Merck KGaA Clinical Trials: 516 Led Studies

Archive historyOct 2022 to Jun 2026

175 recorded changes across Merck KGaA trials

Every status move, completion date shift and enrollment change ComplyRx has recorded across 44 of these trials. One is shown below.

Completion date movePrimary completion moved 184 days laterNCT05882734 · recorded 1 Jun 2026

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+171 more recorded changes · Track a drug to see every change the night it lands

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Most active programmes

The drugs appearing most often across Merck KGaA's recently active trials. Comparator arms are excluded.

Avelumab14 trials
Evobrutinib6 trials
Cisplatin5 trials
Carboplatin5 trials
Tepotinib4 trials
M91404 trials

Upcoming readouts

Next primary completion dates among Merck KGaA's active phase 2 and phase 3 trials. Dates are registry estimates and move often, which is exactly what the tracker watches.

Jul 2028A Study to Compare the Efficacy and Safety of Follitropin Alfa/Lutropin Alfa Versus hMG in Japan…Phase 3
Aug 2028Efficacy and Safety of a New Formulation of Oral Cladribine Compared With Placebo in Participant…Phase 3
May 2029ELOWEN-1: A Study of Enpatoran in Participants With Cutaneous Manifestations of Lupus With or Without Syst…Phase 3
May 2029A Study of Enpatoran in Participants With Cutaneous Manifestations of Lupus With or Without Syst…Phase 3
Oct 2029A Study of Precemtabart Tocentecan With or Without Bevacizumab Compared to Trifluridine/Tipiraci…Phase 3
Nov 2029Study of Pimicotinib in Japanese Participants With Tenosynovial Giant Cell Tumor (TGCT) (J-MANEU…Phase 2

Top therapeutic areas

Conditions studied most often across Merck KGaA's recently active trials.

Multiple Sclerosis7 trials
Advanced Solid Tumor6 trials
Solid Tumors6 trials
Advanced Solid Tumors5 trials
Systemic Lupus Erythematosus3 trials
Desmoid Tumor3 trials

Merck KGaA trials

The 50 most significant of Merck KGaA's recently active trials, soonest estimated readout first.
Select any row for the full record; the change timeline unlocks with tracking.

