Ovarian Cancer Clinical Trial

Palbociclib and Binimetinib in RAS-Mutant Cancers, A ComboMATCH Treatment Trial

Summary

This phase II clinical trial evaluates the effectiveness of palbociclib and binimetinib in treating patients with RAS-mutated cancers. Palbociclib and binimetinib are both in a class of medications called kinase inhibitors. They work by blocking the action of abnormal proteins that signals cancer cells to multiply. This trial may help researchers understand if giving the combination of palbociclib and binimetinib can help improve the amount of time before the cancer grows in patients with patients with low grade serous ovarian cancer who have certain changes in the tumor DNA. This trial may also help researchers understand if giving the combination of palbociclib and binimetinib can help improve outcomes among patients with low grade serous ovarian cancer who have previously received a MEK inhibitor. For patients with other tumors, with the exception of lung cancer, colon cancer, melanoma and low grade serous ovarian cancers, this trial may help researchers understand if giving the combination of palbociclib and binimetinib can improve the clinical outcome of survival without progression in patients who have certain changes in their tumor's DNA.

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Full Description

PRIMARY OBJECTIVES:

I. To determine whether palbociclib and binimetinib combination therapy improves progression free survival (PFS) compared to binimetinib alone in patients with MEK-inhibitor naive low-grade serous ovarian cancer (LGSOC) harboring MAP kinase activation (KRAS/NRAS/non BRAF V600E mutation). (Cohort 1) II. To determine whether palbociclib and binimetinib improves clinical activity in comparison to historical control, as measured by objective response rate (ORR), in women with LGSOC whose disease has previously progressed on a MEK inhibitor. (Cohort 2) III. To determine whether palbociclib and binimetinib combination therapy improves the objective response rate compared to historical control in patients with pancreatic cancer harboring any KRAS/NRAS/HRAS mutation or non-BRAF V600E aMOIs or rare RAF fusion. (Cohort 3) IV. To determine whether palbociclib and binimetinib combination therapy improves objective response rate compared to historical control in patients with tumors harboring any KRAS/NRAS/HRAS mutations or non-BRAF V600E aMOIs or rare RAF fusions (excluding LGSOC, non-small cell lung cancer [NSCLC], colorectal cancer, pancreatic cancer and melanoma). (Cohort 4)

SECONDARY OBJECTIVES:

I. To determine whether palbociclib and binimetinib combination therapy improves objective response rate (ORR), overall survival (OS), duration of response (DOR), and disease control rate (DCR) compared to binimetinib alone in patients with MEK inhibitor-naïve LGSOC. (Cohort 1) II. Conduct whole-exome sequencing to evaluate concordance with the designated laboratory result. (Cohort 1) III. To assess the clinical activity of palbociclib and binimetinib as measured by PFS, OS, DOR, and DCR in women with LGSOC whose disease has previously progressed on a MEK inhibitor. (Cohort 2) IV. Conduct whole-exome sequencing to evaluate concordance with the designated laboratory result. (Cohort 2) V. To assess the clinical activity of palbociclib and binimetinib as measured by PFS, OS, DOR, and DCR in patients with RAS mutated pancreatic cancer. (Cohort 3) VI. Conduct whole-exome sequencing to evaluate concordance with the designated laboratory result. (Cohort 3) VII. To assess the clinical activity of palbociclib and binimetinib as measured by PFS, OS, DOR, and DCR in patients with RAS mutated cancers, excluding LGSOC, NSCLC, colorectal cancer (CRC), pancreatic cancer and melanoma. (Cohort 4) VIII. Conduct whole-exome sequencing to evaluate concordance with the designated laboratory result. (Cohort 4)

EXPLORATORY OBJECTIVES:

I. Explore thymidine kinase 1 (TK1) activity in response to palbociclib. (Cohort 1) II. Assess the correlation between presence of KRAS mutation and activity of both monotherapy and the combination. (Cohort 1) III. Conduct ribonucleic acid (RNA)-sequencing (seq) to assess determinants of response and resistance. (Cohort 1) IV. Explore changes in plasma RAS allelic burden in KRAS-mutated tumors using circulating tumor deoxyribonucleic acid (ctDNA) and correlate changes with clinical activity. (Cohort 1) V. Explore TK1 activity in response to palbociclib.(Cohort 2) VI. Assess the correlation between presence of KRAS mutation and activity of the combination. (Cohort 2) VII. Conduct RNA-seq to assess determinants of response and resistance. (Cohort 2) VIII. Explore changes in plasma RAS allelic burden in KRAS-mutated tumors using ctDNA and correlate changes with clinical activity. (Cohort 2) IX. Explore TK1 activity in response to palbociclib. (Cohort 3) X. Evaluate changes in deoxyribonucleic acid (DNA), RNA and ctDNA to evaluate concordance with the designated laboratory result and to assess determinants of response, signatures of intrinsic resistance or response and the plasma RAS allelic burden in relation to treatment response, respectively. (Cohort 3) XI. Explore TK1 activity in response to palbociclib. (Cohort 4) XII. Evaluate changes in DNA, RNA and ctDNA to evaluate concordance with the designated laboratory result and to assess determinants of response, signatures of intrinsic resistance or response and the plasma RAS allelic burden in relation to treatment response, respectively. (Cohort 4)

OUTLINE: Patients with KRAS, NRAS, non-BRAF V600E aMOIs or rare RAF fusions LGSOC, naïve to MEK or CDK4/6 inhibitor therapy are randomized to either combination cohort 1 or monotherapy cohort 1. Patients with LGSOC who have received prior MEK inhibitor therapy are assigned to combination cohort 2. Patients with KRAS/NRAS/HRAS/non-V600E a MOIs or rare RAF fusion pancreatic cancer are assigned to combination cohort 3. Patients with all other KRAS/NRAS/HRAS, non -BRAF V600E a MOIs or rare FAR fusion tumor types (excluding LGSOC, NSCLC, CRC, pancreatic, and melanoma) are assigned to combination cohort 4.

COMBINATION COHORTS 1, 2, 3, 4: Patients receive palbociclib orally (PO), once per day (QD) on days 1-21 and binimetinib PO twice per day (BID) on days 1-28 of each cycle. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity for up to 3 years. Patients may also undergo biopsy at screening and undergo magnetic resonance imaging (MRI), computed tomography (CT), bone scan, and collection of blood samples during screening, on study, and/or during follow up.

