Clinical trials: sponsored by 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.
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.
Metastatic Solid Tumors, Esophageal Cancer
M1231 in Participants With Solid Tumors
This study is to establish a safe and tolerable dose and to investigate pharmacokinetics and the first clinical efficacy signals of M1231 as a single agent in participants with solid tumors (Part 1) and with metastatic Non-small…
- Conditions
- Metastatic Solid Tumors, Esophageal Cancer, Non-Small Cell Lung Cancer
- Trial name
- NCT04695847
- Testing
- M1231
- Where
- 3 sites in United States, Canada
- Volunteers
- 23 people
- Sponsor
- EMD Serono Research & Development Institute, Inc.
Triple Negative Breast Neoplasms
Bintrafusp Alfa in High Mobility Group AT-Hook 2 (HMGA2) Expressing Triple Negative Breast Cancer
The main purpose of this study was to evaluate bintrafusp alfa monotherapy in participants with triple negative breast cancer (TNBC) who express high levels of HMGA2 as determined by a centralized reverse transcriptase-polymerase…
- Trial name
- NCT04489940
- Testing
- Bintrafusp alfa
- Where
- 45 sites in United States, Belgium and 4 more
- Volunteers
- 11 people
- Sponsor
- EMD Serono Research & Development Institute, Inc.
Multiple Myeloma
First in Human Dose Escalation of M3258 as a Single Agent and Expansion Study of M3258 in Combination With Dexamethasone
The purpose of this study was to determine the safety, tolerability, pharmacokinetics, pharmacodynamics and early efficacy signs of M3258 as a single agent and co-administered with dexamethasone in participants with Relapsed…
- Trial name
- NCT04075721
- Testing
- M3258, M3258 20 mg
- Where
- 7 sites in United States, France
- Volunteers
- 10 people
- Sponsor
- EMD Serono Research & Development Institute, Inc.
Locally Advanced Rectal Cancer
Study of Peposertib in Combination With Capecitabine and RT in Rectal Cancer
The main purpose of the study was to define maximum tolerated dose (MTD), recommended Phase II dose (RP2D) safety and tolerability of Peposertib in combination with capecitabine and radiotherapy (RT).
- Trial name
- NCT03770689
- Testing
- Peposertib 50 mg, Peposertib 100 mg, Peposertib 150 mg
- Where
- 14 sites in United States, Spain
- Volunteers
- 19 people
- Sponsor
- EMD Serono Research & Development Institute, Inc.