Clinical trials: sponsored by EMD Serono Research & Development Institute, Inc.
Relapsing Multiple Sclerosis
Study of Evobrutinib in Participants With RMS (evolutionRMS 2)
The study is to evaluate the efficacy and safety of evobrutinib administered orally twice daily versus Teriflunomide (Aubagio®), administered orally once daily in participants with Relapsing Multiple Sclerosis (RMS).
- Trial name
- NCT04338061
- Testing
- Teriflunomide, Evobrutinib
- Where
- 278 sites in United States, Belarus and 30 more
- Volunteers
- 1,166 people
- Sponsor
- Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany
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.
Recurrent High-grade Glioma
Study to Assess Xevinapant in Preoperative Subjects With Recurrent High-Grade Glioma (rHGG)
Researchers will investigate the ability of Xevinapant to cross the blood-brain barrier and exert anti-tumor effects on rHGG through activation of apoptosis.
- Trial name
- NCT06463184
- Testing
- Xevinapant
- Sponsor
- H. Lee Moffitt Cancer Center and Research Institute
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.
Urothelial Carcinoma
Study of Avelumab and Tuvusertib in Participants With Advanced Urothelial Cancer That Has Progressed on Prior Anti-PD-(L)1 Therapy (JAVELIN DDRiver Bladder)
The purpose of this study is to assess the antitumor activity of avelumab in combination with tuvusertib in terms of objective response in participants with advanced urothelial carcinoma.
- Trial name
- NCT06424717
- Testing
- Avelumab, Tuvusertib
- 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.
Advanced Solid Tumors
A Phase Ib Study to Evaluate the Safety, Tolerability, and Pharmacokinetics (PK) of Avelumab in Combination With M9241(NHS-IL12) (JAVELIN IL-12)
The study consisted of 2 parts: Dose Escalation phase (Part A) and Expansion phase (Part B). The dose escalation phase evaluated the safety, tolerability, and PK of avelumab in combination with M9241 in subjects with locally…
- Trial name
- COMBO (NCT02994953)
- Testing
- Avelumab, M9241, Avelumab (Once weekly)
- Where
- 33 sites in United States, Belgium and 5 more
- Volunteers
- 52 people
- Sponsor
- EMD Serono Research & Development Institute, Inc.
Multiple Sclerosis
The MS-LINK™ Outcomes Study
The Multiple Sclerosis (MS) Leadership and Innovation Network (MS-LINK™) is comprised of networks working cooperatively to advance Multiple Sclerosis (MS) science and improve MS participant outcomes.
- Trial name
- NCT04735406
- Where
- 9 sites in United States
- Volunteers
- 2,182 people
- Sponsor
- EMD Serono Research & Development Institute, Inc.
Hepatic Impairment
Tepotinib Hepatic Impairment Trial
The study investigated the effect of various degrees of hepatic impairment on the pharmacokinetics (PK), safety and tolerability of tepotinib.
- Trial name
- NCT03546608
- Testing
- Tepotinib
- Where
- 2 sites in United States
- Volunteers
- 18 people, healthy volunteers welcome
- Sponsor
- EMD Serono Research & Development Institute, Inc.
Refractory or Relapsed Solid Tumors, Lymphoma
Phase I/II Study of Avelumab in Pediatric Cancer Participants
This is a multi-center, open-label, international study to evaluate the dose, safety and tolerability, antitumor activity, pharmacokinetic and pharmacodynamics of avelumab in pediatric subjects 0 to less than 18 years of age with…
- Trial name
- NCT03451825
- Testing
- Avelumab
- Where
- 11 sites in United States, Belgium and 3 more
- Volunteers
- 21 people
- Sponsor
- EMD Serono Research & Development Institute, Inc.
Multiple Sclerosis (MS)
Next-Gen MS: Feed-forward PRO Data for MS Research
This Next Generation learning health system for Multiple Sclerosis (Next-Gen MS) study is a sub-study of the MS-LINK™ Outcomes Study (NCT04735406).
- Trial name
- NCT04907305
- Where
- 8 sites in United States
- Volunteers
- 1,594 people
- Sponsor
- EMD Serono Research & Development Institute, Inc.
Solid Tumors
MSB0011359C (M7824) in Metastatic or Locally Advanced Solid Tumors
The main purpose of this Phase I study was to test MSB0011359C (M7824) at different dose levels to see if it is safe and well tolerated when given once every 2 weeks.