MONOTHERAPY COHORT 1: Patients receive binimetinib PO BID daily, in the absence of disease progression or unacceptable toxicity, for up to 3 years. Patients who experience disease progression may elect to migrate to the combination cohort. Patients may also undergo biopsy at screening and undergo MRI, CT, bone scan, and collection of blood samples during screening, on study, and/or during follow up.

After completion of study treatment, patients are followed up every 3 months for up to 3 years following registration.

View Eligibility Criteria

Eligibility Criteria

Inclusion Criteria:

GENERAL ComboMATCH EAY191 REGISTRATION INCLUSION CRITERIA:
Patients must be enrolled on the EAY191 registration study and be assigned to this protocol by EAY191
Patients must have KRAS/NRAS/HRAS or BRAF alterations RAF mutations or RAF fusions as determined by the ComboMATCH screening assessment
Patients with low grade serous ovarian cancer who have progressed on a prior MEK inhibitor are not required to have a KRAS/NRAS/HRAS or BRAF alteration
Patients must not have a BRAF V600E alteration as determined by the ComboMATCH screening assessment
Patients with a tumor harboring KRAS G12C mutation will be eligible either after they have received a G12C inhibitor or can be enrolled if they do not meet eligibility for a G12C inhibitor. However, patients with tumors harboring KRAS G12C mutation will be prioritized for a G12C inhibitor-based substudy if eligible
Patients must have disease that can be safely biopsied and agree to a pre-treatment biopsy or have archival tissue available from within 12 months prior to registration
Please note the current actionable marker of interest (aMOI)/actionable alteration list for this treatment trial can be found on the Cancer Trials Support Unit (CTSU) website: www.ctsu.org (final URL pending)
EAY191-A3 IELIGIBILITY CRITERIA:
Histologically confirmed cancer for each cohort for which curable treatment modalities are not an option. Rare BRAF fusions and non-BRAF V600E aMOIs are acceptable
Measurable disease per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1. There is a mandatory baseline biopsy for all ComboMATCH studies. Hence, patient must have a biopsiable lesion at baseline. Of note, in the case when a baseline biopsy is done after scans are obtained, a lesion separate from one that is biopsied needs to be measurable per RECIST 1.1. All radiologic studies must be performed within 28 days prior to randomization
COHORT 1: Low grade serous ovarian cancer with KRAS, NRAS non-BRAF V600E aMOIs or rare RAF fusions are acceptable
COHORT 1: No prior MEK inhibitor or CDK4/6 inhibitor therapy
COHORT 1: Any number of prior therapies permitted
COHORT 1: No major surgery within 4 weeks (excluding placement of vascular access), minor surgery within 2 weeks, or palliative radiotherapy within 2 weeks of the first dose of study therapy
COHORT 1: No prior cancer-directed therapy within 28 days prior to registration. Patients may have received cancer-directed hormonal therapy up to 14 days prior to the start of study treatment
COHORT 2: Low grade serous ovarian cancer
COHORT 2: Prior progression of disease on a MEK inhibitor (prior binimetinib permitted)
COHORT 2: If patient has previously received binimetinib, they cannot have required dose reduction or discontinuation of binimetinib due to adverse events
COHORT 2: No prior receipt of a CDK4/6 inhibitor
COHORT 2: No major surgery within 4 weeks (excluding placement of vascular access), minor surgery within 2 weeks, or palliative radiotherapy within 2 weeks of the first dose of study therapy
COHORT 2: No prior cancer-directed therapy within 28 days prior to registration. Patients may have received cancer-directed hormonal therapy up to 14 days prior to the start of study treatment. Patients migrating from cohort 1 may have received binimetinib within 28 days of registering to cohort 2
COHORT 3: Pancreatic cancer with KRAS/NRAS/HRAS, non-BRAF V600E aMOIs or rare RAF fusions are acceptable
COHORT 3: No prior MEK inhibitor (MEKi) and CDK4/6i therapy
COHORT 3: Progression after at least one line of prior therapy as long as there is no standard therapy available or acceptable to patients that is thought to be of benefit
COHORT 3: Any number of prior therapies are permitted
COHORT 3: No major surgery within 4 weeks (excluding placement of vascular access), minor surgery within 2 weeks, or palliative radiotherapy within 2 weeks of the first dose of study therapy
COHORT 3: No prior cancer-directed therapy within 28 days prior to registration. Patients may have received cancer-directed hormonal therapy up to 14 days prior to the start of study treatment
COHORT 4: KRAS/NRAS/HRAS non-BRAF V600E aMOIs or rare RAF fusions are acceptable
COHORT 4: No prior MEKi and CDK4/6i therapy and progression after at least one line of prior therapy, as long as there is no standard therapy available or acceptable to patients that is thought to be of benefit
COHORT 4: Any number of prior therapies are permitted
COHORT 4: No more than 6 patients with a given tumor type allowed in this cohort
COHORT 4: Any tumor type, except: LGSOC/NSCLC/CRC/pancreatic/melanoma
COHORT 4: No major surgery within 4 weeks (excluding placement of vascular access), minor surgery within 2 weeks, or palliative radiotherapy within 2 weeks of the first dose of study therapy
COHORT 4: No prior cancer-directed therapy within 28 days prior to registration. Patients may have received cancer-directed hormonal therapy up to 14 days prior to the start of study treatment
Not pregnant and not nursing, because this study involves an investigational agent whose genotoxic, mutagenic and teratogenic effects on the developing fetus and newborn are unknown. Therefore, for women of childbearing potential only, a negative pregnancy test done =< 7 days prior to registration is required
Age >= 18 years
Eastern Cooperative Oncology Group (ECOG) performance status < 2
Absolute neutrophil count (ANC) >= 1,500/mm^3
Platelet count >= 100,000/mm^3
Hemoglobin > 9 g/dL
Creatinine =< 1.5 x upper limit of normal (ULN) or calculated (calc.) creatinine clearance >= 30 mL/min as calculated by the Cockcroft-Gault formula
Total bilirubin =< 1.5 x upper limit of normal (ULN). Patients with Gilbert syndrome may enroll if total bilirubin (bili) < 3 mg/dL (51 micromole/L)
Aspartate aminotransferase (AST)/alanine aminotransferase (ALT) =< 2.5 x upper limit of normal (ULN)
Creatine phosphokinase (CPK) =< 2.5 x ULN
Patients must be able to swallow oral formulations of the agents
No history of interstitial lung disease. No history of idiopathic pulmonary fibrosis, organizing pneumonia (e.g., bronchiolitis obliterans), drug-induced pneumonitis, or idiopathic pneumonitis, or evidence of active pneumonitis on screening chest computed tomography (CT) scan
Patients should not have history of bowel perforation or intestinal fistulas in the last 6 months
No patients with the inability to swallow oral medications or impaired gastrointestinal absorption due to gastrectomy or active inflammatory bowel disease
No active skin disorder that has required systemic therapy within the past 1 year
No history of rhabdomyolysis

