Targeted Treatment for Metastatic Prostate Cancer, The PREDICT Trial

NCT ID: NCT06632977

Last Updated: 2026-01-07

Study Results

Results pending

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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Recruitment Status

RECRUITING

Clinical Phase

PHASE2

Total Enrollment

474 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-02-06

Study Completion Date

2034-10-11

Brief Summary

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This phase II trial evaluates whether genetic testing in prostate cancer is helpful in deciding which study treatment patients are assigned. Patient cancer tissue samples are obtained from a previous surgery or biopsy procedure and tested for deoxyribonucleic acid (DNA) and ribonucleic acid (RNA) abnormalities or mutations in their cancer. Valemetostat tosylate is in a class of medications called EZH1/EZH2 inhibitors. It blocks proteins called EZH1 and EZH2, which may help slow or stop the spread of tumor cells. Carboplatin is in a class of medications known as platinum-containing compounds. It works in a way similar to the anticancer drug cisplatin, but may be better tolerated than cisplatin. Carboplatin works by killing, stopping or slowing the growth of tumor cells. Cabazitaxel injection is in a class of medications called microtubule inhibitors. It works by slowing or stopping the growth of tumor cells. Abiraterone acetate blocks tissues from making androgens (male hormones), such as testosterone. This may cause the death of tumor cells that need androgens to grow. It is a type of anti-androgen. Enzalutamide is in a class of medications called androgen receptor inhibitors. It works by blocking the effects of androgen (a male reproductive hormone) to stop the growth and spread of tumor cells. Lutetium Lu 177 vipivotide tetraxetan is in a class of medications called radiopharmaceuticals. It works by targeting and delivering radiation directly to tumor cells which damages and kills these cells. Assigning patients to targeted treatment based on genetic testing may help shrink or slow the cancer from growing

Detailed Description

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The primary and secondary objectives of the study:

PRIMARY OBJECTIVE:

I. Evaluate objective response rate in patients with measurable disease by Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 for measurable disease, in each treatment arm.

SECONDARY OBJECITVES:

I. To determine safety and tolerability as determined by Common Terminology Criteria in Adverse Events (CTCAE) version 5.0 in each treatment arm.

II. To evaluate 9-month radiographic progression free survival in each arm as defined by Prostate Cancer Clinical Trials Working Group 3 (PCWG-3) for patients with bone metastases and RECIST version 1.1 for patients with measurable disease.

III. To evaluate radiographic progression free survival in each arm as defined by PCWG-3 for patients with bone metastases and RECIST version 1.1 for patients with measurable disease.

IV. To evaluate prostate-specific antigen (PSA) response defined as ≥ 50% decline in PSA from baseline using PCWG-3 criteria in patients in each treatment arm.

V. To evaluate time to PSA progression as defined by PCWG-3 criteria in patients in each treatment arm.

VI. To evaluate time to occurrence of first symptomatic skeletal event. VII. To evaluate time to first subsequent anti-cancer therapy (including androgen receptor signaling agents, cytotoxic chemotherapy, immunotherapy, or investigational agents) or death.

VIII. To evaluate overall survival, defined as time from registration to death due to any cause censored at the date of last follow-up, in each treatment arm.

IX. To evaluate patient-reported outcomes (PRO) via Patient-Reported Outcomes (PRO)-CTCAE in each treatment arm.

X. To evaluate duration of response as defined by RECIST version 1.1 for patients with measurable disease.

CORRELATIVE OBJECTIVES:

I. Correlate presence of molecular abnormalities with baseline clinical characteristics.

II. Evaluate co-occurring molecular alterations within each biomarker arm. III. Evaluate mechanisms of response and resistance using available tissue (archival or baseline) and circulating cell free tumor DNA (cfDNA) and circulating tumor cells (CTCs) at baseline, on treatment, and at progression.

IV. Evaluate efficacy parameters (objective response rate \[ORR\], PSA response, 9-month radiographic progression-free survival \[rPFS\], rPFS) based on arm allocation by:

IVa. DNA versus RNA qualifying molecular alterations; IVb. Blood versus tissue-based qualifying molecular alteration; IVc. Primary versus metastasis qualifying molecular alteration.

V. Evaluate efficacy parameters (ORR, PSA response, 9-month rPFS, rPFS) based on the following clinical parameters:

Va. Presence or absence of visceral metastases at baseline; Vb. Number of prior lines of therapy for metastatic castration resistant cancer (mCRPC) (one versus \> 1); Vc. In patients having had prior exposure to taxane chemotherapy; Vd. Presence or absence of neuroendocrine differentiation at baseline. VI. Evaluate exceptional responders (defined as those with rPFS ≥ 18 months) and exceptional non-responders.

