Adenosine Receptor Antagonist Combination Therapy for Metastatic Castrate Resistant Prostate Cancer
NCT ID: NCT04381832
Last Updated: 2025-07-22
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1/PHASE2
173 participants
INTERVENTIONAL
2020-07-07
2024-08-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Stage 1 and 2: Etrumadenant + zimberelimab + enzalutamide
Participants will receive oral etrumadenant in combination with intravenous (IV) zimberelimab and standard oral enzalutamide
Etrumadenant
Etrumadenant is an A2aR and A2bR antagonist
Zimberelimab
Zimberelimab is an anti-PD-1 antibody
Enzalutamide
Enzalutamide is an androgen receptor inhibitor
Stage 2: enzalutamide
Participants will receive standard oral enzalutamide
Enzalutamide
Enzalutamide is an androgen receptor inhibitor
Stage 1 and 2: Etrumadenant + zimberelimab + docetaxel
Participants will receive oral etrumadenant in combination with IV zimberelimab and standard IV docetaxel
Etrumadenant
Etrumadenant is an A2aR and A2bR antagonist
Zimberelimab
Zimberelimab is an anti-PD-1 antibody
Docetaxel
Docetaxel is type of chemotherapy
Stage 2: docetaxel
Participants will receive standard dose of IV docetaxel
Docetaxel
Docetaxel is type of chemotherapy
Stage 1 and 2: Etrumadenant + zimberelimab
Oral etrumadenant in combination IV zimberelimab
Etrumadenant
Etrumadenant is an A2aR and A2bR antagonist
Zimberelimab
Zimberelimab is an anti-PD-1 antibody
Stage 2: Etrumadenant + zimberelimab + quemliclustat
Participants will receive oral etrumadenant in combination with IV zimberelimab and IV quemliclustat
Etrumadenant
Etrumadenant is an A2aR and A2bR antagonist
Zimberelimab
Zimberelimab is an anti-PD-1 antibody
Quemliclustat
Quemliclustat is a Cluster of Differentiation (CD)73 Inhibitor.
Stage 2: Etrumadenant + quemliclustat
Participants will receive oral etrumadenant in combination with IV quemliclustat
Etrumadenant
Etrumadenant is an A2aR and A2bR antagonist
Quemliclustat
Quemliclustat is a Cluster of Differentiation (CD)73 Inhibitor.
Stage 1: Etrumadenant + zimberelimab PK Sub-Study
Participants will receive oral etrumadenant in combination with IV zimberelimab
Etrumadenant
Etrumadenant is an A2aR and A2bR antagonist
Zimberelimab
Zimberelimab is an anti-PD-1 antibody
Stage 1 and 2: Etrumadenant + SG
Participants will receive oral etrumadenant in combination with IV SG.
Etrumadenant
Etrumadenant is an A2aR and A2bR antagonist
SG
Sacituzumab govitecan is an antibody-drug conjugate
Stage 1 and 2: Etrumadenant + Zimberelimab + SG
Participants will receive oral etrumadenant in combination with IV zimberelimab and SG.
Etrumadenant
Etrumadenant is an A2aR and A2bR antagonist
Zimberelimab
Zimberelimab is an anti-PD-1 antibody
SG
Sacituzumab govitecan is an antibody-drug conjugate
Interventions
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Etrumadenant
Etrumadenant is an A2aR and A2bR antagonist
Zimberelimab
Zimberelimab is an anti-PD-1 antibody
Quemliclustat
Quemliclustat is a Cluster of Differentiation (CD)73 Inhibitor.