No concurrent ocular disorders including:

Subjects with history of glaucoma, history of retinal vein occlusion (RVO), predisposing factors for RVO, including uncontrolled hypertension, uncontrolled diabetes
Subject with history of retinal pathology or evidence of visible retinal pathology that is considered a risk factor for RVO, intraocular pressure > 21 mm Hg as measured by tonometry, or other significant ocular pathology, such as anatomical abnormalities that increase the risk for RVO
Subjects with a history of corneal erosion (instability of corneal epithelium), corneal degeneration, active or recurrent keratitis, and other forms of serious ocular surface inflammatory conditions
No patients with a history of hypersensitivity to any of the study drug(s)
No prior allogeneic stem cell or solid organ transplantation
Central nervous system (CNS) metastases must have been treated with local therapy (surgery, radiation, ablation) and patient off of systemic steroids, and brain metastases stable for at least 1 month
No residual Common Terminology Criteria for Adverse Events (CTCAE) >= grade 2 toxicity from any prior anticancer therapy, with the exception of grade 2 alopecia or grade 2 neuropathy
Human immunodeficiency virus (HIV)-infected patients on effective anti-retroviral therapy with undetectable viral load within 6 months are eligible for this trial
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
Patients whose left ventricular ejection fraction (LVEF) has been evaluated by echocardiography (ECHO)/multigated acquisition scan (MUGA) are excluded if the most recent exam shows an LVEF < 50%
Chronic concomitant treatment with strong inhibitors of CYP3A4 is not allowed on this study. Patients on strong CYP3A4 inhibitors must discontinue the drug for 14 days prior to registration on the study
Chronic concomitant treatment with strong CYP3A4 inducers is not allowed. Patients must discontinue the drug 14 days prior to the start of study treatment
No exposure to P-glycoprotein (P-gp) inhibitors or inducers within 14 days prior to the first dose and during the course of therapy
Patients treated with Cohort 1 control treatment binimetinib who experience disease progression may elect to migrate to cohort 2 and receive combination treatment with palbociclib and binimetinib. Patients who choose to do so must meet laboratory values and performance status requirements as above and must be begin treatment within 21 days

Study is for people with:

Ovarian Cancer

Phase:

Phase 2

Estimated Enrollment:

199

Study ID:

NCT05554367

Recruitment Status:

Recruiting

Sponsor:

National Cancer Institute (NCI)

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There are 152 Locations for this study