VII. To determine how circulating biomarker quantification correlates with clinical features and outcomes.

VIII. To determine the clinical impact of lineage plasticity alterations in predicting outcomes and response to therapy.

EXPLORATORY OBJECTIVE:

I. To compare patient-assessed adverse events via PRO-CTCAE™ with clinician-assessed adverse events in each treatment arm.

OUTLINE: Patients undergo genetic testing on previously-collected tissue samples. Patients are then assigned to 1 of 3 arms based on genetic testing results and Molecular Tumor Board (MTB) decision.

ARM A: Patients receive valemetostat tosylate orally (PO) once daily (QD) on days 1-28 of each cycle. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.

ARM B: Patients receive carboplatin intravenously (IV) over 30 minutes and cabazitaxel IV over 60 minutes on day 1 of each cycle. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity.

ARM C: Patients receive one of the following treatment regimens per treating physician: 1) Cabazitaxel IV over 60 minutes on day 1 of each cycle. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity. 2) Abiraterone acetate PO QD on days 1-28 of each cycle and prednisone PO twice daily (BID) on days 1-28 of each cycle. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. 3) Enzalutamide PO QD on days 1-28 of each cycle. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. 4) Lutetium Lu 177 vipivotide tetraxetan IV on day 1 of each cycle. Treatment repeats every 42 days for up to 6 cycles in the absence of disease progression or unacceptable toxicity.

All patients also undergo magnetic resonance imaging (MRI) or computed tomography (CT) and bone scan throughout the trial. Patients may also undergo optional fludeoxyglucose F-18 (FDG) or prostate-specific membrane antigen (PSMA) positron emission tomography (PET), as well as optional blood collection throughout the trial.

After completion of study treatment, patients without disease progression are followed every 2 months for the first 6 months and then every 3 months after that for up to 5 years. Patients with disease progression are followed every 6 months for 5 years.

Conditions

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Castration-Resistant Prostate Carcinoma Stage IVB Prostate Cancer AJCC v8

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Arm A (genetic testing, valemetostat tosylate)

Patients undergo genetic testing on previously-collected tissue samples. Patients receive valemetostat tosylate PO QD on days 1-28 of each cycle. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients also undergo MRI or CT and bone scan throughout the trial. Patients may also undergo optional FDG or PSMA PET, as well as optional blood collection throughout the trial.

Group Type EXPERIMENTAL

Genetic testing

Intervention Type OTHER

undergo genetic testing

Valemetostat Tosylate

Intervention Type DRUG

Given PO

Magnetic Resonance Imaging

Intervention Type PROCEDURE

undergo Magnetic Resonance Imaging

Computed Tomography

Intervention Type PROCEDURE

undergo Computed Tomography

Bone scan

Intervention Type PROCEDURE

undergo Bone scan

FDG-Positron Emission Tomography

Intervention Type PROCEDURE

Undergo FDG PET

PSMA PET Scan

Intervention Type PROCEDURE

Undergo PSMA PET

Biospecimen Collection

Intervention Type PROCEDURE

undergo blood collection

Arm B (genetic testing, carboplatin, cabazitaxel)

Patients undergo genetic testing on previously-collected tissue samples. Patients receive carboplatin IV over 30 minutes and cabazitaxel IV over 60 minutes on day 1 of each cycle. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity. Patients also undergo MRI or CT and bone scan throughout the trial. Patients may also undergo optional FDG or PSMA PET, as well as optional blood collection throughout the trial.

Group Type EXPERIMENTAL

Genetic testing

Intervention Type OTHER

undergo genetic testing

Magnetic Resonance Imaging

Intervention Type PROCEDURE

undergo Magnetic Resonance Imaging

Computed Tomography

Intervention Type PROCEDURE

undergo Computed Tomography

Bone scan

Intervention Type PROCEDURE

undergo Bone scan

FDG-Positron Emission Tomography

Intervention Type PROCEDURE

Undergo FDG PET

PSMA PET Scan

Intervention Type PROCEDURE

Undergo PSMA PET

Biospecimen Collection

Intervention Type PROCEDURE

undergo blood collection

Carboplatin

Intervention Type DRUG

Given IV

Cabazitaxel

Intervention Type DRUG

Given IV

Arm C (genetic testing, physician choice treatment)

Patients undergo genetic testing on previously-collected tissue. Patients receive one of the following treatment regimens per treating physician: 1)Cabazitaxel IV over 60 minutes on day 1 of each cycle. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity. 2)Abiraterone acetate PO QD on days 1-28 of each cycle and prednisone PO BID on days 1-28 of each cycle. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. 3) Enzalutamide PO QD on days 1-28 of each cycle. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. 4) Lutetium Lu 177 vipivotide tetraxetan IV on day 1 of each cycle. Treatment repeats every 42 days for up to 6 cycles in the absence of disease progression or unacceptable toxicity. Patients also undergo MRI or CT and bone scan throughout the trial. Patients may also undergo optional FDG or PSMA PET, as well as optional blood collection throughout the trial.

