (Week 18). 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).
Injury, poisoning and procedural complications Accidental overdose	2.6% 1/39 • Number of events 1 • Date of first signature of informed consent until the Follow-up/End-of-Trial visit (Week 18). 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).	0.00% 0/41 • Date of first signature of informed consent until the Follow-up/End-of-Trial visit (Week 18). 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).	0.00% 0/42 • Date of first signature of informed consent until the Follow-up/End-of-Trial visit (Week 18). 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).
Injury, poisoning and procedural complications Anastomotic leak	0.00% 0/39 • Date of first signature of informed consent until the Follow-up/End-of-Trial visit (Week 18). 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).	2.4% 1/41 • Number of events 1 • Date of first signature of informed consent until the Follow-up/End-of-Trial visit (Week 18). 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).	0.00% 0/42 • Date of first signature of informed consent until the Follow-up/End-of-Trial visit (Week 18). 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).
Injury, poisoning and procedural complications Gastrointestinal anastomotic leak	2.6% 1/39 • Number of events 1 • Date of first signature of informed consent until the Follow-up/End-of-Trial visit (Week 18). 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).	0.00% 0/41 • Date of first signature of informed consent until the Follow-up/End-of-Trial visit (Week 18). 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).	0.00% 0/42 • Date of first signature of informed consent until the Follow-up/End-of-Trial visit (Week 18). 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).
Injury, poisoning and procedural complications Gastrointestinal stoma complication	5.1% 2/39 • Number of events 2 • Date of first signature of informed consent until the Follow-up/End-of-Trial visit (Week 18). 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).	0.00% 0/41 • Date of first signature of informed consent until the Follow-up/End-of-Trial visit (Week 18). 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).	0.00% 0/42 • Date of first signature of informed consent until the Follow-up/End-of-Trial visit (Week 18). 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).
Injury, poisoning and procedural complications Post procedural complication	0.00% 0/39 • Date of first signature of informed consent until the Follow-up/End-of-Trial visit (Week 18). 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).	0.00% 0/41 • Date of first signature of informed consent until the Follow-up/End-of-Trial visit (Week 18). 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).	2.4% 1/42 • Number of events 1 • Date of first signature of informed consent until the Follow-up/End-of-Trial visit (Week 18). 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).
Injury, poisoning and procedural complications Procedural intestinal perforation	0.00% 0/39 • Date of first signature of informed consent until the Follow-up/End-of-Trial visit (Week 18). 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).	0.00% 0/41 • Date of first signature of informed consent until the Follow-up/End-of-Trial visit (Week 18). 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).	2.4% 1/42 • Number of events 1 • Date of first signature of informed consent until the Follow-up/End-of-Trial visit (Week 18). 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).
Injury, poisoning and procedural complications Radiation skin injury	0.00% 0/39 • Date of first signature of informed consent until the Follow-up/End-of-Trial visit (Week 18). 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).	0.00% 0/41 • Date of first signature of informed consent until the Follow-up/End-of-Trial visit (Week 18). 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).	2.4% 1/42 • Number of events 1 • Date of first signature of informed consent until the Follow-up/End-of-Trial visit (Week 18). 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).
Investigations Gamma-glutamyltransferase increased	0.00% 0/39 • Date of first signature of informed consent until the Follow-up/End-of-Trial visit (Week 18). 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).	0.00% 0/41 • Date of first signature of informed consent until the Follow-up/End-of-Trial visit (Week 18). 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).	2.4% 1/42 • Number of events 1 • Date of first signature of informed consent until the Follow-up/End-of-Trial visit (Week 18). 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).
Metabolism and nutrition disorders Dehydration	0.00% 0/39 • Date of first signature of informed consent until the Follow-up/End-of-Trial visit (Week 18). 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).	4.9% 2/41 • Number of events 2 • Date of first signature of informed consent until the Follow-up/End-of-Trial visit (Week 18). 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).	2.4% 1/42 • Number of events 1 • Date of first signature of informed consent until the Follow-up/End-of-Trial visit (Week 18). 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).
