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Testing Dabrafenib and Trametinib With or Without Hydroxychloroquine in Stage IIIC or IV BRAF V600E/K Melanoma

Primary Purpose

Clinical Stage IV Cutaneous Melanoma AJCC v8, Locally Advanced Melanoma, Pathologic Stage IIIC Cutaneous Melanoma AJCC v8

Status
Active
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Dabrafenib Mesylate
Hydroxychloroquine Sulfate
Placebo Administration
Trametinib Dimethyl Sulfoxide
Sponsored by
ECOG-ACRIN Cancer Research Group
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Clinical Stage IV Cutaneous Melanoma AJCC v8

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • 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 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
  • 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 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 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 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

Exclusion Criteria:

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

Sites / Locations

  • Anchorage Associates in Radiation Medicine
  • Anchorage Radiation Therapy Center
  • Alaska Breast Care and Surgery LLC
  • Alaska Oncology and Hematology LLC
  • Alaska Women's Cancer Care
  • Anchorage Oncology Centre
  • Katmai Oncology Group
  • Providence Alaska Medical Center
  • Cancer Center at Saint Joseph's
  • Mayo Clinic Hospital in Arizona
  • Mayo Clinic in Arizona
  • Mercy Hospital Fort Smith
  • CHI Saint Vincent Cancer Center Hot Springs
  • Mission Hope Medical Oncology - Arroyo Grande
  • Providence Saint Joseph Medical Center/Disney Family Cancer Center
  • Cedars Sinai Medical Center
  • Pacific Central Coast Health Center-San Luis Obispo
  • Mission Hope Medical Oncology - Santa Maria
  • Penrose-Saint Francis Healthcare
  • Rocky Mountain Cancer Centers-Penrose
  • Saint Francis Cancer Center
  • Porter Adventist Hospital
  • Mercy Medical Center
  • Southwest Oncology PC
  • Saint Anthony Hospital
  • Littleton Adventist Hospital
  • Longmont United Hospital
  • Rocky Mountain Cancer Centers-Longmont
  • Parker Adventist Hospital
  • Saint Mary Corwin Medical Center
  • Beebe South Coastal Health Campus
  • Beebe Medical Center
  • Delaware Clinical and Laboratory Physicians PA
  • Helen F Graham Cancer Center
  • Medical Oncology Hematology Consultants PA
  • Christiana Care Health System-Christiana Hospital
  • Beebe Health Campus
  • TidalHealth Nanticoke / Allen Cancer Center
  • Christiana Care Health System-Wilmington Hospital
  • MedStar Georgetown University Hospital
  • UM Sylvester Comprehensive Cancer Center at Aventura
  • UM Sylvester Comprehensive Cancer Center at Coral Gables
  • UM Sylvester Comprehensive Cancer Center at Deerfield Beach
  • University of Miami Miller School of Medicine-Sylvester Cancer Center
  • UM Sylvester Comprehensive Cancer Center at Kendall
  • UM Sylvester Comprehensive Cancer Center at Plantation
  • Saint Luke's Cancer Institute - Boise
  • Saint Luke's Cancer Institute - Fruitland
  • Saint Luke's Cancer Institute - Meridian
  • Saint Luke's Cancer Institute - Nampa
  • Saint Luke's Cancer Institute - Twin Falls
  • Saint Anthony's Health
  • Rush - Copley Medical Center
  • Loyola Center for Health at Burr Ridge
  • Carle on Vermilion
  • Carle Physician Group-Effingham
  • Loyola Medicine Homer Glen
  • Carle Physician Group-Mattoon/Charleston
  • Loyola University Medical Center
  • Marjorie Weinberg Cancer Center at Loyola-Gottlieb
  • Good Samaritan Regional Health Center
  • Carle Cancer Center
  • The Carle Foundation Hospital
  • Rush-Copley Healthcare Center
  • Reid Health
  • Mary Greeley Medical Center
  • McFarland Clinic PC - Ames
  • McFarland Clinic PC-Boone
  • Saint Anthony Regional Hospital
  • Medical Oncology and Hematology Associates-West Des Moines
  • Mercy Cancer Center-West Lakes
  • Alegent Health Mercy Hospital
  • Greater Regional Medical Center
  • Iowa Methodist Medical Center
  • Medical Oncology and Hematology Associates-Des Moines
  • Broadlawns Medical Center
  • Mercy Medical Center - Des Moines
  • Mission Cancer and Blood - Laurel
  • Iowa Lutheran Hospital
  • McFarland Clinic PC-Trinity Cancer Center
  • Trinity Regional Medical Center
  • McFarland Clinic PC-Jefferson
  • McFarland Clinic PC-Marshalltown
  • Methodist West Hospital
  • Mercy Medical Center-West Lakes
  • Central Care Cancer Center - Garden City
  • Central Care Cancer Center - Great Bend
  • Flaget Memorial Hospital
  • Commonwealth Cancer Center-Corbin
  • Saint Joseph Radiation Oncology Resource Center
  • Saint Joseph Hospital East
  • Saint Joseph London
  • Jewish Hospital
  • Saints Mary and Elizabeth Hospital
  • UofL Health Medical Center Northeast
  • Jewish Hospital Medical Center South
  • MedStar Franklin Square Medical Center/Weinberg Cancer Institute
  • Mayo Clinic in Rochester
  • Saint Louis Cancer and Breast Institute-Ballwin
  • Central Care Cancer Center - Bolivar
  • Cox Cancer Center Branson
  • Freeman Health System
  • Mercy Hospital Joplin
  • Delbert Day Cancer Institute at PCRMC
  • Mercy Clinic-Rolla-Cancer and Hematology
  • Heartland Regional Medical Center
  • Saint Louis Cancer and Breast Institute-South City
  • Mercy Hospital South
  • Mercy Hospital Saint Louis
  • Mercy Hospital Springfield
  • CoxHealth South Hospital
  • Mercy Hospital Washington
  • Saint Patrick Hospital - Community Hospital
  • CHI Health Saint Francis
  • CHI Health Good Samaritan
  • Saint Elizabeth Regional Medical Center
  • Alegent Health Immanuel Medical Center
  • Alegent Health Bergan Mercy Medical Center
  • Alegent Health Lakeside Hospital
  • Creighton University Medical Center
  • Midlands Community Hospital
  • Laura and Isaac Perlmutter Cancer Center at NYU Langone
  • Indu and Raj Soin Medical Center
  • Saint Elizabeth Boardman Hospital
  • Dayton Physicians LLC-Miami Valley South
  • Miami Valley Hospital South
  • Good Samaritan Hospital - Cincinnati
  • Oncology Hematology Care Inc-Kenwood
  • Bethesda North Hospital
  • TriHealth Cancer Institute-Westside
  • TriHealth Cancer Institute-Anderson
  • Miami Valley Hospital
  • Dayton Physician LLC-Miami Valley Hospital North
  • Miami Valley Hospital North
  • Armes Family Cancer Center
  • Blanchard Valley Hospital
  • Orion Cancer Care
  • Atrium Medical Center-Middletown Regional Hospital
  • Dayton Physicians LLC-Atrium
  • Dayton Physicians LLC-Wayne
  • Wayne Hospital
  • Greater Dayton Cancer Center
  • Kettering Medical Center
  • Springfield Regional Cancer Center
  • Springfield Regional Medical Center
  • Dayton Physicians LLC-Upper Valley
  • Upper Valley Medical Center
  • Saint Joseph Warren Hospital
  • Saint Elizabeth Youngstown Hospital
  • Mercy Hospital Oklahoma City
  • Saint Charles Health System
  • Clackamas Radiation Oncology Center
  • Providence Cancer Institute Clackamas Clinic
  • Bay Area Hospital
  • Providence Newberg Medical Center
  • Providence Portland Medical Center
  • Providence Saint Vincent Medical Center
  • Saint Charles Health System-Redmond
  • Christiana Care Health System-Concord Health Center
  • University of Pennsylvania/Abramson Cancer Center
  • University of Pittsburgh Cancer Institute (UPCI)
  • Saint Joseph Regional Cancer Center
  • Huntsman Cancer Institute/University of Utah
  • Providence Regional Cancer System-Aberdeen
  • PeaceHealth Saint Joseph Medical Center
  • Harrison HealthPartners Hematology and Oncology-Bremerton
  • Harrison Medical Center
  • Highline Medical Center-Main Campus
  • Providence Regional Cancer System-Centralia
  • Swedish Cancer Institute-Edmonds
  • Saint Elizabeth Hospital
  • Providence Regional Cancer Partnership
  • Saint Francis Hospital
  • Swedish Cancer Institute-Issaquah
  • Kadlec Clinic Hematology and Oncology
  • Providence Regional Cancer System-Lacey
  • Saint Clare Hospital
  • PeaceHealth Saint John Medical Center
  • Harrison HealthPartners Hematology and Oncology-Poulsbo
  • Pacific Gynecology Specialists
  • Swedish Medical Center-Ballard Campus
  • Swedish Medical Center-Cherry Hill
  • Swedish Medical Center-First Hill
  • PeaceHealth United General Medical Center
  • Providence Regional Cancer System-Shelton
  • Franciscan Research Center-Northwest Medical Plaza
  • PeaceHealth Southwest Medical Center
  • Providence Saint Mary Regional Cancer Center
  • Providence Regional Cancer System-Yelm
  • Marshfield Clinic-Chippewa Center
  • Marshfield Medical Center-EC Cancer Center
  • Marshfield Clinic - Ladysmith Center
  • Marshfield Medical Center-Marshfield
  • Marshfield Clinic-Minocqua Center
  • Marshfield Medical Center-Rice Lake
  • Marshfield Medical Center-River Region at Stevens Point
  • Marshfield Clinic-Wausau Center
  • Marshfield Medical Center - Weston
  • Marshfield Clinic - Wisconsin Rapids Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Arm A (dabrafenib, trametinib, hydroxychloroquine)