Group Type EXPERIMENTAL

Genetic testing

Intervention Type OTHER

undergo genetic testing

Magnetic Resonance Imaging

Intervention Type PROCEDURE

undergo Magnetic Resonance Imaging

Computed Tomography

Intervention Type PROCEDURE

undergo Computed Tomography

Bone scan

Intervention Type PROCEDURE

undergo Bone scan

FDG-Positron Emission Tomography

Intervention Type PROCEDURE

Undergo FDG PET

PSMA PET Scan

Intervention Type PROCEDURE

Undergo PSMA PET

Biospecimen Collection

Intervention Type PROCEDURE

undergo blood collection

Cabazitaxel

Intervention Type DRUG

Given IV

Abiraterone Acetate

Intervention Type DRUG

Given PO

Enzalutamide

Intervention Type DRUG

Given PO

Lutetium Lu 177 Vipivotide Tetraxetan

Intervention Type DRUG

Given IV

Interventions

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Genetic testing

undergo genetic testing

Intervention Type OTHER

Valemetostat Tosylate

Given PO

Intervention Type DRUG

Magnetic Resonance Imaging

undergo Magnetic Resonance Imaging

Intervention Type PROCEDURE

Computed Tomography

undergo Computed Tomography

Intervention Type PROCEDURE

Bone scan

undergo Bone scan

Intervention Type PROCEDURE

FDG-Positron Emission Tomography

Undergo FDG PET

Intervention Type PROCEDURE

PSMA PET Scan

Undergo PSMA PET

Intervention Type PROCEDURE

Biospecimen Collection

undergo blood collection

Intervention Type PROCEDURE

Carboplatin

Given IV

Intervention Type DRUG

Cabazitaxel

Given IV

Intervention Type DRUG

Abiraterone Acetate

Given PO

Intervention Type DRUG

Enzalutamide

Given PO

Intervention Type DRUG

Lutetium Lu 177 Vipivotide Tetraxetan

Given IV

Intervention Type DRUG

Other Intervention Names

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MRI CAT Scan CT Scan Prostate-specific Membrane Antigen PET Xtandi Pluvicto

Eligibility Criteria

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Inclusion Criteria

* PRE-REGISTRATION: Histological or cytological evidence of prostate cancer. Patients with variant histologies including neuroendocrine, small cell and sarcomatoid prostate cancer are allowed to enroll and these will not be used as selection criteria for individual arms. Central pathology review is not required.
* PRE-REGISTRATION: Measurable disease and/or non-measurable metastatic disease per RECIST version 1.1.
* PRE-REGISTRATION: Tissue procured within 12 months of pre-registration (metastatic disease preferred over primary tissue, though both are acceptable) available for submission per Section 6.2. For patients who have progressed on A032102 and are pre-registering again, repeat tissue procurement will not be mandated.
* PRE-REGISTRATION: Molecular report available performed as part of standard of care testing via any Clinical Laboratory Improvement Act (CLIA)-certified next generation sequencing (NGS) assay. Patients may be assigned based on pre-determined qualifying molecular/DNA alterations as stated in Section 4.8 after receipt of local molecular testing by the A032102 molecular tumor board (MTB). Final determination of arm assignment will be determined by the MTB. For qualifying DNA alteration determined by the MTB, testing may be from tumor tissue collected at any time or circulating tumor DNA (ctDNA) within 12 months of pre-registration. If no qualifying DNA alteration is identified based on the CLIA-certified next generation sequencing assay and MTB review, Caris testing, should be performed for both DNA/RNA profiling. Arm assignment based RNA requires testing of tumor tissue collected within 12 months of pre-registration and MTB review.
* PRE-REGISTRATION: Age ≥ 18 years.
* REGISTRATION: Progressive mCRPC as defined: 1) castrate levels of serum testosterone \< 50 ng/dL AND one or more of the following criteria (choose all the apply):