Metabolism and nutrition disorders Hyponatraemia	0.00% 0/39 • Date of first signature of informed consent until the Follow-up/End-of-Trial visit (Week 18). 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).	0.00% 0/41 • Date of first signature of informed consent until the Follow-up/End-of-Trial visit (Week 18). 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).	2.4% 1/42 • Number of events 1 • Date of first signature of informed consent until the Follow-up/End-of-Trial visit (Week 18). 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).
Metabolism and nutrition disorders Hypovolaemia	0.00% 0/39 • Date of first signature of informed consent until the Follow-up/End-of-Trial visit (Week 18). 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).	2.4% 1/41 • Number of events 1 • Date of first signature of informed consent until the Follow-up/End-of-Trial visit (Week 18). 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).	0.00% 0/42 • Date of first signature of informed consent until the Follow-up/End-of-Trial visit (Week 18). 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).
Musculoskeletal and connective tissue disorders Coccydynia	0.00% 0/39 • Date of first signature of informed consent until the Follow-up/End-of-Trial visit (Week 18). 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).	2.4% 1/41 • Number of events 1 • Date of first signature of informed consent until the Follow-up/End-of-Trial visit (Week 18). 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).	0.00% 0/42 • Date of first signature of informed consent until the Follow-up/End-of-Trial visit (Week 18). 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).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Peritumoural oedema	0.00% 0/39 • Date of first signature of informed consent until the Follow-up/End-of-Trial visit (Week 18). 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).	2.4% 1/41 • Number of events 1 • Date of first signature of informed consent until the Follow-up/End-of-Trial visit (Week 18). 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).	0.00% 0/42 • Date of first signature of informed consent until the Follow-up/End-of-Trial visit (Week 18). 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).
Nervous system disorders Central nervous system lesion	0.00% 0/39 • Date of first signature of informed consent until the Follow-up/End-of-Trial visit (Week 18). 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).	2.4% 1/41 • Number of events 1 • Date of first signature of informed consent until the Follow-up/End-of-Trial visit (Week 18). 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).	0.00% 0/42 • Date of first signature of informed consent until the Follow-up/End-of-Trial visit (Week 18). 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).
Nervous system disorders Hemiplegia	0.00% 0/39 • Date of first signature of informed consent until the Follow-up/End-of-Trial visit (Week 18). 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).	2.4% 1/41 • Number of events 1 • Date of first signature of informed consent until the Follow-up/End-of-Trial visit (Week 18). 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).	2.4% 1/42 • Number of events 1 • Date of first signature of informed consent until the Follow-up/End-of-Trial visit (Week 18). 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).
Nervous system disorders Ischaemic stroke	0.00% 0/39 • Date of first signature of informed consent until the Follow-up/End-of-Trial visit (Week 18). 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).	0.00% 0/41 • Date of first signature of informed consent until the Follow-up/End-of-Trial visit (Week 18). 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).	2.4% 1/42 • Number of events 1 • Date of first signature of informed consent until the Follow-up/End-of-Trial visit (Week 18). 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).
Nervous system disorders Syncope	0.00% 0/39 • Date of first signature of informed consent until the Follow-up/End-of-Trial visit (Week 18). 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).	0.00% 0/41 • Date of first signature of informed consent until the Follow-up/End-of-Trial visit (Week 18). 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).	2.4% 1/42 • Number of events 1 • Date of first signature of informed consent until the Follow-up/End-of-Trial visit (Week 18). 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).
Renal and urinary disorders Renal colic	0.00% 0/39 • Date of first signature of informed consent until the Follow-up/End-of-Trial visit (Week 18). 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).	2.4% 1/41 • Number of events 1 • Date of first signature of informed consent until the Follow-up/End-of-Trial visit (Week 18). 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).	0.00% 0/42 • Date of first signature of informed consent until the Follow-up/End-of-Trial visit (Week 18). 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).
