A Study of Botensilimab and Balstilimab for the Treatment of Colorectal Cancer

PHASE2Active, not recruitingINTERVENTIONAL
Enrollment

234

Participants

Timeline

Start Date

November 30, 2022

Primary Completion Date

September 30, 2027

Study Completion Date

September 30, 2029

Conditions
Metastatic Colorectal Cancer
Interventions
DRUG

Botensilimab

An anti-cytotoxic T-lymphocyte antigen 4 (CTLA-4) monoclonal antibody.

DRUG

Balstilimab

An anti-programmed death (ligand) 1 \[PD-(L)1\] monoclonal antibody.

DRUG

Standard of Care

Regorafenib or trifluridine and tipiracil.

Trial Locations (65)

2650

Antwerp University Hospital (UZA), Edegem

3000

Universitair Ziekenhuis Leuven, Leuven

8035

Vall d'Hebron Institute of Oncology (VHIO), Barcelona

10021

Weill Cornell Medicine, New York

10029

Mount Sinai Hospital - New York, New York

10065

Memorial Sloan Kettering, New York

13009

Institut Paoli-Calmettes, Marseille

19713

Medical Oncology Hematology Consultants, Newark

20133

Fondazione IRCCS Instituto Nazionale dei Tumori, Milan

20162

ASST Grande Ospedale Metropolitano Niguarda, Milan

22031

Virginia Cancer Specialists/NEXT Virginia, Fairfax

25000

Service d'Oncologie Medicale - CHRU Besancon, Besançon

28027

Clínica Universidad de Navarra - Sede Madrid, Madrid

31008

Clínica Universidad de Navarra - Sede Pamplona, Pamplona

32746

Florida Cancer Specialists and Research Institute - Lake Mary, Lake Mary

35128

Istituto Oncologico Veneto-I.R.C.C.S. - Ospedale Busonera, Padua

37203

Tennessee Oncology Nashville (Sarah Cannon), Nashville

37215

Vanderbilt University School of Medicine, Nashville

39008

Hospital Universitario Marques de Valdecilla, Santander

44195

Cleveland Clinic, Cleveland

48084

University of Michigan, Ann Arbor

75012

Hôpital Saint Antoine/AP-HP Hopital Saint Antoine (Pierre and Marie Curie University), Paris

75246

Texas Oncology - Baylor Charles A. Sammons Cancer Center, Dallas

77030

MDACC, Houston

78705

Texas Oncology - Austin Midtown, Austin

80012

Rocky Mountain Cancer Center - Aurora, Aurora

80220

University of Colorado, Denver

85258

HonorHealth Research Institute, Scottsdale

86000

CHU Poitiers - Pole Regional de Cancerologie de Poitiers (PRC), Poitiers

90033

Keck School of Medicine of the University of Southern California, Los Angeles

91010

City of Hope National Medical Center, Duarte

94805

Unversite Paris-Saclay Gustave Roussy Cancer Center Campus Paris, Villejuif

97213

Earle A. Chiles Research Institute - Robert W. Franz Cancer Center - Providence Cancer Institute, Portland

97239

Oregon Health & Science University (OHSU), Portland

98104

Swedish Cancer Institute, Seattle

98684

Northwest Cancer Center Specialists - Vancouver Cancer Center - Compass Oncology Vancouver, Vancouver

111123

"State Budgetary Institution of Healthcare of the City of Moscow Moscow Clinical Scientific and Practical Center named after A.S. Loginov of the Department of Health of the City of Moscow", Moscow

119991

Federal State Autonomous Educational Institution of Higher Education I. M. Sechenov First Moscow State Medical University of the Ministry of Health of the Russian Federation, Moscow

121205

"Branch office of Hadassah Medical Ltd", Moscow

195271

"Clinical Hospital RZD-Medicine of Saint Petersburg", Saint Petersburg

197758

"Federal State Budgetary Institution National Medical Research Center of Oncology named after N.N.Petrov of the Ministry of Health of the Russian Federation", Saint Petersburg

"Napalkov SBHI Saint-Petersburg clinical scientific and practical center for specialised types of medical care (oncological)", Saint Petersburg

305524

"Regional Budgetary Healthcare Institution Kursk Oncological Research and Clinical Center named after G. E. Ostroverkhov", Kursk

350040

"State Budgetary Institution of Health Care Clinical Oncological Dispensary No. 1 of the Ministry of Health of the Krasnodar region", Krasnodar

454048

"Limited Liability Company EVIMED", Chelyabinsk

630099

"Closed Joint Stock Company Medical Center AVICENNA", Novosibirsk

634028

Siberian State Medical University, Tomsk

644013

"BHI of the Omsk region Clinical oncological dispensary", Omsk

656045

"Regional State Budgetary Institution of HealthcareAltai Regional Oncology Dispensary", Barnaul

02215

Beth Israel Deaconess Medical Center, Boston

Dana-Farber Cancer Institute, Boston

07960

Atlantic Health System - Morristown Medical Center, Morristown

02915

Lifespan Clinical Research Center/Cancer Institute (Providence Rhode Island), East Providence

17210-080

Centro de Pesquisas Clinicas da Fundação Doutor Amaral Carvalho, Jaú

70200-730

Hospital Sirio Libanes Brasilia, Brasília

98700-000

Oncosite - Centro de Pesquisa Clinica Em Oncologia, Ijuí

90110-270

Centro Gaucho Integrado de Oncologia, Hematologia, Ensino e Pesquisa, Porto Alegre

37554-216

Instituto Sul Mineiro de Oncologia - ONCOMINAS, Pouso Alegre

22775-001

Instituto Americas, Rio de Janeiro

01509-010

Hospital A.C. Camargo Cancer Center, São Paulo

04538-132

Centro Paulista de Oncologia, São Paulo

0144

High Technology Hospital Medcenter Ltd, Batumi

0159

Innova LLC, Tbilisi

Tbilisi Central Hospital Ltd, Tbilisi

Unknown

Saint-Petersburg Clinical Research Center of Specialized Types of Medical Care (Oncology), Saint Petersburg

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Agenus Inc.

INDUSTRY