* PSA progression, defined by at least 2 consecutive rising PSA values at a minimum of 1-week intervals with the most recent PSA value being 2.0 ng/mL or higher, if confirmed PSA rise is the only indication of progression. Patients who received an anti-androgen must have PSA progression after withdrawal of anti-androgen therapy.
* Radiographic progression per RECIST 1.1 criteria for soft tissue lesions
* Bone metastasis progression per Prostate Cancer Working Group 3 (PCWG3) criteria.
* REGISTRATION: Patients selected to receive lutetium Lu 177 vipivotide tetraxetan treatment are required to have prostate-specific membrane antigen (PSMA) positive mCRPC as determined by investigator assessment. For reference, in the VISION trial this was defined as at least 1 PSMA+ metastatic lesion (defined as uptake greater than that of liver parenchyma in lesions of any size in any organ system) and no PSMA- lesions (defined as uptake equal to or lower than that of liver parenchyma in any lymph node with a short axis of at least 2.5 cm, in any solid organ lesion with a short axis of at least 1.0 cm, or in any bone lesion with a soft-tissue component of at least 1.0 cm in the short axis).
* REGISTRATION: Prior treatment with androgen receptor signaling inhibitor (ARSI) in either the metastatic hormone sensitive setting or mCRPC is required. Prior taxane therapy in either metastatic hormone sensitive setting or mCRPC is mandated unless patient is taxane ineligible or the patient refuses taxane therapy. Prior lutetium LU177 vipivotide tetraxetan treatment is permitted but not mandated. Patients with known germline or somatic deleterious BRCA 1/2 mutations must have received a prior PARPi.
* REGISTRATION: Resolved toxicities from previous anticancer therapy, defined as toxicities (other than alopecia) resolved to Common Terminology Criteria for Adverse Events (CTCAE) version 5.0, grade ≤ 1 or baseline. Note: Subjects may be enrolled with chronic, stable grade 2 toxicities (defined as no worsening to \> grade 2 for at least 3 months prior to registration and managed with standard of care treatment) that the investigator deems related to previous anticancer therapy, comprised of:

* Chemotherapy-induced neuropathy
* Fatigue
* Residual toxicities from prior treatment: Grade 1 or grade 2 endocrinopathies which may include: Hypothyroidism/hyperthyroidism. type I diabetes, hyperglycemia, adrenal insufficiency, adrenalitis, skin hypopigmentation (vitiligo)
* REGISTRATION: No cytotoxic, biologic, radiopharmaceutical or other non-kinase inhibitor investigational agent within 4 weeks of registration. Treatment with any type of small molecular kinase inhibitor (including investigational kinase inhibitor) within 2 weeks of registration. Treatment with abiraterone acetate, apalutamide, or darolutamide within 2 weeks of registration. Treatment with enzalutamide within 4 weeks of registration. No treatment with radiation therapy within 2 weeks of registration.
* REGISTRATION: No major surgery within 4 weeks of registration.
* REGISTRATION: No prior treatment with EZH inhibitors.
* REGISTRATION: Prior treatment with cabazitaxel + carboplatin.
* REGISTRATION: None of the following conditions:

* Current use of moderate or strong cytochrome P450 (CYP)3A inducers.
* Known or suspected hypersensitivity to valemetostat tosylate (DS-3201b) or any of the excipients.
* For patients with evidence of chronic hepatitis B virus (HBV) infection, the HBV viral load must be undetectable on suppressive therapy, if indicated. Patients with a history of hepatitis C virus (HCV) infection must have been treated and cured. For patients with HCV infection who are currently on treatment, they are eligible if they have an undetectable HCV viral load.

