Study of Quavonlimab (MK-1308) in Combination With Pembrolizumab (MK-3475) in Advanced Solid Tumors (MK-1308-001)

PHASE1/PHASE2CompletedINTERVENTIONAL
Enrollment

415

Participants

Timeline

Start Date

July 2, 2017

Primary Completion Date

April 8, 2024

Study Completion Date

April 8, 2024

Conditions
Advanced Solid Tumors
Interventions
BIOLOGICAL

Quavonlimab

Quavonlimab is administered intravenously (IV) during the Dose Escalation Phase and Dose Confirmation Phase at either DL1 or DL2, and is administered IV during the Efficacy Expansion Phase at DL2.

BIOLOGICAL

Pembrolizumab

Pembrolizumab is administered IV at PDL1 on Day 1 of each cycle starting Cycle 2 for the Dose Escalation Phase or starting Cycle 1 of the Dose Confirmation Phase. Pembrolizumab is administered IV at PDL2 on Day 1 of each cycle for the Efficacy Expansion Phase (Arm G).

DRUG

Pembrolizumab/Quavonlimab

Pembrolizumab/Quavonlimab is a coformulated product composed of quavonlimab at DL1 in combination with pembrolizumab at dose level 2 (PDL2).

Trial Locations (53)

1023

Auckland City Hospital ( Site 0016), Auckland

2065

Melanoma Institute Australia ( Site 0017), Wollstonecraft

2148

Blacktown Hospital. Western Sydney local health district ( Site 0009), Blacktown

2196

Sandton Oncology Medical Group PTY LTD ( Site 2701), Johannesburg

2298

Calvary Mater Newcastle ( Site 0025), Waratah

3004

Alfred Health ( Site 0018), Melbourne

3350

Ballarat Health Services ( Site 0022), Ballarat

4120

Gallipoli Medical Research Foundation-GMRF CTU ( Site 0019), Brisbane

4870

Cairns and Hinterland Hospital and Health Service ( Site 0020), Cairns

5037

Ashford Cancer Centre Research ( Site 0012), Kurralta Park

7570

Cape Town Oncology Trials Pty Ltd ( Site 2704), Kraaifontein

7700

Cancercare Rondebosch Oncology ( Site 2706), Rondebosch

8011

Canterbury District Health Board ( Site 0023), Christchurch

13005

Hopital La Timone ( Site 3303), Marseille

20014

Onkologikoa - Instituto Oncologico de San Sebastian ( Site 3405), Donostia / San Sebastian

33076

Institut Bergonie ( Site 3306), Bordeaux

35128

IRCCS Istituto Oncologico Veneto ( Site 3905), Padua

37203

Tennessee Oncology Nashville ( Site 0004), Nashville

41009

Hospital Universitario Virgen de la Macarena ( Site 3402), Seville

46014

Hospital General Universitario de Valencia ( Site 3404), Valencia

52621

Sheba Medical Center - Cancer Center ( Site 0002), Ramat Gan

53100

Policlinico Le Scotte - A.O. Senese ( Site 3907), Siena

59037

CHRU Lille - Hopital Claude Huriez ( Site 3302), Lille

69495

CH Lyon Sud Hospices Civils de Lyon ( Site 3307), Pierre-Bénite

78229

South Texas Accelerated Research Therapeutics, LLC (START) ( Site 0001), San Antonio

80131

Istituto Nazionale Tumori Fondazione Pascale ( Site 3903), Napoli

85234

Banner MD Anderson Cancer Center ( Site 0013), Gilbert

94800

Gustave Roussy ( Site 3305), Villejuif

100142

Beijing Cancer hospital-Digestive Oncology ( Site 5001), Beijing

310016

Sir Run Run Shaw Hospital-Medical Oncology ( Site 5003), Hangzhou

400030

Chongqing Cancer Hospital-Phase 1 Unite ( Site 5004), Chongqing

3109601

Rambam Medical Center ( Site 0003), Haifa

7500921

Fundacion Arturo Lopez Perez ( Site 5601), Santiago

9112001

Hadassah Ein Karem Hebrew University Medical Center ( Site 0021), Jerusalem

07601

John Theurer Cancer Center at Hackensack University Medical Center ( Site 0005), Hackensack

22031-4867

Inova Schar Cancer Institute ( Site 1001), Fairfax

M4N 3M5

Sunnybrook Research Institute ( Site 1103), Toronto

M5G 2M9

Princess Margaret Cancer Centre ( Site 1104), Toronto

H2X 0A9

Centre Hospitalier de l Universite de Montreal - CHUM ( Site 1102), Montreal

H3T 1E2

Jewish General Hospital ( Site 1105), Montreal

H4A 3J1

McGill University Health Centre ( Site 1101), Montreal

115 27

"Regional General Hospital of Athens Laiko ( Site 3001)", Athens

277-8577

National Cancer Center Hospital East ( Site 0014), Kashiwa

673-8558

Hyogo Cancer Center ( Site 0015), Akashi

60-780

Szpital Kliniczny im. Heliodora Swiecickiego Uniwers Medyczn ( Site 4803), Poznan

02-781

Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie - P-Oddzial Badan Wczesnych Faz ( Site 4801, Warsaw

05505

Asan Medical Center ( Site 0006), Seoul

03080

Seoul National University Hospital ( Site 0007), Seoul

03722

Severance Hospital Yonsei University Health System ( Site 0008), Seoul

06351

Samsung Medical Center ( Site 0010), Seoul

08908

Instituto Catalan de Oncologia ICO - Hospital Duran i Reynals ( Site 3403), L'Hospitalet de Llobregat

08036

Hospital Clinic i Provincial de Barcelona ( Site 3401), Barcelona

221 85

Skanes Universitetssjukhus Lund. ( Site 4601), Lund

All Listed Sponsors
lead

Merck Sharp & Dohme LLC

INDUSTRY

NCT03179436 - Study of Quavonlimab (MK-1308) in Combination With Pembrolizumab (MK-3475) in Advanced Solid Tumors (MK-1308-001) | Biotech Hunter | Biotech Hunter