Clinical trials: completed, sponsored by EMD Serono Research & Development Institute, Inc.
- Lead sponsor (exact) EMD Serono Research & Development Institute, Inc.
- Status Completed
- Has posted results yes
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.
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.
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.
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.
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.
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.
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.
Uterine Cervical Neoplasms
Bintrafusp Alfa Monotherapy in Platinum-Experienced Cervical Cancer
The main purpose of this study was to evaluate clinical efficacy and safety of bintrafusp alfa in participants with advanced, unresectable cervical cancer with disease progression during or after platinum-containing chemotherapy.
- Trial name
- NCT04246489
- Testing
- Bintrafusp alfa
- Where
- 73 sites in United States, Argentina and 10 more
- Volunteers
- 146 people
- Sponsor
- EMD Serono Research & Development Institute, Inc.
Carcinoma, Non-Small-Cell Lung
M7824 in Combination With Chemotherapy in Stage IV Non-small Cell Lung Cancer (NSCLC)
The main purpose of the study was to evaluate the safety and tolerability of M7824 in combination with chemotherapy.
- Trial name
- NCT03840915
- Testing
- Cisplatin, Carboplatin, Pemetrexed
- Where
- 19 sites in United States, Belgium and 1 more
- Volunteers
- 70 people
- Sponsor
- EMD Serono Research & Development Institute, Inc.