Arm B (dabrafenib, trametinib, placebo)

Arm Description

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

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.

Outcomes

Primary Outcome Measures

Progression-free survival (PFS) rate
Estimated from the Kaplan-Meier curves and compared by treatment arm. A test statistic of the difference in one-year PFS rates divided by the square root or the sum of the variances will be used with a normal approximation. Progression will be evaluated based on international criteria proposed by the revised Response Evaluation Criteria in Solid Tumors (RECIST) guideline (version 1.1).

Secondary Outcome Measures

PFS distribution
Will be estimated using the method of Kaplan-Meier by treatment arm and compared using the log-rank test. In this analysis, all cases with PFS assessed (including cases with censored < one-year) will be included. Progression will be evaluated based on international criteria proposed by the revised RECIST guideline (version 1.1).
Overall response rate
Will be estimated by treatment arm and 95% confidence intervals (CIs) will be provided. Response will be defined by the RECIST guidelines (version 1.1).
Complete response rate
Will be estimated by treatment arm and 95% CIs will be provided. Response will be defined by the RECIST guidelines (version 1.1).
Overall survival
Overall survival will be described using the method of Kaplan-Meier by treatment arm.
Incidence of adverse events
Will be monitored carefully throughout the study and will be summarized by treatment arm. Adverse events will be graded using the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE).
Treatment duration
Will be estimated by treatment arm.