\* HIV-infected patients on effective anti-retroviral therapy with undetectable viral load within 6 months are eligible for this trial.
* Imminent or established spinal cord compression based on clinical and/or imaging findings.
* Known brain metastases or cranial epidural disease unless adequately treated with radiotherapy and/or surgery (including radiosurgery) and stable for at least 4 weeks prior to registration after radiotherapy or at least 4 weeks prior to registration after major surgery (e.g., removal or biopsy of brain metastasis). Patients must have complete wound healing from major surgery or minor surgery before registration.
* Significant cardiovascular defined as:
* Myocardial infarction within 6 months prior to enrollment.
* Uncontrolled angina pectoris within 6 months prior to enrollment.
* New York Heart Association Class 3 or 4 congestive heart failure.
* Corrected QT interval calculated by the Fridericia\'s formula (QTcF) ≥ 470 ms per electrocardiogram (ECG) within 42 days before randomization in any individual with any history of any cardiac disease or medication which can impact QTcF. Patients with known history or current symptoms of cardiac disease, history of treatment with cardiotoxic agents, or agents/conditions known to impact QTcF should have a clinical risk assessment of cardiac function using the New York Heart Association Functional Classification and ECG.
* Uncontrolled hypertension (resting systolic blood pressure \>160 mmHg or diastolic blood pressure \> 100 mmHg).
* Clinically significant acute infection requiring systemic antibacterial, antifungal or antiviral therapy.
* Moderate to severe hepatic impairment (Child-Pugh Class C)
* REGISTRATION: No freezing or donating sperm ≤ 14 days prior to registration.
* REGISTRATION: Eastern Cooperative Oncology Group (ECOG) performance status 0-2.
* REGISTRATION: No granulocyte colony-stimulating factor (GCSF) within 2 weeks of registration.
* REGISTRATION: No red blood cell (RBC) transfusions within 2 weeks of registration.
* REGISTRATION: No platelet transfusions within 2 weeks of registration.
* REGISTRATION: No bleeding diathesis.
* REGISTRATION: White blood cell count (WBC) ≥ 2,500/mcL.
* REGISTRATION: Absolute neutrophil count (ANC) ≥ 1,500/mcL.
* REGISTRATION: Hemoglobin ≥ 9 g/dL.
* REGISTRATION: Platelet count ≥ 100,000/mcL.
* REGISTRATION: Creatinine clearance ≥ 30 mL/min as defined by Cockcroft-Gault equation.
* REGISTRATION: Total bilirubin ≤ 1.5 x ULN (≤ 3 x upper limit of normal \[ULN\] for subjects with documented Gilbert\'s disease).
* REGISTRATION: Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 3 x ULN.
* REGISTRATION: Albumin ≥ 2.8 g/dL.
* REGISTRATION: The A032102 molecular tumor board will review the local pathology report and molecular sequencing report, and the Alliance registration/randomization office will relay the assignment to the submitting site. Once the site receives this assignment, they can register the patient to A032102. Any questions about the molecular board treatment assignments can be directed to [email protected].
* RE-REGISTRATION: Progressive mCRPC (after receiving the tumor board assigned therapy) as defined: 1) castrate levels of serum testosterone \< 50 ng/dL AND 2) progressive disease defined by radiographic progression on conventional imaging (CT/MRI chest, abdomen and pelvis and bone scan within 42 days of re-registration).
* RE-REGISTRATION: Resolved toxicities from previous anticancer therapy, defined as toxicities (other than alopecia) resolved to CTCAE version 5.0, grade ≤ 1 or baseline. Note: Subjects may be enrolled with chronic, stable grade 2 toxicities (defined as no worsening to \> grade 2 for at least 3 months prior to registration and managed with standard of care treatment) that the investigator deems related to previous anticancer therapy, comprised of:

* Chemotherapy-induced neuropathy
* Fatigue
* Residual toxicities from prior treatment: Grade 1 or grade 2 endocrinopathies which may include: Hypothyroidism/hyperthyroidism. type I diabetes, hyperglycemia, adrenal insufficiency, adrenalitis, skin hypopigmentation (vitiligo).
* RE-REGISTRATION: None of the following conditions:

* Imminent or established spinal cord compression based on clinical and/or imaging findings.
* Known brain metastases or cranial epidural disease unless adequately treated with radiotherapy and/or surgery (including radiosurgery) and stable for at least 4 weeks prior to registration after radiotherapy or at least 4 weeks prior to re-registration after major surgery (e.g., removal or biopsy of brain metastasis). Patients must have complete wound healing from major surgery or minor surgery before re-registration.
* Corrected QT interval calculated by the Fridericia\'s formula (QTcF) \< 470 ms per ECG within 42 days before randomization in any individual with any history of any cardiac disease or medication which can impact QTcF.
* Significant cardiovascular defined as:
* Myocardial infarction within 6 months prior to enrollment.
* Uncontrolled angina pectoris within 6 months prior to enrollment.
* New York Heart Association Class 3 or 4 congestive heart failure.
* Uncontrolled hypertension (resting systolic blood pressure \> 160 mmHg or diastolic blood pressure \> 100 mmHg).
* RE-REGISTRATION: ECOG Performance Status 0-2.
* RE-REGISTRATION: No GCSF within 2 weeks of registration.
* RE-REGISTRATION: No RBC transfusions within 2 weeks of registration.
* RE-REGISTRATION: No platelet transfusions within 2 weeks of registration.
* RE-REGISTRATION: WBC ≥ 2,500/mcL.
* RE-REGISTRATION: ANC ≥ 1,500/mcL.
* RE-REGISTRATION: Hemoglobin ≥ 9 g/dL (transfusions permitted).
* RE-REGISTRATION: Platelet count ≥ 100,000/mcL.
* RE-REGISTRATION: Creatinine clearance ≥ 30 mL/min as defined by Cockcroft-Gault equation.
* RE-REGISTRATION: Total bilirubin ≤ 1.5 x ULN (≤ 3 x ULN for subjects with documented Gilbert\'s disease).
* RE-REGISTRATION: AST and ALT ≤ 3 x ULN.
* RE-REGISTRATION: Albumin ≥ 2.8 g/dL.
* RE-REGISTRATION: QT Interval (QTcF) \< 470 ms (in individuals with any cardiac history of any medication or condition known to impact QTcF).
* RE-REGISTRATION: The A032102 molecular tumor board will review the CARIS molecular sequencing report, the Alliance registration/randomization office will relay the assignment to the site. Any questions about the molecular board treatment assignments can be directed to [email protected].

