Melanoma (Skin Cancer)

EA6191 / BAMM2



Testing the Combination of Dabrafenib and Trametinib with or without Hydroxychloroquine in Patients with Stage IIIC or IV BRAF V600E/K Melanoma with Elevated LDH

STATUS: Closed to Accrual


This phase II trial investigates how well adding hydroxychloroquine to the standard treatment of dabrafenib and trametinib works to overcome resistance and delay disease progression in treating patients with stage IIIC or IV BRAF V600E/K melanoma with elevated lactate dehydrogenase (LDH). Hydroxychloroquine may cause cell death in tumor cells that rely on a process called "autophagy" for survival. Dabrafenib and trametinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Giving hydroxychloroquine together with dabrafenib and trametinib may work better than dabrafenib and trametinib alone to shrink and stabilize the cancer.
  • Patient must be >= 18 years of age

  • Patient must have locally advanced unresectable stage IIIC or stage IV melanoma

  • Patient must have BRAF V600E or BRAF V600K tumor genotype based on a Clinical Laboratory Improvement Act (CLIA) approved assay

  • Patient must have serum LDH > upper limit of normal per institution standards

  • Patient must have measurable disease by Response Evaluation Criteria in Solid Tumors (RECIST) 1.1. Baseline measurements of sites of disease must be obtained within 3 weeks prior to study randomization

  • Patient must have been treated with prior immune checkpoint inhibitor therapy (anti PD-1 antibody, anti-CTLA-4 antibody or a combination regimen including either or both agents) either in the adjuvant or metastatic setting. Patient may have received investigational agents in combination with standard therapy, as long as it was adhering to the timeframes * Patient must have discontinued active immunotherapy (IL-2, interferon, anti-CTLA-4 antibody, anti-PD-1 antibody etc.) or chemotherapy at least 4 weeks prior to randomization * Patient must have discontinued any oral targeted therapy at least 2 weeks prior to randomization * Patients must not receive any other investigational anticancer therapy during the period on study or the 4 weeks prior to randomization

  • Patient may have been treated with prior adjuvant therapy including combined BRAF and MEK inhibitor therapy. Patients will be eligible if they tolerated this therapy and did not discontinue the therapy due to toxicity AND >= 6 months have elapsed since the end of adjuvant BRAF and MEK inhibition. If patients received BRAF and MEK inhibitor therapy in the metastatic setting, they are not eligible

  • Patient may have been treated with prior chemotherapy or radiation therapy

  • Patients who are known to be experiencing an objective partial response to immunotherapy at the time of study enrollment are not eligible

  • Patient must have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1

  • 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

  • Women must not be pregnant or breast-feeding due to the potential harm to an unborn fetus and possible risk for adverse events in nursing infants with the treatment regimens being used. All females of childbearing potential must have a blood test or urine study within 14 days prior to randomization to rule out pregnancy. A female of childbearing potential is defined as any woman, regardless of sexual orientation or whether they have undergone tubal ligation, who meets the following criteria: 1) has achieved menarche at some point, 2) has not undergone a hysterectomy or bilateral oophorectomy; or 3) has not been naturally postmenopausal (amenorrhea following cancer therapy does not rule out childbearing potential) for at least 24 consecutive months (i.e., has had menses at any time in the preceding 24 consecutive months)

  • Women of childbearing potential and sexually active males must not expect to conceive or father children by using accepted and effective method(s) of contraception or abstaining from sexual intercourse for the duration of their participation in the study and for 4 months after the last dose of protocol treatment

  • Patient must have recovered from clinically significant reversible toxicities from previous treatment prior to randomization. Abnormal laboratory values may be grade 1, as long as they meet the eligibility criteria

  • Patient must not have a history of interstitial lung disease (ILD) or chronic pneumonitis * NOTE: If there is radiographic evidence of ILD that is clinically insignificant and asymptomatic, the patient would be eligible

  • Patient must not have porphyria or psoriasis due to risk of disease exacerbation unless the disease is well controlled and they are under the care of a specialist for the disorder who agrees to monitor the patient for exacerbations

