OSE Immunotherapeutics Trials

Trial + Data / Events

Status

Region

Interventions

Sponsor

Conditions

Primary compl

Study compl

Tedopi (OSE 2101) / OSE Immunotherapeutics

ATALANTE 1, NCT02654587 / 2015-003183-36: OSE2101 Versus Chemotherapy in HLA-A2 Positive Patients With Advanced NSCLC After Immune Checkpoint Inhibitor Failure

Terminated

219

Europe, US, RoW

OSE2101, TEDOPI, EP-2101, EP2101, IDM-2101, Docetaxel, Taxotere, Pemetrexed, Alimta

OSE Immunotherapeutics, OSE Immunotherapeutics, OSE Pharma

Non Small Cell Lung Cancer

01/21

ARTEMIA, NCT06472245: Trial of Therapeutic Cancer Vaccine OSE2101 in Patients With Non-Small Cell Lung Cancer and Secondary Resistance to Immune Checkpoint Inhibitor

Recruiting

363

Europe, Canada, US

OSE2101, Docetaxel, NGS HLAA2 assay

OSE Immunotherapeutics, Exystat, Genome Diagnostics (GenDx)

Patients With Non-Small Cell Lung Cancer

12/27

12/28

2017-004548-40: Phase II randomized of Maintenance therapy with OSE2101 vaccine alone or in combination with nivolumab, or FOLFIRI after induction therapy with FOLFIRINOX in patients with pancreatic carcinoma

Not yet recruiting

156

Europe

TEDOPI, nivolumab, OSE2101, Emulsion and suspension for emulsion for injection, Solution for infusion, OPDIVO

GERCOR, OSE IMMUNOTHERAPEUTICS - SA, Bristol Myers Squibb

Locally advanced or metastatic Pancreatic ductal adenocarcinoma, metastatic Pancreatic cancer, Diseases [C] - Cancer [C04]

COMBI-TED, NCT04884282 / 2020-005170-10: Efficacy of Tedopi Plus Docetaxel or Tedopi Plus Nivolumab as Second-line Therapy in Metastatic Non-small-cell Lung Cancer Progressing After First-line Chemo-immunotherapy (Combi-TED)

Recruiting

105

Europe

Tedopi, Nivolumab, Docetaxel

Fondazione Ricerca Traslazionale, Bristol Myer Squibb International Corporation, OSE Immunotherapeutics

Metastatic Non Small Cell Lung Cancer

10/23

05/25

TEDOPAM, NCT03806309: Maintenance With OSE2101 Plus FOLFIRI, or FOLFIRI After FOLFIRINOX-based Induction Therapy in Locally Advanced or Metastatic Pancreatic Ductal Adenocarcinoma

Recruiting

106

Europe

FOLFIRI, Leucovorin (Folinic Acid), Fluorouracil, Irinotecan, OSE2101, Tedopi

GERCOR - Multidisciplinary Oncology Cooperative Group, OSE Immunotherapeutics

Pancreatic Ductal Adenocarcinoma, Locally Advanced Cancer, Metastatic Cancer

12/23

12/24

TEDOVA, NCT04713514 / 2020-004364-25: OSE2101 Alone or in Combination With Pembrolizumab vs BSC in Patient With Platinum-sensitive Recurrent OC

Active, not recruiting

180

Europe

OSE2101, TEDOPI®, Pembrolizumab 25 MG/ML [Keytruda], KEYTRUDA®, MK-3475

ARCAGY/ GINECO GROUP, OSE Immunotherapeutics, Merck Sharp & Dohme LLC

Platinum-sensitive Ovarian Cancer, Relapsed Ovarian Cancer

12/25

pegrizeprument (FR104) / OSE Immunotherapeutics, Asahi Kasei

2020-000599-38: Phase 1/2 study of FR104 first administration In patient with Renal Transplantation: FIRsT study Étude de phase 1/2 : première administration de FR104 chez des patients ayant une première transplantation rénale : étude FIRsT

Not yet recruiting

1/2

Europe

FR104, FR104, Solution for infusion

NANTES CHU, OSE Immunotherapeutics

Kidney transplant Transplantés rénaux, Kidney transplant Transplantés rénaux, Diseases [C] - Symptoms and general pathology [C23]

FIRsT Study, NCT04837092: Phase I/II Study of FR104 First Administration in Patient with Renal Transplantation:

Active, not recruiting

1/2

Europe

FR104

Nantes University Hospital, OSE Immunotherapeutics

Kidney Transplantation

03/25

NCT05238493: A Dose Escalation Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of VEL-101

Completed

VEL-101, Placebo

Veloxis Pharmaceuticals

Healthy Volunteers

01/23

lusvertikimab (OSE-127) / OSE Immunotherapeutics

CoTikiS, NCT04882007 / 2020-001398-59: Study of OSE-127 vs Placebo in Patients With Moderate to Severe Active Ulcerative Colitis

