Clinical trials: sponsored by EMD Serono Research & Development Institute, Inc.
Locally Advanced or Metastatic Urothelial Carcinoma
A Study of the Safety and Efficacy of Various Combinations of Avelumab as Therapy in Locally Advanced or Metastatic Urothelial Carcinoma (JAVELIN Bladder Medley)
The purpose of this study is to assess the safety and efficacy of avelumab in combination with other anti-tumor agents as a maintenance treatment in participants with bladder cancer.
- Trial name
- NCT05327530
- Testing
- Avelumab, Sacituzumab Govitecan (SG), M6223
- Where
- 98 sites in United States, Australia and 10 more
- Volunteers
- 256 people
- Sponsor
- EMD Serono Research & Development Institute, Inc.
Dermatomyositis, Polymyositis
Study of M5049 in DM and PM Participants (NEPTUNIA)
The purpose of this study is to evaluate the efficacy and safety of orally administered M5049 in idiopathic inflammatory myopathies, specifically dermatomyositis (DM) and polymyositis (PM) participants for 24 weeks.
- Trial name
- NCT05650567
- Testing
- M5049 dose
- Where
- 31 sites in United States, Czechia and 5 more
- Volunteers
- 20 people
- Sponsor
- EMD Serono Research & Development Institute, Inc.
Non-small Cell Lung Cancer
A Study of Tepotinib Plus Osimertinib in Osimertinib Relapsed MET Amplified NSCLC (INSIGHT 2)
This study was to assess the antitumor activity, safety, tolerability, and pharmacokinetics (PK) of the Mesenchymal-epithelial Transition Factor (MET) inhibitor tepotinib combined with the 3rd generation EGFR inhibitor…
- Trial name
- NCT03940703
- Testing
- Tepotinib, Osimertinib
- Where
- 179 sites in United States, Belgium and 15 more
- Volunteers
- 140 people
- Sponsor
- EMD Serono Research & Development Institute, Inc.
Advanced (Stage IIIB/IV) Non-small Cell Lung Cancer (NSCLC) With MET Exon 14 (METex14) Skipping Alterations or MET Amplification, Lung Adenocarcinoma Stage IIIB/IV
Tepotinib Phase II in NSCLC Harboring MET Alterations (VISION)
This study looked at how effective the study drug (tepotinib) was at stopping the growth and spread of lung cancer. This study also measures a number of other things including safety of the study drug and the side effects, how…
- Trial name
- NCT02864992
- Testing
- Tepotinib
- Where
- 176 sites in United States, Austria and 13 more
- Volunteers
- 337 people
- Sponsor
- EMD Serono Research & Development Institute, Inc.
Metastatic Solid Tumors
First in Human Study of M6223
The main purpose of this study was to determine the safety, tolerability, pharmacokinetics (PK), immunogenicity and (if observed) the maximum tolerated dose (MTD) of M6223 as a single agent (Part 1A) for both the every 2 weeks…
- Trial name
- NCT04457778
- Testing
- M6223, Bintrafusp alfa
- Where
- 4 sites in United States, Canada
- Volunteers
- 58 people
- Sponsor
- EMD Serono Research & Development Institute, Inc.
Metastatic or Locally Advanced Unresectable Solid Tumors
First in Human Study of M1069 in Advanced Solid Tumors
The main purpose of this study was to determine the safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD) and early signs of efficacy of M1069 in participants with advanced solid malignancies.
- Trial name
- NCT05198349
- Testing
- M1069
- Where
- 3 sites in United States, Canada
- Volunteers
- 15 people
- Sponsor
- EMD Serono Research & Development Institute, Inc.
Head and Neck Cancer
Phase III Xevinapant (Debio 1143) and Radiotherapy in Resected LA SCCHN, High Risk, Cisplatin-ineligible Participants (XRAY VISION)
The purpose of this study is to demonstrate the superior efficacy of Xevinapant (Debio 1143) versus placebo when added to radiotherapy in the treatment of high-risk participants with resected locally advanced squamous cell…
- Trial name
- NCT05386550
- Testing
- Xevinapant, IMRT
- Where
- 206 sites in United States, Argentina and 24 more
- Volunteers
- 166 people
- Sponsor
- EMD Serono Research & Development Institute, Inc.