  • Patient must not have a previously documented retinal vein occlusion

  • Patient must not have a history or evidence of increased cardiovascular risk including: * Left ventricular ejection fraction (LVEF) < institutional lower limit of normal measured within 14 days prior to randomization * A QT interval corrected for heart rate using the Bazett‘s formula >= 480 msec * Current clinically significant uncontrolled arrhythmias. Exception: Patients with controlled atrial fibrillation for > 30 days prior to randomization are eligible * Acute coronary syndromes (including myocardial infarction and unstable angina), coronary angioplasty, or stenting within 6 months prior to randomization * Abnormal cardiac valve morphology (>= grade 2) documented by echocardiogram unless a cardiologist concludes the valve abnormality is not clinically significant. Patients with grade 1 abnormalities (i.e., mild regurgitation/stenosis) are eligible * 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

  • Patient must be able to swallow and retain oral medication and must not have any clinically significant gastrointestinal abnormalities that may alter absorption such as malabsorption syndrome or major resection of the stomach or bowels

  • Patient with known serious concurrent infection or medical illness, including psychiatric disorders, which would jeopardize the ability of the patient to receive the treatment outlined in this protocol with reasonable safety are not eligible

  • Patient must not be receiving concurrent therapy for their tumor (i.e. chemotherapeutics or investigational agents). Radiotherapy delivered to palliate pain is allowed as long as it is not targeting a lesion that meets RECIST criteria for progression. Radiation therapy to the surgical bed with gamma knife radiotherapy while on treatment during the first cycle is allowed for small volume surgically resected brain metastases. Gamma knife radiotherapy for known active, asymptomatic small volume central nervous system (CNS) lesions may be performed during the first cycle while on study. Radiotherapy for new CNS lesions identified beyond the first cycle is not allowed on study

  • Patient must not have a known immediate or delayed hypersensitivity reaction or idiosyncrasy to drugs chemically related to study drug, or excipients or to dimethyl sulfoxide (DMSO)

  • Patient must not have received cytochrome P450 enzyme –inducing anticonvulsant drugs (extended-interval aminoglycoside dosing [EIADs]) (i.e. phenytoin, carbamazepine, phenobarbital, primidone or oxcarbazepine) within 4 weeks prior to randomization

  • Patient must not have a current use of a prohibited medication

  • Patient must have the ability to understand and the willingness to sign a written informed consent document. Patients with impaired decision-making capacity (IDMC) who have a legally authorized representative (LAR) or caregiver and/or family member available will also be considered eligible

  • Absolute neutrophil count >= 1,500/mcL (obtained =< 14 days prior to protocol randomization)

  • Platelets >= 100,000/mcL (obtained =< 14 days prior to protocol randomization)

  • Total bilirubin =< institutional upper limit of normal (ULN) (obtained =< 14 days prior to protocol randomization)

  • Aspartate aminotransferase (AST) (serum glutamic-oxaloacetic transaminase [SGOT])/alanine aminotransferase (ALT) (serum glutamate pyruvate transaminase [SGPT]) =< 3.0 x institutional ULN (obtained =< 14 days prior to protocol randomization)

  • Creatinine =< 1.5 x institutional ULN (obtained =< 14 days prior to protocol randomization)

  • 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

  • Patient with asymptomatic new or progressive brain metastases (active brain metastases) are eligible if the treating physician determines that CNS specific treatment is not required * NOTE: Patient with treated brain metastases are eligible. No brain imaging is required, however, 1 week must elapse after gamma knife therapy. Patient treated with whole brain radiation that have been stable for 2 months are eligible. Patient are excluded if they have leptomeningeal disease or metastases causing spinal cord compression that are symptomatic or untreated or not stable (documented by imaging) for at least 3 months or requiring corticosteroids. Patients on a stable dose of corticosteroids for at least 1 month or who have been off of corticosteroids for at least 1 week are eligible

United States
AK
Anchorage
Alaska Breast Care and Surgery LLC
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Email: AKPAMC.OncologyResearchSupport@providence.org

Alaska Oncology and Hematology LLC
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Alaska Women's Cancer Care
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Anchorage Associates in Radiation Medicine
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Anchorage Oncology Centre
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Anchorage Radiation Therapy Center
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Email: AKPAMC.OncologyResearchSupport@providence.org

Katmai Oncology Group
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Email: AKPAMC.OncologyResearchSupport@providence.org

