Trial · NCT01507103
Tecemotide (L-BLP25) in Rectal Cancer
NCT01507103, Phase 2, Completed, Merck KGaA, Darmstadt, Germany; results first posted 2016-06-02
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Tecemotide (L-BLP25) in Rectal Cancer. Trials, record NCT01507103. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01507103
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Tecemotide (L-BLP25) in Rectal Cancer
- NCT number
- NCT01507103
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 124 participants, actual
- Lead sponsor
- Merck KGaA, Darmstadt, Germany
- Conditions
- Rectal Cancer
- Interventions
- Tecemotide (L-BLP25), cyclophosphamide (CPA), Chemoradiotherapy
- First posted
- 2012-01-10
- Last updated
- 2017-01-13
- Other registries' IDs
- eudract:2011-000847-25
- Results first posted
- 2016-06-02
- Limitations and caveats
- Not all efficacy data were analyzed as no acceptable ELISpot assay is available. The Sponsor decided to discontinue the development of tecemotide (L-BLP25) in September 2014
Source ClinicalTrials.gov
Registered outcomes6
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Change From Baseline in Tumor Immune Response Evaluated by Immunohistochemical (IHC) Analysis of Tumor Infiltrating Lymphocytes (TILs) at Week 14 (Post-surgery) | Baseline and Week 14 (post-surgery) | 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. |
| Primary | Immunological Response to Treatment in Relation to Microsatellite Instability (MSI) Status: Number of Subjects Per MSI Category | 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). |
| Primary | Change From Baseline in Interferon (IFN)-Gamma Secretion of Mononuclear Cells in Response to MUC1 by Enzyme-linked Immunosorbent Spot (ELISpot) at Post-baseline | Baseline, Week 5, Week 13 (pre-surgery), and Week 18 (end-of trial) | 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. |
| Primary | Change From Baseline in IFN-gamma Secretion of Mononuclear Cells in Response to Carcinoembryonic Antigen (CEA) by ELISpot at Post-baseline | Baseline, Week 5, Week 13 (pre-surgery), and Week 18 (end-of trial) | 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. |
| Secondary | Change From Baseline in Peritumoral Immune Response at Week 14 (Post-surgery) | Baseline and Week 14 (post-surgery) | 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). |
| Secondary | Change From Baseline in Immunological Response in Peripheral Blood at Week 18 (Follow-up / end-of Trial) | 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. |
Source ClinicalTrials.gov
Outcomes6
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Change From Baseline in Tumor Immune Response Evaluated by Immunohistochemical (IHC) Analysis of Tumor Infiltrating Lymphocytes (TILs) at Week 14 (Post-surgery) | Baseline and Week 14 (post-surgery) | 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. | TILs per 100 tumor cells | MEAN |
| PRIMARY | Immunological Response to Treatment in Relation to Microsatellite Instability (MSI) Status: Number of Subjects Per MSI Category | 18 weeks | 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. | subjects | NUMBER |
| PRIMARY | Change From Baseline in Interferon (IFN)-Gamma Secretion of Mononuclear Cells in Response to MUC1 by Enzyme-linked Immunosorbent Spot (ELISpot) at Post-baseline | Baseline, Week 5, Week 13 (pre-surgery), and Week 18 (end-of trial) | Data were not analyzed as no acceptable ELISpot assay is available | ||
| SECONDARY | Change From Baseline in Peritumoral Immune Response at Week 14 (Post-surgery) | Baseline and Week 14 (post-surgery) | 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. | ||
| SECONDARY | Change From Baseline in Immunological Response in Peripheral Blood at Week 18 (Follow-up / end-of Trial) | Baseline and Week 18 (follow-up / end-of trial) | Immunomonitoring analysis set included all subjects for whom at least the baseline ELISpot blood and tumor sample, tumor sample at surgery and pre-surgery ELISpot blood drawing are available and whose tumor biopsy at baseline is MUC1-positive. Within the data table, n=number of subjects analysed for each category. | log2 (percentage of T cells) | MEAN |
| PRIMARY | Change From Baseline in IFN-gamma Secretion of Mononuclear Cells in Response to Carcinoembryonic Antigen (CEA) by ELISpot at Post-baseline | Baseline, Week 5, Week 13 (pre-surgery), and Week 18 (end-of trial) | Data were not analyzed as no acceptable ELISpot assay is available |
Source ClinicalTrials.gov
Results by group72
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Change From Baseline in Tumor Immune Response Evaluated by Immunohistochemical (IHC) Analysis of Tumor Infiltrating Lymphocytes (TILs) at Week 14 (Post-surgery) | Chemoradiotherapy+Tecemotide (L-BLP25)+Cyclophosphamide | CD8+ (n=23, 27, 26) | 0.609 | Standard Deviation 5.4241 | TILs per 100 tumor cells |
