Ovarian Cancer Clinical Trial

Testing the Use of the Combination of Selumetinib and Olaparib or Selumetinib Alone Targeted Treatment for RAS Pathway Mutant Recurrent or Persistent Ovarian and Endometrial Cancers, A ComboMATCH Treatment Trial

Summary

This phase II trial compares selumetinib plus olaparib to selumetinib alone in women with endometrial or ovarian cancer that has come back (recurrent) or that remains despite treatment (persistent) and harbors a mutation in the RAS pathway. Selumetinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Olaparib is an inhibitor of PARP, an enzyme that helps repair deoxyribonucleic acid (DNA) when it becomes damaged. Blocking PARP may help keep tumor cells from repairing their damaged DNA, causing them to die. PARP inhibitors are a type of targeted therapy. The addition of olaparib to selumetinib could increase the percentage of tumors that shrink as well as lengthen the time that the tumors remain stable (without progression) as compared to selumetinib alone.

View Full Description

Full Description

PRIMARY OBJECTIVES:

I. Compare progression free survival of combination of olaparib and selumetinib sulfate (selumetinib) to selumetinib alone in patients with RAS mutant ovarian cancer. (Cohort 1) II. Compare progression free survival of combination of olaparib and selumetinib to selumetinib alone in patients with RAS mutant endometrial cancer. (Cohort 2)

SECONDARY OBJECTIVES:

I. Determine safety of both arms per Common Terminology Criteria for Adverse Events (CTCAE) version (v)5.0.

II. Compare objective response rate per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 between the two arms.

III. Determine rate of objective response per RECIST 1.1 in those patients that crossover from the single agent arm to the combination arm.

IV. Report duration of response of the two treatment arms. V. Collect tissue and provide it to the ComboMATCH Registration protocol to assess concordance between the diagnostic tumor mutation profile generated by the designated laboratories, the pre-treatment biopsy mutation profile, and the pre-treatment circulating tumor (ct)DNA mutation profile from plasma, as described in ComboMATCH Registration protocol. For this treatment substudy, the outcome objective will be to report the proportion of cases providing sufficient tissue for that integrated scientific activity in the ComboMATCH Registration protocol.

TRANSLATIONAL OBJECTIVE:

I. To assess association of baseline genomic and transcriptomic status with response and resistance to therapy.

OUTLINE: Patients in both cohorts are randomized to 1 of 2 arms.

ARM I: Patients receive selumetinib orally (PO) and olaparib PO on study. Patients also undergo a tumor biopsy and blood collection during screening and on study, as well as echocardiogram (ECHO) or multigated acquisition (MUGA), and computed tomography (CT) scans throughout the trial. Patients may undergo bone marrow aspiration or biopsy as clinically indicated.

ARM II: Patients receive selumetinib PO on study. Patients who experience progression may elect to cross over to Arm I provided they have not had dose limiting toxicities to monotherapy selumetinib. Patients also undergo a tumor biopsy and blood collection during screening and on study, as well as ECHO or MUGA, and CT scans throughout the trial. Patients may undergo bone marrow aspiration or biopsy as clinically indicated.

After completion of study treatment, patients are followed up every 3 months for 2 years and then every 6 months for 3 years.

View Eligibility Criteria

Eligibility Criteria

Inclusion Criteria:

Patient must have enrolled onto EAY191 and must have been given a treatment assignment to ComboMATCH to EAY191-N4 based on the presence of an actionable mutation as defined in EAY191
Patients must be enrolled on the ComboMATCH Master Registration Trial EAY191

Patients must have RAS pathway mutations as determined by the ComboMATCH screening assessment

Cohort 1: Patients with histologically confirmed RAS pathway mutant ovarian, primary peritoneal, or fallopian tube ("ovarian") cancer (activating mutations in KRAS, NRAS, HRAS, BRAF, MEK1, MEK2, or inactivating mutations in NF1)
Cohort 2: Patients with histologically confirmed RAS pathway mutant endometrial cancer (activating mutations in KRAS, NRAS, HRAS, BRAF, MEK1, MEK2, or inactivating mutations in NF1).
Patients must have disease that can be safely biopsied and agree to a pre-treatment biopsy, if disease cannot be safely biopsied, or have archival tissue available from within 12 months prior to registration on the ComboMATCH Registration Trial (EAY191)
Patients must have progressed after first-line treatment for recurrent or persistent disease
Patients with ovarian cancer should not be eligible for further platinum-based therapy
Patients with endometrial cancer must have received or been offered an immune oncology agent (alone or in combination with lenvatinib) unless there are existing contraindications for immune oncology agents or lenvatinib
Patients may have received unlimited prior therapy

