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Clinical trial register · European Union · CTIS

Clinical Trials in Italy

The most recently authorised trials on the EU Clinical Trials Information System (CTIS), the single register for every trial run under the EU Clinical Trials Regulation (536/2014). CTIS holds a far larger historical archive than any one list can usefully show — this register states both numbers rather than picking one.

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Source: EMA Clinical Trials Information System (CTIS). Showing the 2500 most recently authorised of 12445 total CTIS records — a stated recency window, not the full historical archive. Synced 19 Sep 2026, 04:26 UTC
2500
Shown in this register
most recently authorised
12,445
Total on CTIS
full historical archive
745
Phase III
within the shown window
Top member states
Spain 1023 France 890 Germany 861 Italy 742 Poland 581 Netherlands 524
Narrow the registerReset
Phase
Phase I 558 Phase I/II 214 Phase II 726 Phase III 745 Phase IV 257
Lead sponsor
AstraZeneca AB 60 Assistance Publique Hopitaux De Paris 49 Merck Sharp & Dohme LLC 48 Pfizer Inc. 45 Novo Nordisk A/S 42 Clear sponsor filter
Member state
Spain 1023 France 890 Germany 861 Italy 742 Poland 581 Netherlands 524 Belgium 426 Czechia 327
All 28 states
16 of 2500 shown studies
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Phase
Study
Lead sponsor
Area
Member states
Decision
Phase III
A Phase 3, Randomized, Placebo-Controlled Study of Adjuvant Intismeran Autogene Plus Subcutaneous Pembrolizumab and Berahyaluronidase Alfa (MK-3475A) or Intismeran Autogene Monotherapy Versus Placebo in Participants With Completely Resected High-Risk Stage I Non-Small Cell Lung Cancer (INTerpath-014)
2025-522643-18-00Stage I NSCLC
Merck Sharp & Dohme LLC
Neoplasms
Greece, Poland, Italy, Hungary, Germany, Netherlands, France, Spain
16/06/2026
Phase III
A Phase 3, Randomized, Double-blind, Placebo- and Active-Comparator-Controlled Study of MK-1084 Plus Durvalumab Versus Placebo Plus Durvalumab in Participants With Locally Advanced, Unresected KRAS G12C-Mutant Non-Small Cell Lung Cancer Without Disease Progression Following Definitive Platinum-Based Chemoradiotherapy (KANDLELIT-015)
2025-522038-29-00Locally advanced, unresected (unresectable or medically ino…
Merck Sharp & Dohme LLC
Neoplasms
Italy, Netherlands, France, Germany, Spain, Poland, Greece
12/06/2026
Phase III
A Phase 2/3, Randomized, Open-Label, Comparison Study of MK-1045 Versus Blinatumomab in Participants With Relapsed or Refractory CD19+ B-Cell Acute Lymphoblastic Leukemia (B-ALL)
2025-522267-15-00​Relapsed/refractory B-cell Acute Lymphoblastic Leukemia​
Merck Sharp & Dohme LLC
Neoplasms
Greece, Netherlands, Sweden, France, Italy, Spain, Denmark
12/06/2026
Phase III
A Phase 2/3 randomized, open-label study of MK-1045 in combination with rituximab in patients with 1L follicular lymphoma.
2025-522777-10-00Follicular Lymphoma
Merck Sharp & Dohme LLC
Neoplasms
France, Spain, Germany, Greece, Italy, Poland
09/06/2026
Phase III
A Phase 3, Randomized, Double-blind, Study of Belzutifan + Zanzalintinib Versus Belzutifan + Placebo in Participants with Advanced RCC who have progressed on or after both PD-1/L1 and VEGF-TKI therapies in sequence or in combination (LITESPARK-034)
2024-516993-31-00Renal Cell Carcinoma
Merck Sharp & Dohme LLC
Neoplasms
Denmark, Spain, Netherlands, Germany, France, Czechia, Poland, Italy, Greece
04/05/2026
Phase III
A Phase 3, Randomized, Open-label, Multicenter Study of Sacituzumab Tirumotecan (sac-TMT, MK-2870) Maintenance Treatment With or Without Bevacizumab Versus Standard of Care in Participants With Newly Diagnosed Advanced HRD-Negative Ovarian Cancer Following First-line Platinum-based Chemotherapy (TroFuse-021/ENGOTov85/ GOG-3102)
2023-508047-40-00Ovarian cancer
Merck Sharp & Dohme LLC
Neoplasms
Norway, Ireland, Spain, Greece, France, Poland, Denmark, Austria, Hungary, Belgium, Czechia, Finland, Germany, Italy, Sweden
28/04/2026
Phase III
A Phase 3, Randomized, Open-label Study of Sacituzumab Tirumotecan (MK-2870) Versus Investigator’s Choice of Non-platinum Chemotherapy in Participants with Pretreated Locally Advanced/Metastatic Urothelial Carcinoma
2024-520014-22-00Locally advanced/metastatic urothelial carcinoma
Merck Sharp & Dohme LLC
Neoplasms
Netherlands, Greece, Italy, Germany, Spain, Belgium, Sweden, France
20/04/2026
Phase III
An Operationally Seamless Phase 2/3 Study to Evaluate the Safety, Efficacy, and Pharmacokinetics of Enlicitide Decanoate in Pediatric Participants with Heterozygous Familial Hypercholesterolemia
2024-519068-42-00​Heterozygous Familial Hypercholesterolemia​ in pediatric p…
Merck Sharp & Dohme LLC
Cardiovascular Diseases