Providence Alaska Medical Center
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Email: AKPAMC.OncologyResearchSupport@providence.org

AR
Ft. Smith
Mercy Hospital Fort Smith
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Hot Springs
CHI Saint Vincent Cancer Center Hot Springs
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Email: ResearchInstituteInquiries@CommonSpirit.org

AZ
Phoenix
Cancer Center at Saint Joseph's
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Email: CancerInstitute@DignityHealth.org

Mayo Clinic Hospital in Arizona
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Scottsdale
Mayo Clinic in Arizona
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CA
Arroyo Grande
Mission Hope Medical Oncology - Arroyo Grande
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Burbank
Providence Saint Joseph Medical Center/Disney Family Cancer Center
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Email: Najee.Boucher@providence.org

Carmichael
Mercy Cancer Center - Carmichael
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Email: ecog.rss@jimmy.harvard.edu

Mercy San Juan Medical Center
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Email: OncologyResearch@DignityHealth.org

Elk Grove
Mercy Cancer Center - Elk Grove
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Los Angeles
Cedars Sinai Medical Center
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The Angeles Clinic and Research Institute - West Los Angeles Office
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Rocklin
Mercy Cancer Center - Rocklin
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Email: OncologyResearch@DignityHealth.org

Sacramento
Mercy Cancer Center - Sacramento
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Email: OncologyResearch@DignityHealth.org

San Luis Obispo
Pacific Central Coast Health Center-San Luis Obispo
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Email: ResearchInstituteInquiries@CommonSpirit.org

Santa Maria
Mission Hope Medical Oncology - Santa Maria
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Woodland
Woodland Memorial Hospital
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Email: OncologyResearch@DignityHealth.org

CO
Colorado Springs
Penrose-Saint Francis Healthcare
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Email: ResearchTracking@Centura.Org

Rocky Mountain Cancer Centers-Penrose
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Email: ResearchTracking@Centura.Org

Saint Francis Cancer Center
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Denver
Porter Adventist Hospital
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Email: ResearchTracking@Centura.Org

Durango
Mercy Medical Center
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Email: ResearchTracking@Centura.Org

Southwest Oncology PC
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Email: ResearchTracking@Centura.Org

Lakewood
Saint Anthony Hospital
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Email: ResearchTracking@Centura.Org

Littleton
Littleton Adventist Hospital
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Email: ResearchTracking@Centura.Org

Longmont
Longmont United Hospital
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Email: ResearchTracking@Centura.Org

Rocky Mountain Cancer Centers-Longmont
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Email: ResearchTracking@Centura.Org

Parker
Parker Adventist Hospital
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Email: ResearchTracking@Centura.Org

Pueblo
Saint Mary Corwin Medical Center
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DC
Washington
MedStar Georgetown University Hospital
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DE
Lewes
Beebe Medical Center
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Email: research@beebehealthcare.org

Millville
Beebe South Coastal Health Campus
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Email: research@beebehealthcare.org

Newark
Christiana Care Health System-Christiana Hospital
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Email: lbarone@christianacare.org

Delaware Clinical and Laboratory Physicians PA
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Email: mhayden@christianacare.org

Helen F Graham Cancer Center
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Email: lbarone@christianacare.org

Medical Oncology Hematology Consultants PA
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Email: lbarone@christianacare.org

Rehoboth Beach
Beebe Health Campus
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Email: research@beebehealthcare.org

Seaford
TidalHealth Nanticoke / Allen Cancer Center
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Email: anna-maria.howard@peninsula.org

Wilmington
Christiana Care Health System-Wilmington Hospital
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Email: lbarone@christianacare.org

FL
Aventura
UM Sylvester Comprehensive Cancer Center at Aventura
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Coral Gables
UM Sylvester Comprehensive Cancer Center at Coral Gables
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Deerfield Beach
UM Sylvester Comprehensive Cancer Center at Deerfield Beach
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Miami
UM Sylvester Comprehensive Cancer Center at Kendall
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University of Miami Miller School of Medicine-Sylvester Cancer Center
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Plantation
UM Sylvester Comprehensive Cancer Center at Plantation
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IA
Ames
Mary Greeley Medical Center
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McFarland Clinic - Ames
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Email: ksoder@mcfarlandclinic.com