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University of Alabama at Birmingham Cancer Center
Birmingham Alabama, 35233, United States More Info
Site Public Contact
Contact
205-934-0220
[email protected]
Rebecca C. Arend
Principal Investigator
University of South Alabama Mitchell Cancer Institute
Mobile Alabama, 36688, United States More Info
Site Public Contact
Contact
251-445-9870
[email protected]
Ahmed Abdalla
Principal Investigator
University of Florida Health Science Center - Gainesville
Gainesville Florida, 32610, United States More Info
Site Public Contact
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352-273-8010
[email protected]
Thomas J. George
Principal Investigator
Saint Alphonsus Cancer Care Center-Boise
Boise Idaho, 83706, United States More Info
Site Public Contact
Contact
734-712-3671
[email protected]
John M. Schallenkamp
Principal Investigator
Saint Luke's Cancer Institute - Boise
Boise Idaho, 83712, United States More Info
Site Public Contact
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208-381-2774
[email protected]
Alison K. Conlin
Principal Investigator
Saint Alphonsus Cancer Care Center-Caldwell
Caldwell Idaho, 83605, United States More Info
Site Public Contact
Contact
734-712-3671
[email protected]
John M. Schallenkamp
Principal Investigator
Kootenai Health - Coeur d'Alene
Coeur d'Alene Idaho, 83814, United States More Info
Site Public Contact
Contact
406-969-6060
[email protected]
John M. Schallenkamp
Principal Investigator
Saint Alphonsus Cancer Care Center-Nampa
Nampa Idaho, 83687, United States More Info
Site Public Contact
Contact
406-969-6060
[email protected]
John M. Schallenkamp
Principal Investigator
Kootenai Clinic Cancer Services - Post Falls
Post Falls Idaho, 83854, United States More Info
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Contact
406-969-6060
[email protected]
John M. Schallenkamp
Principal Investigator
Kootenai Clinic Cancer Services - Sandpoint
Sandpoint Idaho, 83864, United States More Info
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406-969-6060
[email protected]
John M. Schallenkamp
Principal Investigator
Illinois CancerCare-Bloomington
Bloomington Illinois, 61704, United States More Info
Site Public Contact
Contact
309-243-3605
[email protected]
Bryan A. Faller
Principal Investigator
Illinois CancerCare-Canton
Canton Illinois, 61520, United States More Info
Site Public Contact
Contact
309-243-3605
[email protected]
Bryan A. Faller
Principal Investigator
Illinois CancerCare-Carthage
Carthage Illinois, 62321, United States More Info
Site Public Contact
Contact
309-243-3605
[email protected]
Bryan A. Faller
Principal Investigator
Northwestern University
Chicago Illinois, 60611, United States More Info
Site Public Contact
Contact
312-695-1301
[email protected]
Devalingam Mahalingam
Principal Investigator
John H Stroger Jr Hospital of Cook County
Chicago Illinois, 60612, United States More Info
Site Public Contact
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312-864-5204
Thomas E. Lad
Principal Investigator
University of Chicago Comprehensive Cancer Center
Chicago Illinois, 60637, United States More Info
Site Public Contact
Contact
773-702-8222
[email protected]
Ardaman Shergill
Principal Investigator
Carle at The Riverfront
Danville Illinois, 61832, United States More Info
Site Public Contact
Contact
800-446-5532
[email protected]
Maria T. Grosse-Perdekamp
Principal Investigator
Cancer Care Specialists of Illinois - Decatur
Decatur Illinois, 62526, United States More Info
Site Public Contact
Contact
217-876-4762
[email protected]
Bryan A. Faller
Principal Investigator
Decatur Memorial Hospital
Decatur Illinois, 62526, United States More Info
Site Public Contact
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217-876-4762
[email protected]
Bryan A. Faller
Principal Investigator
Northwestern Medicine Cancer Center Kishwaukee
DeKalb Illinois, 60115, United States More Info
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630-352-5360
[email protected]
Devalingam Mahalingam
Principal Investigator
Illinois CancerCare-Dixon
Dixon Illinois, 61021, United States More Info
Site Public Contact
Contact
815-285-7800
Bryan A. Faller
Principal Investigator
Carle Physician Group-Effingham
Effingham Illinois, 62401, United States More Info
Site Public Contact
Contact
800-446-5532
[email protected]
Maria T. Grosse-Perdekamp
Principal Investigator
Crossroads Cancer Center
Effingham Illinois, 62401, United States More Info
Site Public Contact
Contact
217-876-4762
[email protected]
Bryan A. Faller
Principal Investigator
Illinois CancerCare-Eureka
Eureka Illinois, 61530, United States More Info
Site Public Contact
Contact
309-243-3605
[email protected]
Bryan A. Faller
Principal Investigator
Illinois CancerCare-Galesburg
Galesburg Illinois, 61401, United States More Info
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Contact
309-243-3605
[email protected]
Bryan A. Faller
Principal Investigator
Northwestern Medicine Cancer Center Delnor
Geneva Illinois, 60134, United States More Info
Site Public Contact
Contact
630-352-5360
[email protected]
Devalingam Mahalingam
Principal Investigator
Northwestern Medicine Glenview Outpatient Center
Glenview Illinois, 60026, United States More Info
Site Public Contact
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312-695-1102
Devalingam Mahalingam
Principal Investigator
Northwestern Medicine Grayslake Outpatient Center
Grayslake Illinois, 60030, United States More Info
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312-695-1102
Devalingam Mahalingam
Principal Investigator
Illinois CancerCare-Kewanee Clinic
Kewanee Illinois, 61443, United States More Info
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Contact
309-243-3605
[email protected]
Bryan A. Faller
Principal Investigator
Northwestern Medicine Lake Forest Hospital
Lake Forest Illinois, 60045, United States More Info
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Contact
[email protected]
Devalingam Mahalingam
Principal Investigator
Illinois CancerCare-Macomb
Macomb Illinois, 61455, United States More Info
Site Public Contact
Contact
309-243-3605
[email protected]
Bryan A. Faller
Principal Investigator
Carle Physician Group-Mattoon/Charleston
Mattoon Illinois, 61938, United States More Info
Site Public Contact
Contact
800-446-5532
[email protected]
Maria T. Grosse-Perdekamp
Principal Investigator
UC Comprehensive Cancer Center at Silver Cross
New Lenox Illinois, 60451, United States More Info
Site Public Contact
Contact
773-702-8222
[email protected]
Ardaman Shergill
Principal Investigator
Cancer Care Center of O'Fallon
O'Fallon Illinois, 62269, United States More Info