Renal and urinary disorders Renal failure	0.00% 0/39 • Date of first signature of informed consent until the Follow-up/End-of-Trial visit (Week 18). 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).	2.4% 1/41 • Number of events 1 • Date of first signature of informed consent until the Follow-up/End-of-Trial visit (Week 18). 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).	2.4% 1/42 • Number of events 1 • Date of first signature of informed consent until the Follow-up/End-of-Trial visit (Week 18). 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).
Renal and urinary disorders Urinary retention	0.00% 0/39 • Date of first signature of informed consent until the Follow-up/End-of-Trial visit (Week 18). 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).	0.00% 0/41 • Date of first signature of informed consent until the Follow-up/End-of-Trial visit (Week 18). 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).	2.4% 1/42 • Number of events 1 • Date of first signature of informed consent until the Follow-up/End-of-Trial visit (Week 18). 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).
Reproductive system and breast disorders Female genital tract fistula	2.6% 1/39 • Number of events 1 • Date of first signature of informed consent until the Follow-up/End-of-Trial visit (Week 18). 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).	0.00% 0/41 • Date of first signature of informed consent until the Follow-up/End-of-Trial visit (Week 18). 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).	0.00% 0/42 • Date of first signature of informed consent until the Follow-up/End-of-Trial visit (Week 18). 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).

Other adverse events
Measure	Chemoradiotherapy+Tecemotide (L-BLP25)+CPA n=39 participants at risk 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.	Chemoradiotherapy+Tecemotide (L-BLP25) n=41 participants at risk 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.	Chemoradiotherapy n=42 participants at risk 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.
Blood and lymphatic system disorders Anaemia	12.8% 5/39 • Number of events 5 • Date of first signature of informed consent until the Follow-up/End-of-Trial visit (Week 18). 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).	9.8% 4/41 • Number of events 4 • Date of first signature of informed consent until the Follow-up/End-of-Trial visit (Week 18). 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).	14.3% 6/42 • Number of events 6 • Date of first signature of informed consent until the Follow-up/End-of-Trial visit (Week 18). 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).
Blood and lymphatic system disorders Leukopenia	10.3% 4/39 • Number of events 4 • Date of first signature of informed consent until the Follow-up/End-of-Trial visit (Week 18). 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).	12.2% 5/41 • Number of events 5 • Date of first signature of informed consent until the Follow-up/End-of-Trial visit (Week 18). 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).	11.9% 5/42 • Number of events 5 • Date of first signature of informed consent until the Follow-up/End-of-Trial visit (Week 18). 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).
Blood and lymphatic system disorders Neutropenia	5.1% 2/39 • Number of events 2 • Date of first signature of informed consent until the Follow-up/End-of-Trial visit (Week 18). 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).	2.4% 1/41 • Number of events 1 • Date of first signature of informed consent until the Follow-up/End-of-Trial visit (Week 18). 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).	4.8% 2/42 • Number of events 2 • Date of first signature of informed consent until the Follow-up/End-of-Trial visit (Week 18). 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).
Blood and lymphatic system disorders Thrombocytopenia	2.6% 1/39 • Number of events 1 • Date of first signature of informed consent until the Follow-up/End-of-Trial visit (Week 18). 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).	0.00% 0/41 • Date of first signature of informed consent until the Follow-up/End-of-Trial visit (Week 18). 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).	9.5% 4/42 • Number of events 4 • Date of first signature of informed consent until the Follow-up/End-of-Trial visit (Week 18). 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).
Gastrointestinal disorders Abdominal distension	2.6% 1/39 • Number of events 1 • Date of first signature of informed consent until the Follow-up/End-of-Trial visit (Week 18). 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).	7.3% 3/41 • Number of events 3 • Date of first signature of informed consent until the Follow-up/End-of-Trial visit (Week 18). 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).	7.1% 3/42 • Number of events 3 • Date of first signature of informed consent until the Follow-up/End-of-Trial visit (Week 18). 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).