Boone
McFarland Clinic - Boone
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Carroll
Saint Anthony Regional Hospital
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Email: sbenson@iora.org

Clive
Mercy Cancer Center-West Lakes
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Email: cancerresearch@mercydesmoines.org

Mission Cancer and Blood - West Des Moines
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Council Bluffs
Alegent Health Mercy Hospital
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Email: ResearchInstituteInquiries@CommonSpirit.org

Creston
Greater Regional Medical Center
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Email: cancerresearch@mercydesmoines.org

Des Moines
Broadlawns Medical Center
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Iowa Lutheran Hospital
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Iowa Methodist Medical Center
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Mercy Medical Center - Des Moines
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Email: cancerresearch@mercydesmoines.org

Mission Cancer and Blood - Des Moines
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Mission Cancer and Blood - Laurel
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Fort Dodge
McFarland Clinic - Trinity Cancer Center
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Trinity Regional Medical Center
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Jefferson
McFarland Clinic - Jefferson
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Marshalltown
McFarland Clinic - Marshalltown
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West Des Moines
Mercy Medical Center-West Lakes
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Email: cancerresearch@mercydesmoines.org

Methodist West Hospital
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ID
Boise
Saint Luke's Cancer Institute - Boise
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Email: eslinget@slhs.org

Fruitland
Saint Luke's Cancer Institute - Fruitland
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Email: eslinget@slhs.org

Meridian
Saint Luke's Cancer Institute - Meridian
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Email: eslinget@slhs.org

Nampa
Saint Luke's Cancer Institute - Nampa
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Email: eslinget@slhs.org

Twin Falls
Saint Luke's Cancer Institute - Twin Falls
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Email: eslinget@slhs.org

IL
Alton
Saint Anthony's Health
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Aurora
Rush - Copley Medical Center
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Email: Cancer.Research@rushcopley.com

Burr Ridge
Loyola Center for Health at Burr Ridge
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Danville
Carle at The Riverfront
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Email: Research@carle.com

Effingham
Carle Physician Group-Effingham
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Email: Research@carle.com

Homer Glen
Loyola Medicine Homer Glen
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Mattoon
Carle Physician Group-Mattoon/Charleston
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Email: Research@carle.com

Maywood
Loyola University Medical Center
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Melrose Park
Marjorie Weinberg Cancer Center at Loyola-Gottlieb
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Mount Vernon
Good Samaritan Regional Health Center
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Urbana
Carle Cancer Center
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Email: Research@carle.com

The Carle Foundation Hospital
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Email: Research@carle.com

Yorkville
Rush-Copley Healthcare Center
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Email: Cancer.Research@rushcopley.com

IN
Richmond
Reid Health
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Email: clinical.trials@daytonncorp.org

KS
Garden City
Central Care Cancer Center - Garden City
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Email: aroland@kccop.org

Great Bend
Central Care Cancer Center - Great Bend
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Email: aroland@kccop.org

KY
Bardstown
Flaget Memorial Hospital
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Email: ResearchInstituteInquiries@CommonSpirit.org

Corbin
Commonwealth Cancer Center-Corbin
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Lexington
Saint Joseph Hospital
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Saint Joseph Hospital East
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Saint Joseph Radiation Oncology Resource Center
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London
Saint Joseph London
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Louisville
Jewish Hospital
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Saints Mary and Elizabeth Hospital
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UofL Health Medical Center Northeast
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Mount Sterling
Saint Joseph Mount Sterling
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Shepherdsville
Jewish Hospital Medical Center South
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MD
Baltimore
MedStar Franklin Square Medical Center/Weinberg Cancer Institute
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MN
Rochester
Mayo Clinic in Rochester
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MO
Ballwin
Saint Louis Cancer and Breast Institute-Ballwin
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Bolivar
Central Care Cancer Center - Bolivar
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Email: aroland@kccop.org

Branson
Cox Cancer Center Branson
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Joplin
Freeman Health System
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Email: LJCrockett@freemanhealth.com

Mercy Hospital Joplin
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Email: esmeralda.carrillo@mercy.net

Rolla
Delbert Day Cancer Institute at PCRMC
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Email: research@phelpshealth.org

