Not provided
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The study was terminated for strategic reasons, not due to any safety concerns.
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| Name | Class |
|---|---|
| Arcus Biosciences, Inc. | INDUSTRY |
| Surface Oncology | INDUSTRY |
Not provided
Not provided
Not provided
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This trial will look at the safety and preliminary efficacy of SRF617 in combination with etrumadenant and zimberelimab in patients with metastatic castration-resistant prostate cancer (mCRPC).
This is a phase 2, open-label, safety and preliminary efficacy trial in patients with mCRPC using the combination of SRF617, etrumadenant (AB928), and zimberelimab (AB122).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| SRF617 in combination with etrumadenant and zimberelimab | Experimental | All patients will receive SRF617 administered in combination with etrumadenant (AB928) and zimberelimab (AB122). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SRF617 | Drug | SRF617 is a fully human antibody designed to inhibit the enzymatic activity of CD39. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Response | Response was defined as Prostate-Specific Antigen (PSA) decline of ≥ 50% (PSA50) and/or radiographic objective response of Complete Response (CR) or Partial Response (PR) per Prostate Cancer Working Group 3 (PCWG3) Criteria. The number of participants with response shows participants with any one or combination of these response types.
| From the date of first dose administration to the end of treatment (maximum exposure: 168 days) |
| Number of Participants With Adverse Events (AEs) | An AE was defined as any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. Serious Adverse Events (SAEs) were defined as death, a life-threatening AE, inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity, a congenital anomaly or birth defect, or an important medical event that jeopardized participant and required medical intervention to prevent 1 of the outcomes listed in this definition. A summary of other non-serious AEs and all serious AEs, regardless of causality is located in Reported AE section. | From date of first dose until 90 days after the last dose of treatment (maximum treatment exposure: 168 days) |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Response Per PCWG3 Criteria | The number of participants achieving CR or PR by PCWG3 criteria is reported:
|
Not provided
Inclusion Criteria:
≥ 18 years of age.
Metastatic CRPC with castrate levels of testosterone (≤ 50 ng/dL or ≤ 1.7 nmol/L).
Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1.
Progressed (by PSA or radiologic criteria) during or following treatment with a novel androgen receptor signaling inhibitor (ARSI, eg, abiraterone, enzalutamide, apalutamide, darolutamide), which may have been given for either hormone-sensitive prostate cancer or CRPC.
Received 1 to 2 prior lines of taxane chemotherapy, unless the physician and patient believe the patient is medically ineligible or the patient refuses (ineligibility or refusal must be documented in the source documents).
Progressed by PSA or radiologic criteria on or during last therapy for prostate cancer.
Measurable or non-measurable disease as per radiographic evaluation. Lesions situated in a previously irradiated area are considered evaluable if progression has been demonstrated in such lesions since radiation.
• Note: If disease is considered non-measurable, a minimum PSA of 1 ng/dL is required with at least 1 confirmed rise at a minimum of a 1-week interval.
Adequate hematologic function, defined as absolute neutrophil count ≥ 1.5 × 109/L, hemoglobin ≥ 9.0 g/dL, and platelet count ≥ 100 × 109/L. Transfusions are permitted to meet hemoglobin and platelet criteria. However, the patient must have a stable hemoglobin level and platelet count for ≥ 2 weeks prior to dosing without transfusion.
Adequate renal function, defined as serum creatinine clearance ≥ 30 mL/min per Cockcroft-Gault formula.
Total bilirubin ≤ 1.5 × upper limit of normal (ULN) (≤ 3 × ULN if elevated because of Gilbert's syndrome, and ≤ 2 × ULN for patients with known liver metastases).
Aspartate aminotransferase and alanine aminotransferase < 2.5 × ULN (< 5 × ULN if liver metastases present).
Prothrombin time (PT) or international normalized ratio (INR) and activated partial thromboplastin time (aPTT) ≤ 1.5 × ULN unless the patient is receiving anticoagulant therapy, in which case PT/INR or aPTT must be within therapeutic range of intended use of anticoagulants.
Exclusion Criteria:
Currently participating in or has participated in a trial of an investigational device or has used an investigational device within 21 days before the first dose of study drug.
Any component of small cell or neuroendocrine histology.
Previously received an anti-CD39 antibody, anti-CD39 targeted therapy, or other agent targeting the adenosine pathway.