Site Public Contact
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217-876-4762
[email protected]
Bryan A. Faller
Principal Investigator
Northwestern Medicine Orland Park
Orland Park Illinois, 60462, United States More Info
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Contact
[email protected]
Devalingam Mahalingam
Principal Investigator
University of Chicago Medicine-Orland Park
Orland Park Illinois, 60462, United States More Info
Site Public Contact
Contact
773-702-8222
[email protected]
Ardaman Shergill
Principal Investigator
Illinois CancerCare-Ottawa Clinic
Ottawa Illinois, 61350, United States More Info
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Contact
309-243-3605
[email protected]
Bryan A. Faller
Principal Investigator
Illinois CancerCare-Pekin
Pekin Illinois, 61554, United States More Info
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309-243-3605
[email protected]
Bryan A. Faller
Principal Investigator
Illinois CancerCare-Peoria
Peoria Illinois, 61615, United States More Info
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309-243-3605
[email protected]
Bryan A. Faller
Principal Investigator
Illinois CancerCare-Peru
Peru Illinois, 61354, United States More Info
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309-243-3605
[email protected]
Bryan A. Faller
Principal Investigator
Illinois CancerCare-Princeton
Princeton Illinois, 61356, United States More Info
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309-243-3605
[email protected]
Bryan A. Faller
Principal Investigator
Southern Illinois University School of Medicine
Springfield Illinois, 62702, United States More Info
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217-545-7929
Bryan A. Faller
Principal Investigator
Springfield Clinic
Springfield Illinois, 62702, United States More Info
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800-444-7541
Bryan A. Faller
Principal Investigator
Memorial Medical Center
Springfield Illinois, 62781, United States More Info
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217-528-7541
[email protected]
Bryan A. Faller
Principal Investigator
Carle Cancer Center
Urbana Illinois, 61801, United States More Info
Site Public Contact
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800-446-5532
[email protected]
Maria T. Grosse-Perdekamp
Principal Investigator
Northwestern Medicine Cancer Center Warrenville
Warrenville Illinois, 60555, United States More Info
Site Public Contact
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630-352-5360
[email protected]
Devalingam Mahalingam
Principal Investigator
Illinois CancerCare - Washington
Washington Illinois, 61571, United States More Info
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309-243-3605
[email protected]
Bryan A. Faller
Principal Investigator
Mission Cancer and Blood - Ankeny
Ankeny Iowa, 50023, United States
Mercy Hospital
Cedar Rapids Iowa, 52403, United States More Info
Site Public Contact
Contact
319-365-4673
Deborah W. Wilbur
Principal Investigator
Oncology Associates at Mercy Medical Center
Cedar Rapids Iowa, 52403, United States More Info
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319-363-2690
Deborah W. Wilbur
Principal Investigator
Mission Cancer and Blood - Des Moines
Des Moines Iowa, 50309, United States More Info
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Contact
515-241-3305
Seema Harichand-Herdt
Principal Investigator
University of Kentucky/Markey Cancer Center
Lexington Kentucky, 40536, United States More Info
Site Public Contact
Contact
859-257-3379
Susanne M. Arnold
Principal Investigator
Harold Alfond Center for Cancer Care
Augusta Maine, 04330, United States More Info
Site Public Contact
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207-626-4855
Leslie S. Bradford
Principal Investigator
Lafayette Family Cancer Center-EMMC
Brewer Maine, 04412, United States More Info
Site Public Contact
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800-987-3005
Sarah J. Sinclair
Principal Investigator
Maine Medical Center- Scarborough Campus
Scarborough Maine, 04074, United States More Info
Site Public Contact
Contact
207-396-8090
[email protected]
Leslie S. Bradford
Principal Investigator
Maine Medical Partners - South Portland
South Portland Maine, 04106, United States More Info
Site Public Contact
Contact
207-396-8670
[email protected]
Leslie S. Bradford
Principal Investigator
UPMC Western Maryland
Cumberland Maryland, 21502, United States More Info
Site Public Contact
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240-964-1400
Sarah E. Taylor
Principal Investigator
Trinity Health Saint Joseph Mercy Hospital Ann Arbor
Ann Arbor Michigan, 48106, United States More Info
Site Public Contact
Contact
734-712-7251
[email protected]
Tareq Al Baghdadi
Principal Investigator
Bronson Battle Creek
Battle Creek Michigan, 49017, United States More Info
Site Public Contact
Contact
616-391-1230
[email protected]
Kathleen J. Yost
Principal Investigator
Trinity Health IHA Medical Group Hematology Oncology - Brighton
Brighton Michigan, 48114, United States More Info
Site Public Contact
Contact
734-712-7251
[email protected]
Tareq Al Baghdadi
Principal Investigator
Trinity Health Medical Center - Brighton
Brighton Michigan, 48114, United States More Info
Site Public Contact
Contact
734-712-7251
[email protected]
Tareq Al Baghdadi
Principal Investigator
Trinity Health IHA Medical Group Hematology Oncology - Canton
Canton Michigan, 48188, United States More Info
Site Public Contact
Contact
734-712-7251
[email protected]
Tareq Al Baghdadi
Principal Investigator
Trinity Health Medical Center - Canton
Canton Michigan, 48188, United States More Info
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Contact
734-712-7251
[email protected]
Tareq Al Baghdadi
Principal Investigator
Chelsea Hospital
Chelsea Michigan, 48118, United States More Info
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Contact
734-712-7251
[email protected]
Tareq Al Baghdadi
Principal Investigator
Trinity Health IHA Medical Group Hematology Oncology - Chelsea Hospital
Chelsea Michigan, 48118, United States More Info
Site Public Contact
Contact
734-712-7251
[email protected]
Tareq Al Baghdadi
Principal Investigator
Beaumont Hospital - Dearborn
Dearborn Michigan, 48124, United States More Info
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Contact
248-551-7695
Dana Zakalik
Principal Investigator
Beaumont Hospital - Farmington Hills
Farmington Hills Michigan, 48336, United States More Info
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Contact
248-551-7695
Dana Zakalik
Principal Investigator