Trial	Phase	Stability	Status	Enrollment	Est. readout
Tuvusertib (M1774) in Participants With Metastatic or Locally Advanced Unresectable Solid Tumors (DDRiver Solid Tumors 301)NCT04170153M1774	Phase 1	Locked · track to reveal	OngoingActive, not recruiting	161 est.	30 Jul 2026
Avelumab Program Rollover StudyNCT03815643Avelumab	Phase 3	Locked · track to reveal	OngoingActive, not recruiting	205 est.	21 Aug 2026
Effect of Hepatic Impairment on the Pharmacokinetics of MirdametinibNCT06997276Mirdametinib (MEK Inhibitor)	Phase 1	Locked · track to reveal	OngoingRecruiting	32 est.	30 Sept 2026
Tuvusertib (M1774) in Combination With Cemiplimab in Participants With Non-Squamous NSCLC (DDRiver NSCLC 322)NCT05882734M1774	Phase 1	Locked · track to reveal	OngoingActive, not recruiting	61 est.	30 Sept 2026
Anti-CEACAM5 ADC Precemtabart Tocentecan (M9140) in Chinese Participants With Solid TumorsNCT06806046M9140	Phase 1	Locked · track to reveal	OngoingActive, not recruiting	12 est.	30 Sept 2026
Anti-CEACAM5 ADC M9140 in Advanced Solid Tumors (PROCEADE-CRC-01)NCT05464030M9140	Phase 1	Locked · track to reveal	OngoingRecruiting	200 est.	23 Oct 2026
Phase 1 Single Ascending Doses (SAD) of M5542 in Healthy ParticipantsNCT06577337M5542	Phase 1	Locked · track to reveal	OngoingRecruiting	49 est.	16 Nov 2026
Study of Tuvusertib (M1774) in Combination With DNA Damage Response Inhibitor or Immune Checkpoint Inhibitor (DDRiver Solid Tumors 320)NCT05396833Tuvusertib	Phase 1	Locked · track to reveal	OngoingActive, not recruiting	120 est.	14 Jan 2027
SW-682 in Advanced Solid TumorsNCT06251310SW-682	Phase 1	Locked · track to reveal	OngoingRecruiting	186 est.	18 Jan 2027
M9466 Alone or in Combination in Advanced Solid Tumors (DDriver 501)NCT06421935M9466	Phase 1	Locked · track to reveal	OngoingActive, not recruiting	60 est.	22 Feb 2027
Anti-GD2 ADC M3554 in Advanced Solid TumorsNCT06641908M3554	Phase 1	Locked · track to reveal	OngoingRecruiting	52 est.	16 Apr 2027
A Study of Nirogacestat in Japanese Adults With Desmoid Tumors/Aggressive Fibromatosis (DT/AF)NCT07170644Nirogacestat oral tablet	Phase 2	Locked · track to reveal	OngoingActive, not recruiting	20 est.	28 May 2027
Study of Anti-CEACAM5 ADC M9140 in Participants With Advanced Solid Tumors (PROCEADE PanTumor)NCT06710132M9140	Phase 1	Locked · track to reveal	OngoingActive, not recruiting	250 est.	23 Dec 2027
Met Non Small Cell Cancer Registry (MOMENT)NCT05376891	—	Not yet scored	OngoingRecruiting	700 est.	28 Apr 2028
A Study to Compare the Efficacy and Safety of Follitropin Alfa/Lutropin Alfa Versus hMG in Japanese Participants With LH and FSH Deficiency Undergoing ART (HINATA)NCT07340827Follitropin alfa/lutropin alfa (MBJ-0011)	Phase 3	Locked · track to reveal	OngoingRecruiting	266 est.	5 Jul 2028
The Willow LTE Study With M5049 in Participants With SCLE, DLE and/or SLE (WILLOW LTE)NCT05540327M5049 low dose	Phase 2	Locked · track to reveal	OngoingActive, not recruiting	379 est.	12 Aug 2028
Efficacy and Safety of a New Formulation of Oral Cladribine Compared With Placebo in Participants With Generalized Myasthenia Gravis (MyClad)NCT06463587Cladribine Low Dose	Phase 3	Locked · track to reveal	OngoingRecruiting	264 est.	23 Aug 2028
Anti-Ly6E Exatecan ADC M7437 in Advanced Solid TumorsNCT07360314M7437	Phase 1	Locked · track to reveal	OngoingRecruiting	138 est.	20 Sept 2028
Cladribine Tablets Level of Response Predictors in Clinical Practice (CLODINA)NCT05797740Mavenclad	—	Not yet scored	OngoingActive, not recruiting	367 est.	31 Jan 2029
TITERM0324 as Monotherapy and in Combination With Pembrolizumab or Chemotherapy in Participants With Selected Advanced Solid TumorsNCT07166601M0324	Phase 1	Locked · track to reveal	OngoingRecruiting	77 est.	23 Feb 2029
ELOWEN-1A Study of Enpatoran in Participants With Cutaneous Manifestations of Lupus With or Without Systemic DiseaseNCT07332481Enpatoran	Phase 3	Locked · track to reveal	OngoingRecruiting	202 est.	24 May 2029
A Study of Enpatoran in Participants With Cutaneous Manifestations of Lupus With or Without Systemic Disease (ELOWEN-2)NCT07355218Enpatoran	Phase 3	Locked · track to reveal	OngoingRecruiting	202 est.	25 May 2029
A Study of Precemtabart Tocentecan With or Without Bevacizumab Compared to Trifluridine/Tipiracil Plus Bevacizumab in Participants With Previously Treated Metastatic Colorectal Cancer (PROCEADE-CRC-03)NCT07549412Precemtabart tocentecan	Phase 3	Locked · track to reveal	OngoingRecruiting	1,020 est.	16 Oct 2029
Study of Pimicotinib in Japanese Participants With Tenosynovial Giant Cell Tumor (TGCT) (J-MANEUVER)NCT07499362Pimicotinib	Phase 2	Locked · track to reveal	OngoingRecruiting	20 est.	22 Nov 2029
Nirogacestat in Premenopausal Females With Desmoid Tumor/Aggressive Fibromatosis (DT/AF)NCT07176689Nirogacestat	Phase 4	Locked · track to reveal	OngoingRecruiting	50 est.	14 Jan 2031