Prior treatment with programmed death-ligand 1 (PD-L1)/programmed death receptor-1 (PD-1) inhibitors.
Prior treatment with ≥ 3 lines of taxane chemotherapy administered as a single agent or as part of a combination regimen.
Symptomatic or untreated brain metastases (including leptomeningeal metastases). Patients previously treated for brain metastases must be at least 4 weeks from completion of radiation treatment with follow-up imaging showing no progression.
Current pneumonitis with or without steroid requirement or history of pneumonitis requiring steroids.
Another malignancy other than prostate within 2 years of trial entry, except for those with a low risk of spreading or negligible risk of death such as non-melanoma skin cancer or Ta superficial bladder cancer.
Active autoimmune disease that has required systemic treatment in past 2 years (ie, with use of disease modifying agents, corticosteroids, or immunosuppressive drugs).
Medical conditions requiring chronic steroid (ie, > 10 mg/day of prednisone or its equivalent).
• Note: Replacement therapy (eg, levothyroxine, insulin, or physiologic corticosteroid replacement therapy for thyroid, adrenal, or pituitary insufficiency) is allowed.
Administration of a live attenuated vaccine within 6 weeks before the first dose of study drug.
• Exception: Health Authority approved COVID-19 vaccines are permitted.
Any gastrointestinal condition that would preclude the use of oral medications (eg, difficulty swallowing, nausea, vomiting, or malabsorption).
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| Name | Affiliation | Role |
|---|---|---|
| Vienna Reichert, PhD | Coherus BioSciences | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Miami - Sylvester Comprehensive Cancer Center | Miami | Florida | 33136 | United States | ||
| University of Michigan Health System |
Not provided
Not provided
Not provided
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A total of 16 participants were enrolled. 1 participant discontinued due to an adverse event prior to the first dose and was therefore not included in the analyses. 15 participants received study treatment and were included in the analyses.
Not provided
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| ID | Title | Description |
|---|---|---|
| FG000 | SRF617 + Etrumadenant + Zimberelimab | SRF617 was administered in combination with etrumadenant and zimberelimab in 28-day cycles according to the following dosing schedule:
|
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Jul 30, 2021 | Feb 22, 2024 |
Not provided
Not provided
Not provided
Not provided
Not provided
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Not provided
| etrumadenant | Drug | Etrumadenant is an A2aR and A2bR antagonist. |
|
|
| zimberelimab | Drug | Zimberelimab is a fully human anti-PD-1 monoclonal antibody. |
|
|
| From the date of first dose administration to the end of treatment (maximum exposure: 168 days) |
| Duration of Response (DOR) | DOR was defined as the time from first documented response (PSA50 and/or CR/PR) to documented disease progression as determined by applicable disease criteria, or documented death due to any cause, whichever occured first. | From the date of first dose administration to the end of treatment (maximum exposure: 168 days) |
| Disease Control Rate (DCR) | DCR was defined as the percentage of participants with CR, PR, or SD lasting a minimum of 12 weeks by PCWG3 or PSA50 criteria. | From the date of first dose administration to the end of treatment (maximum exposure: 168 days) |
| Number of Participants With PSA50 Response | PSA50 response is defined as a confirmed PSA decrease from Baseline of 50% or more based on 2 consecutive assessments measured 3 to 4 weeks apart. | From the date of first dose administration to the end of treatment (maximum exposure: 168 days) |
| Number of Participants With PSA Decline of ≥ 30% (PSA30) Response | PSA30 response is defined as a confirmed PSA decrease from Baseline of 30% or more based on 2 consecutive assessments measured 3 to 4 weeks apart. | From the date of first dose administration to the end of treatment (maximum exposure: 168 days) |
| Time to PSA Progression | From the date of first dose administration to the end of treatment (maximum exposure: 168 days) |
| Radiographic Progression Free Survival (PFS) | From the date of first dose administration to the end of treatment (maximum exposure: 168 days) |
| Landmark PFS Rate | Landmark PFS was defined as the percentage of participants who have not developed PFS events of death or documented disease progression as determined by applicable disease criteria. | Months 6 and 12 |
| Maximum Observed Serum Concentration of SRF617 (Cmax) | From the date of first dose administration to the end of treatment (maximum exposure: 168 days) |
| Minimum Observed Serum Concentration of SRF617 Prior to Administration of Subsequent Dose (Cmin) | From the date of first dose administration to the end of treatment (maximum exposure: 168 days) |
| Number of Participants With Antidrug Antibodies (ADAs) | From the date of first dose administration to the end of treatment (maximum exposure: 168 days) |
