A Study to Evaluate Safety and Therapeutic Activity of RO6874281 in Combination with Pembrolizumab, in Participants with Advanced or Metastatic Melanoma

PHASE1CompletedINTERVENTIONAL
Enrollment

83

Participants

Timeline

Start Date

June 24, 2019

Primary Completion Date

July 14, 2022

Study Completion Date

July 14, 2022

Conditions
Metastatic Melanoma
Interventions
DRUG

RO6874281

"Part I Safety Run in:~Cohort 1.1: RO6874281 will be administered by intravenous (IV) infusion; 10 mg (Q3W) every 3 weeks and will be observed over 2 administration cycles (i.e. 6 weeks) in order to confirm the safety of the proposed dose and schedule that will be used in Part II of this study.~Cohort 1.2: RO6874281 will be administered by IV infusion via an induction and maintenance phase; 10 mg (QW) every week for 3 weeks followed by 10 mg (Q3W) every 3 weeks and will be observed over 2 administration cycles (6 weeks) to confirm safety of the proposed dose and schedule to be used in Part III of this study.~Part II Expansion: RO6874281 will be administered by IV infusion; 10 mg (Q3W) every 3 weeks (or lower dose level depending on Part I Cohort 1.1 outcome).~Part III Expansion: RO6874281 will be administered by IV infusion; 10 mg (QW) every week or 10mg (Q3W) every 3 weeks (or lower dose level depending on Part I Cohorts 1.1 and 1.2 outcomes) in either a Q3W or QW/Q3W schedule."

DRUG

Pembrolizumab

"Part I Safety Run in (Cohorts 1.1 and 1.2): Pembrolizumab will be administered by IV; 200 mg Q3W and will be observed over 2 administration cycles (i.e. 6 weeks).~Part II Expansion: Pembrolizumab will be administered by IV; 200 mg Q3W (or lower dose level depending on Part I Cohort 1.1 outcome)~Part III Expansion: Pembrolizumab will be administered by IV; 200 mg Q3W (or lower dose level depending on Part I Cohorts 1.1 and 1.2 outcomes)"

Trial Locations (23)

2060

Melanoma Institute Australia, North Sydney

2650

UZ Antwerpen, Edegem

3000

Peter Maccallum Cancer Institute; Clinical Trial Unit, Melbourne

UZ Leuven Gasthuisberg, Leuven

13005

Hôpital de la Timone; Dermatologie, Marseille

28027

Clinica Universidad de Navarra Madrid; Servicio de Oncología, Madrid

28034

Hospital Ramon y Cajal; Servicio de Oncologia, Madrid

31008

Clinica Universitaria de Navarra; Servicio de Oncologia, Pamplona

35042

Centre Eugene Marquis; Service d'oncologie, Rennes

52242

University of Iowa, Iowa City

59037

Hopital Claude Huriez; Sce Dermatologie, Lille

94805

Institut Gustave Roussy; Dermatologie, Villejuif

105229

Main Military Clinical Hospital named after N.N. Burdenko, Moscow

115478

Russian Oncology Research Center n.a. N.N. Blokhin, Moscow

125284

P.A. Gertsen Cancer Research Inst. ; Chemotherapy Dept, Moscow

06510

Yale University, New Haven

02215

Beth Israel Deaconess Med Ctr, Boston

Dana Farber Cancer Institute, Boston

M5G 1Z5

Princess Margaret Cancer Centre, Toronto

H3T 1E2

Jewish General Hospital, Montreal

Unknown

"FBI Scientific Research Institute of Oncology n. a. N. N. Petrov", Saint Petersburg

08035

Hospital Universitari Vall d'Hebron; Oncology, Barcelona

08036

Hospital Clínic i Provincial; Servicio de Oncología, Barcelona

All Listed Sponsors
lead

Hoffmann-La Roche

INDUSTRY

NCT03875079 - A Study to Evaluate Safety and Therapeutic Activity of RO6874281 in Combination with Pembrolizumab, in Participants with Advanced or Metastatic Melanoma | Biotech Hunter | Biotech Hunter