Full Information

First Posted
August 24, 2020
Last Updated
June 21, 2023
Sponsor
ECOG-ACRIN Cancer Research Group
Collaborators
National Cancer Institute (NCI)
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1. Study Identification

Unique Protocol Identification Number
NCT04527549
Brief Title
Testing Dabrafenib and Trametinib With or Without Hydroxychloroquine in Stage IIIC or IV BRAF V600E/K Melanoma
Official Title
The BAMM2 (BRAF, Autophagy, MEK Inhibition in Melanoma) Study: A Randomized Double Blind Phase II Study of Dabrafenib and Trametinib With or Without Hydroxychloroquine in Advanced BRAF V600E/K Melanoma
Study Type
Interventional

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
June 1, 2021 (Actual)
Primary Completion Date
November 30, 2025 (Anticipated)
Study Completion Date
November 30, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
ECOG-ACRIN Cancer Research Group
Collaborators
National Cancer Institute (NCI)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
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. 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.
Detailed Description
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. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Clinical Stage IV Cutaneous Melanoma AJCC v8, Locally Advanced Melanoma, Pathologic Stage IIIC Cutaneous Melanoma AJCC v8, Pathologic Stage IV Cutaneous Melanoma AJCC v8, Unresectable Melanoma

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
84 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Arm A (dabrafenib, trametinib, hydroxychloroquine)
Arm Type
Experimental
Arm Description
Patients receive dabrafenib mesylate PO BID, trametinib dimethyl sulfoxide PO 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 Title
Arm B (dabrafenib, trametinib, placebo)
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Dabrafenib Mesylate
Other Intervention Name(s)
Dabrafenib Methanesulfonate, GSK2118436 Methane Sulfonate Salt, GSK2118436B, Tafinlar
Intervention Description
Given PO
Intervention Type
Drug
Intervention Name(s)
Hydroxychloroquine Sulfate
Other Intervention Name(s)
Plaquenil
Intervention Description
Given PO
Intervention Type
Drug
Intervention Name(s)
Placebo Administration
Intervention Description
Given PO
Intervention Type
Drug
Intervention Name(s)
Trametinib Dimethyl Sulfoxide
Intervention Description
Given PO
Primary Outcome Measure Information:
Title
Progression-free survival (PFS) rate
Description
Estimated from the Kaplan-Meier curves and compared by treatment arm. A test statistic of the difference in one-year PFS rates divided by the square root or the sum of the variances will be used with a normal approximation. Progression will be evaluated based on international criteria proposed by the revised Response Evaluation Criteria in Solid Tumors (RECIST) guideline (version 1.1).
Time Frame
From randomization to progression or death (whichever occurs first), assessed at 1 year after completion of treatment
Secondary Outcome Measure Information:
Title
PFS distribution
Description
Will be estimated using the method of Kaplan-Meier by treatment arm and compared using the log-rank test. In this analysis, all cases with PFS assessed (including cases with censored < one-year) will be included. Progression will be evaluated based on international criteria proposed by the revised RECIST guideline (version 1.1).
Time Frame
From randomization to progression or death (whichever occurs first), assessed at 1 year after completion of treatment
Title
Overall response rate
Description
Will be estimated by treatment arm and 95% confidence intervals (CIs) will be provided. Response will be defined by the RECIST guidelines (version 1.1).
Time Frame
Up to 1 year after completion of treatment
Title
Complete response rate
Description
Will be estimated by treatment arm and 95% CIs will be provided. Response will be defined by the RECIST guidelines (version 1.1).
Time Frame
Up to 1 year after completion of treatment
Title
Overall survival
Description
Overall survival will be described using the method of Kaplan-Meier by treatment arm.
Time Frame
From randomization to death from any cause, assessed up to 1 year after completion of treatment
Title
Incidence of adverse events
Description
Will be monitored carefully throughout the study and will be summarized by treatment arm. Adverse events will be graded using the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE).
Time Frame
Up to 1 year after completion of treatment
Title
Treatment duration
Description
Will be estimated by treatment arm.
Time Frame
Up to 1 year after completion of treatment