| Number of Participants With Symptomatic Skeletal Events (SSEs) | Number of participants with SSEs per PCWG3 criteria, defined as symptomatic fracture, radiation or surgery to bone, or spinal cord compression, is reported. | From date of first dose until 90 days after the last dose of treatment (maximum treatment exposure: 168 days) |
| Ann Arbor |
| Michigan |
| 48109 |
| United States |
| Comprehensive Cancer Centers of Nevada | Las Vegas | Nevada | 84119 | United States |
| UT Southwestern | Dallas | Texas | 75390 | United States |
| START South Texas Accelerated Research Therapeutics, LLC | San Antonio | Texas | 78229 | United States |
| START Mountain Region, Utah Cancer Specialists | West Valley City | Utah | 84119 | United States |
| Fred Hutchinson Cancer Research Center | Seattle | Washington | 98109 | United States |
| BC Cancer - The Vancouver Centre | Vancouver | British Columbia | V5Z 4E6 | Canada |
| Université de Montreal - Centre de Recherche du Centre Hospitalier de L'Université de Montreal (CRCHUM) | Montreal | Quebec | H2X 0A9 | Canada |
| Received at Least 1 Dose of Study Drug | Safety Analysis Set |
|
| COMPLETED | Completion was defined as completing the safety follow up visit. |
|
| NOT COMPLETED |
|
|
The Safety Analysis Set included all participants who received any amount of study drug
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | SRF617 + Etrumadenant + Zimberelimab | SRF617 was administered in combination with etrumadenant and zimberelimab in 28-day cycles according to the following dosing schedule:
|
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||||
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of Participants With Response | Response was defined as Prostate-Specific Antigen (PSA) decline of ≥ 50% (PSA50) and/or radiographic objective response of Complete Response (CR) or Partial Response (PR) per Prostate Cancer Working Group 3 (PCWG3) Criteria. The number of participants with response shows participants with any one or combination of these response types.
| The Response-Evaluable Analysis Set is defined as all participants at Baseline who received study drug and had at least 1 post-Baseline response assessment or who discontinued the treatment phase because of radiographic or symptomatic disease progression (including death caused by disease progression) within 6 weeks (+ 2 week window) of the first dose of study drug. | Posted | Count of Participants | Participants | From the date of first dose administration to the end of treatment (maximum exposure: 168 days) |
|
|
| ||||||||||||||||||||||||||
| Primary | Number of Participants With Adverse Events (AEs) | An AE was defined as any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. Serious Adverse Events (SAEs) were defined as death, a life-threatening AE, inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity, a congenital anomaly or birth defect, or an important medical event that jeopardized participant and required medical intervention to prevent 1 of the outcomes listed in this definition. A summary of other non-serious AEs and all serious AEs, regardless of causality is located in Reported AE section. | The Safety Analysis Set included all participants who received any amount of study drug | Posted | Count of Participants | Participants | From date of first dose until 90 days after the last dose of treatment (maximum treatment exposure: 168 days) |
|
| |||||||||||||||||||||||||||
| Secondary | Number of Participants With Response Per PCWG3 Criteria | The number of participants achieving CR or PR by PCWG3 criteria is reported:
| Analysis was not performed as data were not collected for this outcome measure due to early study termination | Posted | From the date of first dose administration to the end of treatment (maximum exposure: 168 days) |
|
| |||||||||||||||||||||||||||||
| Secondary | Duration of Response (DOR) | DOR was defined as the time from first documented response (PSA50 and/or CR/PR) to documented disease progression as determined by applicable disease criteria, or documented death due to any cause, whichever occured first. | Analysis was not performed as data were not collected for this outcome measure due to early study termination | Posted | From the date of first dose administration to the end of treatment (maximum exposure: 168 days) |
|
| |||||||||||||||||||||||||||||
| Secondary | Disease Control Rate (DCR) | DCR was defined as the percentage of participants with CR, PR, or SD lasting a minimum of 12 weeks by PCWG3 or PSA50 criteria. | Analysis was not performed as data were not collected for this outcome measure due to early study termination | Posted | From the date of first dose administration to the end of treatment (maximum exposure: 168 days) |
|
| |||||||||||||||||||||||||||||
| Secondary | Number of Participants With PSA50 Response | PSA50 response is defined as a confirmed PSA decrease from Baseline of 50% or more based on 2 consecutive assessments measured 3 to 4 weeks apart. | The Response-Evaluable Analysis Set is defined as all participants at Baseline who received study drug and had at least 1 post-Baseline response assessment or who discontinued the treatment phase because of radiographic or symptomatic disease progression (including death caused by disease progression) within 6 weeks (+ 2 week window) of the first dose of study drug. | Posted | Count of Participants | Participants | From the date of first dose administration to the end of treatment (maximum exposure: 168 days) |
