NCT02861573 - Study of Pembrolizumab (MK-3475) Combination Therapies in Metastatic Castration-Resistant Prostate Cancer (MK-3475-365/KEYNOTE-365) | Biotech Hunter

Enrollment

1,200

Participants

Timeline

Start Date

November 17, 2016

Primary Completion Date

October 22, 2027

Study Completion Date

October 22, 2027

Conditions

Metastatic Castration-Resistant Prostate Cancer

Interventions

BIOLOGICAL

Pembrolizumab 200 mg

IV Q3W

DRUG

Olaparib 400 mg

Eight 50-mg capsules PO BID

DRUG

Docetaxel 75 mg/m^2

IV Q3W

DRUG

Prednisone 5 mg

One 5-mg tablet PO BID

DRUG

Enzalutamide 160 mg

Four 40-mg capsules, four 40-mg tablets, or two 80-mg tablets PO QD

OTHER

Dexamethasone 8 mg

Premedication for Cohort B given PO at 12, 3, and 1 hours prior to docetaxel infusion Q3W

DRUG

Olaparib 300 mg

Two 150-mg tablets PO BID

DRUG

Abiraterone acetate 1000 mg

Two 500-mg or four 250-mg tablets PO QD

DRUG

Lenvatinib

20 mg PO QD

BIOLOGICAL

Pembrolizumab/Vibostolimab coformulation

IV Q3W

DRUG

Carboplatin

IV Q3W

DRUG

Etoposide

IV on Days 1, 2 and 3 of each cycle

BIOLOGICAL

Belzutifan 120mg

PO QD

Trial Locations (24)

15232

RECRUITING

Call for Information (Investigational Site 0008), Pittsburgh

29401

RECRUITING

Call for Information (Investigational Site 2065), Charleston

29572

RECRUITING

Call for Information (Investigational Site 0019), Myrtle Beach

44195

RECRUITING

Call for Information (Investigational Site 2091), Cleveland

80045

RECRUITING

Call for Information (Investigational Site 2041), Aurora

90404

RECRUITING

Call for Information (Investigational Site 0005), Los Angeles

97239

RECRUITING

Call for Information (Investigational Site 2027), Portland

RECRUITING

Call for Information (Investigational Site 2094), Portland

98109

RECRUITING

Call for Information (Investigational Site 0016), Seattle

Unknown

RECRUITING

MSD Australia, North Ryde

RECRUITING

MSD Denmark, Glostrup Municipality

RECRUITING

MSD France, Paris

RECRUITING

MSD Sharp & Dohme GmbH, München

RECRUITING

MSD Ireland (Human Health) Ltd., Dublin

RECRUITING

MSD Italia S.r.l., Rome

RECRUITING

MSD Comercializadora, S. de R.L. de C.V., Mexico City

RECRUITING

Merck Sharp & Dohme BV, Haarlem

RECRUITING

Merck Sharp & Dohme (New Zealand) Ltd.,, Auckland

RECRUITING

MSD Polska Sp. Z o.o., Warsaw

RECRUITING

Merck Sharp and Dohme de Espana S.A., Madrid

RECRUITING

MSD Sweden, Stockholm

RECRUITING

Merck Sharp & Dohme Ilaclari Ltd. Sti, Istanbul

RECRUITING

Merck Sharp & Dohme Ltd., London

H9H 4M7

RECRUITING

Merck Canada, Kirkland

All Listed Sponsors

lead

Merck Sharp & Dohme LLC

INDUSTRY