Phase
Condition
Rectal Cancer
Colon Cancer
Colon Cancer; Rectal Cancer
Treatment
RO7589831
Pembrolizumab
Bevacizumab
Clinical Study ID
Ages > 18 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1
Have a microsatellite instability (MSI) and/or deficient mismatch repair (dMMR),histologically or cytologically documented advanced (unresectable and/or metastatic)solid tumor; For the combination with bevacizumab only: advanced, or metastaticcolorectal adenocarcinoma (CRC) treated with at least 2 but no more than 3 priorlines of systemic therapy for the treatment of advanced CRC; For the combinationwith pembrolizumab only: Histologically confirmed locally advanced, or metastaticCRC with no prior systemic treatment for metastatic disease and not amenable tosurgery
Have received and then progressed following, or are intolerant to, standard therapyin the advanced setting
Presence of measurable disease according to Response Evaluation Criteria in SolidTumors (RECIST) version 1.1
Life expectancy of at least (≥)12 weeks
Availability of formaldehyde-fixed paraffin-embedded (FFPE) archival tumor tissuefor submission to Sponsor/central laboratory for retrospective central testing; forparticipants without archival tissue, a biopsy from either primary or metastatictumor lesion, deemed medically feasible, must be taken
Adequate hematologic, end-organ, and cardiovascular function, as defined in theprotocol
Exclusion
Exclusion Criteria:
Inability or unwillingness to swallow pills
Malabsorption syndrome or other condition that would interfere with enteralabsorption
Known hypersensitivity or intolerance to ingredients from the study drug formulationincluding patients with rare genetic disorders such as galactosaemia,glucose-galactose intolerance or congenital lactase deficiency
Known uncontrolled central nervous system (CNS) metastases (progressing or requiringanticonvulsants or corticosteroids for symptomatic control) and/or carcinomatousmeningitis
Known active or uncontrolled bacterial, viral, fungal, mycobacterial (including butnot limited to tuberculosis and atypical mycobacterial disease), parasitic, or otherinfection (excluding fungal infections of nail beds), or any major episode ofinfection requiring treatment with intravenous antibiotics or hospitalization within 2 weeks prior to the start of drug administration (related to the completion of thecourse of antibiotics, except if for tumor fever) or 6 months for any intracranialabscess
Has a positive test at screening for hepatitis B virus, hepatitis C virus, or forhuman immodeficiency virus (HIV), per local diagnostic standard and in accordancewith local laws and regulations
Uncontrolled diabetes or symptomatic hyperglycemia (i.e., well controlled defined asa screening hemoglobin A1c <8% and no urinary ketoacidosis)
Significant cardiovascular/cerebrovascular disease within 6 months prior to Day 1 ofstudy drug administration
Alcohol or drug dependence or abuse
Patients with known Werner (WRN) syndrome
Prior treatment with any WRN helicase inhibitor
Treatment with moderate or strong CYP3A4 inducers within 14 days prior to initiationof study treatment
Treatment with moderate or strong CYP3A4 or P-glycoprotein inhibitors within 14 daysprior to initiation of study treatment
Pregnancy, breastfeeding, or intention of becoming pregnant during the study
Additional Exclusion Criteria for the Combination with Bevacizumab Only:
Had major surgery within 4 weeks prior to study drug administration
Deep venous thrombosis (DVT) or pulmonary embolism (PE) within 12 weeks prior tostudy drug administration
Known coagulopathy that increases the risk of bleeding
Patients with Grade 2+ proteinuria (exception: if 24-hour urinary protein is lessthan 1.0 gm/24 hours)
Additional Exclusion Criteria for the Combination with Pembrolizumab Only:
Active or history of autoimmune disease or immune deficiency with some exceptions
History of interstitial lung disease or pneumonitis
Treatment with systemic immunosuppressive medication (such as corticosteroids)within 2 weeks prior to initiation of study treatment with some exceptions
Treatment with organ transplant/graft tissue
Study Design
Connect with a study center
St Vincents Sydney
Darlinghurst, New South Wales 2010
AustraliaActive - Recruiting
Alfred Hospital
Melbourne, Victoria 3181
AustraliaActive - Recruiting