Germany, Spain, Belgium, Czechia, Norway, France, Poland, Netherlands, Italy, Finland
26/01/2026
Phase III
A Phase 3, Randomized, Open-label, Multicenter Study to Evaluate the Efficacy and Safety of Sacituzumab Tirumotecan (MK-2870) in Combination With Pembrolizumab With or Without Bevacizumab Compared With Standard of Care as Firstline Maintenance Treatment for Participants With Persistent, Recurrent, or Newly Diagnosed Metastatic Cervical Cancer With PD-L1 CPS Greater Than or Equal to 1 (TroFuse-036/GOG-3123/ENGOT-cx22)
2025-521514-26-00Persistent, Recurrent, or Newly Diagnosed Metastatic Cervic…
Merck Sharp & Dohme LLC
Neoplasms
Greece, Ireland, France, Belgium, Czechia, Hungary, Austria, Spain, Sweden, Germany, Poland, Denmark, Italy
14/01/2026
Phase III
An Open-label Long-term Follow-up Study to Evaluate the Effects of Sotatercept When Added to Background Pulmonary Arterial Hypertension (PAH) Therapy for the Treatment of PAH (MK-7962-038)
2025-521970-33-00​​Pulmonary Arterial Hypertension (PAH)
Merck Sharp & Dohme LLC
Cardiovascular Diseases
Czechia, Germany, Sweden, Greece, Croatia, Belgium, Poland, Spain, Portugal, Italy, Denmark, France, Netherlands
01/12/2025
Phase III
A Phase 3, Randomized, Open-label, Multicenter Clinical Study to Evaluate the Safety and Efficacy of MK-1084 in Combination With Subcutaneous Pembrolizumab and Berahyaluronidase alfa (MK-3475A) Versus MK-3475A in Combination With Pemetrexed/Platinum (Carboplatin or Cisplatin) Chemotherapy as First-line Treatment of Participants With KRAS G12C-Mutant, Advanced or Metastatic Nonsquamous NSCLC (KANDLELIT-007)
2024-514500-14-00Participants with KRAS G12C-Mutant, Advanced or Metastatic …
Merck Sharp & Dohme LLC
Neoplasms
Germany, Italy, France, Poland, Spain, Hungary, Romania, Greece, Austria, Netherlands, Belgium
27/11/2025
Phase III
A Phase 3, Randomized, Open-label Study of Belzutifan + Zanzalintinib Versus Cabozantinib in Participants with Advanced RCC who Experienced Disease Recurrence During or After Prior Adjuvant Anti-PD-1/L1 Therapy (LITESPARK-033)
2024-517136-21-00Renal Cell Carcinoma
Merck Sharp & Dohme LLC
Neoplasms
Greece, Germany, France, Italy, Croatia, Denmark, Czechia, Austria, Belgium, Ireland, Spain, Poland
10/11/2025
Phase III
An Open-label, Randomized, Phase 3 Study to Evaluate Patritumab Deruxtecan Monotherapy versus Treatment of Physician’s Choice in Hormone Receptor-positive, HER2-negative Unresectable Locally Advanced or Metastatic Breast Cancer (HERTHENA-Breast04)
2025-520582-51-00Hormone receptor positive breast cancer
Merck Sharp & Dohme LLC
Neoplasms
Greece, Poland, France, Italy, Spain, Hungary, Germany
29/09/2025
Phase III
A Phase 3, Randomized, Open-label, Multicenter Clinical Study to Evaluate the Safety and Efficacy of MK-1084, Cetuximab, and mFOLFOX6 versus mFOLFOX6 With or Without Bevacizumab as First-line Treatment of Participants With KRAS G12C-mutant, Locally Advanced Unresectable or Metastatic Colorectal Cancer (KANDLELIT-012).
2024-517232-22-00KRAS G12C-mutant, Locally Advanced Unresectable or Metastat…
Merck Sharp & Dohme LLC
Neoplasms
Poland, Spain, Netherlands, Italy, Finland, Romania, France, Germany, Hungary
17/09/2025
Phase III
A Phase 3, Randomized, Double-Blind, Placebo-Controlled Program to Evaluate the Efficacy and Safety of Tulisokibart in Participants with Moderately to Severely Active Crohn’s Disease
2024-518296-56-00Crohn’s Disease
Merck Sharp & Dohme LLC
Digestive System Diseases
Spain, Austria, Lithuania, France, Belgium, Germany, Sweden, Czechia, Finland, Croatia, Latvia, Portugal, Netherlands, Italy, Denmark, Slovakia, Romania, Poland, Ireland, Hungary, Greece
03/09/2025
Phase III
A Phase 3, Randomized, Open-label Study to Evaluate the Efficacy and Safety of Sac-TMT (Sacituzumab Tirumotecan, MK-2870) Followed by Carboplatin/Paclitaxel vs Chemotherapy, Both in Combination With Pembrolizumab as Neoadjuvant Therapy for High-Risk Early-Stage Triple-Negative Breast Cancer (TNBC) or Hormone Receptor-low positive/HER2-negative Breast Cancer
2024-520190-12-00Breast Cancer: triple negative breast cancer (TNBC) and hor…
Merck Sharp & Dohme LLC
Neoplasms
France, Sweden, Poland, Spain, Finland, Portugal, Belgium, Czechia, Germany, Greece, Hungary, Italy, Romania, Norway
27/08/2025
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Cite this view

Priya Life Science (2026). EU Clinical Trials Register (CTIS), filtered. Derived from the EMA Clinical Trials Information System. Retrieved 19 September 2026. https://priyalifescience.com/clinical-trials-europe/country/italy

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Listing here is informational and not medical advice; eligibility is determined by each study team. Looking for Irish sites? See the Ireland, UK or USA registers. For approved medicines, see the EMA Approvals Tracker.