JAVEMACS: Japan AVElumab Maintenance And Continuous Treatment StudyNCT06412848Avelumab	—	Not yet scored	OngoingActive, not recruiting	360 est.	30 Jun 2026
Tuvusertib Combined With Niraparib or Lartesertib in Participants With Epithelial Ovarian Cancer (DDRiver EOC 302)NCT06433219Tuvusertib (M1774)	Phase 2	Locked · track to reveal	OngoingActive, not recruiting	63 est.	14 Jun 2026
Tuvusertib (M1774) Human Mass Balance and Absolute Bioavailability Study (DDRIVER Solid Tumors 303)NCT06308263Tuvusertib [14C]Tuvusertib microtracer	Phase 1	Locked · track to reveal	Completed	12 est.	14 Apr 2026
Effect of Renal Impairment on Enpatoran PharmacokineticsNCT06589713Enpatoran	Phase 1	Locked · track to reveal	Completed	34 est.	13 Apr 2026
To Determine the Effect of CYP Induction Following Administration of Nirogacestat in Healthy Adult Male ParticipantsNCT07259330Nirogacestat	Phase 1	Locked · track to reveal	Completed	20 est.	27 Mar 2026
An Ethno-bridging Study of Pergoveris in Healthy Premenopausal Participants of Japanese or Caucasian OriginNCT07269327Desogestrel and ethinylestradiol fixed dose combination	Phase 1	Locked · track to reveal	Completed	24 est.	9 Mar 2026
To Assess the Enzyme Inducing Effects of Carbamazepine on the PK of Mirdametinib in Healthy ParticipantsNCT07279233Mirdametinib	Phase 1	Locked · track to reveal	Completed	36 est.	27 Feb 2026
Study of Avelumab in Combination With Lenvatinib for Children With Primary CNS TumorsNCT05081180Avelumab	Phase 1	Locked · track to reveal	OngoingActive, not recruiting	17 est.	11 Feb 2026
Study of Avelumab and Tuvusertib in Participants With Advanced Urothelial Cancer That Has Progressed on Prior Anti-PD-(L)1 Therapy (JAVELIN DDRiver Bladder)NCT06424717Avelumab	Phase 2	Locked · track to reveal	StoppedWithdrawn	0 est.	12 Jan 2026
A Study to Assess the Bioequivalence of Follitropin Alfa Solution in Pen and Follitropin Alfa Powder in Vial in Healthy Downregulated Male ParticipantsNCT07097259Test: Follitropin alfa	Phase 1	Locked · track to reveal	Completed	55 est.	23 Dec 2025
M9466 in Combination With Topoisomerase 1 Inhibitors-based Regimens in Advanced Solid Tumors and Colorectal Cancer (DDRiver 511)NCT06509906M9466	Phase 1	Locked · track to reveal	StoppedTerminated	3 est.	2 Dec 2025
Evaluate the Effects of Famotidine or Rabeprazole on the PK of NirogacestatNCT07171619Nirogacestat	Phase 1	Locked · track to reveal	Completed	24 est.	10 Nov 2025
Study of M5049 in DM and PM Participants (NEPTUNIA)NCT05650567M5049 high dose	Phase 2	Locked · track to reveal	StoppedTerminated	40 est.	25 Jun 2025
A Study of the Safety and Efficacy of Various Combinations of Avelumab as Therapy in Locally Advanced or Metastatic Urothelial Carcinoma (JAVELIN Bladder Medley)NCT05327530Avelumab	Phase 2	Locked · track to reveal	OngoingActive, not recruiting	256 est.	20 Jun 2025
Phase 1 Study of M9466 Combined With Carboplatin and Platinum-based Anticancer Therapy (DDRiver 521)NCT06719973M9466	Phase 1	Locked · track to reveal	StoppedWithdrawn	0 est.	14 May 2025
Bintrafusp Alfa Program Rollover StudyNCT05061823Bintrafusp alfa	Phase 3	Locked · track to reveal	Completed	22 est.	21 Mar 2025
Efficacy, Safety, and PK of M5717 in Combination With Pyronaridine as Chemoprevention in Adults and Adolescents With Asymptomatic Plasmodium Falciparum Infection (CAPTURE-2)NCT05974267M5717 60 mg	Phase 2	Locked · track to reveal	Completed	192 est.	29 Dec 2024
A TQT Study to Investigate the Effect of Enpatoran on Cardiac Repolarization in Healthy ParticipantsNCT06589726Moxifloxacin	Phase 1	Locked · track to reveal	Completed	40 est.	2 Dec 2024
The WILLOW Study With M5049 in SLE and CLE (SCLE and/or DLE) (WILLOW)NCT05162586Enpatoran low dose	Phase 2	Locked · track to reveal	Completed	456 est.	20 Nov 2024
A Study of Suboptimally Controlled Participants Previously Taking Oral or Infusion DMDs for RMS (MASTER-2)NCT03933202Cladribine Tablets	—	Not yet scored	Completed	291 est.	11 Nov 2024
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)NCT04459715Xevinapant (Debio 1143)	Phase 3	Locked · track to reveal	StoppedTerminated	730 est.	18 Sept 2024
Phase III Xevinapant (Debio 1143) and Radiotherapy in Resected LA SCCHN, High Risk, Cisplatin-ineligible Participants (XRAY VISION)NCT05386550Xevinapant	Phase 3	Locked · track to reveal	StoppedTerminated	166 est.	27 Aug 2024
Phase 1b Safety Study of Xevinapant, Weekly Cisplatin, and RT in Participants With Unresected LA SCCHN (HyperlynX)NCT06056310Xevinapant	Phase 1	Locked · track to reveal	StoppedTerminated	18 est.	20 Aug 2024
An Observational Study to Evaluate the Efficacy and Safety of Avelumab + Axitinib Combination in Participants With aRCC (AVION)NCT04941768	—	Not yet scored	Completed	105 est.	8 Aug 2024
A Study to Learn About the Study Medicine (Called Avelumab) in People With Advanced Urothelial Cancer After ChemotherapyNCT05366725Avelumab	—	Not yet scored	Completed	106 est.	27 Jun 2024