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 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 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 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 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 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 Exclusion Criteria: Patients who are known to be experiencing an objective partial response to immunotherapy at the time of study enrollment are not eligible 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) 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 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ravi Amaravadi
Organizational Affiliation
ECOG-ACRIN Cancer Research Group
Official's Role
Principal Investigator
Facility Information:
Facility Name
Anchorage Associates in Radiation Medicine
City
Anchorage
State/Province
Alaska
ZIP/Postal Code
98508
Country
United States
Facility Name
Anchorage Radiation Therapy Center
City
Anchorage
State/Province
Alaska
ZIP/Postal Code
99504
Country
United States
Facility Name
Alaska Breast Care and Surgery LLC
City
Anchorage
State/Province
Alaska
ZIP/Postal Code
99508
Country
United States
Facility Name
Alaska Oncology and Hematology LLC
City
Anchorage
State/Province
Alaska
ZIP/Postal Code
99508
Country
United States
Facility Name
Alaska Women's Cancer Care
City
Anchorage
State/Province
Alaska
ZIP/Postal Code
99508
Country
United States
Facility Name
Anchorage Oncology Centre
City
Anchorage
State/Province
Alaska
ZIP/Postal Code
99508
Country
United States
Facility Name
Katmai Oncology Group
City
Anchorage
State/Province
Alaska
ZIP/Postal Code
99508
Country
United States
Facility Name
Providence Alaska Medical Center
City
Anchorage
State/Province
Alaska
ZIP/Postal Code
99508
Country
United States
Facility Name
Cancer Center at Saint Joseph's
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85004
Country
United States
Facility Name
Mayo Clinic Hospital in Arizona
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85054
Country
United States
Facility Name
Mayo Clinic in Arizona
City
Scottsdale
State/Province
Arizona
ZIP/Postal Code
85259
Country
United States
Facility Name
Mercy Hospital Fort Smith
City
Fort Smith
State/Province
Arkansas
ZIP/Postal Code
72903
Country
United States
Facility Name
CHI Saint Vincent Cancer Center Hot Springs
City
Hot Springs
State/Province
Arkansas
ZIP/Postal Code
71913
Country
United States
Facility Name
Mission Hope Medical Oncology - Arroyo Grande
City
Arroyo Grande
State/Province
California
ZIP/Postal Code
93420
Country
United States
Facility Name
Providence Saint Joseph Medical Center/Disney Family Cancer Center
City
Burbank
State/Province
California
ZIP/Postal Code
91505
Country
United States
Facility Name
Cedars Sinai Medical Center
City
Los Angeles
State/Province
California
ZIP/Postal Code
90048
Country
United States
Facility Name
Pacific Central Coast Health Center-San Luis Obispo
City
San Luis Obispo
State/Province
California
ZIP/Postal Code
93401
Country
United States
Facility Name
Mission Hope Medical Oncology - Santa Maria
City
Santa Maria
State/Province
California
ZIP/Postal Code
93444
Country
United States
Facility Name
Penrose-Saint Francis Healthcare
City
Colorado Springs
State/Province
Colorado
ZIP/Postal Code
80907
Country
United States
Facility Name
Rocky Mountain Cancer Centers-Penrose
City
Colorado Springs
State/Province
Colorado
ZIP/Postal Code
80907
Country
United States
Facility Name
Saint Francis Cancer Center
City
Colorado Springs
State/Province
Colorado
ZIP/Postal Code
80923
Country
United States
Facility Name
Porter Adventist Hospital
City
Denver
State/Province
Colorado
ZIP/Postal Code
80210
Country
United States
Facility Name
Mercy Medical Center
City
Durango
State/Province
Colorado
ZIP/Postal Code
81301
Country
United States
Facility Name
Southwest Oncology PC
City
Durango
State/Province
Colorado
ZIP/Postal Code
81301
Country
United States
Facility Name
Saint Anthony Hospital
City
Lakewood
State/Province
Colorado
ZIP/Postal Code
80228
Country
United States
Facility Name
Littleton Adventist Hospital
City
Littleton
State/Province
Colorado
ZIP/Postal Code
80122
Country
United States
Facility Name
Longmont United Hospital
City
Longmont
State/Province
Colorado
ZIP/Postal Code
80501
Country
United States
Facility Name
Rocky Mountain Cancer Centers-Longmont
City
Longmont
State/Province
Colorado
ZIP/Postal Code
80501
Country
United States
Facility Name
Parker Adventist Hospital
City
Parker
State/Province
Colorado
ZIP/Postal Code
80138
Country
United States
Facility Name
Saint Mary Corwin Medical Center
City
Pueblo
State/Province
Colorado
ZIP/Postal Code
81004
Country
United States
Facility Name
Beebe South Coastal Health Campus
City
Frankford
State/Province
Delaware
ZIP/Postal Code
19945
Country
United States
Facility Name
Beebe Medical Center
City
Lewes
State/Province
Delaware
ZIP/Postal Code
19958
Country
United States
Facility Name
Delaware Clinical and Laboratory Physicians PA
City
Newark
State/Province
Delaware
ZIP/Postal Code
19713
Country
United States
Facility Name
Helen F Graham Cancer Center
City
Newark
State/Province
Delaware
ZIP/Postal Code
19713
Country
United States
Facility Name
Medical Oncology Hematology Consultants PA
City
Newark
State/Province
Delaware
ZIP/Postal Code
19713
Country
United States
Facility Name
Christiana Care Health System-Christiana Hospital
City
