Clinical trials: sponsored by EMD Serono Research & Development Institute, Inc.
Solid Tumor, Advanced Solid Tumor
First in Human Study of M4344 in Participants With Advanced Solid Tumors
The purpose of this study was to evaluate the safety and tolerability of multiple ascending doses of single-agent M4344 administered twice-weekly (BIW), twice daily (BID) or once daily dose schedule in participants with advanced…
- Trial name
- NCT02278250
- Testing
- M4344 10 mg BIW, M4344 20 mg BIW, M4344 40 mg BIW
- Where
- 16 sites in United States, Netherlands and 2 more
- Volunteers
- 97 people
- Sponsor
- EMD Serono Research & Development Institute, Inc.
Colorectal Neoplasms
Study of Tepotinib Combined With Cetuximab in Participants With Left-Sided RAS/BRAF Wild Type Metastatic Colorectal Cancer (PERSPECTIVE)
The purpose of this study was to assess the preliminary antitumor activity, safety and tolerability of tepotinib in combination with cetuximab in participants with RAS/BRAF wild-type left-sided Metastatic Colorectal Cancer (mCRC)…
- Trial name
- NCT04515394
- Testing
- Tepotinib, Cetuximab
- Where
- 65 sites in United States, Belgium and 6 more
- Volunteers
- 3 people
- Sponsor
- EMD Serono Research & Development Institute, Inc.
Unresectable, Locally Advanced or Metastatic, Adenocarcinoma of the Stomach, or of the Gastro Esophageal Junction
Avelumab in First-Line Maintenance Gastric Cancer (JAVELIN Gastric 100)
The purpose of this study was to demonstrate superiority of treatment with avelumab versus continuation of first-line chemotherapy.
- Trial name
- NCT02625610
- Testing
- Avelumab, Oxaliplatin, 5-Fluorouracil
- Where
- 200 sites in United States, Australia and 15 more
- Volunteers
- 499 people
- Sponsor
- EMD Serono Research & Development Institute, Inc.
Coronavirus Disease 2019
Study of M5049 in Participants With COVID-19 Pneumonia (ANEMONE)
The study will evaluate the safety and efficacy of orally-administered M5049 in Coronavirus disease 2019 (COVID-19) pneumonia participants who are hospitalized but not on mechanical ventilation.
- Trial name
- NCT04448756
- Testing
- M5049
- Where
- 21 sites in United States, Brazil and 1 more
- Volunteers
- 149 people
- Sponsor
- EMD Serono Research & Development Institute, Inc.
Advanced Solid Tumors, Metastatic Renal Cell Carcinoma
M8891 First in Human in Solid Tumors
The purpose of this study was to determine the maximum tolerated dose (MTD), safety, tolerability, Pharmacokinetic (PK), pharmacodynamic and clinical activity of M8891 as single agent in participants with advanced solid tumors in…
- Trial name
- M8891 (NCT03138538)
- Testing
- Part 1: M8891
- Where
- 7 sites in United States
- Volunteers
- 27 people
- Sponsor
- EMD Serono Research & Development Institute, Inc.
Solid Tumors
Avelumab in Metastatic or Locally Advanced Solid Tumors (JAVELIN Solid Tumor)
This is a Phase 1, open-label, dose-escalation trial of avelumab [antibody targeting programmed death ligand 1 (anti PD-L1)] with consecutive parallel group expansion in participants with selected tumor indications.
- Trial name
- NCT01772004
- Testing
- Avelumab
- Where
- 74 sites in United States, Belgium and 7 more
- Volunteers
- 1,756 people
- Sponsor
- EMD Serono Research & Development Institute, Inc.
Relapsing-remitting Multiple Sclerosis
Study of Evobrutinib in Participants With Relapsing Multiple Sclerosis (RMS)
The study was to evaluate the efficacy and safety of evobrutinib administered orally twice daily versus Interferon-beta-1a (Avonex®), once a week intramuscularly in participants with RMS.
