A Study of the Safety, Pharmacokinetics, and Therapeutic Activity of RO6958688 in Combination With Atezolizumab in Participants With Locally Advanced and/or Metastatic Carcinoembryonic Antigen (CEA)-Positive Solid Tumors

PHASE1CompletedINTERVENTIONAL
Enrollment

228

Participants

Timeline

Start Date

January 7, 2016

Primary Completion Date

January 13, 2020

Study Completion Date

January 13, 2020

Conditions
Solid Tumors
Interventions
DRUG

Atezolizumab

Atezolizumab will be administered at a fixed dose of 1200 milligrams (mg) by intravenous (IV) infusion.

DRUG

RO6958688

"RO6958688 is administered by IV infusion~In Part IA: RO6958688 is administered weekly (QW) on days 1,8 and 15 of each 21-day cycle.~In Part 1b: RO6958688 is administered weekly (QW) or every 3 weeks (Q3W). Cohort A: RO6958688 starting dose will be 100 mg either QW or Q3W.~Step Up dose cohorts: RO6958688 starting dose will be 40mg and increase with each administration up to the MTD or 1200 mg whichever is lower."

Trial Locations (24)

2100

Rigshospitalet; Onkologisk Klinik, København Ø

10032

Columbia Univ Med Ctr, New York

10065

Memorial Sloan Kettering Cancer Center, New York

27710

Duke Cancer Center, Durham

28040

START Madrid-FJD, Hospital Fundacion Jimenez Diaz, Madrid

28041

Hospital Universitario 12 de Octubre; Servicio de Oncologia, Madrid

28050

START Madrid. Centro Integral Oncologico Clara Campal; CIOCC, Madrid

29425

Medical University of South Carolina, Charleston

31008

Clinica Universitaria de Navarra; Servicio de Oncologia, Pamplona

38138

Sarah Cannon Cancer Center, Germantown

53100

Azienda Ospedaliera Universitaria Senese, U.O.C. Immunoterapia Oncologica, Siena

69373

Centre Leon Berard; Departement Oncologie Medicale, Lyon

77030

MD Anderson Cancer Center, Houston

80045

University Of Colorado, Aurora

80131

IRCCS IST. Tumori Fondaz. Pascale; S.C. Oncologia Medica,Melanoma,Immunoterapia E Terapie Innovative, Napoli

90404

UCLA Cancer Center, Santa Monica

94305

Stanford Comprehensive Cancer Center, Stanford

94805

Institut Gustave Roussy, Villejuif

06510

Smilow Cancer Hospital at Yale- New Haven Oncology Investigational Drug Pharmacy, New Haven

02215

Dana Farber Can Ins, Boston

M5G 1Z5

Princess Margaret Cancer Center, Toronto

1066 CX

Antoni Van Leeuwenhoek Ziekenhuis; Gastro-Enterologie, Amsterdam

08003

Hospital del Mar; Servicio de Oncologia, Barcelona

08035

Hospital Univ Vall d'Hebron; Servicio de Oncologia, Barcelona

All Listed Sponsors
lead

Hoffmann-La Roche

INDUSTRY

NCT02650713 - A Study of the Safety, Pharmacokinetics, and Therapeutic Activity of RO6958688 in Combination With Atezolizumab in Participants With Locally Advanced and/or Metastatic Carcinoembryonic Antigen (CEA)-Positive Solid Tumors | Biotech Hunter | Biotech Hunter