Enzalutamide
Enzalutamide is an androgen receptor inhibitor
Docetaxel
Docetaxel is type of chemotherapy
SG
Sacituzumab govitecan is an antibody-drug conjugate
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Metastatic castrate-resistant prostate cancer while on anti-androgen treatment with castrate levels of testosterone (≤1.7 nanomoles per liter \[nmol/L\] or 50 nanograms per deciliter \[ng/dL\])
* Measurable or non-measurable disease as per radiographic evaluation
* Participants with measurable disease may require a fresh tumor biopsy at study entry
* Eastern Cooperative Oncology Group (ECOG) Performance status of 0 or 1
* Life expectancy of at least 3 months
* Adequate hematologic and end-organ function
* Human immunodeficiency virus (HIV), Hepatitis B, and C test results negative prior to first study treatment
* Disease progression after prior treatment with abiraterone
* Disease progression after prior androgen synthesis inhibitor therapy
* Disease progression after prior androgen synthesis inhibitor treatment and up to 2 prior lines of taxane chemotherapy
Exclusion Criteria
* Prior anticancer treatment including approved agents, systemic radiotherapy, or investigational therapy, within 2-4 weeks prior first study treatment
* Corrected QT interval (QTc) ≥480 msec using Fredericia's QT correction formula (based on an average of triplicate recordings)
* Prior allogeneic stem cell or solid organ transplantation
* Prior treatment with drugs that stimulate the immune system within 4 weeks prior to first study treatment
* Prior treatment with drugs that suppress the immune system within 2 weeks prior to first study treatment
* Received a live, attenuated vaccine within 4 weeks prior to first study treatment, or may need to receive a vaccine during study treatment
* Presence of metastases in the brain or cancer spreading into the cerebrospinal fluid - CSF (leptomeningeal disease)
* Prior pulmonary fibrosis, pneumonia, or pneumonitis
* Cancer other than prostate within 2 years prior to study entry, except for some cancers with a low risk of spreading like non-melanoma skin
* Prior treatment with an agent targeting the adenosine pathway
* No oral or IV antibiotics within 2 weeks prior to first study treatment
* No severe infection within 4 weeks prior to first study treatment
* No clinically significant cardiac disease
* Inability to swallow medications
* Prior treatment with docetaxel, cabazitaxel, or other taxane chemotherapy (prior docetaxel \[up to 6 cycles\] for hormone-sensitive prostate cancer is allowed if the last dose was at least 6 months prior to study treatment initiation)
* Prior treatment with enzalutamide or similar therapy other than abiraterone
* Active or history of autoimmune disease or immune deficiency
* History of severe allergic reactions to antibody therapy
* Concomitant use of a medication prohibited by the protocol (including certain transporter substrates as well as known strong CYP3A4 inducers and CYP3A4 inhibitors) within 4 weeks prior to and throughout study treatment
* Prior treatment with docetaxel, cabazitaxel, or other taxane chemotherapy
* Active or history of autoimmune disease or immune deficiency
* History of severe allergic reactions to antibody therapy
* Concomitant use of a medication prohibited by the protocol (including certain transporter substrates as well as known strong CYP3A4 inducers and CYP3A4 inhibitors) within 4 weeks prior to and throughout study treatment
* Prior treatment with docetaxel, cabazitaxel, topoisomerase 1 inhibitors, or other taxane chemotherapy
* Active or history of autoimmune disease or immune deficiency
* History of severe allergic reactions to antibody therapy
* Concomitant use of a medication prohibited by the protocol (including certain transporter substrates as well as known strong CYP3A4 inducers and CYP3A4 inhibitors) within 4 weeks prior to and throughout study treatment
18 Years
MALE
No
Sponsors
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Gilead Sciences
INDUSTRY
Arcus Biosciences, Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Medical Director
Role: STUDY_DIRECTOR
Arcus Biosciences
Locations
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The Oncology Institute of Hope & Innovation
Cerritos, California, United States
The University of California, Los Angeles
Encino, California, United States
The University of California, Irvine Medical Center
Orange, California, United States
Florida Cancer Specialists South
Sarasota, Florida, United States
Florida Cancer Specialists North
St. Petersburg, Florida, United States
Florida Cancer Specialists Panhandle
Tallahassee, Florida, United States
Florida Cancer Specialists East
West Palm Beach, Florida, United States
Northwestern University Feinberg School of Medicine
Chicago, Illinois, United States
Affinity Health Hope & Healing Cancer Services
Hinsdale, Illinois, United States
Johns Hopkins University
Baltimore, Maryland, United States
New York University, Langone Health
New York, New York, United States
Wilmot Cancer Institute Oncology, University of Rochester
Rochester, New York, United States
Cleveland Clinic
Cleveland, Ohio, United States
Tennessee Oncology - Chattanooga
Chattanooga, Tennessee, United States
Tennessee Oncology - Nashville
Nashville, Tennessee, United States
MD Anderson Cancer Center
Houston, Texas, United States
Medical Oncology Associates, PS (dba Summit Cancer Centers)
Spokane, Washington, United States
Juravinski Cancer Center
Hamilton, Ontario, Canada
Centre hospitalier de l'Université de Montréal (CHUM) Centre de Recherche
Montreal, Quebec, Canada
Countries
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Other Identifiers
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ARC-6
Identifier Type: -
Identifier Source: org_study_id
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