Patients must have measurable and biopsiable disease. Measurable disease is defined by RECIST 1.1 as at least one lesion that can be accurately measured in at least one dimension (longest diameter to be recorded). Each lesion must be > 10 mm when measured by CT, magnetic resonance imaging (MRI) or caliper measurement by clinical exam; or > 20 mm when measured by chest x-ray. Lymph nodes must be > 15 mm in short axis when measured by CT or MRI

Patients must have at least one "target lesion" separate from the lesion to be biopsied to be used to assess response on this protocol as defined by RECIST version 1.1. Tumors within a previously irradiated field will be designated as "non-target" lesions unless progression is documented or a biopsy is obtained to confirm persistence at least 90 days following completion of radiation therapy
Prior therapy must have been completed at least four weeks prior to registration
Age >= 18
Eastern Cooperative Oncology Group (ECOG) Performance Status of 0, 1 or 2
Hemoglobin (Hgb) >= 9.5 g/dL with no blood transfusion in the past 28 days (within 14 days prior to registration)
Platelets >= 100,000/mcl (within 14 days prior to registration)
Absolute neutrophil count (ANC) >= 1,500/mcl (within 14 days prior to registration)
Patients must have creatinine clearance estimated of >= 50 mL/min using the Cockcroft-Gault equation or based on a 24 hour urine test (within 14 days prior to registration)
Total serum bilirubin level =< 1.5 x institutional upper limit of normal (ULN) or =< 3 x ULN in the presence of documented Gilbert's syndrome (unconjugated hyperbilirubinemia) (within 14 days prior to registration)
Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) =< 3 x ULN (within 14 days prior to registration)
Patients must be able to swallow and retain oral medications and be without gastrointestinal illnesses that would preclude absorption of selumetinib or olaparib
Patients with known history or current symptoms of cardiac disease, or history of treatment with cardiotoxic agents, should have a clinical risk assessment of cardiac function using the New York Heart Association Functional Classification. To be eligible for this trial, patients should be class 2B or better

Women of childbearing potential (WOCBP) must agree to use two forms of birth control (hormonal or barrier method of birth control; abstinence) during the study and for 12 weeks after completing treatment

Non-sterilized male partners of WOCBP (including males sterilized by a method other than bilateral orchidectomy e.g., vasectomy) who intend to be sexually active with a female partner must be using an acceptable method of contraception such as male condom plus spermicide (condom alone in countries where spermicides are not approved) from the time of screening throughout the total duration of the study and the drug washout period (at least 16 weeks after the last dose of study intervention) to prevent pregnancy in a partner. Periodic abstinence, the rhythm method, and the withdrawal method are not acceptable methods of contraception. Vasectomized (i.e., sterile) males are considered fertile and should still use a male condom plus spermicide as indicated above during the clinical study
Patients with a prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or efficacy assessment of the investigational regimen are eligible for this trial
Human immunodeficiency virus (HIV)-infected patients on effective anti-retroviral therapy with undetectable viral load within 6 months of registration are eligible for this trial

Patients with evidence of chronic hepatitis B virus (HBV) infection must have an undetectable HBV viral load 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 with new or progressive brain metastases (active brain metastases) or leptomeningeal disease are eligible if the treating physician determines that immediate central nervous system (CNS) specific treatment is not required and is unlikely to be required during the first cycle of therapy

Patients with treated brain metastases are eligible if follow-up brain imaging after CNS-directed therapy shows no evidence of progression
Extra caution should be taken with olaparib, as it crosses the blood brain barrier and can cause edema in brain metastases
The patient or a legally authorized representative must provide study-specific informed consent prior to study entry and, for patients treated in the United States (U.S.), authorization permitting release of personal health information

Exclusion Criteria:

Patients who have received any MEK inhibitors
Patients who have progressed while receiving a PARP inhibitor
Patients who have received chemotherapy or radiotherapy within 4 weeks (6 weeks for nitrosoureas or mitomycin C) prior to registration
Patients who have not recovered from adverse events due to prior anti-cancer therapy (i.e., have residual toxicities > grade 1) with the exception of alopecia
Patients with uncontrolled intercurrent illness
Patients with >= grade 2 neuropathy within 14 days of registration
Patients with severe (Child-Pugh C) liver dysfunction
Patients with a history of allergic reactions attributed to compounds of similar chemical or biologic composition to olaparib and selumetinib or any excipients thereof

Concomitant use of known strong (e.g., phenobarbital, enzalutamide, phenytoin, rifampicin, rifabutin, rifapentine, carbamazepine, nevirapine and St John's Wort) or moderate CYP3A inducers (e.g., bosentan, efavirenz, modafinil). The required washout period prior to starting olaparib is 5 weeks for enzalutamide or phenobarbital and 3 weeks for other agents

Supplementation with vitamin E greater than 100% of the daily recommended dose. Any multivitamin containing vitamin E must be stopped prior to study enrollment even if less than 100% of the daily recommended dosing for vitamin E
Vitamin E must not be taken in the 7 days prior to initiation of treatment with selumetinib
Concomitant use of known strong CYP3A inhibitors (e.g., itraconazole, telithromycin, clarithromycin, protease inhibitors boosted with ritonavir or cobicistat, indinavir, saquinavir, nelfinavir, boceprevir, telaprevir) or known moderate CYP3A inhibitors (e.g. ciprofloxacin, erythromycin, diltiazem, Fluconazole, verapamil). The required washout period prior to starting olaparib is at least 14 days or 5 half-lives (whichever is longer) before the first dose of study medication
Concomitant use of strong CYP2C19 inhibitors (e.g., ticlopidine) or moderate CYP2C19 inhibitors (e.g., omeprazole). The required washout period prior to starting selumetinib is at least 14 days or 5 half-lives (whichever is longer) before the first dose of study medication
Have received or are receiving an investigational medicinal product (IMP) or other systemic anti-cancer treatment (including chemotherapy, immunotherapy, targeted therapy, biologic therapy, tumor embolization, or monoclonal antibodies) within 4 weeks prior to registration, or within a period during which the IMP or systemic target treatment has not been cleared from the body (e.g., a period of 5 'half-lives'), whichever is longer
Known myelodysplastic syndrome/acute myeloid leukemia or with features suggestive of myelodysplastic syndrome (MDS)/acute myeloid leukemia (AML)
Patients who have had previous organ transplant, allogenic bone marrow transplant or double umbilical cord blood transplantation
Patients who have had whole blood transfusion within 28 days prior to registration

Patients with ophthalmological conditions as follows:

Current or past history of retinal pigment epithelial detachment/central serous retinopathy or retinal vein occlusion.
Intraocular pressure >21 mmHg (or ULN adjusted by age) or uncontrolled glaucoma (irrespective of intraocular pressure [IOP]). Subjects with known glaucoma and increased IOP who do not have meaningful vision (light perception only or no light perception) and are not experiencing pain related to the glaucoma, may be eligible after discussion with the study chair
Patients with any other significant abnormality on ophthalmic examination should be discussed with the study chair for potential eligibility
Ophthalmological findings secondary to long-standing optic pathway glioma (such as visual loss, optic nerve pallor or strabismus) or longstanding orbito-temporal plexiform neurofibroma (PN) (such as visual loss, strabismus) will NOT be considered a significant abnormality for the purposes of the study

Patients with severe, active co-morbidity defined as any of the following:

History and/or confirmed pneumonitis
Uncontrolled hypertension (blood pressure [BP] >= 150/90 mmHg despite medical therapy)
Acute coronary syndrome within 6 months prior to registration
Uncontrolled atrial fibrillation
Known family history of long QT syndrome
Women who are pregnant or unwilling to discontinue nursing

Study is for people with:

Ovarian Cancer

Phase:

Phase 2

Estimated Enrollment:

165

Study ID:

NCT05554328

Recruitment Status:

Recruiting

Sponsor:

National Cancer Institute (NCI)

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There are 56 Locations for this study