View all trials516

Tuvusertib (M1774) in Participants With Metastatic or Locally Advanced Unresectable Solid Tumors (DDRiver Solid Tumors 301)

Phase 1Active, not recruitingNCT04170153 ↗

Primary completion: Jul 2026; estimated
Enrollment: 161; estimated
Start: Dec 2019; EMD Serono Research & Development Institute, Inc.

Conditions

Metastatic or Locally Advanced Unresectable Solid Tumors

Interventions

M1774
Niraparib

Brief summary

This is an open-label, Phase I, first-in-human (FIH) multicenter, clinical study conducted in multiple parts to establish the safety, tolerability and pharmacokinetic/pharmacodynamic (PK/PD) profile (with and without food) and early signs of efficacy of Tuvuseritib (M1774) as monotherapy and in combination with the…

Full record on ClinicalTrials.gov ↗

Change timeline

9 recorded · latest 1 Jun 2026

Completion date move · 6

Enrollment change · 2

Status change · 1

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Effect of Hepatic Impairment on the Pharmacokinetics of Mirdametinib

Phase 1RecruitingNCT06997276 ↗

Primary completion: Sept 2026; estimated
Enrollment: 32; estimated
Start: May 2025; SpringWorks Therapeutics, Inc., a healthcare company of Merck KGaA, Darmstadt, Germany

Conditions

Healthy
Hepatic Impairment

Interventions

Mirdametinib (MEK Inhibitor)

Brief summary

The purposes of this study are to determine: * The pharmacokinetics (the amount of study drug in your blood and how long it takes the body to get rid of it) of the study drug and its metabolites (substances produced as the body breaks down the study drug) in participants with moderate or severe liver function…

Full record on ClinicalTrials.gov ↗

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1 recorded · latest 1 May 2026

Completion date move · 1

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Tuvusertib (M1774) in Combination With Cemiplimab in Participants With Non-Squamous NSCLC (DDRiver NSCLC 322)

Phase 1Active, not recruitingNCT05882734 ↗

Primary completion: Sept 2026; estimated
Enrollment: 61; estimated
Start: Sept 2023; EMD Serono Research & Development Institute, Inc.

Conditions

Non-Small Cell Lung Cancer

Interventions

M1774
Cemiplimab

Brief summary

This is an Open-label, multicenter clinical study conducted in two Phases to establish the efficacy, safety, tolerability, and pharmacokinetics of the ataxia telangiectasia mutated and Rad3-related protein kinase (ATR) inhibitor Tuvusertib in Combination with Cemiplimab in Participants with Non-Squamous Non-Small Cell…

Full record on ClinicalTrials.gov ↗

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7 recorded · latest 1 Jun 2026

Completion date move · 4

Status change · 2

Enrollment change · 1

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Anti-CEACAM5 ADC M9140 in Advanced Solid Tumors (PROCEADE-CRC-01)

Phase 1RecruitingNCT05464030 ↗

Primary completion: Oct 2026; estimated
Enrollment: 200; estimated
Start: Aug 2022; EMD Serono Research & Development Institute, Inc.

Conditions

Colorectal Cancer

Interventions

M9140
M9140
Bevacizumab
Capecitabine
5-fluorouracil (5-FU)
Folinic acid

Brief summary

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. This study contains 2 parts: Dose escalation (Part 1) and dose expansion (Part 2) Study details include: * Study Duration per participant:…

Full record on ClinicalTrials.gov ↗

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5 recorded · latest 1 May 2026

Completion date move · 4

Enrollment change · 1

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Study of Tuvusertib (M1774) in Combination With DNA Damage Response Inhibitor or Immune Checkpoint Inhibitor (DDRiver Solid Tumors 320)

Phase 1Active, not recruitingNCT05396833 ↗

Primary completion: Jan 2027; estimated
Enrollment: 120; estimated
Start: Jun 2022; EMD Serono Research & Development Institute, Inc.

Conditions

Metastatic or Locally Advanced Unresectable Solid Tumors

Interventions

Tuvusertib
Lartesertib
Avelumab

Brief summary

This is an open-label, multicenter, clinical study conducted in multiple parts to establish the safety, tolerability, Pharmacokinetic/Pharmacodynamic (PK/PD) profile, maximum tolerated dose (MTD) combinations (if observed) and recommended dose for expansion (RDE) combination for tuvusertib in combination with…

Full record on ClinicalTrials.gov ↗

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6 recorded · latest 1 Jun 2026

Completion date move · 2

Status change · 2

Enrollment change · 2

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SW-682 in Advanced Solid Tumors

Phase 1RecruitingNCT06251310 ↗

Primary completion: Jan 2027; estimated
Enrollment: 186; estimated
Start: Jul 2024; SpringWorks Therapeutics, Inc., a healthcare company of Merck KGaA, Darmstadt, Germany

Conditions

Advanced Solid Tumor
Mesothelioma, Malignant

Interventions

SW-682
Combination Therapy

Brief summary

This is a first-in-human (FIH), Phase 1a/1b open-label, multicenter, dose escalation and dose expansion study of SW-682 in adult participants with metastatic or unresectable advanced solid tumors with or without Hippo pathway alterations that are refractory to, or have progressed, during or after appropriate prior…

Full record on ClinicalTrials.gov ↗

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1 recorded · latest 1 Jul 2024

Status change · 1

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M9466 Alone or in Combination in Advanced Solid Tumors (DDriver 501)

Phase 1Active, not recruitingNCT06421935 ↗

Primary completion: Feb 2027; estimated
Enrollment: 60; estimated
Start: Aug 2024; EMD Serono Research & Development Institute, Inc.