Mercy Clinic-Rolla-Cancer and Hematology
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Saint Joseph
Heartland Regional Medical Center
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Email: linda.schumacher@mymlc.com

Saint Louis
Mercy Hospital Saint Louis
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Mercy Hospital South
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Email: janet.lesko@mercy.net

Saint Louis Cancer and Breast Institute-South City
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Springfield
CoxHealth South Hospital
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Mercy Hospital Springfield
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Washington
Mercy Hospital Washington
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MT
Missoula
Saint Patrick Hospital - Community Hospital
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Email: amy.hanneman@providence.org

NE
Grand Island
Nebraska Cancer Specialists/Oncology Hematology West PC
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Kearney
CHI Health Good Samaritan
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Lincoln
Saint Elizabeth Regional Medical Center
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Omaha
Alegent Health Bergan Mercy Medical Center
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Alegent Health Immanuel Medical Center
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Alegent Health Lakeside Hospital
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Creighton University Medical Center
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Papillion
Midlands Community Hospital
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NY
New York
Laura and Isaac Perlmutter Cancer Center at NYU Langone
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Email: CancerTrials@nyulangone.org

OH
Beavercreek
Indu and Raj Soin Medical Center
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Email: clinical.trials@daytonncorp.org

Boardman
Saint Elizabeth Boardman Hospital
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Email: clinical.trials@daytonncorp.org

Centerville
Dayton Physicians LLC-Miami Valley South
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Email: clinical.trials@daytonncorp.org

Miami Valley Hospital South
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Email: clinical.trials@daytonncorp.org

Cincinnati
Bethesda North Hospital
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Email: ResearchInstituteInquiries@CommonSpirit.org

Good Samaritan Hospital - Cincinnati
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Email: ResearchInstituteInquiries@CommonSpirit.org

Oncology Hematology Care Inc-Kenwood
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Email: clinical.trials@daytonncorp.org

TriHealth Cancer Institute-Anderson
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Email: ResearchInstituteInquiries@CommonSpirit.org

TriHealth Cancer Institute-Westside
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Email: ResearchInstituteInquiries@CommonSpirit.org

Dayton
Dayton Physician LLC - Englewood
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Email: clinical.trials@daytonncorp.org

Miami Valley Hospital
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Email: clinical.trials@daytonncorp.org

Miami Valley Hospital North
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Email: clinical.trials@daytonncorp.org

Findlay
Armes Family Cancer Center
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Email: clinical.trials@daytonncorp.org

Blanchard Valley Hospital
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Email: clinical.trials@daytonncorp.org

Orion Cancer Care
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Email: clinical.trials@daytonncorp.org

Franklin
Atrium Medical Center-Middletown Regional Hospital
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Email: clinical.trials@daytonncorp.org

Dayton Physicians LLC-Atrium
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Email: clinical.trials@daytonncorp.org

Greenville
Dayton Physicians LLC-Wayne
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Email: clinical.trials@daytonncorp.org

Wayne Hospital
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Email: clinical.trials@daytonncorp.org

Kettering
Greater Dayton Cancer Center
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Email: clinical.trials@daytonncorp.org

Kettering Medical Center
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Email: clinical.trials@daytonncorp.org

Springfield
Springfield Regional Cancer Center
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Email: clinical.trials@daytonncorp.org

Springfield Regional Medical Center
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Email: clinical.trials@daytonncorp.org

Troy
Dayton Physicians LLC - Troy
Contact: Site Public Contact
Email: clinical.trials@daytonncorp.org

Upper Valley Medical Center
Contact: Site Public Contact
Email: clinical.trials@daytonncorp.org

Warren
Saint Joseph Warren Hospital
Contact: Site Public Contact
Email: clinical.trials@daytonncorp.org

Youngstown
Saint Elizabeth Youngstown Hospital
Contact: Site Public Contact
Email: clinical.trials@daytonncorp.org

OK
Oklahoma City
Mercy Hospital Oklahoma City
Contact: Site Public Contact

OR
Bend
Saint Charles Health System
Contact: Site Public Contact
Email: nosall@stcharleshealthcare.org

Clackamas
Clackamas Radiation Oncology Center
Contact: Site Public Contact
Email: CanRsrchStudies@providence.org

Providence Cancer Institute Clackamas Clinic
Contact: Site Public Contact
Email: CanRsrchStudies@providence.org