Genesee Cancer and Blood Disease Treatment Center
Flint Michigan, 48503, United States More Info
Site Public Contact
Contact
810-762-8038
[email protected]
Tareq Al Baghdadi
Principal Investigator
Genesee Hematology Oncology PC
Flint Michigan, 48503, United States More Info
Site Public Contact
Contact
810-762-8038
[email protected]
Tareq Al Baghdadi
Principal Investigator
Genesys Hurley Cancer Institute
Flint Michigan, 48503, United States More Info
Site Public Contact
Contact
810-762-8038
[email protected]
Tareq Al Baghdadi
Principal Investigator
Hurley Medical Center
Flint Michigan, 48503, United States More Info
Site Public Contact
Contact
810-762-8038
[email protected]
Tareq Al Baghdadi
Principal Investigator
Corewell Health Grand Rapids Hospitals - Butterworth Hospital
Grand Rapids Michigan, 49503, United States More Info
Site Public Contact
Contact
616-391-1230
[email protected]
Kathleen J. Yost
Principal Investigator
Trinity Health Grand Rapids Hospital
Grand Rapids Michigan, 49503, United States More Info
Site Public Contact
Contact
616-391-1230
[email protected]
Kathleen J. Yost
Principal Investigator
Bronson Methodist Hospital
Kalamazoo Michigan, 49007, United States More Info
Site Public Contact
Contact
616-391-1230
[email protected]
Kathleen J. Yost
Principal Investigator
West Michigan Cancer Center
Kalamazoo Michigan, 49007, United States More Info
Site Public Contact
Contact
616-391-1230
[email protected]
Kathleen J. Yost
Principal Investigator
Ascension Borgess Cancer Center
Kalamazoo Michigan, 49009, United States More Info
Site Public Contact
Contact
616-391-1230
[email protected]
Kathleen J. Yost
Principal Investigator
University of Michigan Health - Sparrow Lansing
Lansing Michigan, 48912, United States More Info
Site Public Contact
Contact
517-364-3712
[email protected]
Tareq Al Baghdadi
Principal Investigator
Trinity Health Saint Mary Mercy Livonia Hospital
Livonia Michigan, 48154, United States More Info
Site Public Contact
Contact
734-712-7251
[email protected]
Tareq Al Baghdadi
Principal Investigator
Trinity Health Muskegon Hospital
Muskegon Michigan, 49444, United States More Info
Site Public Contact
Contact
616-391-1230
[email protected]
Kathleen J. Yost
Principal Investigator
Corewell Health Lakeland Hospitals - Niles Hospital
Niles Michigan, 49120, United States More Info
Site Public Contact
Contact
616-391-1230
Kathleen J. Yost
Principal Investigator
Cancer and Hematology Centers of Western Michigan - Norton Shores
Norton Shores Michigan, 49444, United States More Info
Site Public Contact
Contact
616-391-1230
[email protected]
Kathleen J. Yost
Principal Investigator
Michigan Healthcare Professionals Pontiac
Pontiac Michigan, 48341, United States More Info
Site Public Contact
Contact
248-858-6215
[email protected]
Tareq Al Baghdadi
Principal Investigator
Trinity Health Saint Joseph Mercy Oakland Hospital
Pontiac Michigan, 48341, United States More Info
Site Public Contact
Contact
734-712-7251
[email protected]
Tareq Al Baghdadi
Principal Investigator
Corewell Health Reed City Hospital
Reed City Michigan, 49677, United States More Info
Site Public Contact
Contact
616-391-1230
[email protected]
Kathleen J. Yost
Principal Investigator
William Beaumont Hospital-Royal Oak
Royal Oak Michigan, 48073, United States More Info
Site Public Contact
Contact
248-551-7695
Dana Zakalik
Principal Investigator
Corewell Health Lakeland Hospitals - Marie Yeager Cancer Center
Saint Joseph Michigan, 49085, United States More Info
Site Public Contact
Contact
616-391-1230
[email protected]
Kathleen J. Yost
Principal Investigator
Corewell Health Lakeland Hospitals - Saint Joseph Hospital
Saint Joseph Michigan, 49085, United States More Info
Site Public Contact
Contact
616-391-1230
[email protected]
Kathleen J. Yost
Principal Investigator
Munson Medical Center
Traverse City Michigan, 49684, United States More Info
Site Public Contact
Contact
616-391-1230
[email protected]
Kathleen J. Yost
Principal Investigator
William Beaumont Hospital - Troy
Troy Michigan, 48085, United States More Info
Site Public Contact
Contact
248-551-7695
Dana Zakalik
Principal Investigator
University of Michigan Health - West
Wyoming Michigan, 49519, United States More Info
Site Public Contact
Contact
616-391-1230
[email protected]
Kathleen J. Yost
Principal Investigator
Huron Gastroenterology PC
Ypsilanti Michigan, 48106, United States More Info
Site Public Contact
Contact
734-712-7251
[email protected]
Tareq Al Baghdadi
Principal Investigator
Trinity Health IHA Medical Group Hematology Oncology Ann Arbor Campus
Ypsilanti Michigan, 48197, United States More Info
Site Public Contact
Contact
734-712-7251
[email protected]
Tareq Al Baghdadi
Principal Investigator
Sanford Joe Lueken Cancer Center
Bemidji Minnesota, 56601, United States More Info
Site Public Contact
Contact
218-333-5000
[email protected]
Daniel Almquist
Principal Investigator
Essentia Health - Deer River Clinic
Deer River Minnesota, 56636, United States More Info
Site Public Contact
Contact
218-786-3308
[email protected]
Bret E. Friday
Principal Investigator
Essentia Health Cancer Center
Duluth Minnesota, 55805, United States More Info
Site Public Contact
Contact
218-786-3308
[email protected]
Bret E. Friday
Principal Investigator
Essentia Health Hibbing Clinic
Hibbing Minnesota, 55746, United States More Info
Site Public Contact
Contact
218-786-3308
Bret E. Friday
Principal Investigator
Essentia Health Sandstone
Sandstone Minnesota, 55072, United States More Info
Site Public Contact
Contact
218-786-3308
[email protected]
Bret E. Friday
Principal Investigator
Essentia Health Virginia Clinic
Virginia Minnesota, 55792, United States More Info
Site Public Contact
Contact
218-786-3308
[email protected]
Bret E. Friday
Principal Investigator
Saint Francis Medical Center
Cape Girardeau Missouri, 63703, United States More Info
Site Public Contact
Contact
573-334-2230
[email protected]
Bryan A. Faller
Principal Investigator
Siteman Cancer Center at West County Hospital
Creve Coeur Missouri, 63141, United States More Info
Site Public Contact
Contact
800-600-3606
[email protected]
Premal H. Thaker
Principal Investigator
Parkland Health Center - Farmington
Farmington Missouri, 63640, United States More Info
Site Public Contact
Contact
314-996-5569
Bryan A. Faller
Principal Investigator
Washington University School of Medicine
Saint Louis Missouri, 63110, United States More Info
Site Public Contact
Contact
800-600-3606
[email protected]
Premal H. Thaker
Principal Investigator
Siteman Cancer Center-South County
Saint Louis Missouri, 63129, United States More Info
Site Public Contact
Contact
800-600-3606
[email protected]
Premal H. Thaker