Gastrointestinal disorders Abdominal pain	12.8% 5/39 • Number of events 5 • Date of first signature of informed consent until the Follow-up/End-of-Trial visit (Week 18). 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).	19.5% 8/41 • Number of events 8 • Date of first signature of informed consent until the Follow-up/End-of-Trial visit (Week 18). 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).	19.0% 8/42 • Number of events 8 • Date of first signature of informed consent until the Follow-up/End-of-Trial visit (Week 18). 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).
Gastrointestinal disorders Abdominal pain upper	5.1% 2/39 • Number of events 2 • Date of first signature of informed consent until the Follow-up/End-of-Trial visit (Week 18). 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).	12.2% 5/41 • Number of events 5 • Date of first signature of informed consent until the Follow-up/End-of-Trial visit (Week 18). 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).	0.00% 0/42 • Date of first signature of informed consent until the Follow-up/End-of-Trial visit (Week 18). 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).
Gastrointestinal disorders Anorectal discomfort	12.8% 5/39 • Number of events 5 • Date of first signature of informed consent until the Follow-up/End-of-Trial visit (Week 18). 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).	7.3% 3/41 • Number of events 3 • Date of first signature of informed consent until the Follow-up/End-of-Trial visit (Week 18). 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).	16.7% 7/42 • Number of events 7 • Date of first signature of informed consent until the Follow-up/End-of-Trial visit (Week 18). 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).
Gastrointestinal disorders Constipation	15.4% 6/39 • Number of events 6 • Date of first signature of informed consent until the Follow-up/End-of-Trial visit (Week 18). 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).	9.8% 4/41 • Number of events 4 • Date of first signature of informed consent until the Follow-up/End-of-Trial visit (Week 18). 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).	16.7% 7/42 • Number of events 7 • Date of first signature of informed consent until the Follow-up/End-of-Trial visit (Week 18). 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).
Gastrointestinal disorders Defaecation urgency	5.1% 2/39 • Number of events 2 • Date of first signature of informed consent until the Follow-up/End-of-Trial visit (Week 18). 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).	2.4% 1/41 • Number of events 1 • Date of first signature of informed consent until the Follow-up/End-of-Trial visit (Week 18). 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).	2.4% 1/42 • Number of events 1 • Date of first signature of informed consent until the Follow-up/End-of-Trial visit (Week 18). 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).
Gastrointestinal disorders Diarrhoea	38.5% 15/39 • Number of events 15 • Date of first signature of informed consent until the Follow-up/End-of-Trial visit (Week 18). 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).	43.9% 18/41 • Number of events 18 • Date of first signature of informed consent until the Follow-up/End-of-Trial visit (Week 18). 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).	50.0% 21/42 • Number of events 21 • Date of first signature of informed consent until the Follow-up/End-of-Trial visit (Week 18). 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).
Gastrointestinal disorders Dyspepsia	5.1% 2/39 • Number of events 2 • Date of first signature of informed consent until the Follow-up/End-of-Trial visit (Week 18). 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).	2.4% 1/41 • Number of events 1 • Date of first signature of informed consent until the Follow-up/End-of-Trial visit (Week 18). 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).	7.1% 3/42 • Number of events 3 • Date of first signature of informed consent until the Follow-up/End-of-Trial visit (Week 18). 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).
Gastrointestinal disorders Faecal incontinence	5.1% 2/39 • Number of events 2 • Date of first signature of informed consent until the Follow-up/End-of-Trial visit (Week 18). 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).	2.4% 1/41 • Number of events 1 • Date of first signature of informed consent until the Follow-up/End-of-Trial visit (Week 18). 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).	0.00% 0/42 • Date of first signature of informed consent until the Follow-up/End-of-Trial visit (Week 18). 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).
Gastrointestinal disorders Flatulence	5.1% 2/39 • Number of events 2 • Date of first signature of informed consent until the Follow-up/End-of-Trial visit (Week 18). 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).	7.3% 3/41 • Number of events 3 • Date of first signature of informed consent until the Follow-up/End-of-Trial visit (Week 18). 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).	7.1% 3/42 • Number of events 3 • Date of first signature of informed consent until the Follow-up/End-of-Trial visit (Week 18). 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).