Completed

136

Europe, RoW

OSE-127, Placebo

OSE Immunotherapeutics

Ulcerative Colitis

04/24

01/25

NCT04605978 / 2020-001526-59: Efficacy and Safety of S95011 in Primary Sjögren's Syndrome Patients

Completed

Europe, US, RoW

S95011 concentrate for solution for infusion, Placebo concentrate for solution for infusion

Institut de Recherches Internationales Servier, ADIR, a Servier Group company

Primary Sjögren's Syndrome

01/23

05/23

2020-001526-59: Efficacy and safety of S95011 in primary Sjögren’s Syndrome patients

Not yet recruiting

Europe

S95011, S95011, Concentrate for solution for infusion

Institut de Recherches Internationales Servier, Servier Research and Development Ltd, ADIR

Primary Sjögren’s Syndrome, Primary Sjögren’s Syndrome, Diseases [C] - Immune System Diseases [C20]

BI 765063 / Boehringer Ingelheim

NCT03990233: A Trial of BI 765063 Monotherapy and in Combination With BI 754091 in Patients With Advanced Solid Tumours

	From trial in combination with BI 754091 for solid tumors
	Jun 2021 - Jun 2021: From trial in combination with BI 754091 for solid tumors

Completed

100

Europe

BI 765063, OSE-172, BI 754091

OSE Immunotherapeutics, Boehringer Ingelheim

Solid Tumor, Adult

04/23

04/25

NCT05446129: A Study in People With Colorectal Cancer to Test Whether Ezabenlimab or Pembrolizumab in Combination With BI 765063 Lead to Side Effects or Delays in Surgery

Terminated

Ezabenlimab, BI 765063, Pembrolizumab

Boehringer Ingelheim

Colorectal Cancer

08/23

11/23

NCT05068102: A Study to Test How BI 765063 and BI 770371 Are Taken up in Tumours of People With Different Types of Advanced Cancer Who Are Also Taking Ezabenlimab

Recruiting

Europe

BI 765063, Ezabenlimab, [89Zr]Zr- BI 765063, BI 770371, [89Zr]Zr- BI 770371

Boehringer Ingelheim

Carcinoma, Squamous Cell of Head and Neck (HNSCC), Melanoma, Non-small Cell Lung Cancer (NSCLC)

10/25

12/25

NCT05249426: A Study to Test Whether Different Combinations of BI 765063, Ezabenlimab, Chemotherapy, Cetuximab, and BI 836880 Help People With Head and Neck Cancer or Liver Cancer

Active, not recruiting

Europe, Japan, US, RoW

BI 765063, Ezabenlimab, BI 754091, BI 836880, Cetuximab, Investigator´s Choice Chemotherapy

Boehringer Ingelheim

Head and Neck Squamous Cell Carcinoma (HNSCC)

07/24

07/26

CoVepiT / OSE Immunotherapeutics

COVEPIT 3, NCT04885361: To Evaluate the Safety, and Immunogenicity of Vaccine Candidate Against COVID-19, in Healthy Adults

Recruiting

Europe

CoVepiT (OSE13E)

OSE Immunotherapeutics

Coronavirus Disease (COVID-19)

09/21

03/22

BI 770371 / Boehringer Ingelheim

NCT06675929: A Study to Test How Well BI 770371 is Tolerated by People With Cirrhosis Caused by a Liver Disease Called MASH

Recruiting

BI 770371, Placebo for BI 770371

Boehringer Ingelheim

Compensated Liver Cirrhosis, Metabolic Dysfunction Associated Steatohepatitis (MASH)

12/25

NCT05327946: A Study in People With Advanced Cancer to Test How Well Different Doses of BI 770371 Alone or in Combination With Ezabenlimab Are Tolerated

Active, not recruiting

Canada, Japan, US

BI 770371, ezabenlimab

Boehringer Ingelheim

Solid Tumors

07/24

09/26

NCT06806852: A Study to Test Whether Treatment With BI 770371 in Combination With Pembrolizumab With or Without Cetuximab Helps People With Head and Neck Cancer Compared With Pembrolizumab Alone

Recruiting

Europe, Japan, US, RoW

BI 770371, Pembrolizumab, Cetuximab

Boehringer Ingelheim

Head and Neck Squamous Cell Carcinoma

07/27

03/28

OSE-279 / OSE Immunotherapeutics

2022-001136-28: A dose-finding and dose expansion study of OSE-279 in subjects with advanced solid tumors or lymphomas

Not yet recruiting

1/2

Europe

OSE-279, OSE-279, Concentrate for solution for infusion

OSE Immunotherapeutics, OSE Immunotherapeutics

Advanced solid tumors and lymphomas, Solid tumors and lymphomas, Diseases [C] - Cancer [C04]

