Kliinilise uuringu otsus nr RKU-4/37

Nooruse 1 / 50411 Tartu / 737 4140 / [email protected] / www.ravimiamet.ee / Registrikood 70003477

31.05.2024 nr RKU-4/37

OTSUS

Ravimi kliinilise uuringu loa andmiseks Euroopa Parlamendi ja nõukogu määruse (EL) nr

536/2014 (määrus (EL) 536/2014) alusel

Uuringu sponsor Merck Sharp & Dohme LLC esitas 29.04.2024 Ravimiametile taotluse

ravimi kliinilise uuringu teostamiseks määruse (EL) 536/2014 artikli 5 (1) ja ravimiseaduse

(RavS) § 991 lõikes 1 sätestatud tingimustel.

Tuginedes määruse (EL) 536/2014 artiklile 8, hindamisaruande I ja II osaga hõlmatud aspekte

hinnates, otsustab Ravimiamet ravimiseaduse § 996 lg 1 punkti 1 ja lõike 3 alusel

anda uuringu sponsorile Merck Sharp & Dohme LLC loa ravimi kliinilise uuringu

läbiviimiseks vastavalt esitatud uuringuplaanile nr MK-3475-585 järgmistel tingimustel:

uuringuplaani number: MK-3475-585 (versioon 10 kuupäevaga 20. november 2023)

uuringu referentsnumber: 19-060

uuringu nimetus: „A Phase III, Randomized, Double-Blind, Clinical Trial of Pembrolizumab

(MK-3475) Plus Chemotherapy (XP or FP) Versus Placebo Plus Chemotherapy (XP or FP)

as Neoadjuvant/Adjuvant Treatment for Subjects With Gastric and Gastroesophageal

Junction (GEJ) Adenocarcinoma (KEYNOTE-585)“

uuringu sponsor: Merck Sharp & Dohme LLC

uuritavate arv Eestis: 4

vastutavad uurijad ja uuringukeskused:

- Dr Anneli Elme, sihtasutus Põhja-Eesti Regionaalhaigla, J. Sütiste tee 19, 13419

Tallinn, Eesti

Vaide käesolevale otsusele saab esitada Ravimiametile 30 päeva jooksul arvates otsuse

teatavaks tegemisest vastavalt haldusmenetluse seaduse § 71 lõikele 1. Kui otsuse saaja soovib

otsust vaidlustada halduskohtus, võib ta vastavalt halduskohtumenetluse seadustiku § 7 lõikele

1 ja § 46 lõikele 1 esitada kaebuse otsuse peale Tartu Halduskohtule 30 päeva jooksul otsuse

teatavaks tegemisest arvates.

Katrin Moeschlin

Merck Sharp & Dohme LLC

126 East Lincoln Avenue P. O. Box 2000

07065-4607 Rahway

UNITED STATES

2 (2)

Lugupidamisega

(allkirjastatud digitaalselt)

Katrin Kiisk

Peadirektor

Nooruse 1 / 50411 Tartu / 737 4140 / [email protected] / www.ravimiamet.ee / Registrikood 70003477

31.05.2024 nr RKU-4/37

DECISION

to grant authorisation for clinical trial on the basis of Regulation (EU) No 536/2014 of the

European Parliament and of the council

State Agency of Medicines has received the application from sponsor Merck Sharp & Dohme

LLC on 29.04.2024 to conduct a clinical trial under the conditions stipulated in Regulation

(EU) No 536/2014 art 5 (1) and § 991 (1) of Estonian Medicinal Products Act (MPA).

Based on art 8 of Regulation (EU) No 536/2014, considering the aspects covered by Part I and

Part II of the assessment report, on the basis of § 996 section 1 p 1 and (3) of Medicinal Product

Act

State Agency of Medicines has decided to give the approval to conduct the clinical study

protocol no MK-3475-585 under the following conditions:

protocol no: MK-3475-585 (Version 10, dated November 20, 2023)

full title of the trial: A Phase III, Randomized, Double-Blind, Clinical Trial of

Pembrolizumab (MK-3475) Plus Chemotherapy (XP or FP) Versus Placebo Plus

Chemotherapy (XP or FP) as Neoadjuvant/Adjuvant Treatment for Subjects With Gastric and

Gastroesophageal Junction (GEJ) Adenocarcinoma (KEYNOTE-585)

sponsor of the trial: Merck Sharp & Dohme LLC

number of subjects in Estonia: 4

principal investigators and study locations:

- Dr Anneli Elme, North Estonia Medical Centre Foundation, J. Sütiste tee 19, 13419

Tallinn, Estonia

The addressee may file a challenge with State Agency of Medicines within 30 days as of the

day when the addressee became or should have become aware of the decision as prescribed in

Code of Administrative Procedure § 71(1). If the addressee wishes to have the decision to

annulled by the administrative court, he or she may submit a complaint to the Tartu

Administrative Court as prescribed in § 7(1) and § 46(1) of the Code of Administrative Court

Procedure within 30 days after the date on which the decision was notified to the applicant.

Katrin Moeschlin

Merck Sharp & Dohme LLC

126 East Lincoln Avenue P. O. Box 2000

07065-4607 Rahway

AMEERIKA ÜHENDRIIGID

2 (2)

(digitally signed)

Katrin Kiisk

Director General