Exclusion Criteria

\-
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Cancer Institute (NCI)

NIH

Sponsor Role collaborator

Alliance for Clinical Trials in Oncology

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Rana McKay, MD

Role: STUDY_CHAIR

Alliance for Clinical Trials in Oncology

Locations

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Banner University Medical Center - Tucson

Tucson, Arizona, United States

Site Status RECRUITING

University of Arizona Cancer Center-North Campus

Tucson, Arizona, United States

Site Status RECRUITING

UC San Diego Health System - Encinitas

Encinitas, California, United States

Site Status RECRUITING

UCI Health - Chao Family Comprehensive Cancer Center and Ambulatory Care

Irvine, California, United States

Site Status RECRUITING

UC San Diego Moores Cancer Center

La Jolla, California, United States

Site Status RECRUITING

UC Irvine Health/Chao Family Comprehensive Cancer Center

Orange, California, United States

Site Status RECRUITING

University of California Davis Comprehensive Cancer Center

Sacramento, California, United States

Site Status RECRUITING

UC San Diego Medical Center - Hillcrest

San Diego, California, United States

Site Status RECRUITING

UCHealth Memorial Hospital Central

Colorado Springs, Colorado, United States

Site Status RECRUITING

Memorial Hospital North

Colorado Springs, Colorado, United States

Site Status RECRUITING

Poudre Valley Hospital

Fort Collins, Colorado, United States

Site Status RECRUITING

Cancer Care and Hematology-Fort Collins

Fort Collins, Colorado, United States

Site Status RECRUITING

UCHealth Greeley Hospital

Greeley, Colorado, United States

Site Status RECRUITING

Medical Center of the Rockies

Loveland, Colorado, United States

Site Status RECRUITING

Beebe South Coastal Health Campus

Millville, Delaware, United States

Site Status RECRUITING

Helen F Graham Cancer Center

Newark, Delaware, United States

Site Status RECRUITING

Medical Oncology Hematology Consultants PA

Newark, Delaware, United States

Site Status RECRUITING

Beebe Health Campus

Rehoboth Beach, Delaware, United States

Site Status RECRUITING

Jupiter Medical Center

Jupiter, Florida, United States

Site Status RECRUITING

Kootenai Health - Coeur d'Alene

Coeur d'Alene, Idaho, United States

Site Status SUSPENDED

Illinois CancerCare-Bloomington

Bloomington, Illinois, United States

Site Status RECRUITING

Illinois CancerCare-Eureka

Eureka, Illinois, United States

Site Status RECRUITING

Cancer Care Center of O'Fallon

O'Fallon, Illinois, United States

Site Status RECRUITING

Illinois CancerCare-Ottawa Clinic

Ottawa, Illinois, United States

Site Status RECRUITING

Illinois CancerCare-Peru

Peru, Illinois, United States

Site Status RECRUITING

Memorial Hospital East

Shiloh, Illinois, United States

Site Status RECRUITING

McFarland Clinic - Ames

Ames, Iowa, United States

Site Status RECRUITING

University of Iowa Healthcare Cancer Services Quad Cities

Bettendorf, Iowa, United States

Site Status RECRUITING

University of Iowa/Holden Comprehensive Cancer Center

Iowa City, Iowa, United States

Site Status RECRUITING

University of Kansas Cancer Center

Kansas City, Kansas, United States

Site Status RECRUITING

The University of Kansas Cancer Center - Olathe

Olathe, Kansas, United States

Site Status RECRUITING

University of Kansas Hospital-Indian Creek Campus

Overland Park, Kansas, United States

Site Status RECRUITING

University of Kansas Health System Saint Francis Campus

Topeka, Kansas, United States

Site Status RECRUITING

University of Kansas Hospital-Westwood Cancer Center

Westwood, Kansas, United States

Site Status RECRUITING

Saint Elizabeth Healthcare Edgewood

Edgewood, Kentucky, United States

Site Status RECRUITING

Saint Elizabeth Healthcare Fort Thomas

Fort Thomas, Kentucky, United States

Site Status RECRUITING

Dana-Farber Cancer Institute

Boston, Massachusetts, United States

Site Status RECRUITING

Dana-Farber Cancer Institute at Foxborough

Foxborough, Massachusetts, United States

Site Status RECRUITING

Dana Farber-Merrimack Valley

Methuen, Massachusetts, United States

Site Status RECRUITING

Dana-Farber/Brigham and Women's Cancer Center at Milford Regional

Milford, Massachusetts, United States

Site Status RECRUITING

Dana-Farber/Brigham and Women's Cancer Center at South Shore

South Weymouth, Massachusetts, United States

Site Status RECRUITING