Newark
State/Province
Delaware
ZIP/Postal Code
19718
Country
United States
Facility Name
Beebe Health Campus
City
Rehoboth Beach
State/Province
Delaware
ZIP/Postal Code
19971
Country
United States
Facility Name
TidalHealth Nanticoke / Allen Cancer Center
City
Seaford
State/Province
Delaware
ZIP/Postal Code
19973
Country
United States
Facility Name
Christiana Care Health System-Wilmington Hospital
City
Wilmington
State/Province
Delaware
ZIP/Postal Code
19801
Country
United States
Facility Name
MedStar Georgetown University Hospital
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20007
Country
United States
Facility Name
UM Sylvester Comprehensive Cancer Center at Aventura
City
Aventura
State/Province
Florida
ZIP/Postal Code
33180
Country
United States
Facility Name
UM Sylvester Comprehensive Cancer Center at Coral Gables
City
Coral Gables
State/Province
Florida
ZIP/Postal Code
33146
Country
United States
Facility Name
UM Sylvester Comprehensive Cancer Center at Deerfield Beach
City
Deerfield Beach
State/Province
Florida
ZIP/Postal Code
33442
Country
United States
Facility Name
University of Miami Miller School of Medicine-Sylvester Cancer Center
City
Miami
State/Province
Florida
ZIP/Postal Code
33136
Country
United States
Facility Name
UM Sylvester Comprehensive Cancer Center at Kendall
City
Miami
State/Province
Florida
ZIP/Postal Code
33176
Country
United States
Facility Name
UM Sylvester Comprehensive Cancer Center at Plantation
City
Plantation
State/Province
Florida
ZIP/Postal Code
33324
Country
United States
Facility Name
Saint Luke's Cancer Institute - Boise
City
Boise
State/Province
Idaho
ZIP/Postal Code
83712
Country
United States
Facility Name
Saint Luke's Cancer Institute - Fruitland
City
Fruitland
State/Province
Idaho
ZIP/Postal Code
83619
Country
United States
Facility Name
Saint Luke's Cancer Institute - Meridian
City
Meridian
State/Province
Idaho
ZIP/Postal Code
83642
Country
United States
Facility Name
Saint Luke's Cancer Institute - Nampa
City
Nampa
State/Province
Idaho
ZIP/Postal Code
83686
Country
United States
Facility Name
Saint Luke's Cancer Institute - Twin Falls
City
Twin Falls
State/Province
Idaho
ZIP/Postal Code
83301
Country
United States
Facility Name
Saint Anthony's Health
City
Alton
State/Province
Illinois
ZIP/Postal Code
62002
Country
United States
Facility Name
Rush - Copley Medical Center
City
Aurora
State/Province
Illinois
ZIP/Postal Code
60504
Country
United States
Facility Name
Loyola Center for Health at Burr Ridge
City
Burr Ridge
State/Province
Illinois
ZIP/Postal Code
60527
Country
United States
Facility Name
Carle on Vermilion
City
Danville
State/Province
Illinois
ZIP/Postal Code
61832
Country
United States
Facility Name
Carle Physician Group-Effingham
City
Effingham
State/Province
Illinois
ZIP/Postal Code
62401
Country
United States
Facility Name
Loyola Medicine Homer Glen
City
Homer Glen
State/Province
Illinois
ZIP/Postal Code
60491
Country
United States
Facility Name
Carle Physician Group-Mattoon/Charleston
City
Mattoon
State/Province
Illinois
ZIP/Postal Code
61938
Country
United States
Facility Name
Loyola University Medical Center
City
Maywood
State/Province
Illinois
ZIP/Postal Code
60153
Country
United States
Facility Name
Marjorie Weinberg Cancer Center at Loyola-Gottlieb
City
Melrose Park
State/Province
Illinois
ZIP/Postal Code
60160
Country
United States
Facility Name
Good Samaritan Regional Health Center
City
Mount Vernon
State/Province
Illinois
ZIP/Postal Code
62864
Country
United States
Facility Name
Carle Cancer Center
City
Urbana
State/Province
Illinois
ZIP/Postal Code
61801
Country
United States
Facility Name
The Carle Foundation Hospital
City
Urbana
State/Province
Illinois
ZIP/Postal Code
61801
Country
United States
Facility Name
Rush-Copley Healthcare Center
City
Yorkville
State/Province
Illinois
ZIP/Postal Code
60560
Country
United States
Facility Name
Reid Health
City
Richmond
State/Province
Indiana
ZIP/Postal Code
47374
Country
United States
Facility Name
Mary Greeley Medical Center
City
Ames
State/Province
Iowa
ZIP/Postal Code
50010
Country
United States
Facility Name
McFarland Clinic PC - Ames
City
Ames
State/Province
Iowa
ZIP/Postal Code
50010
Country
United States
Facility Name
McFarland Clinic PC-Boone
City
Boone
State/Province
Iowa
ZIP/Postal Code
50036
Country
United States
Facility Name
Saint Anthony Regional Hospital
City
Carroll
State/Province
Iowa
ZIP/Postal Code
51401
Country
United States
Facility Name
Medical Oncology and Hematology Associates-West Des Moines
City
Clive
State/Province
Iowa
ZIP/Postal Code
50325
Country
United States
Facility Name
Mercy Cancer Center-West Lakes
City
Clive
State/Province
Iowa
ZIP/Postal Code
50325
Country
United States
Facility Name
Alegent Health Mercy Hospital
City
Council Bluffs
State/Province
Iowa
ZIP/Postal Code
51503
Country
United States
Facility Name
Greater Regional Medical Center
City
Creston
State/Province
Iowa
ZIP/Postal Code
50801
Country
United States
Facility Name
Iowa Methodist Medical Center
City
Des Moines
State/Province
Iowa
ZIP/Postal Code
50309
Country
United States
Facility Name
Medical Oncology and Hematology Associates-Des Moines
City
Des Moines
State/Province
Iowa
ZIP/Postal Code
50309
Country
United States
Facility Name
Broadlawns Medical Center
City
Des Moines
State/Province
Iowa
ZIP/Postal Code
50314
Country
United States
Facility Name
Mercy Medical Center - Des Moines
City