Lung Cancer, Cancer
Bintrafusp Alfa Program Rollover Study
This study is designed to provide continuous access to treatment with bintrafusp alfa for eligible participants from ongoing bintrafusp alfa parent studies (NCT02517398, NCT02699515, NCT04246489, NCT03840915, NCT03631706…
- Trial name
- NCT05061823
- Testing
- Bintrafusp alfa
- Where
- 21 sites in United States, Belgium and 10 more
- Volunteers
- 22 people
- Sponsor
- EMD Serono Research & Development Institute, Inc.
Multiple Sclerosis
A Study of Suboptimally Controlled Participants Previously Taking Oral or Infusion DMDs for RMS (MASTER-2)
To evaluate the effectiveness, safety and Patient-Reported Outcomes (PROs) of cladribine tablets in participants with RMS including relapsing-remitting multiple sclerosis (RRMS) and active secondary progressive multiple sclerosis…
- Trial name
- NCT03933202
- Testing
- Cladribine Tablets
- Where
- 66 sites in United States
- Volunteers
- 291 people
- Sponsor
- EMD Serono Research & Development Institute, Inc.
Systemic Lupus Erythematosus
The WILLOW Study With M5049 in SLE and CLE (SCLE and/or DLE) (WILLOW)
The purpose of this Proof of Concept (PoC) and Dose-finding (DF) basket study is to evaluate the efficacy and safety of orally administered Enpatoran over 24 weeks in systemic lupus erythematosus (SLE) and cutaneous lupus…
- Trial name
- NCT05162586
- Testing
- Enpatoran low dose, Enpatoran medium dose, Enpatoran high dose
- Where
- 153 sites in United States, Argentina and 20 more
- Volunteers
- 456 people
- Sponsor
- EMD Serono Research & Development Institute, Inc.
Squamous Cell Carcinoma of the Head and Neck
A Study of Xevinapant (Debio 1143) in Combination With Platinum-Based Chemotherapy and Standard Fractionation Intensity-Modulated Radiotherapy in Participants With Locally Advanced Squamous Cell Carcinoma of the Head and Neck, Suitable for Definitive Chemoradiotherapy (TrilynX)
The primary objective of the study was to demonstrate superior efficacy of Xevinapant (Debio 1143) vs placebo when added to chemoradiotherapy (CRT) in locally advanced squamous cell carcinoma of the head and neck (LA-SCCHN).
- Trial name
- NCT04459715
- Testing
- Xevinapant (Debio 1143), Cisplatin, Intensity Modulation Radiation Therapy (IMRT)
- Where
- 288 sites in United States, Argentina and 24 more
- Volunteers
- 730 people
- Sponsor
- EMD Serono Research & Development Institute, Inc.
Head and Neck Cancer
Phase 1b Safety Study of Xevinapant, Weekly Cisplatin, and RT in Participants With Unresected LA SCCHN (HyperlynX)
The purpose of this study is to evaluate the tolerability and safety of Xevinapant when added to weekly cisplatin-based concurrent chemoradiotherapy (CRT) in the treatment of participants with unresectable locally advanced…
- Trial name
- NCT06056310
- Testing
- Xevinapant, Cisplatin, intensity-modulated radiation therapy (IMRT)
- Where
- 23 sites in United States, Belgium and 4 more
- Volunteers
- 18 people
- Sponsor
- EMD Serono Research & Development Institute, Inc.
Relapsing-remitting Multiple Sclerosis
A Study of Efficacy and Safety of M2951 in Participants With Relapsing Multiple Sclerosis
The aim of this protocol is to find out about the safety and effectiveness of M2951 in participants with relapsing multiple sclerosis.
- Trial name
- NCT02975349
- Testing
- Evobrutinib, Tecfidera
- Where
- 56 sites in Bulgaria, Czechia and 6 more
- Volunteers
- 267 people
- Sponsor
- EMD Serono Research & Development Institute, Inc.