Baystate Medical Center

Springfield, Massachusetts, United States

Site Status RECRUITING

Trinity Health IHA Medical Group Hematology Oncology - Brighton

Brighton, Michigan, United States

Site Status RECRUITING

Trinity Health IHA Medical Group Hematology Oncology - Canton

Canton, Michigan, United States

Site Status RECRUITING

Trinity Health IHA Medical Group Hematology Oncology - Chelsea Hospital

Chelsea, Michigan, United States

Site Status RECRUITING

University of Michigan Health - Sparrow Lansing

Lansing, Michigan, United States

Site Status RECRUITING

Trinity Health Saint Mary Mercy Livonia Hospital

Livonia, Michigan, United States

Site Status RECRUITING

Trinity Health IHA Medical Group Hematology Oncology Ann Arbor Campus

Ypsilanti, Michigan, United States

Site Status RECRUITING

Siteman Cancer Center at Saint Peters Hospital

City of Saint Peters, Missouri, United States

Site Status RECRUITING

MU Health - University Hospital/Ellis Fischel Cancer Center

Columbia, Missouri, United States

Site Status ACTIVE_NOT_RECRUITING

Siteman Cancer Center at West County Hospital

Creve Coeur, Missouri, United States

Site Status RECRUITING

Washington University School of Medicine

St Louis, Missouri, United States

Site Status RECRUITING

Siteman Cancer Center at Christian Hospital

St Louis, Missouri, United States

Site Status RECRUITING

Billings Clinic Cancer Center

Billings, Montana, United States

Site Status RECRUITING

Hackensack University Medical Center

Hackensack, New Jersey, United States

Site Status RECRUITING

Roswell Park Cancer Institute

Buffalo, New York, United States

Site Status RECRUITING

Mount Sinai Hospital

New York, New York, United States

Site Status SUSPENDED

UNC Lineberger Comprehensive Cancer Center

Chapel Hill, North Carolina, United States

Site Status RECRUITING

MetroHealth Medical Center

Cleveland, Ohio, United States

Site Status RECRUITING

University of Oklahoma Health Sciences Center

Oklahoma City, Oklahoma, United States

Site Status RECRUITING

Providence Portland Medical Center

Portland, Oregon, United States

Site Status RECRUITING

Providence Saint Vincent Medical Center

Portland, Oregon, United States

Site Status RECRUITING

Oregon Health and Science University

Portland, Oregon, United States

Site Status RECRUITING

Guthrie Medical Group PC-Robert Packer Hospital

Sayre, Pennsylvania, United States

Site Status RECRUITING

Vanderbilt University/Ingram Cancer Center

Nashville, Tennessee, United States

Site Status RECRUITING

UT Southwestern Simmons Cancer Center - RedBird

Dallas, Texas, United States

Site Status RECRUITING

UT Southwestern/Simmons Cancer Center-Dallas

Dallas, Texas, United States

Site Status RECRUITING

UT Southwestern/Simmons Cancer Center-Fort Worth

Fort Worth, Texas, United States

Site Status RECRUITING

UT Southwestern Clinical Center at Richardson/Plano

Richardson, Texas, United States

Site Status RECRUITING

Bon Secours Memorial Regional Medical Center

Mechanicsville, Virginia, United States

Site Status RECRUITING

Bon Secours Saint Francis Medical Center

Midlothian, Virginia, United States

Site Status RECRUITING

Bon Secours Richmond Community Hospital

Richmond, Virginia, United States

Site Status RECRUITING

Bon Secours Saint Mary's Hospital

Richmond, Virginia, United States

Site Status RECRUITING

Bon Secours Cancer Institute at Reynolds Crossing

Richmond, Virginia, United States

Site Status RECRUITING

VCU Massey Cancer Center at Stony Point

Richmond, Virginia, United States

Site Status RECRUITING

VCU Massey Comprehensive Cancer Center

Richmond, Virginia, United States

Site Status RECRUITING

Swedish Cancer Institute-Edmonds

Edmonds, Washington, United States

Site Status RECRUITING

West Virginia University Charleston Division

Charleston, West Virginia, United States

Site Status ACTIVE_NOT_RECRUITING

Edwards Comprehensive Cancer Center

Huntington, West Virginia, United States

Site Status RECRUITING

Marshfield Medical Center-Marshfield

Marshfield, Wisconsin, United States

Site Status RECRUITING

Froedtert Menomonee Falls Hospital

Menomonee Falls, Wisconsin, United States

Site Status RECRUITING

Medical College of Wisconsin

Milwaukee, Wisconsin, United States

Site Status RECRUITING

Drexel Town Square Health Center

Oak Creek, Wisconsin, United States

Site Status RECRUITING

Froedtert West Bend Hospital/Kraemer Cancer Center