Des Moines
State/Province
Iowa
ZIP/Postal Code
50314
Country
United States
Facility Name
Mission Cancer and Blood - Laurel
City
Des Moines
State/Province
Iowa
ZIP/Postal Code
50314
Country
United States
Facility Name
Iowa Lutheran Hospital
City
Des Moines
State/Province
Iowa
ZIP/Postal Code
50316
Country
United States
Facility Name
McFarland Clinic PC-Trinity Cancer Center
City
Fort Dodge
State/Province
Iowa
ZIP/Postal Code
50501
Country
United States
Facility Name
Trinity Regional Medical Center
City
Fort Dodge
State/Province
Iowa
ZIP/Postal Code
50501
Country
United States
Facility Name
McFarland Clinic PC-Jefferson
City
Jefferson
State/Province
Iowa
ZIP/Postal Code
50129
Country
United States
Facility Name
McFarland Clinic PC-Marshalltown
City
Marshalltown
State/Province
Iowa
ZIP/Postal Code
50158
Country
United States
Facility Name
Methodist West Hospital
City
West Des Moines
State/Province
Iowa
ZIP/Postal Code
50266-7700
Country
United States
Facility Name
Mercy Medical Center-West Lakes
City
West Des Moines
State/Province
Iowa
ZIP/Postal Code
50266
Country
United States
Facility Name
Central Care Cancer Center - Garden City
City
Garden City
State/Province
Kansas
ZIP/Postal Code
67846
Country
United States
Facility Name
Central Care Cancer Center - Great Bend
City
Great Bend
State/Province
Kansas
ZIP/Postal Code
67530
Country
United States
Facility Name
Flaget Memorial Hospital
City
Bardstown
State/Province
Kentucky
ZIP/Postal Code
40004
Country
United States
Facility Name
Commonwealth Cancer Center-Corbin
City
Corbin
State/Province
Kentucky
ZIP/Postal Code
40701
Country
United States
Facility Name
Saint Joseph Radiation Oncology Resource Center
City
Lexington
State/Province
Kentucky
ZIP/Postal Code
40504
Country
United States
Facility Name
Saint Joseph Hospital East
City
Lexington
State/Province
Kentucky
ZIP/Postal Code
40509
Country
United States
Facility Name
Saint Joseph London
City
London
State/Province
Kentucky
ZIP/Postal Code
40741
Country
United States
Facility Name
Jewish Hospital
City
Louisville
State/Province
Kentucky
ZIP/Postal Code
40202
Country
United States
Facility Name
Saints Mary and Elizabeth Hospital
City
Louisville
State/Province
Kentucky
ZIP/Postal Code
40215
Country
United States
Facility Name
UofL Health Medical Center Northeast
City
Louisville
State/Province
Kentucky
ZIP/Postal Code
40245
Country
United States
Facility Name
Jewish Hospital Medical Center South
City
Shepherdsville
State/Province
Kentucky
ZIP/Postal Code
40165
Country
United States
Facility Name
MedStar Franklin Square Medical Center/Weinberg Cancer Institute
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21237
Country
United States
Facility Name
Mayo Clinic in Rochester
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55905
Country
United States
Facility Name
Saint Louis Cancer and Breast Institute-Ballwin
City
Ballwin
State/Province
Missouri
ZIP/Postal Code
63011
Country
United States
Facility Name
Central Care Cancer Center - Bolivar
City
Bolivar
State/Province
Missouri
ZIP/Postal Code
65613
Country
United States
Facility Name
Cox Cancer Center Branson
City
Branson
State/Province
Missouri
ZIP/Postal Code
65616
Country
United States
Facility Name
Freeman Health System
City
Joplin
State/Province
Missouri
ZIP/Postal Code
64804
Country
United States
Facility Name
Mercy Hospital Joplin
City
Joplin
State/Province
Missouri
ZIP/Postal Code
64804
Country
United States
Facility Name
Delbert Day Cancer Institute at PCRMC
City
Rolla
State/Province
Missouri
ZIP/Postal Code
65401
Country
United States
Facility Name
Mercy Clinic-Rolla-Cancer and Hematology
City
Rolla
State/Province
Missouri
ZIP/Postal Code
65401
Country
United States
Facility Name
Heartland Regional Medical Center
City
Saint Joseph
State/Province
Missouri
ZIP/Postal Code
64506
Country
United States
Facility Name
Saint Louis Cancer and Breast Institute-South City
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63109
Country
United States
Facility Name
Mercy Hospital South
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63128
Country
United States
Facility Name
Mercy Hospital Saint Louis
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63141
Country
United States
Facility Name
Mercy Hospital Springfield
City
Springfield
State/Province
Missouri
ZIP/Postal Code
65804
Country
United States
Facility Name
CoxHealth South Hospital
City
Springfield
State/Province
Missouri
ZIP/Postal Code
65807
Country
United States
Facility Name
Mercy Hospital Washington
City
Washington
State/Province
Missouri
ZIP/Postal Code
63090
Country
United States
Facility Name
Saint Patrick Hospital - Community Hospital
City
Missoula
State/Province
Montana
ZIP/Postal Code
59802
Country
United States
Facility Name
CHI Health Saint Francis
City
Grand Island
State/Province
Nebraska
ZIP/Postal Code
68803
Country
United States
Facility Name
CHI Health Good Samaritan
City
Kearney
State/Province
Nebraska
ZIP/Postal Code
68847
Country
United States
Facility Name
Saint Elizabeth Regional Medical Center
City
Lincoln
State/Province
Nebraska
ZIP/Postal Code
68510
Country
United States
Facility Name
Alegent Health Immanuel Medical Center
City
Omaha
State/Province
Nebraska
ZIP/Postal Code
68122
Country
United States
Facility Name
Alegent Health Bergan Mercy Medical Center
City
Omaha
State/Province
Nebraska
ZIP/Postal Code
68124
Country
United States
Facility Name
Alegent Health Lakeside Hospital