UZ Leuven Gasthuisberg
Leuven, 3000
BelgiumActive - Recruiting
BCCA-Vancouver Cancer Centre
Vancouver, British Columbia V5Z 4E6
CanadaCompleted
Princess Margaret Cancer Center
Toronto, Ontario M5G 2M9
CanadaActive - Recruiting
Rigshospitalet
København Ø, 2100
DenmarkActive - Recruiting
Rigshospitalet; Onkologisk Klinik
København Ø, 2100
DenmarkActive - Recruiting
CLCC Leon Berard Lyon
Lyon, 69008
FranceCompleted
Gustave Roussy
Villejuif, 94805
FranceActive - Recruiting
Asan Medical Center
Seoul, 05505
Korea, Republic ofActive - Recruiting
Sarawak Public Hospital
Kuching, Sarawak 93586
MalaysiaActive - Recruiting
Kyungpook National University Chilgok Hospital
Daegu, 41404
South KoreaSite Not Available
National Cancer Center
Gyeonggi-do, 10408
South KoreaSite Not Available
Seoul National University Bundang Hospital
Seongnam-si, 13620
South KoreaSite Not Available
Asan Medical Center
Seoul, 05505
South KoreaSite Not Available
Samsung Medical Center
Seoul, 06355
South KoreaSite Not Available
Seoul National University Hospital
Seoul, 03080
South KoreaActive - Recruiting
Severance Hospital
Seoul, 33732
South KoreaSite Not Available
Asan Medical Center
Seoul 1835848, 05505
South KoreaActive - Recruiting
Vall d'Hebron Institute of Oncology (VHIO), Barcelona
Barcelona, BARCELONA 08035
SpainActive - Recruiting
Clinica Universidad de Navarra Madrid
Madrid, Madrid 28027
SpainActive - Recruiting
START Madrid. Centro Integral Oncologico Clara Campal
Madrid, Madrid 28050
SpainActive - Recruiting
Clinica Universidad de Navarra Madrid
Madrid 3117735, Madrid 3117732 28027
SpainSite Not Available
Clinica Universitaria de Navarra; Servicio de Oncologia
Pamplona, Navarra 31008
SpainActive - Recruiting
Clinica Universitaria de Navarra
Pamplona, Navarre 31008
SpainSite Not Available
Hospital Clinico Universitario de Valencia
Valencia, Valencia 46010
SpainSite Not Available
Vall d?Hebron Institute of Oncology (VHIO), Barcelona
Barcelona 3128760, 08035
SpainSite Not Available
Clinica Universidad de Navarra Madrid; Servicio de Oncología
Madrid, 28027
SpainActive - Recruiting
START Madrid. Centro Integral Oncologico Clara Campal; CIOCC
Madrid, 28050
SpainActive - Recruiting
START Madrid. Centro Integral Oncologico Clara Campal
Madrid 3117735, 28050
SpainSite Not Available
Hospital Clinico Universitario de Valencia; Servicio de Onco-hematologia
Valencia, 46010
SpainActive - Recruiting
Hospital Clinico Universitario de Valencia
Valencia 2509954, 46010
SpainSite Not Available
Royal Marsden Hospital - Fulham
London, SW3 6JJ
United KingdomActive - Recruiting
Sarah Cannon Research Institute
London, W1G 6AD
United KingdomActive - Recruiting
The Christie
Manchester, M20 4BX
United KingdomSite Not Available
Royal Marsden Hospital (Sutton)
Sutton, SM2 5PT
United KingdomActive - Recruiting
City of Hope
Duarte, California 91010
United StatesActive - Recruiting
City of Hope Cancer Center
Duarte, California 91010
United StatesActive - Recruiting
City of Hope at Irvine Lennar
Irvine, California 91355
United StatesActive - Recruiting
START Los Angeles
Los Angeles, California 90025
United StatesSite Not Available
Emory University School of Medicine
Atlanta, Georgia 30322
United StatesActive - Recruiting
Norton Cancer Institute - MDC
Louisville, Kentucky 40202
United StatesActive - Recruiting
University of Michigan
Ann Arbor, Michigan 48109
United StatesSite Not Available
START Midwest
Grand Rapids, Michigan 49546
United StatesSite Not Available
Rutgers Cancer Institute of New Jersey
New Brunswick, New Jersey 08901
United StatesActive - Recruiting
Duke University
Durham, North Carolina 27705
United StatesCompleted
Duke University; Office of Research Contracts
Durham, North Carolina 27705
United StatesActive - Recruiting
Oklahoma University Health Sciences Center
Oklahoma City, Oklahoma 73170
United StatesActive - Recruiting
Stephenson Cancer Center Investigational Pharmacy
Oklahoma City, Oklahoma 73104
United StatesSite Not Available
SCRI Oncology Partners
Nashville, Tennessee 37203
United StatesActive - Recruiting
MD Anderson Cancer Center
Houston, Texas 77030
United StatesActive - Recruiting
START San Antonio
San Antonio, Texas 78229
United StatesSite Not Available
START Mountain Region
West Valley City, Utah 84119
United StatesSite Not Available

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