|
| |||||||||||||||||||||||||||
| Secondary | Number of Participants With PSA Decline of ≥ 30% (PSA30) Response | PSA30 response is defined as a confirmed PSA decrease from Baseline of 30% or more based on 2 consecutive assessments measured 3 to 4 weeks apart. | Analysis was not performed as data were not collected for this outcome measure due to early study termination | Posted | From the date of first dose administration to the end of treatment (maximum exposure: 168 days) |
|
| |||||||||||||||||||||||||||||
| Secondary | Time to PSA Progression | Analysis was not performed as data were not collected for this outcome measure due to early study termination | Posted | From the date of first dose administration to the end of treatment (maximum exposure: 168 days) |
|
| ||||||||||||||||||||||||||||||
| Secondary | Radiographic Progression Free Survival (PFS) | Analysis was not performed as data were not collected for this outcome measure due to early study termination | Posted | From the date of first dose administration to the end of treatment (maximum exposure: 168 days) |
|
| ||||||||||||||||||||||||||||||
| Secondary | Landmark PFS Rate | Landmark PFS was defined as the percentage of participants who have not developed PFS events of death or documented disease progression as determined by applicable disease criteria. | Analysis was not performed as data were not collected for this outcome measure due to early study termination | Posted | Months 6 and 12 |
|
| |||||||||||||||||||||||||||||
| Secondary | Maximum Observed Serum Concentration of SRF617 (Cmax) | Analysis was not performed as data were not collected for this outcome measure due to early study termination | Posted | From the date of first dose administration to the end of treatment (maximum exposure: 168 days) |
|
| ||||||||||||||||||||||||||||||
| Secondary | Minimum Observed Serum Concentration of SRF617 Prior to Administration of Subsequent Dose (Cmin) | Analysis was not performed as data were not collected for this outcome measure due to early study termination | Posted | From the date of first dose administration to the end of treatment (maximum exposure: 168 days) |
|
| ||||||||||||||||||||||||||||||
| Secondary | Number of Participants With Antidrug Antibodies (ADAs) | Analysis was not performed as data were not collected for this outcome measure due to early study termination | Posted | From the date of first dose administration to the end of treatment (maximum exposure: 168 days) |
|
| ||||||||||||||||||||||||||||||
| Secondary | Number of Participants With Symptomatic Skeletal Events (SSEs) | Number of participants with SSEs per PCWG3 criteria, defined as symptomatic fracture, radiation or surgery to bone, or spinal cord compression, is reported. | The Safety Analysis Set included all participants who received any amount of study drug | Posted | Count of Participants | Participants | From date of first dose until 90 days after the last dose of treatment (maximum treatment exposure: 168 days) |
|
|
From date of first dose until 90 days after the last dose of treatment (maximum treatment exposure: 168 days)
The Safety Analysis Set included all participants who received any amount of study drug. Also included is 1 participant who discontinued due to an adverse event prior receiving study drug.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | SRF617 + Etrumadenant + Zimberelimab | SRF617 was administered in combination with etrumadenant and zimberelimab in 28-day cycles according to the following dosing schedule:
| 4 | 16 | 7 | 16 | 15 | 16 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Spinal cord compression | Nervous system disorders | MedDRA 24.1 | Systematic Assessment | Resulted in death of 1 participant |
|
| Anaemia | Blood and lymphatic system disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Acute myocardial infarction | Cardiac disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Cardiogenic shock | Cardiac disorders | MedDRA 24.1 | Systematic Assessment | Resulted in death |
|
| Disease progression | General disorders | MedDRA 24.1 | Systematic Assessment | Resulted in death |
|
| Cytokine release syndrome | Immune system disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA 24.1 | Systematic Assessment | Resulted in death |
|
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Tumor Lysis Syndrome | Metabolism and nutrition disorders | MedDRA 24.1 | Systematic Assessment | Screen failure; discontinued prior to receiving study drug. |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Fatigue | General disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Chest discomfort | General disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Chest pain | General disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Chills | General disorders | MedDRA 24.1 | Systematic Assessment |
| |