NCT05751798 / 2022-001136-28: Dose-finding and Dose Expansion Study of OSE-279 in Subjects With Advanced Solid Tumors or Lymphomas

Recruiting

1/2

Europe

OSE-279 100mg, OSE-279 300mg, OSE-279 500mg

OSE Immunotherapeutics, OSE Immunotherapeutics

Solid Advanced Tumor, Lymphoma

12/29

Trial + Data / Events

Status

Region

Interventions

Sponsor

Conditions

Primary compl

Study compl

Tedopi (OSE 2101) / OSE Immunotherapeutics

ATALANTE 1, NCT02654587 / 2015-003183-36: OSE2101 Versus Chemotherapy in HLA-A2 Positive Patients With Advanced NSCLC After Immune Checkpoint Inhibitor Failure

Terminated

219

Europe, US, RoW

OSE2101, TEDOPI, EP-2101, EP2101, IDM-2101, Docetaxel, Taxotere, Pemetrexed, Alimta

OSE Immunotherapeutics, OSE Immunotherapeutics, OSE Pharma

Non Small Cell Lung Cancer

01/21

ARTEMIA, NCT06472245: Trial of Therapeutic Cancer Vaccine OSE2101 in Patients With Non-Small Cell Lung Cancer and Secondary Resistance to Immune Checkpoint Inhibitor

Recruiting

363

Europe, Canada, US

OSE2101, Docetaxel, NGS HLAA2 assay

OSE Immunotherapeutics, Exystat, Genome Diagnostics (GenDx)

Patients With Non-Small Cell Lung Cancer

12/27

12/28

Not yet recruiting

156

Europe

TEDOPI, nivolumab, OSE2101, Emulsion and suspension for emulsion for injection, Solution for infusion, OPDIVO

GERCOR, OSE IMMUNOTHERAPEUTICS - SA, Bristol Myers Squibb

Locally advanced or metastatic Pancreatic ductal adenocarcinoma, metastatic Pancreatic cancer, Diseases [C] - Cancer [C04]

Recruiting

105

Europe

Tedopi, Nivolumab, Docetaxel

Fondazione Ricerca Traslazionale, Bristol Myer Squibb International Corporation, OSE Immunotherapeutics

Metastatic Non Small Cell Lung Cancer

10/23

05/25

TEDOPAM, NCT03806309: Maintenance With OSE2101 Plus FOLFIRI, or FOLFIRI After FOLFIRINOX-based Induction Therapy in Locally Advanced or Metastatic Pancreatic Ductal Adenocarcinoma

Recruiting

106

Europe

FOLFIRI, Leucovorin (Folinic Acid), Fluorouracil, Irinotecan, OSE2101, Tedopi

GERCOR - Multidisciplinary Oncology Cooperative Group, OSE Immunotherapeutics

Pancreatic Ductal Adenocarcinoma, Locally Advanced Cancer, Metastatic Cancer

12/23

12/24

TEDOVA, NCT04713514 / 2020-004364-25: OSE2101 Alone or in Combination With Pembrolizumab vs BSC in Patient With Platinum-sensitive Recurrent OC

Active, not recruiting

180

Europe

OSE2101, TEDOPI®, Pembrolizumab 25 MG/ML [Keytruda], KEYTRUDA®, MK-3475

ARCAGY/ GINECO GROUP, OSE Immunotherapeutics, Merck Sharp & Dohme LLC

Platinum-sensitive Ovarian Cancer, Relapsed Ovarian Cancer

12/25

pegrizeprument (FR104) / OSE Immunotherapeutics, Asahi Kasei

Not yet recruiting

1/2

Europe

FR104, FR104, Solution for infusion

NANTES CHU, OSE Immunotherapeutics

Kidney transplant Transplantés rénaux, Kidney transplant Transplantés rénaux, Diseases [C] - Symptoms and general pathology [C23]

FIRsT Study, NCT04837092: Phase I/II Study of FR104 First Administration in Patient with Renal Transplantation:

Active, not recruiting

1/2

Europe

FR104

Nantes University Hospital, OSE Immunotherapeutics

Kidney Transplantation

03/25

NCT05238493: A Dose Escalation Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of VEL-101

Completed

VEL-101, Placebo

Veloxis Pharmaceuticals

Healthy Volunteers

01/23

lusvertikimab (OSE-127) / OSE Immunotherapeutics

CoTikiS, NCT04882007 / 2020-001398-59: Study of OSE-127 vs Placebo in Patients With Moderate to Severe Active Ulcerative Colitis

Completed

136

Europe, RoW

OSE-127, Placebo

OSE Immunotherapeutics

Ulcerative Colitis

04/24

01/25

NCT04605978 / 2020-001526-59: Efficacy and Safety of S95011 in Primary Sjögren's Syndrome Patients

