Ignite Creation Date:
2025-12-24 @ 9:25 PM
Ignite Modification Date:
2026-01-09 @ 6:16 AM
Study NCT ID:
NCT04381832
Status:
COMPLETED
Last Update Posted:
2025-07-22
First Post:
2020-05-06
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Adenosine Receptor Antagonist Combination Therapy for Metastatic Castrate Resistant Prostate Cancer
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'submissionInfos': [{'resetDate': '2025-12-11', 'mcpReleaseN': 42, 'releaseDate': '2025-11-20'}], 'estimatedResultsFirstSubmitDate': '2025-11-20'}}, 'conditionBrowseModule': {'meshes': [{'id': 'D064129', 'term': 'Prostatic Neoplasms, Castration-Resistant'}], 'ancestors': [{'id': 'D011471', 'term': 'Prostatic Neoplasms'}, {'id': 'D005834', 'term': 'Genital Neoplasms, Male'}, {'id': 'D014565', 'term': 'Urogenital Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D005832', 'term': 'Genital Diseases, Male'}, {'id': 'D000091662', 'term': 'Genital Diseases'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D011469', 'term': 'Prostatic Diseases'}, {'id': 'D052801', 'term': 'Male Urogenital Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C000719848', 'term': 'zimberelimab'}, {'id': 'C000723779', 'term': 'quemliclustat'}, {'id': 'C540278', 'term': 'enzalutamide'}, {'id': 'D000077143', 'term': 'Docetaxel'}, {'id': 'C000608132', 'term': 'sacituzumab govitecan'}], 'ancestors': [{'id': 'D043823', 'term': 'Taxoids'}, {'id': 'D043822', 'term': 'Cyclodecanes'}, {'id': 'D003516', 'term': 'Cycloparaffins'}, {'id': 'D006840', 'term': 'Hydrocarbons, Alicyclic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D004224', 'term': 'Diterpenes'}, {'id': 'D013729', 'term': 'Terpenes'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1', 'PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 173}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-07-07', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-09', 'dispFirstSubmitDate': '2025-07-18', 'completionDateStruct': {'date': '2024-08-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-07-18', 'studyFirstSubmitDate': '2020-05-06', 'studyFirstSubmitQcDate': '2020-05-06', 'dispFirstPostDateStruct': {'date': '2024-09-19', 'type': 'ACTUAL'}, 'lastUpdatePostDateStruct': {'date': '2025-07-22', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-05-11', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-08-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Objective Response Rate (ORR) in Stage 1 and 2', 'timeFrame': 'From study enrolment until participant discontinuation, or first occurrence of progressive disease, or death from any cause, whichever occurs first (approximately 3-5 years)', 'description': 'ORR defined as the composite proportion of participants with a Prostate Specific Antigen (PSA) and/or radiographic complete response (CR) and partial response (PR) determined by the investigator according to the Prostate Cancer Working Group 3 (PCWG3) criteria'}, {'measure': 'Incidence and Severity of AEs and Serious Adverse Events (SAEs) in Stage 1', 'timeFrame': 'From first dose date to 90 days after the last dose (approximately 1.5 years)'}], 'secondaryOutcomes': [{'measure': 'Percentage of participants with a PSA response in Stage 1 and 2', 'timeFrame': 'From study enrollment until disease progression or loss of clinical benefit (approximately 3-5 years)', 'description': 'PSA response defined as the proportion of participants with a confirmed PSA decrease from baseline of 50% or more based on two consecutive assessments measured 3 to 4 weeks apart'}, {'measure': 'Percentage of participants with Radiographic Response in Stage 1 and 2', 'timeFrame': 'From study enrollment until disease progression or loss of clinical benefit (approximately 3-5 years)', 'description': 'Radiographic Response is measurable disease at baseline who achieved a best overall response of CR or PR according to the Response Evaluation Criteria in Solid Tumors (RECIST) v1.1'}, {'measure': 'Percentage of Participants with Disease Control Rate in Stage 1 and 2', 'timeFrame': 'From study enrollment until disease progression or loss of clinical benefit (approximately 3-5 years)', 'description': 'Disease Control Rate is defined as the percentage of participants with measurable disease at baseline who achieved a best overall RECIST response of CR, PR, or Stable Disease (SD).'