Multiple Sclerosis
A Study of Suboptimally Controlled Participants Previously Taking Injectable DMDs for RMS (CLICK-MS)
To evaluate the effectiveness, patient-reported outcomes (PROs) and safety of cladribine tablets in participants with relapsing forms of multiple sclerosis (RMS) including relapsing-remitting multiple sclerosis (RRMS) and active…
- Trial name
- NCT03933215
- Testing
- Cladribine
- Where
- 18 sites in United States
- Volunteers
- 100 people
- Sponsor
- EMD Serono Research & Development Institute, Inc.
Oncology, Solid Tumors
Study of Avelumab-M3814 Combinations
The main purpose of the study was to evaluate a safe, tolerable recommended Phase II dose (RP2D) and/or the maximum tolerated dose (MTD) of M3814 when given in combination with avelumab with and without radiotherapy in…
- Trial name
- NCT03724890
- Testing
- M3814, Avelumab, Radiotherapy
- Where
- 8 sites in United States
- Volunteers
- 57 people
- Sponsor
- EMD Serono Research & Development Institute, Inc.
Non-small Cell Lung Cancer
M7824 Versus Pembrolizumab as a First-line (1L) Treatment in Participants With Programmed Death-ligand 1 (PD-L1) Expressing Advanced Non-small Cell Lung Cancer (NSCLC)
The purpose of the study is to evaluate the efficacy and safety of bintrafusp alfa (M7824) compared with pembrolizumab in participants with advanced NSCLC with high PD-L1-tumor expression, with no epidermal growth factor receptor…
- Trial name
- NCT03631706
- Testing
- M7824, Pembrolizumab
- Where
- 119 sites in United States, Argentina and 16 more
- Volunteers
- 304 people
- Sponsor
- EMD Serono Research & Development Institute, Inc.
Advanced Solid Tumors
First-in-human Study of M4076 in Advanced Solid Tumors (DDRiver Solid Tumors 410)
The purpose of this study was to determine the safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD), maximum tolerated dose (MTD) (if reached) and early signs of efficacy of M4076 monotherapy in participants with…
- Trial name
- NCT04882917
- Testing
- M4076
- Where
- 3 sites in United States, Canada
- Volunteers
- 22 people
- Sponsor
- EMD Serono Research & Development Institute, Inc.
First Line Non-Small Cell Lung Cancer
Avelumab in First-line NSCLC (JAVELIN Lung 100)
The purpose of this study was to demonstrate superiority with regard to Overall Survival (OS) or Progression Free Survival (PFS) of avelumab versus platinum-based doublet, based on an Independent Review Committee assessment, in…
- Trial name
- NCT02576574
- Testing
- Avelumab, Pemetrexed, Paclitaxel
- Where
- 349 sites in United States, Australia and 40 more
- Volunteers
- 1,214 people
- Sponsor
- EMD Serono Research & Development Institute, Inc.
Advanced Solid Tumors
Phase 1 Trial of MSC2490484A, an Inhibitor of a DNA-dependent Protein Kinase, in Combination With Radiotherapy
M3814 was an investigational drug that is being evaluated for the treatment of participants with locally advanced tumors. The main purposes of this study was to determine the safety, the tolerability and the efficacy of M3814 in…
- Trial name
- NCT02516813
- Testing
- M3814 100 mg, M3814 200 mg, M3814 300 mg
- Where
- 26 sites in United States, Belgium and 6 more
- Volunteers
- 52 people
- Sponsor
- EMD Serono Research & Development Institute, Inc.
Small-cell Lung Cancer
Berzosertib + Topotecan in Relapsed Platinum-Resistant Small-Cell Lung Cancer (DDRiver SCLC 250)
The main purpose of this study is to assess efficacy, safety, tolerability and pharmacokinetics (PK) of Berzosertib in combination with Topotecan in participants with relapsed, platinum-resistant small-cell lung cancer (SCLC).
- Trial name
- NCT04768296
- Testing
- Berzosertib, Topotecan
- Where
- 51 sites in United States, Belgium and 5 more
- Volunteers
- 76 people
- Sponsor
- EMD Serono Research & Development Institute, Inc.