Tecemotide
Overview and results of all trials
Tecemotide clinical trials (as of September 2, 2014) sorted by (Estimated) Primary Completion Date:

Tecemotide

Section Title: Overview and results of all trials
Table Section Text: Tecemotide clinical trials (as of September 2, 2014) sorted by (Estimated) Primary Completion Date:

Clinical trials: Lung cancer, Breast cancer, Prostate cancer, Colorectal cancer and Multiple myeloma

NCT Number / Title	Other IDs	Start Date	(Estimated) Primary Completion Date	Recruitment	Conditions	Interventions	Phases	Enrollment (Patients)	Sponsor / Collaborators

NCT00157209 Phase IIb Randomized Controlled Study of BLP25 Liposome Vaccine for Immunotherapy of Non-Small Cell Lung Cancer	B25-LG-304 / EMR 63325-005	August 2000	March 2006	Completed	Lung Neoplasms, Carcinoma, Non-Small-Cell Lung	Biological: BLP25 Liposome Vaccine plus best supportive care; Other: Best Supportive Care (BSC)	Phase 2	171	Merck KGaA

Results: A Phase IIb clinical trial of 171 patients with inoperable stage IIIb non-small-cell lung cancer (NSCLC), in which tecemotide showed a trend towards extending median overall survival from 13.3 months for patients receiving best supportive care (BSC) to 30.6 months for patients receiving tecemotide plus BSC.

NCT00157196 Safety Study of BLP25 Liposome Vaccine in Non-Small Cell Lung Cancer Patients With Unresectable Stage III Disease	B25-LG-305 / EMR 63325-006	April 2005	September 2009	Completed	Carcinoma, Non-Small-Cell Lung, Lung Neoplasms	Biological: BLP25 Liposome Vaccine	Phase 2	22	Merck KGaA

NCT00925548 STRIDE - STimulating Immune Response In aDvanced brEast Cancer	STRIDE, EMR 200038-010, 2008-005544-17	September 2009	August 2010	Terminated	Breast Cancer	Biological: Tecemotide (L-BLP25) and Hormonal Treatment, Biological: Placebo of tecemotide (L-BLP25) and Hormonal Treatment, Drug: cyclophosphamide, Drug: sodium chloride (NaCl)	Phase 3	16	EMD Serono

A thirty-site phase III trial (STRIDE) began in September 2009 on 900 women. The purpose of this study is to determine whether the addition of tecemotide to hormonal treatment is effective in prolonging progression-free survival in postmenopausal women with endocrine-sensitive inoperable locally advanced, recurrent or metastatic breast cancer.

NCT01094548 Study of Stimuvax in Patients With Slowly Progressive Multiple Myeloma With no Symptoms and Who Have Had no Chemotherapy	EMR63325-008	February 2008	February 2011	Completed	Multiple Myeloma	Biological: L-BLP25, cyclophosphamide prior to first vaccination, Biological: L-BLP25	Phase 2	34	Merck KGaA

NCT00409188 Cancer Vaccine Study for Unresectable Stage III Non-small Cell Lung Cancer	START, EMR 63325-001	January 2007	August 2012	Completed	Non-small Cell Lung Cancer	Biological: Tecemotide (L-BLP25), Biological: Placebo	Phase 3	1513	EMD Serono, Merck KGaA

Results: The primary endpoint of overall survival was not met in the START trial. However, the exploratory subgroup analysis in the START trial generated a reasonable hypothesis to warrant additional study.

NCT01731587 Anti-cancer MUC1-specific Immunotherapy for Unresectable Stage III Non-small Cell Lung Cancer	FINGERPRINT, EMR 63325-019, 2012-001435-31	Withdrawn	Non-small Cell Lung Cancer (NSCLC) Stage III	Other: Biological: MUC1 peptide specific immunotherapy, Drug: Cyclophosphamide (CPA)	Phase 1	0	Merck KGaA

NCT00960115 Study of EMD531444 in Subjects With Stage III Unresectable Non-small Cell Lung Cancer (NSCLC) Following Primary Chemoradiotherapy	EMR063325-009	December 2008	May 2014	Completed	Non-small Cell Lung Cancer	Biological: cyclophosphamide + EMD531444 + BSC, Biological: Saline + Placebo + BSC	Phase 1, Phase 2	205	Merck KGaA, Merck Serono Co., Ltd., Japan

Results: The analysis of EMR 63325-009, a randomized, double-blind, placebo-controlled Phase I/II study in Japanese patients with Stage III unresectable, locally advanced NSCLC who had received concurrent or sequential chemoradiotherapy (CRT), with a minimum of two cycles of platinum-based chemotherapy and radiation dose ≥50 Gy shows following results: Of the patients included in the Phase II part of the study, the majority had received concurrent CRT.