Conditions

Advanced Solid Tumor

Interventions

M9466
Tuvusertib
Abiraterone acetate
Prednisone/Prednisolone

Brief summary

The purpose of this study is to evaluate the safety, tolerability, pharmacokinetic, pharmacodynamic profile of M9466 with and without tuvusertib or an ARPi and early signs of clinical activity of M9466 with tuvusertib in participants with advanced solid tumors. Study details include: Study/Treatment Duration:…

Full record on ClinicalTrials.gov ↗

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5 recorded · latest 1 Jan 2026

Status change · 2

Enrollment change · 2

Completion date move · 1

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Study of Anti-CEACAM5 ADC M9140 in Participants With Advanced Solid Tumors (PROCEADE PanTumor)

Phase 1Active, not recruitingNCT06710132 ↗

Primary completion: Dec 2027; estimated
Enrollment: 250; estimated
Start: Jan 2025; EMD Serono Research & Development Institute, Inc.

Conditions

Solid Tumors
Gastric Cancer
Non-Small Cell Lung Cancer (NSCLC)
Pancreatic Cancer
Pancreatic Ductal Adenocarcinoma (PDAC)

Interventions

M9140

Brief summary

The PROCEADE PanTumor study aims to investigate M9140 in multiple tumor types which express carcinoembryonic antigen-related cell adhesion molecule 5 (CEACAM5) and it is therefore designed as a matrix study. This study aims to assess the antitumor activity, tolerability, safety, and pharmacokinetics (PK) of M9140 as…

Full record on ClinicalTrials.gov ↗

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4 recorded · latest 1 Jun 2026

Status change · 2

Completion date move · 2

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A Study to Compare the Efficacy and Safety of Follitropin Alfa/Lutropin Alfa Versus hMG in Japanese Participants With LH and FSH Deficiency Undergoing ART (HINATA)

Phase 3RecruitingNCT07340827 ↗

Primary completion: Jul 2028; estimated
Enrollment: 266; estimated
Start: Feb 2026; Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany

Conditions

Infertility

Interventions

Follitropin alfa/lutropin alfa (MBJ-0011)
hMG
Cetrorelix acetate
Coriogonadotropin alfa
Progesterone gel

Brief summary

The purpose of this study is to assess the efficacy and safety of follitropin alfa/lutropin alfa in Japanese participants with Luteinizing hormone (LH) and Follicle stimulating hormone (FSH) deficiency undergoing Assisted reproductive technology (ART). The study duration is approximately 5.5 months for nonpregnant…

Full record on ClinicalTrials.gov ↗

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1 recorded · latest 1 Apr 2026

Status change · 1

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The Willow LTE Study With M5049 in Participants With SCLE, DLE and/or SLE (WILLOW LTE)

Phase 2Active, not recruitingNCT05540327 ↗

Primary completion: Aug 2028; estimated
Enrollment: 379; estimated
Start: Sept 2022; Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany

Conditions

Systemic Lupus Erythematosus

Interventions

M5049 low dose
M5049 medium dose
M5049 high dose
Placebo

Brief summary

The purpose of the study is to evaluate the long term safety and efficacy of orally administered M5049 in participants with subacute cutaneous lupus erythematosus (SCLE), discoid lupus erythematosus (DLE) and/or systemic lupus erythematosus (SLE) who have completed the 24 week treatment period of Willow study…

Full record on ClinicalTrials.gov ↗

Change timeline

6 recorded · latest 1 Aug 2025

Enrollment change · 2

Status change · 2

Completion date move · 2

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Efficacy and Safety of a New Formulation of Oral Cladribine Compared With Placebo in Participants With Generalized Myasthenia Gravis (MyClad)

Phase 3RecruitingNCT06463587 ↗

Primary completion: Aug 2028; estimated
Enrollment: 264; estimated
Start: Jun 2024; Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany

Conditions

Generalized Myasthenia Gravis

Interventions

Placebo
Cladribine Low Dose
Cladribine High Dose

Brief summary

The purpose of this clinical study is to determine the efficacy and safety of a new oral cladribine formulation in participants with Generalized Myasthenia Gravis (gMG) in comparison to placebo. It will also investigate the sustained efficacy, the need for retreatment, and the long-term safety of oral cladribine in…

Full record on ClinicalTrials.gov ↗

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2 recorded · latest 1 Jun 2026

Completion date move · 1

Status change · 1

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TITER: M0324 as Monotherapy and in Combination With Pembrolizumab or Chemotherapy in Participants With Selected Advanced Solid Tumors

Phase 1RecruitingNCT07166601 ↗

Primary completion: Feb 2029; estimated
Enrollment: 77; estimated
Start: Oct 2025; EMD Serono Research & Development Institute, Inc.