Gastrointestinal disorders Gastrointestinal pain	5.1% 2/39 • Number of events 2 • Date of first signature of informed consent until the Follow-up/End-of-Trial visit (Week 18). 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).	0.00% 0/41 • Date of first signature of informed consent until the Follow-up/End-of-Trial visit (Week 18). 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).	0.00% 0/42 • Date of first signature of informed consent until the Follow-up/End-of-Trial visit (Week 18). 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).
Gastrointestinal disorders Nausea	20.5% 8/39 • Number of events 8 • Date of first signature of informed consent until the Follow-up/End-of-Trial visit (Week 18). 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).	29.3% 12/41 • Number of events 12 • Date of first signature of informed consent until the Follow-up/End-of-Trial visit (Week 18). 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).	31.0% 13/42 • Number of events 13 • Date of first signature of informed consent until the Follow-up/End-of-Trial visit (Week 18). 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).
Gastrointestinal disorders Painful defaecation	7.7% 3/39 • Number of events 3 • Date of first signature of informed consent until the Follow-up/End-of-Trial visit (Week 18). 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).	2.4% 1/41 • Number of events 1 • Date of first signature of informed consent until the Follow-up/End-of-Trial visit (Week 18). 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).	9.5% 4/42 • Number of events 4 • Date of first signature of informed consent until the Follow-up/End-of-Trial visit (Week 18). 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).
Gastrointestinal disorders Proctalgia	25.6% 10/39 • Number of events 10 • Date of first signature of informed consent until the Follow-up/End-of-Trial visit (Week 18). 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).	34.1% 14/41 • Number of events 14 • Date of first signature of informed consent until the Follow-up/End-of-Trial visit (Week 18). 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).	28.6% 12/42 • Number of events 12 • Date of first signature of informed consent until the Follow-up/End-of-Trial visit (Week 18). 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).
Gastrointestinal disorders Rectal haemorrhage	12.8% 5/39 • Number of events 5 • Date of first signature of informed consent until the Follow-up/End-of-Trial visit (Week 18). 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).	4.9% 2/41 • Number of events 2 • Date of first signature of informed consent until the Follow-up/End-of-Trial visit (Week 18). 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).	9.5% 4/42 • Number of events 4 • Date of first signature of informed consent until the Follow-up/End-of-Trial visit (Week 18). 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).
Gastrointestinal disorders Rectal tenesmus	5.1% 2/39 • Number of events 2 • Date of first signature of informed consent until the Follow-up/End-of-Trial visit (Week 18). 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).	4.9% 2/41 • Number of events 2 • Date of first signature of informed consent until the Follow-up/End-of-Trial visit (Week 18). 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).	0.00% 0/42 • Date of first signature of informed consent until the Follow-up/End-of-Trial visit (Week 18). 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).
Gastrointestinal disorders Toothache	2.6% 1/39 • Number of events 1 • Date of first signature of informed consent until the Follow-up/End-of-Trial visit (Week 18). 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).	7.3% 3/41 • Number of events 3 • Date of first signature of informed consent until the Follow-up/End-of-Trial visit (Week 18). 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).	0.00% 0/42 • Date of first signature of informed consent until the Follow-up/End-of-Trial visit (Week 18). 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).
Gastrointestinal disorders Vomiting	15.4% 6/39 • Number of events 6 • Date of first signature of informed consent until the Follow-up/End-of-Trial visit (Week 18). 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).	9.8% 4/41 • Number of events 4 • Date of first signature of informed consent until the Follow-up/End-of-Trial visit (Week 18). 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).	4.8% 2/42 • Number of events 2 • Date of first signature of informed consent until the Follow-up/End-of-Trial visit (Week 18). 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).