Coos Bay
Bay Area Hospital
Contact: Site Public Contact
Email: cherie.cox@bayareahospital.org

Newberg
Providence Newberg Medical Center
Contact: Site Public Contact
Email: CanRsrchStudies@providence.org

Portland
Providence Portland Medical Center
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Email: CanRsrchStudies@providence.org

Providence Saint Vincent Medical Center
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Email: CanRsrchStudies@providence.org

Redmond
Saint Charles Health System-Redmond
Contact: Site Public Contact

PA
Chadds Ford
Christiana Care Health System-Concord Health Center
Contact: Site Public Contact
Email: lbarone@christianacare.org

Philadelphia
University of Pennsylvania/Abramson Cancer Center
Contact: Site Public Contact

Pittsburgh
University of Pittsburgh Cancer Institute (UPCI)
Contact: Site Public Contact

TX
Bryan
Saint Joseph Regional Cancer Center
Contact: Site Public Contact
Email: ResearchInstituteInquiries@CommonSpirit.org

UT
Salt Lake City
Huntsman Cancer Institute/University of Utah
Contact: Site Public Contact
Email: cancerinfo@hci.utah.edu

WI
Chippewa Falls
Marshfield Clinic-Chippewa Center
Contact: Site Public Contact
Email: oncology.clinical.trials@marshfieldresearch.org

Eau Claire
Marshfield Medical Center-EC Cancer Center
Contact: Site Public Contact
Email: oncology.clinical.trials@marshfieldresearch.org

Ladysmith
Marshfield Medical Center - Ladysmith
Contact: Site Public Contact
Email: oncology.clinical.trials@marshfieldresearch.org

Marshfield
Marshfield Medical Center-Marshfield
Contact: Site Public Contact
Email: oncology.clinical.trials@marshfieldresearch.org

Minocqua
Marshfield Clinic-Minocqua Center
Contact: Site Public Contact
Email: oncology.clinical.trials@marshfieldresearch.org

Rice Lake
Marshfield Medical Center-Rice Lake
Contact: Site Public Contact
Email: oncology.clinical.trials@marshfieldresearch.org

Stevens Point
Marshfield Medical Center-River Region at Stevens Point
Contact: Site Public Contact
Email: oncology.clinical.trials@marshfieldresearch.org

Wausau
Marshfield Clinic-Wausau Center
Contact: Site Public Contact
Email: oncology.clinical.trials@marshfieldresearch.org

Weston
Marshfield Medical Center - Weston
Contact: Site Public Contact
Email: oncology.clinical.trials@marshfieldresearch.org

Wisconsin Rapids
Marshfield Clinic - Wisconsin Rapids Center
Contact: Site Public Contact
Email: oncology.clinical.trials@marshfieldresearch.org

PRIMARY OBJECTIVE:
I. To determine the rate of one year progression-free survival (PFS) when hydroxychloroquine sulfate (hydroxychloroquine) or placebo is added to dabrafenib mesylate (dabrafenib) and trametinib dimethyl sulfoxide (trametinib) in advanced BRAFV600E/K melanoma with elevated LDH. 

SECONDARY OBJECTIVES:
I. To compare the PFS of both arms.
II. To evaluate the best overall response rate by treatment arm.
III. To evaluate the complete response (CR) rate by treatment arm.
IV. To evaluate the adverse event rate by treatment arm.
V. To evaluate overall survival (OS) by treatment arm.

OUTLINE: Patients are randomized to 1 of 2 arms.

ARM A: Patients receive dabrafenib mesylate orally (PO) twice daily (BID), trametinib dimethyl sulfoxide PO once daily (QD), and hydroxychloroquine sulfate PO BID on days 1-28. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.

ARM B: Patients receive dabrafenib mesylate PO BID, trametinib dimethyl sulfoxide PO QD, and placebo PO BID on days 1-28. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed up for 1 year.

Interactive content above is from the official study record on the National Cancer Institute website, cancer.gov.


The ECOG-ACRIN Cancer Research Group designed this trial and is conducting it with funding from the National Cancer Institute through its National Clinical Trials Network.


EA6191 / BAMM2 (Closed)
ECOG-ACRIN Cancer Research Group