Principal Investigator
Missouri Baptist Medical Center
Saint Louis Missouri, 63131, United States More Info
Site Public Contact
Contact
314-996-5569
Bryan A. Faller
Principal Investigator
Siteman Cancer Center at Christian Hospital
Saint Louis Missouri, 63136, United States More Info
Site Public Contact
Contact
800-600-3606
[email protected]
Premal H. Thaker
Principal Investigator
Siteman Cancer Center at Saint Peters Hospital
Saint Peters Missouri, 63376, United States More Info
Site Public Contact
Contact
800-600-3606
[email protected]
Premal H. Thaker
Principal Investigator
Sainte Genevieve County Memorial Hospital
Sainte Genevieve Missouri, 63670, United States More Info
Site Public Contact
Contact
314-996-5569
Bryan A. Faller
Principal Investigator
Missouri Baptist Sullivan Hospital
Sullivan Missouri, 63080, United States More Info
Site Public Contact
Contact
314-996-5569
Bryan A. Faller
Principal Investigator
BJC Outpatient Center at Sunset Hills
Sunset Hills Missouri, 63127, United States More Info
Site Public Contact
Contact
314-996-5569
Bryan A. Faller
Principal Investigator
Community Hospital of Anaconda
Anaconda Montana, 59711, United States More Info
Site Public Contact
Contact
406-969-6060
[email protected]
John M. Schallenkamp
Principal Investigator
Billings Clinic Cancer Center
Billings Montana, 59101, United States More Info
Site Public Contact
Contact
800-996-2663
[email protected]
John M. Schallenkamp
Principal Investigator
Bozeman Health Deaconess Hospital
Bozeman Montana, 59715, United States More Info
Site Public Contact
Contact
406-969-6060
[email protected]
John M. Schallenkamp
Principal Investigator
Benefis Sletten Cancer Institute
Great Falls Montana, 59405, United States More Info
Site Public Contact
Contact
406-969-6060
[email protected]
John M. Schallenkamp
Principal Investigator
Kalispell Regional Medical Center
Kalispell Montana, 59901, United States More Info
Site Public Contact
Contact
406-969-6060
[email protected]
John M. Schallenkamp
Principal Investigator
Community Medical Center
Missoula Montana, 59804, United States More Info
Site Public Contact
Contact
406-969-6060
[email protected]
John M. Schallenkamp
Principal Investigator
University of New Mexico Cancer Center
Albuquerque New Mexico, 87106, United States More Info
Site Public Contact
Contact
505-925-0348
[email protected]
Carolyn Y. Muller
Principal Investigator
Roswell Park Cancer Institute
Buffalo New York, 14263, United States More Info
Site Public Contact
Contact
800-767-9355
[email protected]
Ellis G. Levine
Principal Investigator
Mount Sinai Hospital
New York New York, 10029, United States More Info
Site Public Contact
Contact
212-824-7309
[email protected]
Deborah B. Doroshow
Principal Investigator
Sanford Bismarck Medical Center
Bismarck North Dakota, 58501, United States More Info
Site Public Contact
Contact
701-323-5760
[email protected]
Daniel Almquist
Principal Investigator
Sanford Broadway Medical Center
Fargo North Dakota, 58122, United States More Info
Site Public Contact
Contact
701-323-5760
[email protected]
Daniel Almquist
Principal Investigator
Sanford Roger Maris Cancer Center
Fargo North Dakota, 58122, United States More Info
Site Public Contact
Contact
701-234-6161
[email protected]
Daniel Almquist
Principal Investigator
Miami Valley Hospital South
Centerville Ohio, 45459, United States More Info
Site Public Contact
Contact
937-528-2900
[email protected]
Tarek M. Sabagh
Principal Investigator
Good Samaritan Hospital - Cincinnati
Cincinnati Ohio, 45220, United States More Info
Site Public Contact
Contact
720-874-1881
[email protected]
Shahzad Siddique
Principal Investigator
Columbus Oncology and Hematology Associates Inc
Columbus Ohio, 43214, United States More Info
Site Public Contact
Contact
614-788-3860
[email protected]
Aine E. Clements
Principal Investigator
Riverside Methodist Hospital
Columbus Ohio, 43214, United States More Info
Site Public Contact
Contact
614-788-3860
[email protected]
Aine E. Clements
Principal Investigator
Grant Medical Center
Columbus Ohio, 43215, United States More Info
Site Public Contact
Contact
614-788-3860
[email protected]
Aine E. Clements
Principal Investigator
Doctors Hospital
Columbus Ohio, 43228, United States More Info
Site Public Contact
Contact
614-788-3860
[email protected]
Aine E. Clements
Principal Investigator
Miami Valley Hospital
Dayton Ohio, 45409, United States More Info
Site Public Contact
Contact
937-528-2900
[email protected]
Tarek M. Sabagh
Principal Investigator
Premier Blood and Cancer Center
Dayton Ohio, 45409, United States More Info
Site Public Contact
Contact
937-276-8320
Tarek M. Sabagh
Principal Investigator
Dayton Physician LLC - Englewood
Dayton Ohio, 45415, United States More Info
Site Public Contact
Contact
937-528-2900
[email protected]
Howard M. Gross
Principal Investigator
Miami Valley Hospital North
Dayton Ohio, 45415, United States More Info
Site Public Contact
Contact
937-528-2900
[email protected]
Tarek M. Sabagh
Principal Investigator
Delaware Health Center-Grady Cancer Center
Delaware Ohio, 43015, United States More Info
Site Public Contact
Contact
614-788-3860
[email protected]
Aine E. Clements
Principal Investigator
Grady Memorial Hospital
Delaware Ohio, 43015, United States More Info
Site Public Contact
Contact
614-788-3860
[email protected]
Aine E. Clements
Principal Investigator
Columbus Oncology and Hematology Associates
Dublin Ohio, 43016, United States More Info
Site Public Contact
Contact
614-788-3860
[email protected]
Aine E. Clements
Principal Investigator
Dublin Methodist Hospital
Dublin Ohio, 43016, United States More Info
Site Public Contact
Contact
614-788-3860
[email protected]
Aine E. Clements
Principal Investigator
Atrium Medical Center-Middletown Regional Hospital
Franklin Ohio, 45005, United States More Info
Site Public Contact
Contact
937-528-2900
[email protected]
Tarek M. Sabagh
Principal Investigator
Miami Valley Cancer Care and Infusion
Greenville Ohio, 45331, United States More Info
Site Public Contact
Contact
937-569-7515
Tarek M. Sabagh
Principal Investigator
Kettering Medical Center
Kettering Ohio, 45429, United States More Info
Site Public Contact
Contact
937-528-2900
[email protected]
Howard M. Gross
Principal Investigator
OhioHealth Mansfield Hospital
Mansfield Ohio, 44903, United States More Info
Site Public Contact
Contact
614-788-3860
[email protected]
Aine E. Clements
Principal Investigator
OhioHealth Marion General Hospital
Marion Ohio, 43302, United States More Info
Site Public Contact
Contact
614-788-3860
[email protected]
Aine E. Clements
Principal Investigator
Upper Valley Medical Center
Troy Ohio, 45373, United States More Info