}, {'measure': 'Serum/Plasma Concentration for etrumadenant, zimberelimab, and enzalutamide when administered as part of a combination regimen in Stage 1 and 2.', 'timeFrame': 'Recorded at baseline (enrollment), during the first 5 months of treatment and 3 additional timepoints in the first year of treatment. (approximately 1.5 years)'}, {'measure': 'Serum/Plasma Concentration for etrumadenant and zimberelimab when administered as part of a combination regimen with docetaxel in Stage 1 and 2', 'timeFrame': 'Recorded at baseline (enrollment), during the first 5 months of treatment and 3 additional timepoints in the first year of treatment. (approximately 1.5 years)'}, {'measure': 'Serum/Plasma Concentration for etrumadenant and zimberelimab when administered as part of a combination regimen in Stage 1 and 2', 'timeFrame': 'Recorded at baseline (enrollment), during the first 5 months of treatment and 3 additional timepoints in the first year of treatment. (approximately 1.5 years)'}, {'measure': 'Serum/Plasma Concentration for etrumadenant, zimberelimab, and AB680 when administered as part of a combination regimen in Stage 1 and 2', 'timeFrame': 'Recorded at baseline (enrollment), during the first 5 months of treatment and 3 additional timepoints in the first year of treatment. (approximately 1.5 years)'}, {'measure': 'Serum/Plasma Concentration for etrumadenant and AB680 when administered as part of a combination regimen in Stage 1 and 2.', 'timeFrame': 'Recorded at baseline (enrollment), during the first 5 months of treatment and 3 additional timepoints in the first year of treatment. (approximately 1.5 years)'}, {'measure': 'Percentage of participants with anti-drug antibodies to zimberelimab in Stage 1 and 2', 'timeFrame': 'Recorded at baseline (enrollment), during the first 4 months of treatment, 4 additional timepoints in the first year of treatment, and at end of treatment. (approximately 1.5 years)'}, {'measure': 'Incidence and severity of AEs and serious adverse events (SAEs) in Stage 2', 'timeFrame': 'From first dose date to 90 days after the last dose (approximately 3-5 years)'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Prostatic Neoplasms, Castration-Resistant', 'Androgen-Resistant Prostatic Neoplasms', 'Castration Resistant Prostatic Neoplasms', 'Prostatic Cancer, Castration-Resistant']}, 'descriptionModule': {'briefSummary': 'This is a Phase 1b/2, open-label, multicenter platform trial to evaluate the antitumor activity and safety of etrumadenant (AB928)-based combination therapy in participants with metastatic castrate resistant prostate cancer (mCRPC).'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "General Inclusion Criteria:\n\n* Male participants; age ≥ 18 years\n* 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\\])\n* Measurable or non-measurable disease as per radiographic evaluation\n* Participants with measurable disease may require a fresh tumor biopsy at study entry\n* Eastern Cooperative Oncology Group (ECOG) Performance status of 0 or 1\n* Life expectancy of at least 3 months\n* Adequate hematologic and end-organ function\n* Human immunodeficiency virus (HIV), Hepatitis B, and C test results negative prior to first study treatment\n\nInclusion Criteria for Participants receiving an enzalutamide-containing treatment\n\n* Disease progression after prior treatment with abiraterone\n\nInclusion Criteria for Participants receiving a docetaxel-containing treatment\n\n* Disease progression after prior androgen synthesis inhibitor therapy\n\nInclusion Criteria for all other Participants\n\n* Disease progression after