- Trial name
- NCT04032158
- Testing
- Evobrutinib, Avonex®
- Where
- 2 sites in United States, Germany
- Volunteers
- 3 people
- Sponsor
- EMD Serono Research & Development Institute, Inc.
Relapsing-remitting Multiple Sclerosis
Study of Evobrutinib in Participants With RMS
The study was to evaluate the efficacy and safety of evobrutinib administered orally twice daily versus Interferon-beta-1a (Avonex®), once a week intramuscularly in participants with Relapsing Multiple Sclerosis (RMS).
- Trial name
- NCT04032171
- Testing
- Evobrutinib, Avonex®
- Where
- 2 sites in United States, Germany
- Volunteers
- 1 people
- Sponsor
- EMD Serono Research & Development Institute, Inc.
Advanced Solid Tumor, Breast Cancer
Study of M4344 in Combination With Niraparib
Study will include 3 parts. Aim of Part 1 of this study is to establish the maximum tolerated dose (MTD) and recommended dose for expansion (RDE) for M4344 (is an Ataxia Telangiectasia Mutated and Rad3-related [ATR] inhibitors)…
- Trial name
- NCT04655183
- Testing
- Niraparib, M4344
- Sponsor
- EMD Serono Research & Development Institute, Inc.
Systemic Lupus Erythematosus
A Phase II Study of M2951 in SLE
M2951 is an investigational drug under evaluation for treatment of autoimmune and inflammatory disorders. The purpose of the study was to assess the Safety and Efficacy of M2951 in participants with Systemic Lupus Erythematosus…
- Trial name
- NCT02975336
- Testing
- M2951
- Where
- 157 sites in United States, Argentina and 17 more
- Volunteers
- 469 people
- Sponsor
- EMD Serono Research & Development Institute, Inc.
Multiple Sclerosis
Oral Cladribine in Early Multiple Sclerosis (MS)
A randomized, double-blind, clinical trial to assess the safety and efficacy of two doses of oral cladribine versus placebo in participants who had a first clinical demyelinating event (clinically isolated syndrome).
- Trial name
- ORACLE MS (NCT00725985)
- Testing
- Cladribine, Rebif® new formulation (RNF)
- Where
- 158 sites in United States, Argentina and 32 more
- Volunteers
- 617 people
- Sponsor
- EMD Serono Research & Development Institute, Inc.
IgA Nephropathy
Efficacy and Safety of Atacicept in IgA Nephropathy
This main purpose of this study was to evaluate the safety, tolerability, dose response and efficacy of Atacicept in participants with IgA nephropathy and persistent proteinuria.
- Trial name
- NCT02808429
- Testing
- Atacicept 25 mg, Atacicept 75 mg
- Where
- 18 sites in United States, Japan and 1 more
- Volunteers
- 16 people
- Sponsor
- EMD Serono Research & Development Institute, Inc.
Relapsing-Remitting Multiple Sclerosis
CLARITY Extension Study
The purpose of this extension trial was to further evaluate the safety and tolerability of oral cladribine in subjects who have previously completed treatment within Trial 25643 (CLARITY).
- Trial name
- NCT00641537
- Testing
- Cladribine
- Where
- 116 sites in United States, Australia and 29 more
- Volunteers
- 867 people
- Sponsor
- EMD Serono Research & Development Institute, Inc.
Unresectable, Recurrent, Locally Advanced or Metastatic Gastric or Gastroesophageal Junction Adenocarcinoma, Gastric Cancer Third Line
Avelumab in Third-Line Gastric Cancer (JAVELIN Gastric 300)
The purpose of this study was to demonstrate superiority of treatment with avelumab plus best supportive care (BSC) versus physician's choice (chosen from a pre-specified list of therapeutic options) plus BSC.