| General physical health deterioration | General disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Malaise | General disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Non-cardiac chest pain | General disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Oedema peripheral | General disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Abdominal distension | Gastrointestinal disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Oral dysaesthesia | Gastrointestinal disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Dyspepsia | Gastrointestinal disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Flatulence | Gastrointestinal disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Gastrointestinal disorder | Gastrointestinal disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Gastrooesophageal reflux disease | Gastrointestinal disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Oesophageal pain | Gastrointestinal disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Stomatitis | Gastrointestinal disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Alanine aminotransferase increased | Investigations | MedDRA 24.1 | Systematic Assessment |
| |
| Weight decreased | Investigations | MedDRA 24.1 | Systematic Assessment |
| |
| Blood alkaline phosphatase increased | Investigations | MedDRA 24.1 | Systematic Assessment |
| |
| Blood creatinine increased | Investigations | MedDRA 24.1 | Systematic Assessment |
| |
| Blood lactate dehydrogenase increased | Investigations | MedDRA 24.1 | Systematic Assessment |
| |
| Lipase increased | Investigations | MedDRA 24.1 | Systematic Assessment |
| |
| Amylase increased | Investigations | MedDRA 24.1 | Systematic Assessment |
| |
| Aspartate aminotransferase increased | Investigations | MedDRA 24.1 | Systematic Assessment |
| |
| International normalised ratio increased | Investigations | MedDRA 24.1 | Systematic Assessment |
| |
| Lymphocyte count increased | Investigations | MedDRA 24.1 | Systematic Assessment |
| |
| Decreased appetite | Metabolism and nutrition disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Hypocalcaemia | Metabolism and nutrition disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Hyperglycaemia | Metabolism and nutrition disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Hypoalbuminaemia | Metabolism and nutrition disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Hyponatraemia | Metabolism and nutrition disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Hypophosphataemia | Metabolism and nutrition disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Bone pain | Musculoskeletal and connective tissue disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Muscular weakness | Musculoskeletal and connective tissue disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Anosmia | Nervous system disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Cognitive disorder | Nervous system disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Dysgeusia | Nervous system disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Hypoglossal nerve disorder | Nervous system disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Insomnia | Psychiatric disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Agitation | Psychiatric disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Delirium | Psychiatric disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Hypotension | Vascular disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Deep vein thrombosis | Vascular disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Peripheral vascular disorder | Vascular disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Hiccups | Respiratory, thoracic and mediastinal disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Hypoxia | Respiratory, thoracic and mediastinal disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Soft tissue infection | Infections and infestations | MedDRA 24.1 | Systematic Assessment |
| |
| Urinary tract infection pseudomonal | Infections and infestations | MedDRA 24.1 | Systematic Assessment |
| |
| Contusion | Injury, poisoning and procedural complications | MedDRA 24.1 | Systematic Assessment |
| |
| Infusion related reaction | Injury, poisoning and procedural complications | MedDRA 24.1 | Systematic Assessment |
| |
| Photosensitivity reaction | Skin and subcutaneous tissue disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Hyperthyroidism | Endocrine disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Eyelid function disorder | Eye disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Pollakiuria | Renal and urinary disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Anaemia | Blood and lymphatic system disorders | MedDRA 24.1 | Systematic Assessment |
|
This study was originally intended to be conducted in 2 stages (1 and 2); however, a strategic decision was made to terminate the study during Stage 1.
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Allison Intondi, Vice President, Clinical Operations | Coherus BioSciences | 800-794-5434 | ClinicalTrials@Coherus.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Jun 19, 2023 | Feb 22, 2024 | SAP_001.pdf |
Not provided
| ID | Term |
|---|---|
| D011471 | Prostatic Neoplasms |
| D009369 | Neoplasms |
| ID | Term |
|---|---|
| D005834 | Genital Neoplasms, Male |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D005832 | Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D011469 | Prostatic Diseases |
| D052801 | Male Urogenital Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| C000719848 | zimberelimab |
Not provided
Not provided
Not provided
| Unknown or Not Reported |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
|
|
|
|
|