West Bend, Wisconsin, United States

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

United States

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Rana McKay, MD

Role: CONTACT

858-822-6185

Shiva Baghaie

Role: CONTACT

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Site Public Contact

Role: primary

Site Public Contact

Role: primary

Site Public Contact

Role: primary

760-536-7700

Site Public Contact

Role: primary

877-827-8839

Site Public Contact

Role: primary

858-822-5354

Site Public Contact

Role: primary

877-827-8839

Site Public Contact

Role: primary

916-734-3089

Site Public Contact

Role: primary

Site Public Contact

Role: primary

719-365-2406

Site Public Contact

Role: primary

719-364-6700

Site Public Contact

Role: primary

970-297-6150

Site Public Contact

Role: primary

773-702-9171

Site Public Contact

Role: primary

773-702-9171

Site Public Contact

Role: primary

970-203-7083

Site Public Contact

Role: primary

302-291-6730

Site Public Contact

Role: primary

302-623-4450

Site Public Contact

Role: primary

302-623-4450

Site Public Contact

Role: primary

302-291-6730

Site Public Contact

Role: primary

561-263-5791

Site Public Contact

Role: primary

309-243-3605

Site Public Contact

Role: primary

309-243-3605

Site Public Contact

Role: primary

217-876-4762

Site Public Contact

Role: primary

309-243-3605

Site Public Contact

Role: primary

309-243-3605

Site Public Contact

Role: primary

314-747-9912

Site Public Contact

Role: primary

515-239-4734

Site Public Contact

Role: primary

563-355-7733

Site Public Contact

Role: primary

800-237-1225

Site Public Contact

Role: primary

913-588-3671

Site Public Contact

Role: primary

913-588-1569

Site Public Contact

Role: primary

913-588-3671

Site Public Contact

Role: primary

785-295-8000

Site Public Contact

Role: primary

913-588-3671

Site Public Contact

Role: primary

859-301-4730

Site Public Contact

Role: primary

859-301-4730

Site Public Contact

Role: primary

877-442-3324

Site Public Contact

Role: primary

877-338-7425

Site Public Contact

Role: primary

877-338-7425

Site Public Contact

Role: primary

877-332-4294

Site Public Contact

Role: primary

781-624-5000

Site Public Contact

Role: primary

413-794-3565

Site Public Contact

Role: primary

734-712-7251

Site Public Contact

Role: primary

734-712-7251

Site Public Contact

Role: primary

734-712-7251

Site Public Contact

Role: primary

517-364-3712

Site Public Contact

Role: primary

734-712-7251

Site Public Contact

Role: primary

734-712-7251

Site Public Contact

Role: primary

800-600-3606

Site Public Contact

Role: primary

800-600-3606

Site Public Contact

Role: primary

800-600-3606

Site Public Contact

Role: primary

800-600-3606

Site Public Contact

Role: primary

800-996-2663

Site Public Contact

Role: primary

551-996-2897

Site Public Contact

Role: primary

800-767-9355

Site Public Contact

Role: primary

877-668-0683

Site Public Contact

Role: primary

216-778-7559

Site Public Contact

Role: primary

405-271-8777

Site Public Contact

Role: primary

503-215-2614

Site Public Contact

Role: primary

503-215-2614

Site Public Contact

Role: primary

503-494-1080

Site Public Contact

Role: primary

800-836-0388

Site Public Contact

Role: primary

800-811-8480

Site Public Contact

Role: primary

214-648-7097

Site Public Contact

Role: primary

214-648-7097

Site Public Contact

Role: primary

214-648-7097

Site Public Contact

Role: primary

972-669-7044

Site Public Contact

Role: primary

804-893-8978

Site Public Contact

Role: primary

804-893-8978

Site Public Contact

Role: primary

804-893-8978

Site Public Contact

Role: primary

804-893-8978

Site Public Contact

Role: primary

804-893-8978

Site Public Contact

Role: primary

Site Public Contact

Role: primary

804-628-6430

Site Public Contact

Role: primary

206-215-2343

Site Public Contact

Role: primary

304-399-6566

Site Public Contact

Role: primary

800-782-8581

Site Public Contact

Role: primary

262-257-5100

Site Public Contact

Role: primary

414-805-3666

Site Public Contact

Role: primary

414-805-0505

Site Public Contact

Role: primary

414-805-0505

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

NCI-2024-04960

Identifier Type: OTHER

Identifier Source: secondary_id

A032102

Identifier Type: -

Identifier Source: org_study_id

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