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Kingman Regional Medical Center
Kingman Arizona, 86401, United States More Info
Site Public Contact
Contact
702-384-0013
[email protected]
John A. Ellerton
Principal Investigator
PCR Oncology
Arroyo Grande California, 93420, United States More Info
Site Public Contact
Contact
702-384-0013
[email protected]
John A. Ellerton
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
Contact
208-381-2774
[email protected]
Nitya Alluri
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 Luke's Cancer Institute - Fruitland
Fruitland Idaho, 83619, United States More Info
Site Public Contact
Contact
208-381-2774
[email protected]
Nitya Alluri
Principal Investigator
Saint Luke's Cancer Institute - Meridian
Meridian Idaho, 83642, United States More Info
Site Public Contact
Contact
208-381-2774
[email protected]
Nitya Alluri
Principal Investigator
Saint Luke's Cancer Institute - Nampa
Nampa Idaho, 83686, United States More Info
Site Public Contact
Contact
208-381-2774
[email protected]
Nitya Alluri
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 Cancer Clinic
Sandpoint Idaho, 83864, United States More Info
Site Public Contact
Contact
406-969-6060
[email protected]
John M. Schallenkamp
Principal Investigator
Saint Luke's Cancer Institute - Twin Falls
Twin Falls Idaho, 83301, United States More Info
Site Public Contact
Contact
208-381-2774
[email protected]
Nitya Alluri
Principal Investigator
National Institutes of Health Clinical Center
Bethesda Maryland, 20892, United States More Info
Site Public Contact
Contact
800-411-1222
A P. Chen
Principal Investigator
UPMC Western Maryland
Cumberland Maryland, 21502, United States More Info
Site Public Contact
Contact
240-964-1400
Alexander B. Olawaiye
Principal Investigator
Saint Joseph Mercy Hospital
Ann Arbor Michigan, 48106, United States More Info
Site Public Contact
Contact
734-712-7251
[email protected]
Tareq Al Baghdadi
Principal Investigator
Saint Joseph Mercy 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 - Brighton
Brighton Michigan, 48114, United States More Info
Site Public Contact
Contact
734-712-7251
[email protected]
Tareq Al Baghdadi
Principal Investigator
Saint Joseph Mercy Canton
Canton Michigan, 48188, 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
Saint Joseph Mercy Chelsea
Chelsea Michigan, 48118, 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 - Chelsea Hospital
Chelsea Michigan, 48118, United States More Info
Site Public Contact
Contact
734-712-7251
[email protected]
Tareq Al Baghdadi
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
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
Huron Gastroenterology PC
Ypsilanti Michigan, 48106, 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 Ann Arbor Campus
Ypsilanti Michigan, 48197, United States More Info
Site Public Contact
Contact
734-712-7251
[email protected]
Tareq Al Baghdadi
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 Deaconess Hospital
Bozeman Montana, 59715, United States More Info
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Contact
406-969-6060
[email protected]
John M. Schallenkamp
Principal Investigator
Benefis Healthcare- Sletten Cancer Institute
Great Falls Montana, 59405, United States More Info
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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 Hospital
Missoula Montana, 59804, United States More Info
Site Public Contact
Contact
406-969-6060
[email protected]
John M. Schallenkamp
Principal Investigator
OptumCare Cancer Care at Charleston
Las Vegas Nevada, 89102, United States More Info
Site Public Contact
Contact
702-384-0013
[email protected]
John A. Ellerton
Principal Investigator
OptumCare Cancer Care at Fort Apache
Las Vegas Nevada, 89148, United States More Info
Site Public Contact
Contact
702-384-0013
[email protected]
John A. Ellerton
Principal Investigator
Memorial Sloan Kettering Monmouth
Middletown New Jersey, 07748, United States More Info
Site Public Contact
Contact
212-639-7592
Claire F. Friedman
Principal Investigator
Memorial Sloan Kettering Commack
Commack New York, 11725, United States More Info
Site Public Contact
Contact
212-639-7592
Claire F. Friedman
Principal Investigator
Memorial Sloan Kettering Westchester
Harrison New York, 10604, United States More Info
Site Public Contact
Contact
212-639-7592
Claire F. Friedman
Principal Investigator