City
Omaha
State/Province
Nebraska
ZIP/Postal Code
68130
Country
United States
Facility Name
Creighton University Medical Center
City
Omaha
State/Province
Nebraska
ZIP/Postal Code
68131
Country
United States
Facility Name
Midlands Community Hospital
City
Papillion
State/Province
Nebraska
ZIP/Postal Code
68046
Country
United States
Facility Name
Laura and Isaac Perlmutter Cancer Center at NYU Langone
City
New York
State/Province
New York
ZIP/Postal Code
10016
Country
United States
Facility Name
Indu and Raj Soin Medical Center
City
Beavercreek
State/Province
Ohio
ZIP/Postal Code
45431
Country
United States
Facility Name
Saint Elizabeth Boardman Hospital
City
Boardman
State/Province
Ohio
ZIP/Postal Code
44512
Country
United States
Facility Name
Dayton Physicians LLC-Miami Valley South
City
Centerville
State/Province
Ohio
ZIP/Postal Code
45459
Country
United States
Facility Name
Miami Valley Hospital South
City
Centerville
State/Province
Ohio
ZIP/Postal Code
45459
Country
United States
Facility Name
Good Samaritan Hospital - Cincinnati
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45220
Country
United States
Facility Name
Oncology Hematology Care Inc-Kenwood
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45236
Country
United States
Facility Name
Bethesda North Hospital
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45242
Country
United States
Facility Name
TriHealth Cancer Institute-Westside
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45247
Country
United States
Facility Name
TriHealth Cancer Institute-Anderson
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45255
Country
United States
Facility Name
Miami Valley Hospital
City
Dayton
State/Province
Ohio
ZIP/Postal Code
45409
Country
United States
Facility Name
Dayton Physician LLC-Miami Valley Hospital North
City
Dayton
State/Province
Ohio
ZIP/Postal Code
45415
Country
United States
Facility Name
Miami Valley Hospital North
City
Dayton
State/Province
Ohio
ZIP/Postal Code
45415
Country
United States
Facility Name
Armes Family Cancer Center
City
Findlay
State/Province
Ohio
ZIP/Postal Code
45840
Country
United States
Facility Name
Blanchard Valley Hospital
City
Findlay
State/Province
Ohio
ZIP/Postal Code
45840
Country
United States
Facility Name
Orion Cancer Care
City
Findlay
State/Province
Ohio
ZIP/Postal Code
45840
Country
United States
Facility Name
Atrium Medical Center-Middletown Regional Hospital
City
Franklin
State/Province
Ohio
ZIP/Postal Code
45005-1066
Country
United States
Facility Name
Dayton Physicians LLC-Atrium
City
Franklin
State/Province
Ohio
ZIP/Postal Code
45005
Country
United States
Facility Name
Dayton Physicians LLC-Wayne
City
Greenville
State/Province
Ohio
ZIP/Postal Code
45331
Country
United States
Facility Name
Wayne Hospital
City
Greenville
State/Province
Ohio
ZIP/Postal Code
45331
Country
United States
Facility Name
Greater Dayton Cancer Center
City
Kettering
State/Province
Ohio
ZIP/Postal Code
45409
Country
United States
Facility Name
Kettering Medical Center
City
Kettering
State/Province
Ohio
ZIP/Postal Code
45429
Country
United States
Facility Name
Springfield Regional Cancer Center
City
Springfield
State/Province
Ohio
ZIP/Postal Code
45504
Country
United States
Facility Name
Springfield Regional Medical Center
City
Springfield
State/Province
Ohio
ZIP/Postal Code
45505
Country
United States
Facility Name
Dayton Physicians LLC-Upper Valley
City
Troy
State/Province
Ohio
ZIP/Postal Code
45373
Country
United States
Facility Name
Upper Valley Medical Center
City
Troy
State/Province
Ohio
ZIP/Postal Code
45373
Country
United States
Facility Name
Saint Joseph Warren Hospital
City
Warren
State/Province
Ohio
ZIP/Postal Code
44484
Country
United States
Facility Name
Saint Elizabeth Youngstown Hospital
City
Youngstown
State/Province
Ohio
ZIP/Postal Code
44501
Country
United States
Facility Name
Mercy Hospital Oklahoma City
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73120
Country
United States
Facility Name
Saint Charles Health System
City
Bend
State/Province
Oregon
ZIP/Postal Code
97701
Country
United States
Facility Name
Clackamas Radiation Oncology Center
City
Clackamas
State/Province
Oregon
ZIP/Postal Code
97015
Country
United States
Facility Name
Providence Cancer Institute Clackamas Clinic
City
Clackamas
State/Province
Oregon
ZIP/Postal Code
97015
Country
United States
Facility Name
Bay Area Hospital
City
Coos Bay
State/Province
Oregon
ZIP/Postal Code
97420
Country
United States
Facility Name
Providence Newberg Medical Center
City
Newberg
State/Province
Oregon
ZIP/Postal Code
97132
Country
United States
Facility Name
Providence Portland Medical Center
City
Portland
State/Province
Oregon
ZIP/Postal Code
97213
Country
United States
Facility Name
Providence Saint Vincent Medical Center
City
Portland
State/Province
Oregon
ZIP/Postal Code
97225
Country
United States
Facility Name
Saint Charles Health System-Redmond
City
Redmond
State/Province
Oregon
ZIP/Postal Code
97756
Country
United States
Facility Name
Christiana Care Health System-Concord Health Center
City
Chadds Ford
State/Province
Pennsylvania
ZIP/Postal Code
19317
Country
United States
Facility Name
University of Pennsylvania/Abramson Cancer Center
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States
Facility Name
University of Pittsburgh Cancer Institute (UPCI)
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15232
Country
United States