Conditions

Advanced Solid Tumor

Interventions

M0324
M0324
Pembrolizumab
mFOLFIRINOX

Brief summary

The purpose of this first-in-human study is to identify a recommend dose(s) for subsequent larger studies (recommended dose(s) for expansion, RDE), examining increasing doses of M0324, primarily looking at safety, but also preliminary signs of efficacy, pharmacokinetics (PK), and pharmacodynamics (PD). Three different…

Full record on ClinicalTrials.gov ↗

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1 recorded · latest 1 Nov 2025

Status change · 1

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ELOWEN-1: A Study of Enpatoran in Participants With Cutaneous Manifestations of Lupus With or Without Systemic Disease

Phase 3RecruitingNCT07332481 ↗

Primary completion: May 2029; estimated
Enrollment: 202; estimated
Start: Mar 2026; EMD Serono Research & Development Institute, Inc.

Conditions

Systemic Lupus Erythematosus (SLE)
Cutaneous Lupus Erythematosus (CLE)

Interventions

Enpatoran
Placebo
Standard of care (SoC)

Brief summary

The purpose of this global, multicenter, Phase 3 study is to evaluate the efficacy and safety of enpatoran over 24 weeks in participants with active cutaneous manifestations of lupus erythematosus with or without systemic disease. Study details include: Study Duration: Up to 35 weeks. Treatment Duration: 24 weeks.…

Full record on ClinicalTrials.gov ↗

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2 recorded · latest 1 May 2026

Status change · 1

Completion date move · 1

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A Study of Enpatoran in Participants With Cutaneous Manifestations of Lupus With or Without Systemic Disease (ELOWEN-2)

Phase 3RecruitingNCT07355218 ↗

Primary completion: May 2029; estimated
Enrollment: 202; estimated
Start: Apr 2026; EMD Serono Research & Development Institute, Inc.

Conditions

Systematic Lupus Erythematosus
Cutaneous Lupus Erythematosus

Interventions

Enpatoran
Placebo
Standard of care (SoC)

Brief summary

Full record on ClinicalTrials.gov ↗

Change timeline

2 recorded · latest 1 May 2026

Status change · 1

Completion date move · 1

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A Study of Precemtabart Tocentecan With or Without Bevacizumab Compared to Trifluridine/Tipiracil Plus Bevacizumab in Participants With Previously Treated Metastatic Colorectal Cancer (PROCEADE-CRC-03)

Phase 3RecruitingNCT07549412 ↗

Primary completion: Oct 2029; estimated
Enrollment: 1,020; estimated
Start: May 2026; EMD Serono Research & Development Institute, Inc.

Conditions

Metastatic Colorectal Cancer

Interventions

Precemtabart tocentecan
Bevacizumab
Trifluridine/Tipiracil (FTD-TPI)

Brief summary

This study aims to address the unmet medical need of participants with metastatic colorectal cancer (mCRC) who have previously been treated with irinotecan, oxaliplatin, a fluoropyrimidine, and bevacizumab, by demonstrating an overall survival prolongation with precemtabart tocentecan (Precem-TcT) as single agent or…

Full record on ClinicalTrials.gov ↗

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2 recorded · latest 1 Jun 2026

Completion date move · 1

Status change · 1

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Tuvusertib Combined With Niraparib or Lartesertib in Participants With Epithelial Ovarian Cancer (DDRiver EOC 302)

Phase 2Active, not recruitingNCT06433219 ↗

Primary completion: Jun 2026; estimated
Enrollment: 63; estimated
Start: Oct 2024; EMD Serono Research & Development Institute, Inc.

Conditions

Ovarian Cancer

Interventions

Tuvusertib (M1774)
Niraparib
Lartesertib (M4076)

Brief summary

The purpose of this study is to measure the effect and safety of treatment with tuvusertib combined with either niraparib or lartesertib in participants with epithelial ovarian cancer and to assess any differences between tuvusertib monotherapy and combination therapy. The participants will previously have progressed…

Full record on ClinicalTrials.gov ↗

Change timeline

5 recorded · latest 1 Mar 2026

Status change · 2

Enrollment change · 2

Completion date move · 1

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Tuvusertib (M1774) Human Mass Balance and Absolute Bioavailability Study (DDRIVER Solid Tumors 303)

Phase 1CompletedNCT06308263 ↗

Primary completion: Apr 2026; actual
Enrollment: 12; estimated
Start: Mar 2024; Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany

Conditions

Solid Tumor

Interventions

Tuvusertib [14C]Tuvusertib microtracer
Tuvusertib
Tuvusertib + [14C]Tuvusertib microdose bolus injection

Brief summary

This is a single sequence 2-period open label study in participants with advanced solid tumors. The purpose of Period 1 of this study is to assess the mass balance to determine drug-related entities present in circulation and excreta and provide a comprehensive understanding of biotransformation pathways and clearance…