General disorders Asthenia	23.1% 9/39 • Number of events 9 • Date of first signature of informed consent until the Follow-up/End-of-Trial visit (Week 18). 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).	17.1% 7/41 • Number of events 7 • Date of first signature of informed consent until the Follow-up/End-of-Trial visit (Week 18). 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).	14.3% 6/42 • Number of events 6 • Date of first signature of informed consent until the Follow-up/End-of-Trial visit (Week 18). 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).
General disorders Chills	10.3% 4/39 • Number of events 4 • Date of first signature of informed consent until the Follow-up/End-of-Trial visit (Week 18). 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).	4.9% 2/41 • Number of events 2 • Date of first signature of informed consent until the Follow-up/End-of-Trial visit (Week 18). 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).	2.4% 1/42 • Number of events 1 • Date of first signature of informed consent until the Follow-up/End-of-Trial visit (Week 18). 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).
General disorders Fatigue	30.8% 12/39 • Number of events 12 • Date of first signature of informed consent until the Follow-up/End-of-Trial visit (Week 18). 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).	22.0% 9/41 • Number of events 9 • Date of first signature of informed consent until the Follow-up/End-of-Trial visit (Week 18). 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).	28.6% 12/42 • Number of events 12 • Date of first signature of informed consent until the Follow-up/End-of-Trial visit (Week 18). 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).
General disorders Influenza like illness	10.3% 4/39 • Number of events 4 • Date of first signature of informed consent until the Follow-up/End-of-Trial visit (Week 18). 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).	0.00% 0/41 • Date of first signature of informed consent until the Follow-up/End-of-Trial visit (Week 18). 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).	0.00% 0/42 • Date of first signature of informed consent until the Follow-up/End-of-Trial visit (Week 18). 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).
General disorders Injection site erythema	7.7% 3/39 • Number of events 3 • Date of first signature of informed consent until the Follow-up/End-of-Trial visit (Week 18). 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).	26.8% 11/41 • Number of events 11 • Date of first signature of informed consent until the Follow-up/End-of-Trial visit (Week 18). 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).	0.00% 0/42 • Date of first signature of informed consent until the Follow-up/End-of-Trial visit (Week 18). 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).
General disorders Injection site haematoma	5.1% 2/39 • Number of events 2 • Date of first signature of informed consent until the Follow-up/End-of-Trial visit (Week 18). 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).	2.4% 1/41 • Number of events 1 • Date of first signature of informed consent until the Follow-up/End-of-Trial visit (Week 18). 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).	0.00% 0/42 • Date of first signature of informed consent until the Follow-up/End-of-Trial visit (Week 18). 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).
General disorders Injection site induration	10.3% 4/39 • Number of events 4 • Date of first signature of informed consent until the Follow-up/End-of-Trial visit (Week 18). 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).	4.9% 2/41 • Number of events 2 • Date of first signature of informed consent until the Follow-up/End-of-Trial visit (Week 18). 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).	0.00% 0/42 • Date of first signature of informed consent until the Follow-up/End-of-Trial visit (Week 18). 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).
General disorders Injection site nodule	12.8% 5/39 • Number of events 5 • Date of first signature of informed consent until the Follow-up/End-of-Trial visit (Week 18). 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).	26.8% 11/41 • Number of events 11 • Date of first signature of informed consent until the Follow-up/End-of-Trial visit (Week 18). 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).	0.00% 0/42 • Date of first signature of informed consent until the Follow-up/End-of-Trial visit (Week 18). 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).
General disorders Injection site pain	0.00% 0/39 • Date of first signature of informed consent until the Follow-up/End-of-Trial visit (Week 18). 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).	7.3% 3/41 • Number of events 3 • Date of first signature of informed consent until the Follow-up/End-of-Trial visit (Week 18). 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).	0.00% 0/42 • Date of first signature of informed consent until the Follow-up/End-of-Trial visit (Week 18). 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).
