Clinical trials: sponsored by EMD Serono Research & Development Institute, Inc.
Colorectal Cancer
Anti-CEACAM5 ADC M9140 in Advanced Solid Tumors (PROCEADE-CRC-01)
The purpose of this first in-human study is to evaluate the safety, tolerability, pharmacokinetics, and preliminary clinical activity of M9140 in advanced solid tumors.
- Trial name
- NCT05464030
- Testing
- M9140, Bevacizumab, Capecitabine
- Where
- 35 sites in United States, Canada and 3 more
- Volunteers
- 220 people
- Sponsor
- EMD Serono Research & Development Institute, Inc.
Central Nervous System Tumors
Study of Avelumab in Combination With Lenvatinib for Children With Primary CNS Tumors
This study consists of 2 parts: Dose Escalation Part 1 and Dose Expansion Part 2. The Dose Escalation Part 1 will evaluate the safety and tolerability of Avelumab in combination with Lenvatinib and determine the recommended…
- Trial name
- NCT05081180
- Testing
- Avelumab, Lenvatinib
- Where
- 9 sites in Canada, France and 2 more
- Volunteers
- 17 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.
Hypogonadism
A Study to Assess the Bioequivalence of Follitropin Alfa Solution in Pen and Follitropin Alfa Powder in Vial in Healthy Downregulated Male Participants
The purpose of this study is to assess the bioequivalence of Test and Reference in healthy downregulated male participants. This is a 2-sequence, 2-period study using the following treatment sequences across Study Periods 1 and…
- Trial name
- NCT07097259
- Testing
- Test: Follitropin alfa, Reference: Follitropin alfa, Zoladex
- Where
- United States
- Volunteers
- 55 people, healthy volunteers welcome
- 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.
HPV-Related Carcinoma, HPV-Related Cervical Carcinoma
Phase Ib/II of TG4001 and Avelumab in HPV16 Positive R/M Cancers
The study will consist of two parts : In the phase Ib: safety will be assessed in consecutive cohorts of 3 to 6 participants at increasing doses of TG4001 in combination with avelumab according to a 3+3 design.
- Conditions
- HPV-Related Carcinoma, HPV-Related Cervical Carcinoma, HPV-Related Anal Squamous Cell Carcinoma, HPV-Related Penile Squamous Cell Carcinoma
- Trial name
- NCT03260023
- Testing
- TG4001, Avelumab
- Where
- 20 sites in United States, France and 1 more
- Volunteers
- 143 people
- Sponsor
- Transgene
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.
Advanced Solid Tumor
M9466 in Combination With Topoisomerase 1 Inhibitors-based Regimens in Advanced Solid Tumors and Colorectal Cancer (DDRiver 511)
The purpose of this study is to evaluate the safety and preliminary clinical activity of M9466 in combination with topoisomerase 1 inhibitors-based regimens.
- Trial name
- NCT06509906
- Testing
- M9466, Irinotecan, Folinic acid
- Where
- 12 sites in United States, Australia and 3 more
- Volunteers
- 3 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.
Advanced Solid Tumors
Phase 1 Study of M9466 Combined With Carboplatin and Platinum-based Anticancer Therapy (DDRiver 521)
The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamic, and preliminary clinical activity of M9466 in combinations with carboplatin in advanced or metastatic refractory solid tumor…
- Trial name
- NCT06719973
- Testing
- M9466, Carboplatin, Etoposide
- Sponsor
- EMD Serono Research & Development Institute, Inc.
Relapsing Multiple Sclerosis
Study of Evobrutinib in Participants With RMS (evolutionRMS 1)
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
- NCT04338022
- Testing
- Teriflunomide, Evobrutinib
- Where
- 279 sites in United States, Argentina and 29 more
- Volunteers
- 1,124 people
- Sponsor
- Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany
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.