- Trial name
- NCT02625623
- Testing
- Avelumab, Irinotecan, Paclitaxel
- Where
- 75 sites in United States, Australia and 8 more
- Volunteers
- 371 people
- Sponsor
- EMD Serono Research & Development Institute, Inc.
Ovarian Cancer
Phase Ib/II Study of Carboplatin + M6620 + Avelumab in PARPi-resistant Ovarian Cancer
The study was to evaluate the efficacy and safety of avelumab in combination with M6620 + carboplatin in participants with PARPi-resistant, recurrent, platinum sensitive ovarian, primary peritoneal, or fallopian tube cancer.
- Trial name
- NCT03704467
- Testing
- M6620, Avelumab, Carboplatin
- Where
- 13 sites in United States, Belgium and 1 more
- Volunteers
- 3 people
- Sponsor
- EMD Serono Research & Development Institute, Inc.
Multiple Sclerosis
A Phase 2 Study of Cladribine Add-on to Interferon-beta (IFN-beta) Therapy in Multiple Sclerosis (MS) Subjects With Active Disease (ONWARD)
The goal of this study was to evaluate the safety, tolerability and effectiveness of oral cladribine when taken in combination with Interferon-beta (IFN-beta) therapy for the treatment of multiple sclerosis (MS).
- Trial name
- ONWARD (NCT00436826)
- Testing
- Cladribine, Interferon-beta (IFN-beta)
- Where
- 39 sites in United States, Italy and 2 more
- Volunteers
- 172 people
- Sponsor
- EMD Serono Research & Development Institute, Inc.
Rheumatoid Arthritis
Phase IIb Study of Evobrutinib in Subjects With Rheumatoid Arthritis
The purpose of this study was to determine the efficacy, dose response, and safety of M52951 in participants with Rheumatoid Arthritis (RA), and to consider a dose to took forward into Phase III development.
- Trial name
- NCT03233230
- Testing
- M2591 25 mg QD, M2951 75 mg QD, M2951 50 mg BID
- Where
- 97 sites in United States, Argentina and 10 more
- Volunteers
- 390 people
- Sponsor
- EMD Serono Research & Development Institute, Inc.
Small Cell Lung Cancer
Phase Ib/II Study of M3814 With Etoposide and Cisplatin in Small Cell Lung Cancer (SCLC) Extensive Disease (ED)
M3814 is an investigational drug under evaluation for treatment of lung cancer. The purpose of the study was to assess the Safety and Efficacy of M3814 in combination with chemotherapy with SCLC ED.
- Trial name
- NCT03116971
- Testing
- M3814, Cisplatin, Etoposide
- Where
- 80 sites in United States, Belgium and 11 more
- Volunteers
- 2 people
- Sponsor
- EMD Serono Research & Development Institute, Inc.
Carcinoma, Non-Small-Cell Lung
Avelumab in Non-Small Cell Lung Cancer (JAVELIN Lung 200)
The main purpose of this study was to demonstrate superiority with regard to overall survival of avelumab versus docetaxel in participants with programmed death ligand 1 (PD-L1) positive, non-small cell lung cancer (NSCLC) after…
- Trial name
- NCT02395172
- Testing
- Avelumab, Docetaxel
- Where
- 260 sites in United States, Argentina and 27 more
- Volunteers
- 792 people
- Sponsor
- EMD Serono Research & Development Institute, Inc.
Osteoarthritis, Knee
A Study to Investigate the Safety and Effectiveness of Different Doses of Sprifermin in Participants With Osteoarthritis of the Knee
This was a multicenter, randomized, double-blind, placebo-controlled, parallel-group Phase 2 trial of Sprifermin administered intra-articularly in participants with primary osteoarthritis of the knee and Kellgren-Lawrence Grade 2…
- Trial name
- FORWARD (NCT01919164)
- Testing
- Sprifermin
- Where
- 13 sites in United States, Argentina and 6 more
- Volunteers
- 549 people
- Sponsor
- EMD Serono Research & Development Institute, Inc.