Facility Name
Saint Joseph Regional Cancer Center
City
Bryan
State/Province
Texas
ZIP/Postal Code
77802
Country
United States
Facility Name
Huntsman Cancer Institute/University of Utah
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84112
Country
United States
Facility Name
Providence Regional Cancer System-Aberdeen
City
Aberdeen
State/Province
Washington
ZIP/Postal Code
98520
Country
United States
Facility Name
PeaceHealth Saint Joseph Medical Center
City
Bellingham
State/Province
Washington
ZIP/Postal Code
98225
Country
United States
Facility Name
Harrison HealthPartners Hematology and Oncology-Bremerton
City
Bremerton
State/Province
Washington
ZIP/Postal Code
98310
Country
United States
Facility Name
Harrison Medical Center
City
Bremerton
State/Province
Washington
ZIP/Postal Code
98310
Country
United States
Facility Name
Highline Medical Center-Main Campus
City
Burien
State/Province
Washington
ZIP/Postal Code
98166
Country
United States
Facility Name
Providence Regional Cancer System-Centralia
City
Centralia
State/Province
Washington
ZIP/Postal Code
98531
Country
United States
Facility Name
Swedish Cancer Institute-Edmonds
City
Edmonds
State/Province
Washington
ZIP/Postal Code
98026
Country
United States
Facility Name
Saint Elizabeth Hospital
City
Enumclaw
State/Province
Washington
ZIP/Postal Code
98022
Country
United States
Facility Name
Providence Regional Cancer Partnership
City
Everett
State/Province
Washington
ZIP/Postal Code
98201
Country
United States
Facility Name
Saint Francis Hospital
City
Federal Way
State/Province
Washington
ZIP/Postal Code
98003
Country
United States
Facility Name
Swedish Cancer Institute-Issaquah
City
Issaquah
State/Province
Washington
ZIP/Postal Code
98029
Country
United States
Facility Name
Kadlec Clinic Hematology and Oncology
City
Kennewick
State/Province
Washington
ZIP/Postal Code
99336
Country
United States
Facility Name
Providence Regional Cancer System-Lacey
City
Lacey
State/Province
Washington
ZIP/Postal Code
98503
Country
United States
Facility Name
Saint Clare Hospital
City
Lakewood
State/Province
Washington
ZIP/Postal Code
98499
Country
United States
Facility Name
PeaceHealth Saint John Medical Center
City
Longview
State/Province
Washington
ZIP/Postal Code
98632
Country
United States
Facility Name
Harrison HealthPartners Hematology and Oncology-Poulsbo
City
Poulsbo
State/Province
Washington
ZIP/Postal Code
98370
Country
United States
Facility Name
Pacific Gynecology Specialists
City
Seattle
State/Province
Washington
ZIP/Postal Code
98104
Country
United States
Facility Name
Swedish Medical Center-Ballard Campus
City
Seattle
State/Province
Washington
ZIP/Postal Code
98107
Country
United States
Facility Name
Swedish Medical Center-Cherry Hill
City
Seattle
State/Province
Washington
ZIP/Postal Code
98122-5711
Country
United States
Facility Name
Swedish Medical Center-First Hill
City
Seattle
State/Province
Washington
ZIP/Postal Code
98122
Country
United States
Facility Name
PeaceHealth United General Medical Center
City
Sedro-Woolley
State/Province
Washington
ZIP/Postal Code
98284
Country
United States
Facility Name
Providence Regional Cancer System-Shelton
City
Shelton
State/Province
Washington
ZIP/Postal Code
98584
Country
United States
Facility Name
Franciscan Research Center-Northwest Medical Plaza
City
Tacoma
State/Province
Washington
ZIP/Postal Code
98405
Country
United States
Facility Name
PeaceHealth Southwest Medical Center
City
Vancouver
State/Province
Washington
ZIP/Postal Code
98664
Country
United States
Facility Name
Providence Saint Mary Regional Cancer Center
City
Walla Walla
State/Province
Washington
ZIP/Postal Code
99362
Country
United States
Facility Name
Providence Regional Cancer System-Yelm
City
Yelm
State/Province
Washington
ZIP/Postal Code
98597
Country
United States
Facility Name
Marshfield Clinic-Chippewa Center
City
Chippewa Falls
State/Province
Wisconsin
ZIP/Postal Code
54729
Country
United States
Facility Name
Marshfield Medical Center-EC Cancer Center
City
Eau Claire
State/Province
Wisconsin
ZIP/Postal Code
54701
Country
United States
Facility Name
Marshfield Clinic - Ladysmith Center
City
Ladysmith
State/Province
Wisconsin
ZIP/Postal Code
54848
Country
United States
Facility Name
Marshfield Medical Center-Marshfield
City
Marshfield
State/Province
Wisconsin
ZIP/Postal Code
54449
Country
United States
Facility Name
Marshfield Clinic-Minocqua Center
City
Minocqua
State/Province
Wisconsin
ZIP/Postal Code
54548
Country
United States
Facility Name
Marshfield Medical Center-Rice Lake
City
Rice Lake
State/Province
Wisconsin
ZIP/Postal Code
54868
Country
United States
Facility Name
Marshfield Medical Center-River Region at Stevens Point
City
Stevens Point
State/Province
Wisconsin
ZIP/Postal Code
54482
Country
United States
Facility Name
Marshfield Clinic-Wausau Center
City
Wausau
State/Province
Wisconsin
ZIP/Postal Code
54401
Country
United States
Facility Name
Marshfield Medical Center - Weston
City
Weston
State/Province
Wisconsin
ZIP/Postal Code
54476
Country
United States
Facility Name
Marshfield Clinic - Wisconsin Rapids Center
City
Wisconsin Rapids
State/Province
Wisconsin
ZIP/Postal Code
54494
Country
United States

12. IPD Sharing Statement

Learn more about this trial

Testing Dabrafenib and Trametinib With or Without Hydroxychloroquine in Stage IIIC or IV BRAF V600E/K Melanoma

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