prior androgen synthesis inhibitor treatment and up to 2 prior lines of taxane chemotherapy\n\nGeneral Exclusion Criteria:\n\n* Prior treatment with immune checkpoint blockade therapy\n* Prior anticancer treatment including approved agents, systemic radiotherapy, or investigational therapy, within 2-4 weeks prior first study treatment\n* Corrected QT interval (QTc) ≥480 msec using Fredericia's QT correction formula (based on an average of triplicate recordings)\n* Prior allogeneic stem cell or solid organ transplantation\n* Prior treatment with drugs that stimulate the immune system within 4 weeks prior to first study treatment\n* Prior treatment with drugs that suppress the immune system within 2 weeks prior to first study treatment\n* Received a live, attenuated vaccine within 4 weeks prior to first study treatment, or may need to receive a vaccine during study treatment\n* Presence of metastases in the brain or cancer spreading into the cerebrospinal fluid - CSF (leptomeningeal disease)\n* Prior pulmonary fibrosis, pneumonia, or pneumonitis\n* 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\n* Prior treatment with an agent targeting the adenosine pathway\n* No oral or IV antibiotics within 2 weeks prior to first study treatment\n* No severe infection within 4 weeks prior to first study treatment\n* No clinically significant cardiac disease\n* Inability to swallow medications\n\nExclusion Criteria for Participants receiving an enzalutamide-containing treatment\n\n* 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)\n* Prior treatment with enzalutamide or similar therapy other than abiraterone\n* Active or history of autoimmune disease or immune deficiency\n* History of severe allergic reactions to antibody therapy\n* 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\n\nExclusion Criteria for Participants receiving a docetaxel-containing treatment\n\n* Prior treatment with docetaxel, cabazitaxel, or other taxane chemotherapy\n* Active or history of autoimmune disease or immune deficiency\n* History of severe allergic reactions to antibody therapy\n* 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\n\nExclusion Criteria for all other Participants\n\n* Prior treatment with docetaxel, cabazitaxel, topoisomerase 1 inhibitors, or other taxane chemotherapy\n* Active or history of autoimmune disease or immune deficiency\n* History of severe allergic reactions to antibody therapy\n* 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"}, 'identificationModule': {'nctId': 'NCT04381832', 'briefTitle': 'Adenosine Receptor Antagonist Combination Therapy for Metastatic Castrate Resistant Prostate Cancer', 'organization': {'class': 'INDUSTRY', 'fullName': 'Arcus Biosciences, Inc.'}, 'officialTitle': 'A Phase 1b/2, Open-Label, Randomized Platform Study Evaluating the Efficacy and Safety of AB928-Based Treatment Combinations in Patients With Metastatic Castrate Resistant Prostate Cancer', 'orgStudyIdInfo': {'id': 'ARC-6'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Stage 1 and 2: Etrumadenant + zimberelimab + enzalutamide', 'description': 'Participants will receive oral etrumadenant in combination with intravenous (IV) zimberelimab and standard oral enzalutamide', 'interventionNames': ['Drug: Etrumadenant', 'Drug: Zimberelimab', 'Drug: Enzalutamide']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Stage 2: enzalutamide', 'description': 'Participants will receive standard oral enzalutamide', 'interventionNames': ['Drug: Enzalutamide']}, {'type': 'EXPERIMENTAL', 'label': 'Stage 1 and 2: Etrumadenant + zimberelimab + docetaxel', 'description': 'Participants will receive oral etrumadenant in combination with IV zimberelimab and standard IV docetaxel', 'interventionNames': ['Drug: Etrumadenant', 'Drug: Zimberelimab', 'Drug: Docetaxel']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Stage 2: docetaxel', 'description': 'Participants will receive standard dose of IV docetaxel', 'interventionNames': ['Drug: Docetaxel']}, {'type': 'EXPERIMENTAL', 'label': 'Stage 1 and 2: Etrumadenant + zimberelimab', 'description': 'Oral etrumadenant in combination IV zimberelimab', 'interventionNames': ['Drug: Etrumadenant', 'Drug: Zimberelimab']}, {'type': 'EXPERIMENTAL', 'label': 'Stage 2: Etrumadenant + zimberelimab + quemliclustat', 'description': 'Participants will receive oral etrumadenant in combination with IV zimberelimab and IV quemliclustat', 'interventionNames': ['Drug: Etrumadenant', 'Drug: Zimberelimab', 'Drug: Quemliclustat']}, {'type': 'EXPERIMENTAL', 'label': 'Stage 2: Etrumadenant + quemliclustat', 'description': 'Participants will receive oral etrumadenant in combination with IV quemliclustat', 'interventionNames': ['Drug: Etrumadenant', 'Drug: Quemliclustat']}, {'type': 'EXPERIMENTAL', 'label': 'Stage 1: Etrumadenant + zimberelimab PK Sub-Study', 'description': 'Participants will receive oral etrumadenant in combination with IV zimberelimab', 'interventionNames': ['Drug: Etrumadenant', 'Drug: Zimberelimab']}, {'type': 'EXPERIMENTAL', 'label': 'Stage 1 and 2: Etrumadenant + SG', 'description': 'Participants will receive oral etrumadenant in combination with IV SG.', 'interventionNames': ['Drug: Etrumadenant', 'Drug: SG']}, {'type': 'EXPERIMENTAL', 'label': 'Stage 1 and 2: Etrumadenant + Zimberelimab + SG', 'description': 'Participants will receive oral etrumadenant in combination with IV zimberelimab and SG.', 'interventionNames': ['Drug: Etrumadenant', 'Drug: Zimberelimab', 'Drug: SG']}], 'interventions': [{'name': 'Etrumadenant', 'type': 'DRUG', 'otherNames': ['AB928'], 'description': 'Etrumadenant is an A2aR and A2bR antagonist', 'armGroupLabels': ['Stage 1 and 2: Etrumadenant + SG', 'Stage 1 and 2: Etrumadenant + Zimberelimab + SG', 'Stage 1 and 2: Etrumadenant + zimberelimab', 'Stage 1 and 2: Etrumadenant + zimberelimab + docetaxel', 'Stage 1 and 2: Etrumadenant + zimberelimab + enzalutamide', 'Stage 1: Etrumadenant + zimberelimab PK Sub-Study', 'Stage 2: Etrumadenant + quemliclustat', 'Stage 2: Etrumadenant + zimberelimab + quemliclustat']}, {'name': 'Zimberelimab', 'type': 'DRUG', 'otherNames': ['AB122'], 'description': 'Zimberelimab is an anti-PD-1 antibody', 'armGroupLabels': ['Stage 1 and 2: Etrumadenant + Zimberelimab + SG', 'Stage 1 and 2: Etrumadenant + zimberelimab', 'Stage 1 and 2: Etrumadenant + zimberelimab + docetaxel', 'Stage 1 and 2: Etrumadenant + zimberelimab + enzalutamide', 'Stage 1: Etrumadenant + zimberelimab PK Sub-Study', 'Stage 2: Etrumadenant + zimberelimab + quemliclustat']}, {'name': 'Quemliclustat', 'type': 'DRUG', 'otherNames': ['AB680'], 'description': 'Quemliclustat is a Cluster of Differentiation (CD)73 Inhibitor.', 'armGroupLabels': ['Stage 2: Etrumadenant + quemliclustat', 'Stage 2: Etrumadenant + zimberelimab + quemliclustat']}, {'name': 'Enzalutamide', 'type': 'DRUG', 'otherNames': ['Xtandi'], 'description': 'Enzalutamide is an androgen receptor inhibitor', 'armGroupLabels': ['Stage 1 and 2: Etrumadenant + zimberelimab + enzalutamide', 'Stage 2: enzalutamide']}, {'name': 'Docetaxel', 'type': 'DRUG', 'otherNames': ['Taxotere'], 'description': 'Docetaxel is type of chemotherapy', 'armGroupLabels': ['Stage 1 and 2: Etrumadenant + zimberelimab + docetaxel', 'Stage 2: docetaxel']}, {'name': 'SG', 'type': 'DRUG', 'otherNames': ['Trodelvy'], 'description': 'Sacituzumab govitecan is an antibody-drug conjugate', 'armGroupLabels': ['Stage 1 and 2: Etrumadenant + SG', 'Stage 1 and 2: Etrumadenant + Zimberelimab + SG']}]}, 'contactsLocationsModule': {'locations': [{'zip': '90703', 'city': 'Cerritos', 'state': 'California', 'country': 'United States', 'facility': 'The Oncology Institute of Hope & Innovation', 'geoPoint': {'lat': 33.85835, 'lon': -118.06479}}, {'zip': '91436', 'city': 'Encino', 'state': 'California', 'country': 'United States', 'facility': 'The University of California, Los Angeles', 'geoPoint': {'lat': 34.15917, 'lon': -118.50119}}, {'zip': '92868', 'city': 'Orange', 