Memorial Sloan Kettering Cancer Center
New York New York, 10065, United States More Info
Site Public Contact
Contact
212-639-7592
Claire F. Friedman
Principal Investigator
Strecker Cancer Center-Belpre
Belpre Ohio, 45714, United States More Info
Site Public Contact
Contact
800-523-3977
[email protected]
Timothy D. Moore
Principal Investigator
Aultman Health Foundation
Canton Ohio, 44710, United States More Info
Site Public Contact
Contact
330-363-7274
[email protected]
Adarsh Vennepureddy
Principal Investigator
Adena Regional Medical Center
Chillicothe Ohio, 45601, United States More Info
Site Public Contact
Contact
877-779-7585
[email protected]
Timothy D. Moore
Principal Investigator
Mount Carmel East Hospital
Columbus Ohio, 43213, United States More Info
Site Public Contact
Contact
614-488-2118
[email protected]
Timothy D. Moore
Principal Investigator
The Mark H Zangmeister Center
Columbus Ohio, 43219, United States More Info
Site Public Contact
Contact
614-488-2118
[email protected]
Timothy D. Moore
Principal Investigator
Fairfield Medical Center
Lancaster Ohio, 43130, United States More Info
Site Public Contact
Contact
740-687-8863
[email protected]
Timothy D. Moore
Principal Investigator
Marietta Memorial Hospital
Marietta Ohio, 45750, United States More Info
Site Public Contact
Contact
800-523-3977
[email protected]
Timothy D. Moore
Principal Investigator
Knox Community Hospital
Mount Vernon Ohio, 43050, United States More Info
Site Public Contact
Contact
740-393-9000
[email protected]
Timothy D. Moore
Principal Investigator
Licking Memorial Hospital
Newark Ohio, 43055, United States More Info
Site Public Contact
Contact
740-348-4000
[email protected]
Timothy D. Moore
Principal Investigator
Mercy Health Perrysburg Cancer Center
Perrysburg Ohio, 43551, United States More Info
Site Public Contact
Contact
614-488-2118
[email protected]
Timothy D. Moore
Principal Investigator
Southern Ohio Medical Center
Portsmouth Ohio, 45662, United States More Info
Site Public Contact
Contact
614-488-2118
[email protected]
Timothy D. Moore
Principal Investigator
Springfield Regional Cancer Center
Springfield Ohio, 45504, United States More Info
Site Public Contact
Contact
937-528-2900
[email protected]
Timothy D. Moore
Principal Investigator
Springfield Regional Medical Center
Springfield Ohio, 45505, United States More Info
Site Public Contact
Contact
937-528-2900
[email protected]
Timothy D. Moore
Principal Investigator
Mercy Health - Saint Anne Hospital
Toledo Ohio, 43623, United States More Info
Site Public Contact
Contact
614-488-2118
[email protected]
Timothy D. Moore
Principal Investigator
Saint Ann's Hospital
Westerville Ohio, 43081, United States More Info
Site Public Contact
Contact
614-234-5433
[email protected]
Timothy D. Moore
Principal Investigator
Genesis Healthcare System Cancer Care Center
Zanesville Ohio, 43701, United States More Info
Site Public Contact
Contact
740-454-5232
[email protected]
Timothy D. Moore
Principal Investigator
Saint Alphonsus Medical Center-Ontario
Ontario Oregon, 97914, United States More Info
Site Public Contact
Contact
406-969-6060
[email protected]
John M. Schallenkamp
Principal Investigator
Bryn Mawr Hospital
Bryn Mawr Pennsylvania, 19010, United States More Info
Site Public Contact
Contact
484-476-2649
[email protected]
Albert S. DeNittis
Principal Investigator
Riddle Memorial Hospital
Media Pennsylvania, 19063, United States More Info
Site Public Contact
Contact
484-476-2649
[email protected]
Albert S. DeNittis
Principal Investigator
Paoli Memorial Hospital
Paoli Pennsylvania, 19301, United States More Info
Site Public Contact
Contact
484-476-2649
[email protected]
Albert S. DeNittis
Principal Investigator
Lankenau Medical Center
Wynnewood Pennsylvania, 19096, United States More Info
Site Public Contact
Contact
484-476-2649
[email protected]
Albert S. DeNittis
Principal Investigator
Valley Medical Center
Renton Washington, 98055, United States More Info
Site Public Contact
Contact
425-228-3440
[email protected]
John A. Ellerton
Principal Investigator

How clear is this clinincal trial information?

Study is for people with:

Ovarian Cancer

Phase:

Phase 2

Estimated Enrollment:

165

Study ID:

NCT05554328

Recruitment Status:

Recruiting

Sponsor:


National Cancer Institute (NCI)

How clear is this clinincal trial information?

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