General disorders Injection site reaction	17.9% 7/39 • Number of events 7 • Date of first signature of informed consent until the Follow-up/End-of-Trial visit (Week 18). 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).	17.1% 7/41 • Number of events 7 • Date of first signature of informed consent until the Follow-up/End-of-Trial visit (Week 18). 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).	7.1% 3/42 • Number of events 3 • Date of first signature of informed consent until the Follow-up/End-of-Trial visit (Week 18). 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).
General disorders Pyrexia	5.1% 2/39 • Number of events 2 • Date of first signature of informed consent until the Follow-up/End-of-Trial visit (Week 18). 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).	2.4% 1/41 • Number of events 1 • Date of first signature of informed consent until the Follow-up/End-of-Trial visit (Week 18). 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).	2.4% 1/42 • Number of events 1 • Date of first signature of informed consent until the Follow-up/End-of-Trial visit (Week 18). 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).
Infections and infestations Cystitis	7.7% 3/39 • Number of events 3 • Date of first signature of informed consent until the Follow-up/End-of-Trial visit (Week 18). 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).	4.9% 2/41 • Number of events 2 • Date of first signature of informed consent until the Follow-up/End-of-Trial visit (Week 18). 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).	4.8% 2/42 • Number of events 2 • Date of first signature of informed consent until the Follow-up/End-of-Trial visit (Week 18). 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).
Infections and infestations Nasopharyngitis	0.00% 0/39 • Date of first signature of informed consent until the Follow-up/End-of-Trial visit (Week 18). 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).	4.9% 2/41 • Number of events 2 • Date of first signature of informed consent until the Follow-up/End-of-Trial visit (Week 18). 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).	7.1% 3/42 • Number of events 3 • Date of first signature of informed consent until the Follow-up/End-of-Trial visit (Week 18). 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).
Infections and infestations Urinary tract infection	5.1% 2/39 • Number of events 2 • Date of first signature of informed consent until the Follow-up/End-of-Trial visit (Week 18). 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).	9.8% 4/41 • Number of events 4 • Date of first signature of informed consent until the Follow-up/End-of-Trial visit (Week 18). 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).	7.1% 3/42 • Number of events 3 • Date of first signature of informed consent until the Follow-up/End-of-Trial visit (Week 18). 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).
Injury, poisoning and procedural complications Procedural nausea	2.6% 1/39 • Number of events 1 • Date of first signature of informed consent until the Follow-up/End-of-Trial visit (Week 18). 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).	4.9% 2/41 • Number of events 2 • Date of first signature of informed consent until the Follow-up/End-of-Trial visit (Week 18). 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).	7.1% 3/42 • Number of events 3 • Date of first signature of informed consent until the Follow-up/End-of-Trial visit (Week 18). 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).
Injury, poisoning and procedural complications Procedural pain	20.5% 8/39 • Number of events 8 • Date of first signature of informed consent until the Follow-up/End-of-Trial visit (Week 18). 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).	7.3% 3/41 • Number of events 3 • Date of first signature of informed consent until the Follow-up/End-of-Trial visit (Week 18). 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).	16.7% 7/42 • Number of events 7 • Date of first signature of informed consent until the Follow-up/End-of-Trial visit (Week 18). 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).
Injury, poisoning and procedural complications Radiation skin injury	5.1% 2/39 • Number of events 2 • Date of first signature of informed consent until the Follow-up/End-of-Trial visit (Week 18). 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).	22.0% 9/41 • Number of events 9 • Date of first signature of informed consent until the Follow-up/End-of-Trial visit (Week 18). 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).	4.8% 2/42 • Number of events 2 • Date of first signature of informed consent until the Follow-up/End-of-Trial visit (Week 18). 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).
Investigations Antinuclear antibody increased	10.3% 4/39 • Number of events 4 • Date of first signature of informed consent until the Follow-up/End-of-Trial visit (Week 18). 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).	7.3% 3/41 • Number of events 3 • Date of first signature of informed consent until the Follow-up/End-of-Trial visit (Week 18). 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).	0.00% 0/42 • Date of first signature of informed consent until the Follow-up/End-of-Trial visit (Week 18). 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).