Site Public Contact
Contact
937-528-2900
[email protected]
Tarek M. Sabagh
Principal Investigator
University of Oklahoma Health Sciences Center
Oklahoma City Oklahoma, 73104, United States More Info
Site Public Contact
Contact
405-271-8777
[email protected]
Kathleen N. Moore
Principal Investigator
Providence Newberg Medical Center
Newberg Oregon, 97132, United States More Info
Site Public Contact
Contact
503-215-2614
[email protected]
Alison K. Conlin
Principal Investigator
Saint Alphonsus Cancer Care Center-Ontario
Ontario Oregon, 97914, United States More Info
Site Public Contact
Contact
406-969-6060
[email protected]
John M. Schallenkamp
Principal Investigator
Providence Willamette Falls Medical Center
Oregon City Oregon, 97045, United States More Info
Site Public Contact
Contact
503-215-2614
[email protected]
Alison K. Conlin
Principal Investigator
Providence Portland Medical Center
Portland Oregon, 97213, United States More Info
Site Public Contact
Contact
503-215-2614
[email protected]
Alison K. Conlin
Principal Investigator
Providence Saint Vincent Medical Center
Portland Oregon, 97225, United States More Info
Site Public Contact
Contact
503-215-2614
[email protected]
Alison K. Conlin
Principal Investigator
UPMC Altoona
Altoona Pennsylvania, 16601, United States More Info
Site Public Contact
Contact
773-702-9171
[email protected]
Sarah E. Taylor
Principal Investigator
Bryn Mawr Hospital
Bryn Mawr Pennsylvania, 19010, United States More Info
Site Public Contact
Contact
484-476-2649
[email protected]
Paul B. Gilman
Principal Investigator
UPMC Hillman Cancer Center Erie
Erie Pennsylvania, 16505, United States More Info
Site Public Contact
Contact
412-389-5208
[email protected]
Sarah E. Taylor
Principal Investigator
UPMC Cancer Centers - Arnold Palmer Pavilion
Greensburg Pennsylvania, 15601, United States More Info
Site Public Contact
Contact
724-838-1900
Sarah E. Taylor
Principal Investigator
UPMC Hillman Cancer Center at Rocco And Nancy Ortenzio Cancer Pavilion
Mechanicsburg Pennsylvania, 17050, United States More Info
Site Public Contact
Contact
412-389-5208
[email protected]
Sarah E. Taylor
Principal Investigator
Riddle Memorial Hospital
Media Pennsylvania, 19063, United States More Info
Site Public Contact
Contact
484-476-2649
[email protected]
Paul B. Gilman
Principal Investigator
UPMC Hillman Cancer Center - Monroeville
Monroeville Pennsylvania, 15146, United States More Info
Site Public Contact
Contact
412-389-5208
[email protected]
Sarah E. Taylor
Principal Investigator
Paoli Memorial Hospital
Paoli Pennsylvania, 19301, United States More Info
Site Public Contact
Contact
484-476-2649
[email protected]
Paul B. Gilman
Principal Investigator
University of Pittsburgh Cancer Institute (UPCI)
Pittsburgh Pennsylvania, 15232, United States More Info
Site Public Contact
Contact
412-647-8073
Sarah E. Taylor
Principal Investigator
UPMC-Passavant Hospital
Pittsburgh Pennsylvania, 15237, United States More Info
Site Public Contact
Contact
412-367-6454
Sarah E. Taylor
Principal Investigator
Lankenau Medical Center
Wynnewood Pennsylvania, 19096, United States More Info
Site Public Contact
Contact
484-476-2649
[email protected]
Paul B. Gilman
Principal Investigator
Prisma Health Cancer Institute - Butternut
Greenville South Carolina, 29605, United States More Info
Site Public Contact
Contact
864-241-6251
Ki Y. Chung
Principal Investigator
Sanford Cancer Center Oncology Clinic
Sioux Falls South Dakota, 57104, United States More Info
Site Public Contact
Contact
605-312-3320
[email protected]
Daniel Almquist
Principal Investigator
Sanford USD Medical Center - Sioux Falls
Sioux Falls South Dakota, 57117, United States More Info
Site Public Contact
Contact
605-312-3320
[email protected]
Daniel Almquist
Principal Investigator
Hendrick Medical Center
Abilene Texas, 79601, United States More Info
Site Public Contact
Contact
325-670-6340
Mustapha A. Khalife
Principal Investigator
M D Anderson Cancer Center
Houston Texas, 77030, United States More Info
Site Public Contact
Contact
877-632-6789
[email protected]
Funda Meric-Bernstam
Principal Investigator
Inova Schar Cancer Institute
Fairfax Virginia, 22031, United States More Info
Site Public Contact
Contact
703-720-5210
[email protected]
Timothy L. Cannon
Principal Investigator
Inova Fairfax Hospital
Falls Church Virginia, 22042, United States More Info
Site Public Contact
Contact
703-208-6650
[email protected]
Timothy L. Cannon
Principal Investigator
Swedish Cancer Institute-Edmonds
Edmonds Washington, 98026, United States More Info
Site Public Contact
Contact
206-215-3086
[email protected]
Alison K. Conlin
Principal Investigator
Swedish Cancer Institute-Issaquah
Issaquah Washington, 98029, United States More Info
Site Public Contact
Contact
206-215-3086
[email protected]
Alison K. Conlin
Principal Investigator
Swedish Medical Center-First Hill
Seattle Washington, 98122, United States More Info
Site Public Contact
Contact
206-215-3086
[email protected]
Alison K. Conlin
Principal Investigator
West Virginia University Healthcare
Morgantown West Virginia, 26506, United States More Info
Site Public Contact
Contact
304-293-7374
[email protected]
Nour Daboul
Principal Investigator
ThedaCare Regional Cancer Center
Appleton Wisconsin, 54911, United States More Info
Site Public Contact
Contact
920-364-3604
[email protected]
Matthias Weiss
Principal Investigator
Duluth Clinic Ashland
Ashland Wisconsin, 54806, United States More Info
Site Public Contact
Contact
218-786-3308
[email protected]
Bret E. Friday
Principal Investigator
Mercyhealth Hospital and Cancer Center - Janesville
Janesville Wisconsin, 53548, United States More Info
Site Public Contact
Contact
608-756-6871
[email protected]
Emily G. Robinson
Principal Investigator
Gundersen Lutheran Medical Center
La Crosse Wisconsin, 54601, United States More Info
Site Public Contact
Contact
608-775-2385
[email protected]
Michael O. Ojelabi
Principal Investigator
Marshfield Medical Center-River Region at Stevens Point
Stevens Point Wisconsin, 54482, United States More Info
Site Public Contact
Contact
800-782-8581
[email protected]
Adedayo A. Onitilo
Principal Investigator
Marshfield Medical Center - Weston
Weston Wisconsin, 54476, United States More Info
Site Public Contact
Contact
800-782-8581
[email protected]
Adedayo A. Onitilo
Principal Investigator

How clear is this clinincal trial information?

Study is for people with:

Ovarian Cancer

Phase:

Phase 2

Estimated Enrollment:

199

Study ID:

NCT05554367

Recruitment Status:

Recruiting

Sponsor:


National Cancer Institute (NCI)

How clear is this clinincal trial information?

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