- Trial name
- NCT02517398
- Testing
- MSB0011359C
- Where
- 118 sites in United States, Australia and 10 more
- Volunteers
- 600 people
- Sponsor
- EMD Serono Research & Development Institute, Inc.
Carcinoma, Merkel Cell
Avelumab in Participants With Merkel Cell Carcinoma (JAVELIN Merkel 200)
This is a multicenter, international, single-arm, open-label, Phase 2 trial to evaluate the efficacy and safety of avelumab in participants with metastatic Merkel cell carcinoma (MCC).
- Trial name
- NCT02155647
- Testing
- Avelumab
- Where
- 61 sites in United States, Australia and 5 more
- Volunteers
- 204 people
- Sponsor
- EMD Serono Research & Development Institute, Inc.
Cervical Cancer
Bintrafusp Alfa Combination Therapy in Participants With Cervical Cancer (INTR@PID 046)
This study was to evaluate the safety and tolerability of bintrafusp alfa in combination with other anti-cancer therapies in participants with locally advanced or advanced cervical cancer.
- Trial name
- NCT04551950
- Testing
- M7824, Carboplatin, Paclitaxel
- Where
- 13 sites in United States, Japan and 1 more
- Volunteers
- 25 people
- Sponsor
- EMD Serono Research & Development Institute, Inc.
Non-small Cell Lung Cancer
M7824 With cCRT in Unresectable Stage III Non-small Cell Lung Cancer (NSCLC)
The main purpose of this study was to evaluate safety and efficacy in participants treated with concomitant chemoradiation therapy (cCRT) plus M7824 followed by M7824 compared to cCRT plus placebo followed by durvalumab.
- Trial name
- NCT03840902
- Testing
- M7824, Durvalumab, Etoposide
- Where
- 104 sites in United States, Argentina and 13 more
- Volunteers
- 153 people
- Sponsor
- EMD Serono Research & Development Institute, Inc.
Solid Tumors
M3541 in Combination With Radiotherapy in Solid Tumors
This dose-escalation study evaluated the safety, tolerability, pharmacokinetic (PK), pharmacodynamic, and explore antitumor activity of M3541 in combination with fractionated palliative radiotherapy (RT) in participants with…
- Trial name
- NCT03225105
- Testing
- M3541, Palliative Radiotherapy (RT)
- Where
- 5 sites in United States
- Volunteers
- 15 people
- Sponsor
- EMD Serono Research & Development Institute, Inc.
Biliary Tract Cancer, Cholangiocarcinoma
Gemcitabine Plus Cisplatin With or Without Bintrafusp Alfa (M7824) in Participants With 1L BTC
Study consisted of an open-label, safety run-in part and a randomized, double-blind, placebo-controlled Phase 2/3 part. In the Phase 2/3 part, the study was evaluated whether bintrafusp alfa in combination with the current…
- Conditions
- Biliary Tract Cancer, Cholangiocarcinoma, Gallbladder Cancer
- Trial name
- NCT04066491
- Testing
- M7824, Gemcitabine, Cisplatin
- Where
- 99 sites in United States, Argentina and 13 more
- Volunteers
- 309 people
- Sponsor
- EMD Serono Research & Development Institute, Inc.
Multiple Sclerosis (MS)
Long-Term Outcomes and Durability of Effect Following Treatment With Cladribine Tablets for MS (CLASSIC-MS)
The objective of this study was to collect data both retrospectively and prospectively in order to evaluate the long-term outcomes, durability of effect, and real-world treatment patterns following treatment with Cladribine…
- Trial name
- NCT03961204
- Testing
- Data Collection
- Where
- 99 sites in United States, Australia and 27 more
- Volunteers
- 662 people
- Sponsor
- EMD Serono Research & Development Institute, Inc.
Biliary Tract Cancer, Cholangiocarcinoma
M7824 Monotherapy in Locally Advanced or Metastatic Second Line (2L) Biliary Tract Cancer (Cholangiocarcinoma and Gallbladder Cancer)
The study to evaluate M7824 monotherapy in participants with advanced or metastatic biliary tract cancer (BTC) who failed or were intolerant to first-line (1L) chemotherapy.
- Conditions
- Biliary Tract Cancer, Cholangiocarcinoma, Gallbladder Cancer
- Trial name
- NCT03833661
- Testing
- M7824
- Where
- 33 sites in United States, China and 7 more
- Volunteers
- 159 people
- Sponsor
- EMD Serono Research & Development Institute, Inc.