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7 recorded · latest 1 May 2026

Status change · 3

Completion date move · 2

Enrollment change · 2

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An Ethno-bridging Study of Pergoveris in Healthy Premenopausal Participants of Japanese or Caucasian Origin

Phase 1CompletedNCT07269327 ↗

Primary completion: Mar 2026; actual
Enrollment: 24; estimated
Start: Nov 2025; Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany

Conditions

Fertility

Interventions

Desogestrel and ethinylestradiol fixed dose combination
Follitropin alfa/lutropin alfa

Brief summary

The purpose of this study is to assess the Pharmacokinetic (PK) of Recombinant human follicle-stimulating hormone (follitropin alfa) (r-hFSH) and Recombinant human luteinizing hormone (lutropin alfa) (r-hLH) following a single subcutaneous injection of Pergoveris in pituitary-suppressed healthy female participants of…

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3 recorded · latest 1 Apr 2026

Status change · 1

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To Assess the Enzyme Inducing Effects of Carbamazepine on the PK of Mirdametinib in Healthy Participants

Phase 1CompletedNCT07279233 ↗

Primary completion: Feb 2026; actual
Enrollment: 36; estimated
Start: Dec 2025; SpringWorks Therapeutics, Inc., a healthcare company of Merck KGaA, Darmstadt, Germany

Conditions

Healthy
Volunteer

Interventions

Mirdametinib
Mirdametinib and Carbamazepine

Brief summary

The purpose of this study is to determine the effect of carbamazepine on the blood levels of mirdametinib and how long it takes the body to eliminate mirdametinib when both drugs are administered orally in healthy participants. The study may last up to approximately 64 days for each participant.

Full record on ClinicalTrials.gov ↗

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3 recorded · latest 1 May 2026

Enrollment change · 1

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Study of Avelumab in Combination With Lenvatinib for Children With Primary CNS Tumors

Phase 1Active, not recruitingNCT05081180 ↗

Primary completion: Feb 2026; actual
Enrollment: 17; estimated
Start: Dec 2021; EMD Serono Research & Development Institute, Inc.

Conditions

Central Nervous System Tumors

Interventions

Avelumab
Lenvatinib

Brief summary

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 Avelumab and Lenvatinib dose for expansion. Dose Expansion Part 2 will assess the efficacy of…

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4 recorded · latest 1 Jun 2026

Completion date move · 2

Enrollment change · 1

Status change · 1

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Study of Avelumab and Tuvusertib in Participants With Advanced Urothelial Cancer That Has Progressed on Prior Anti-PD-(L)1 Therapy (JAVELIN DDRiver Bladder)

Phase 2WithdrawnNCT06424717 ↗

Primary completion: Jan 2026; estimated
Enrollment: 0; estimated
Start: Aug 2024; EMD Serono Research & Development Institute, Inc.

Conditions

Urothelial Carcinoma

Interventions

Avelumab
Tuvusertib

Brief summary

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. Study details include: Condition/Disease: Participants with urothelial carcinoma (locally advanced and unresectable, or…

Full record on ClinicalTrials.gov ↗

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2 recorded · latest 1 Oct 2024

Status change · 1

Enrollment change · 1

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A Study to Assess the Bioequivalence of Follitropin Alfa Solution in Pen and Follitropin Alfa Powder in Vial in Healthy Downregulated Male Participants

Phase 1CompletedNCT07097259 ↗

Primary completion: Dec 2025; actual
Enrollment: 55; estimated
Start: Jul 2025; EMD Serono Research & Development Institute, Inc.

Conditions

Hypogonadism

Interventions

Test: Follitropin alfa
Reference: Follitropin alfa
Zoladex

Brief summary

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 2. At the end of the first Downregulation period (DR1), eligible participants will be…

Full record on ClinicalTrials.gov ↗

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6 recorded · latest 1 Mar 2026

Completion date move · 2

Enrollment change · 2

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M9466 in Combination With Topoisomerase 1 Inhibitors-based Regimens in Advanced Solid Tumors and Colorectal Cancer (DDRiver 511)

Phase 1TerminatedNCT06509906 ↗

Primary completion: Dec 2025; actual
Enrollment: 3; estimated
Start: Oct 2024; EMD Serono Research & Development Institute, Inc.

Conditions

Advanced Solid Tumor

Interventions

M9466
Irinotecan
Folinic acid
Fluorouracil (5-FU)
Bevacizumab
Granulocyte colony stimulating factor (G-CSF)

Brief summary

The purpose of this study is to evaluate the safety and preliminary clinical activity of M9466 in combination with topoisomerase 1 inhibitors-based regimens. As such the combination with FOLFIRI (folinic acid, fluorouracil, irinotecan) and Bevacizumab will be evaluated in participants with colorectal cancer, to…

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5 recorded · latest 1 Jan 2026

Status change · 3

Completion date move · 1

Enrollment change · 1

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A Study of the Safety and Efficacy of Various Combinations of Avelumab as Therapy in Locally Advanced or Metastatic Urothelial Carcinoma (JAVELIN Bladder Medley)

Phase 2Active, not recruitingNCT05327530 ↗

Primary completion: Jun 2025; actual
Enrollment: 256; estimated
Start: Aug 2022; EMD Serono Research & Development Institute, Inc.