'state': 'California', 'country': 'United States', 'facility': 'The University of California, Irvine Medical Center', 'geoPoint': {'lat': 33.78779, 'lon': -117.85311}}, {'zip': '34232', 'city': 'Sarasota', 'state': 'Florida', 'country': 'United States', 'facility': 'Florida Cancer Specialists South', 'geoPoint': {'lat': 27.33643, 'lon': -82.53065}}, {'zip': '33705', 'city': 'St. Petersburg', 'state': 'Florida', 'country': 'United States', 'facility': 'Florida Cancer Specialists North', 'geoPoint': {'lat': 27.77086, 'lon': -82.67927}}, {'zip': '32308', 'city': 'Tallahassee', 'state': 'Florida', 'country': 'United States', 'facility': 'Florida Cancer Specialists Panhandle', 'geoPoint': {'lat': 30.43826, 'lon': -84.28073}}, {'zip': '33401', 'city': 'West Palm Beach', 'state': 'Florida', 'country': 'United States', 'facility': 'Florida Cancer Specialists East', 'geoPoint': {'lat': 26.71534, 'lon': -80.05337}}, {'zip': '60611', 'city': 'Chicago', 'state': 'Illinois', 'country': 'United States', 'facility': 'Northwestern University Feinberg School of Medicine', 'geoPoint': {'lat': 41.85003, 'lon': -87.65005}}, {'zip': '60521', 'city': 'Hinsdale', 'state': 'Illinois', 'country': 'United States', 'facility': 'Affinity Health Hope & Healing Cancer Services', 'geoPoint': {'lat': 41.80086, 'lon': -87.93701}}, {'zip': '21287', 'city': 'Baltimore', 'state': 'Maryland', 'country': 'United States', 'facility': 'Johns Hopkins University', 'geoPoint': {'lat': 39.29038, 'lon': -76.61219}}, {'zip': '01006', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'New York University, Langone Health', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}, {'zip': '14642', 'city': 'Rochester', 'state': 'New York', 'country': 'United States', 'facility': 'Wilmot Cancer Institute Oncology, University of Rochester', 'geoPoint': {'lat': 43.15478, 'lon': -77.61556}}, {'zip': '44195', 'city': 'Cleveland', 'state': 'Ohio', 'country': 'United States', 'facility': 'Cleveland Clinic', 'geoPoint': {'lat': 41.4995, 'lon': -81.69541}}, {'zip': '37404', 'city': 'Chattanooga', 'state': 'Tennessee', 'country': 'United States', 'facility': 'Tennessee Oncology - Chattanooga', 'geoPoint': {'lat': 35.04563, 'lon': -85.30968}}, {'zip': '37203', 'city': 'Nashville', 'state': 'Tennessee', 'country': 'United States', 'facility': 'Tennessee Oncology - Nashville', 'geoPoint': {'lat': 36.16589, 'lon': -86.78444}}, {'zip': '77030', 'city': 'Houston', 'state': 'Texas', 'country': 'United States', 'facility': 'MD Anderson Cancer Center', 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}, {'zip': '99208', 'city': 'Spokane', 'state': 'Washington', 'country': 'United States', 'facility': 'Medical Oncology Associates, PS (dba Summit Cancer Centers)', 'geoPoint': {'lat': 47.65966, 'lon': -117.42908}}, {'zip': 'L8V5C2', 'city': 'Hamilton', 'state': 'Ontario', 'country': 'Canada', 'facility': 'Juravinski Cancer Center', 'geoPoint': {'lat': 43.25011, 'lon': -79.84963}}, {'zip': 'H2X 3E4', 'city': 'Montreal', 'state': 'Quebec', 'country': 'Canada', 'facility': "Centre hospitalier de l'Université de Montréal (CHUM) Centre de Recherche", 'geoPoint': {'lat': 45.50884, 'lon': -73.58781}}], 'overallOfficials': [{'name': 'Medical Director', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Arcus Biosciences'}]}, 'ipdSharingStatementModule': {'url': 'https://trials.arcusbio.com/our-transparency-policy', 'infoTypes': ['STUDY_PROTOCOL', 'SAP', 'CSR'], 'ipdSharing': 'YES', 'description': 'Arcus will provide access to individual de-identified participant data and related study documents (e.g., protocol, Statistical Analysis Plan \\[SAP\\], Clinical Study Report \\[CSR\\]) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions.\n\nFor more information, please visit our website.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Arcus Biosciences, Inc.', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'Gilead Sciences', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}