| Change From Baseline in Tumor Immune Response Evaluated by Immunohistochemical (IHC) Analysis of Tumor Infiltrating Lymphocytes (TILs) at Week 14 (Post-surgery) | Chemoradiotherapy+Tecemotide (L-BLP25) | CD8+ (n=23, 27, 26) | 0.543 | Standard Deviation 4.5009 | TILs per 100 tumor cells |
| Change From Baseline in Tumor Immune Response Evaluated by Immunohistochemical (IHC) Analysis of Tumor Infiltrating Lymphocytes (TILs) at Week 14 (Post-surgery) | Chemoradiotherapy | CD8+ (n=23, 27, 26) | 1.538 | Standard Deviation 3.9509 | TILs per 100 tumor cells |
| Change From Baseline in Tumor Immune Response Evaluated by Immunohistochemical (IHC) Analysis of Tumor Infiltrating Lymphocytes (TILs) at Week 14 (Post-surgery) | Chemoradiotherapy+Tecemotide (L-BLP25)+Cyclophosphamide | CD8+/GrB+ (n=23, 27, 26) | 0.565 | Standard Deviation 3.1646 | TILs per 100 tumor cells |
| Change From Baseline in Tumor Immune Response Evaluated by Immunohistochemical (IHC) Analysis of Tumor Infiltrating Lymphocytes (TILs) at Week 14 (Post-surgery) | Chemoradiotherapy+Tecemotide (L-BLP25) | CD8+/GrB+ (n=23, 27, 26) | 0.216 | Standard Deviation 2.4187 | TILs per 100 tumor cells |
| Change From Baseline in Tumor Immune Response Evaluated by Immunohistochemical (IHC) Analysis of Tumor Infiltrating Lymphocytes (TILs) at Week 14 (Post-surgery) | Chemoradiotherapy | CD8+/GrB+ (n=23, 27, 26) | 0.936 | Standard Deviation 2.7649 | TILs per 100 tumor cells |
| Immunological Response to Treatment in Relation to Microsatellite Instability (MSI) Status: Number of Subjects Per MSI Category | Chemoradiotherapy+Tecemotide (L-BLP25)+Cyclophosphamide | No | 25 | subjects | |
| Immunological Response to Treatment in Relation to Microsatellite Instability (MSI) Status: Number of Subjects Per MSI Category | Chemoradiotherapy+Tecemotide (L-BLP25) | No | 32 | subjects | |
| Immunological Response to Treatment in Relation to Microsatellite Instability (MSI) Status: Number of Subjects Per MSI Category | Chemoradiotherapy | No | 30 | subjects | |
| Immunological Response to Treatment in Relation to Microsatellite Instability (MSI) Status: Number of Subjects Per MSI Category | Chemoradiotherapy+Tecemotide (L-BLP25)+Cyclophosphamide | Yes | 2 | subjects |
1 to 10 of 72Source ClinicalTrials.gov
See all 72 results by groupParticipant flow9
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Chemoradiotherapy+Tecemotide (L-BLP25)+CPA | 41 | |
| Overall Study | STARTED | Chemoradiotherapy+Tecemotide (L-BLP25) | 41 | |
| Overall Study | STARTED | Chemoradiotherapy | 42 | |
| Overall Study | COMPLETED | Chemoradiotherapy+Tecemotide (L-BLP25)+CPA | 41 | |
| Overall Study | COMPLETED | Chemoradiotherapy+Tecemotide (L-BLP25) | 41 | |
| Overall Study | COMPLETED | Chemoradiotherapy | 42 | |
| Overall Study | NOT COMPLETED | Chemoradiotherapy+Tecemotide (L-BLP25)+CPA | 0 | |
| Overall Study | NOT COMPLETED | Chemoradiotherapy+Tecemotide (L-BLP25) | 0 | |
| Overall Study | NOT COMPLETED | Chemoradiotherapy | 0 |
Source ClinicalTrials.gov
Adverse events318
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Anaemia | Blood and lymphatic system disorders | Chemoradiotherapy+Tecemotide (L-BLP25)+CPA | 5 | 39 | 5 |
| other | Anaemia | Blood and lymphatic system disorders | Chemoradiotherapy+Tecemotide (L-BLP25) | 4 | 41 | 4 |
| other | Anaemia | Blood and lymphatic system disorders | Chemoradiotherapy | 6 | 42 | 6 |
| other | Leukopenia | Blood and lymphatic system disorders | Chemoradiotherapy+Tecemotide (L-BLP25)+CPA | 4 | 39 | 4 |
| other | Leukopenia | Blood and lymphatic system disorders | Chemoradiotherapy+Tecemotide (L-BLP25) | 5 | 41 | 5 |
| other | Leukopenia | Blood and lymphatic system disorders | Chemoradiotherapy | 5 | 42 | 5 |
| other | Neutropenia | Blood and lymphatic system disorders | Chemoradiotherapy+Tecemotide (L-BLP25)+CPA | 2 | 39 | 2 |
| other | Neutropenia | Blood and lymphatic system disorders | Chemoradiotherapy+Tecemotide (L-BLP25) | 1 | 41 | 1 |
| other | Neutropenia | Blood and lymphatic system disorders | Chemoradiotherapy | 2 | 42 | 2 |
| other | Thrombocytopenia | Blood and lymphatic system disorders | Chemoradiotherapy+Tecemotide (L-BLP25)+CPA | 1 | 39 | 1 |
1 to 10 of 318Source ClinicalTrials.gov
See all 318 adverse eventsAdverse event totals9
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Chemoradiotherapy+Tecemotide (L-BLP25)+CPA | ||
| Total, all-cause mortality | Chemoradiotherapy+Tecemotide (L-BLP25) | ||
| Total, all-cause mortality | Chemoradiotherapy | ||
| Total, other adverse events | Chemoradiotherapy+Tecemotide (L-BLP25)+CPA | 38 | 39 |
| Total, other adverse events | Chemoradiotherapy+Tecemotide (L-BLP25) | 41 | 41 |
| Total, other adverse events | Chemoradiotherapy | 41 | 42 |
| Total, serious adverse events | Chemoradiotherapy+Tecemotide (L-BLP25)+CPA | 10 | 39 |
| Total, serious adverse events | Chemoradiotherapy+Tecemotide (L-BLP25) | 10 | 41 |
| Total, serious adverse events | Chemoradiotherapy | 12 | 42 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT01507103
GET https://conductscience.org/api/trials/v1/NCT01507103/results?page=2