Completed

Europe, US, RoW

S95011 concentrate for solution for infusion, Placebo concentrate for solution for infusion

Institut de Recherches Internationales Servier, ADIR, a Servier Group company

Primary Sjögren's Syndrome

01/23

05/23

2020-001526-59: Efficacy and safety of S95011 in primary Sjögren’s Syndrome patients

Not yet recruiting

Europe

S95011, S95011, Concentrate for solution for infusion

Institut de Recherches Internationales Servier, Servier Research and Development Ltd, ADIR

Primary Sjögren’s Syndrome, Primary Sjögren’s Syndrome, Diseases [C] - Immune System Diseases [C20]

BI 765063 / Boehringer Ingelheim

NCT03990233: A Trial of BI 765063 Monotherapy and in Combination With BI 754091 in Patients With Advanced Solid Tumours

	From trial in combination with BI 754091 for solid tumors
	Jun 2021 - Jun 2021: From trial in combination with BI 754091 for solid tumors

Completed

100

Europe

BI 765063, OSE-172, BI 754091

OSE Immunotherapeutics, Boehringer Ingelheim

Solid Tumor, Adult

04/23

04/25

NCT05446129: A Study in People With Colorectal Cancer to Test Whether Ezabenlimab or Pembrolizumab in Combination With BI 765063 Lead to Side Effects or Delays in Surgery

Terminated

Ezabenlimab, BI 765063, Pembrolizumab

Boehringer Ingelheim

Colorectal Cancer

08/23

11/23

NCT05068102: A Study to Test How BI 765063 and BI 770371 Are Taken up in Tumours of People With Different Types of Advanced Cancer Who Are Also Taking Ezabenlimab

Recruiting

Europe

BI 765063, Ezabenlimab, [89Zr]Zr- BI 765063, BI 770371, [89Zr]Zr- BI 770371

Boehringer Ingelheim

Carcinoma, Squamous Cell of Head and Neck (HNSCC), Melanoma, Non-small Cell Lung Cancer (NSCLC)

10/25

12/25

NCT05249426: A Study to Test Whether Different Combinations of BI 765063, Ezabenlimab, Chemotherapy, Cetuximab, and BI 836880 Help People With Head and Neck Cancer or Liver Cancer

Active, not recruiting

Europe, Japan, US, RoW

BI 765063, Ezabenlimab, BI 754091, BI 836880, Cetuximab, Investigator´s Choice Chemotherapy

Boehringer Ingelheim

Head and Neck Squamous Cell Carcinoma (HNSCC)

07/24

07/26

CoVepiT / OSE Immunotherapeutics

COVEPIT 3, NCT04885361: To Evaluate the Safety, and Immunogenicity of Vaccine Candidate Against COVID-19, in Healthy Adults

Recruiting

Europe

CoVepiT (OSE13E)

OSE Immunotherapeutics

Coronavirus Disease (COVID-19)

09/21

03/22

BI 770371 / Boehringer Ingelheim

NCT06675929: A Study to Test How Well BI 770371 is Tolerated by People With Cirrhosis Caused by a Liver Disease Called MASH

Recruiting

BI 770371, Placebo for BI 770371

Boehringer Ingelheim

Compensated Liver Cirrhosis, Metabolic Dysfunction Associated Steatohepatitis (MASH)

12/25

NCT05327946: A Study in People With Advanced Cancer to Test How Well Different Doses of BI 770371 Alone or in Combination With Ezabenlimab Are Tolerated

Active, not recruiting

Canada, Japan, US

BI 770371, ezabenlimab

Boehringer Ingelheim

Solid Tumors

07/24

09/26

NCT06806852: A Study to Test Whether Treatment With BI 770371 in Combination With Pembrolizumab With or Without Cetuximab Helps People With Head and Neck Cancer Compared With Pembrolizumab Alone

Recruiting

Europe, Japan, US, RoW

BI 770371, Pembrolizumab, Cetuximab

Boehringer Ingelheim

Head and Neck Squamous Cell Carcinoma

07/27

03/28

OSE-279 / OSE Immunotherapeutics

2022-001136-28: A dose-finding and dose expansion study of OSE-279 in subjects with advanced solid tumors or lymphomas

Not yet recruiting

1/2

Europe

OSE-279, OSE-279, Concentrate for solution for infusion

OSE Immunotherapeutics, OSE Immunotherapeutics

Advanced solid tumors and lymphomas, Solid tumors and lymphomas, Diseases [C] - Cancer [C04]

NCT05751798 / 2022-001136-28: Dose-finding and Dose Expansion Study of OSE-279 in Subjects With Advanced Solid Tumors or Lymphomas

Recruiting

1/2

Europe

OSE-279 100mg, OSE-279 300mg, OSE-279 500mg

OSE Immunotherapeutics, OSE Immunotherapeutics

Solid Advanced Tumor, Lymphoma

12/29



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