EudraCT: 2011-004822-85 A prospective, open, randomized, phase-II study of a therapeutic cancer vaccine (L-BLP25, Stimuvax) in the pre-operative treatment of women with primary breast cancer	ABCSG-34 / EMR 63325-603	Jan 2012	May 2014	Active, not recruiting	Breast Cancer	L-BLP25 (Stimuvax), Cyclophosphamide (CPA), LETROZOLE, EPIRUBICIN, DOCETAXEL	Phase 2	400	ABCSG (Austrian Breast & Colorectal Cancer Study Group)

Results: 8 May 2012 Enrollment expected to be completed in May 2014 First results available end of 2014 26 Sept 2014 Enrollment of 400 patients completed

NCT01507103 Tecemotide (L-BLP25) in Rectal Cancer	SPRINT, EMR063325-013, 2011-000847-25	February 2012	June 2014	Active, not recruiting	Rectal Cancer	Cyclophosphamide (CPA), Tecemotide (L-BLP25)	Phase 2	124	Merck KGaA

NCT00828009 BLP25 Liposome Vaccine and Bevacizumab After Chemotherapy and Radiation Therapy in Treating Patients With Newly Diagnosed Stage IIIA or Stage IIIB Non-Small Cell Lung Cancer That Cannot Be Removed by Surgery	CDR0000632611, E6508	December 2010	January 2016	Recruiting	Lung Cancer	Biological: bevacizumab, Biological: emepepimut-S, Drug: carboplatin, Drug: cyclophosphamide, Drug: paclitaxel, Radiation: radiation therapy	Phase 2	55	Eastern Cooperative Oncology Group, National Cancer Institute (NCI)

NCT01462513 L-BLP25 in Patients With Colorectal Carcinoma After Curative Resection of Hepatic Metastases	LICC01	August 2011	September 2016	Recruiting	Colon Carcinoma, Rectum Carcinoma	Biological: L-BLP25, Biological: Placebo	Phase 2	159	Johannes Gutenberg University Mainz, Dr. Carl Schimanski

NCT01496131 Tecemotide (L-BLP25) in Prostate Cancer	EMR 63325-015, BB-IND 7787	October 2011	August 2017	Recruiting	Prostate Cancer	Radiation: Radiation therapy, Drug: Goserelin, Drug: Cyclophosphamide, Drug: Tecemotide (L-BLP25)	Phase 2	48	EMD Serono, National Cancer Institute (NCI)

NCT02049151 Tecemotide Following Concurrent Chemo-radiotherapy for Non-small Cell Lung Cancer	START2, EMR 63325-021, 2013-003760-30	March 2014	July 2018	Recruiting	Carcinoma, Non-Small-Cell Lung	Drug: Tecemotide, Drug: Placebo, Drug: Cyclophosphamide (CPA), Drug: Saline (sodium chloride)	Phase 3	1002	EMD Serono

NCT01423760 Collect Long-term Data on Subjects Following Participation in Previous EMD 531444 (L-BLP25 or BLP25 Liposome Vaccine) Clinical Trials	EMR 63325-011	January 2012	December 2019	Enrolling by invitation	Non-Small Cell Lung Cancer, Multiple Myeloma	Biological: Tecemotide, Other: No intervention	262	Merck KGaA

NCT01015443 Cancer Vaccine Study for Stage III, Unresectable, Non-small Cell Lung Cancer (NSCLC) in the Asian Population	INSPIRE, EMR63325-012	December 2009	May 2020	Recruiting	Non-Small Cell Lung Cancer	Biological: Tecemotide (L-BLP25), Biological: Placebo	Phase 3	500	Merck KGaA

Note: Merck KGaA and Oncothyreon are not reporting in their annual reports on colorectal cancer trials and prostate cancer trials

Sentence(s)

Tecemotide emepepimut-S known as BLP25 is a BLP25 liposome cancer vaccine.

final_sentence: Tecemotide emepepimut-S known as BLP25 is a BLP25 liposome cancer vaccine.