Conditions

Locally Advanced or Metastatic Urothelial Carcinoma

Interventions

Avelumab
Sacituzumab Govitecan
M6223
NKTR-255

Brief summary

The purpose of this study is to assess the safety and efficacy of avelumab in combination with other anti-tumor agents as a maintenance treatment in participants with bladder cancer.

Full record on ClinicalTrials.gov ↗

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6 recorded · latest 1 Aug 2025

Completion date move · 3

Status change · 2

Enrollment change · 1

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Phase 1 Study of M9466 Combined With Carboplatin and Platinum-based Anticancer Therapy (DDRiver 521)

Phase 1WithdrawnNCT06719973 ↗

Primary completion: May 2025; actual
Enrollment: 0; estimated
Start: May 2025; EMD Serono Research & Development Institute, Inc.

Conditions

Advanced Solid Tumors

Interventions

M9466
Carboplatin
Etoposide
Atezolizumab
M9446
M9446
Carboplatin

Brief summary

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 and with the standard of care (carboplatin, etoposide, and atezolizumab) in treatment-naïve…

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3 recorded · latest 1 Jul 2025

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Efficacy, Safety, and PK of M5717 in Combination With Pyronaridine as Chemoprevention in Adults and Adolescents With Asymptomatic Plasmodium Falciparum Infection (CAPTURE-2)

Phase 2CompletedNCT05974267 ↗

Primary completion: Dec 2024; actual
Enrollment: 192; estimated
Start: Nov 2023; Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany

Conditions

Malaria Infection

Interventions

M5717 60 mg
Pyronaridine
Atovaquone-Proguanil
M5717 200 mg
M5717 660mg

Brief summary

This study evaluates the efficacy and safety of a single dose of M5717 plus pyronaridine tetraphosphate in clearing current Plasmodium falciparum infection and protecting against recurrent infections in asymptomatic adults and adolescents. The study will also assess the duration of protection provided by different…

Full record on ClinicalTrials.gov ↗

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5 recorded · latest 1 Apr 2025

Completion date move · 2

Status change · 2

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The WILLOW Study With M5049 in SLE and CLE (SCLE and/or DLE) (WILLOW)

Phase 2CompletedNCT05162586 ↗

Primary completion: Nov 2024; actual
Enrollment: 456; estimated
Start: Mar 2022; EMD Serono Research & Development Institute, Inc.

Conditions

Systemic Lupus Erythematosus

Interventions

Enpatoran low dose
Enpatoran medium dose
Enpatoran high dose
Placebo

Brief summary

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 erythematosus (CLE; subacute cutaneous lupus erythematosus \[SCLE\] and/or discoid lupus…

Full record on ClinicalTrials.gov ↗

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6 recorded · latest 1 Jan 2025

Enrollment change · 2

Completion date move · 2

Status change · 2

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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)

Phase 3TerminatedNCT04459715 ↗

Primary completion: Sept 2024; actual
Enrollment: 730; estimated
Start: Aug 2020; EMD Serono Research & Development Institute, Inc.

Conditions

Squamous Cell Carcinoma of the Head and Neck

Interventions

Xevinapant (Debio 1143)
Cisplatin
Intensity Modulation Radiation Therapy (IMRT)
Placebo

Brief summary

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).

Full record on ClinicalTrials.gov ↗

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4 recorded · latest 1 Oct 2024

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Phase III Xevinapant (Debio 1143) and Radiotherapy in Resected LA SCCHN, High Risk, Cisplatin-ineligible Participants (XRAY VISION)

Phase 3TerminatedNCT05386550 ↗

Primary completion: Aug 2024; actual
Enrollment: 166; estimated
Start: Oct 2022; EMD Serono Research & Development Institute, Inc.

Conditions

Head and Neck Cancer

Interventions

Xevinapant
IMRT
Placebo

Brief summary

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 carcinoma of the head and neck (LA SCCHN) who are ineligible to receive cisplatin-based…

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5 recorded · latest 1 Oct 2024

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Phase 1b Safety Study of Xevinapant, Weekly Cisplatin, and RT in Participants With Unresected LA SCCHN (HyperlynX)

Phase 1TerminatedNCT06056310 ↗

Primary completion: Aug 2024; actual
Enrollment: 18; estimated
Start: Jan 2024; EMD Serono Research & Development Institute, Inc.

Conditions

Head and Neck Cancer

Interventions

Xevinapant
Cisplatin
intensity-modulated radiation therapy (IMRT)

Brief summary

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 squamous cell carcinoma of the head and neck, suitable for definitive chemoradiotherapy.

Full record on ClinicalTrials.gov ↗

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4 recorded · latest 1 Oct 2024

Status change · 2

Completion date move · 1

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