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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04462406
Other study ID # EA6192
Secondary ID NCI-2020-04463EA
Status Recruiting
Phase Phase 2
First received
Last updated
Start date February 9, 2021
Est. completion date August 29, 2026

Study information

Verified date June 2023
Source Eastern Cooperative Oncology Group
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

This phase II trial investigates how well biomarkers on PET/CT imaging drive early discontinuation of anti-PD-1 therapy in patients with stage IIIB-IV melanoma that cannot be removed by surgery (unresectable). Anti-PD-1 therapy has become a standard therapy option for patients with unresectable melanoma. This trial is being done to determine if doctors can safely shorten the use of standard of care anti-PD1 therapy for melanoma by using biomarkers seen on PET/CT imaging and tumor biopsy.


Description:

PRIMARY OBJECTIVE: I. To determine the 12 month event free survival (EFS) rate following discontinuation of anti-PD-1 therapy in patients with disease control and negative fludeoxyglucose F-18 (FDG)- positron emission tomography (PET)/computed tomography (CT) scan or biopsy for residual disease after 12 months of anti-PD-1 therapy (Arm A). SECONDARY OBJECTIVES: I. To determine rates of pathologic response in patients with tumor biopsies where positive hypermetabolic activity was present on FDG-PET/CT scan after 12 months of anti-PD-1 therapy (Arm B). II. To determine the overall 24 month EFS. III. To determine overall survival from start of anti-PD-1 therapy. IV. To determine percentage for patients who remain on treatment beyond 12 months because of positive FDG-PET/CT scan and positive biopsy for residual disease (or unable to obtain a biopsy). V. To determine incidence rates of treatment-related adverse events beyond 12 months from start of treatment in patients who discontinue anti-PD-1 therapy at 12 months and in patients who continue anti-PD-1 therapy beyond 12 months (Arm A versus [vs.] Arm B). EXPLORATORY OBJECTIVES: I. To assess agreement in determining FDG-PET/CT positivity between the local site read and central review. II. To determine if metabolic response on serial FDG-PET/CT from pre-therapy to 12 months of anti-PD-1 therapy, as determined centrally by various criteria, is associated with EFS. III. To determine if metabolic response on serial FDG-PET/CT from 12 to 24 months after start of anti-PD-1 therapy, as determined centrally by various criteria, is associated with EFS. BIOMARKER OBJECTIVE: I. To bank tumor samples and peripheral blood for future biomarker studies. OUTLINE: Patients continue their standard of care anti-PD-1 therapy and are then assigned to 1 of 2 arms. STANDARD OF CARE: Treatment may consist of the following regimens: 1) nivolumab intravenously (IV) over 30 minutes every 2 weeks (Q2W) or every 4 weeks (Q4W); 2) pembrolizumab IV over 30 minutes every 3 weeks (Q3W) or every 6 weeks (Q6W); 3) nivolumab IV over 30 minutes and ipilimumab IV Q3W for 4 doses followed by nivolumab IV over 30 minutes Q2W or Q4W; or 4) pembrolizumab IV over 30 minutes and ipilimumab IV Q3W for 4 doses followed by pembrolizumab IV over 30 minutes Q3W or Q6W. Treatment continues until 52 weeks from start of standard of care anti-PD-1 therapy in the absence of disease progression or unacceptable toxicity. ARM A: Patients with a negative FDG-PET/CT scan or a positive FDG-PET/CT scan but with a negative biopsy for viable tumor discontinue the anti-PD-1 therapy and undergo active surveillance. ARM B: Patients with a positive FDG-PET/CT scan and positive biopsy for viable tumor or a positive FDG-PET/CT scan and biopsy not performed continue their standard of care anti-PD-1 therapy for 12 months in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed up through week 97 and then every 3 months for up to 5 years.


Recruitment information / eligibility

Status Recruiting
Enrollment 150
Est. completion date August 29, 2026
Est. primary completion date August 29, 2026
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - STEP 0 PRE-REGISTRATION INCLUSION CRITERIA - Patient must have active advanced melanoma, defined as unresectable stage IIIB-IV by American Joint Committee on Cancer (AJCC) 8th edition - Patient must have melanoma originating from cutaneous, acral-lentiginous, or mucosal primary sites. Patients with melanoma of unknown primary site are eligible. Patients must not have melanoma from an ocular primary site - Patient must have had measurable disease by immune related Response Evaluation Criteria in Solid Tumors (imRECIST) prior to start of initial anti-PD-1 therapy - Patient must be actively receiving standard of care anti-PD-1 therapy, currently be 52 weeks (+/- 2 weeks) from start of anti-PD-1 therapy, and have not experienced a toxicity that prevents them from continuing on therapy. Permitted systemic anti-PD-1 therapy regimens include: - Nivolumab 240 mg IV every (Q)2weeks or 480 mg IV Q4weeks - Pembrolizumab 200 mg IV Q3weeks or 400 mg IV Q6weeks - Nivolumab 1 mg/kg plus ipilimumab 3 mg/kg IV Q3weeks induction x 4 doses, followed by nivolumab 240 mg IV Q2weeks or 480 mg IV Q4weeks maintenance - Nivolumab 3 mg/kg plus Ipilimumab 1 mg/kg IV Q3weeks induction x 4 doses, followed by nivolumab 240 mg IV Q2weeks or 480 mg IV Q4weeks maintenance - Pembrolizumab 2 mg/kg (or 200 mg flat dose) plus Ipilimumab 1 mg/kg IV Q3weeks induction x 4 doses, followed by pembrolizumab 200 mg IV Q3weeks or 400 mg IV Q6weeks maintenance - Patient must have an Eastern Cooperative Oncology Group (ECOG) performance status of 0-2 - Human immunodeficiency virus (HIV)-infected patients on effective anti-retroviral therapy with undetectable viral load within 6 months are eligible for this trial. Patients with detectable viral loads are excluded as it is unclear if these patients have a low risk of melanoma progression off anti-PD-1 treatment - For patients with evidence of chronic hepatitis B virus (HBV) infection, the HBV viral load must be undetectable on suppressive therapy, if indicated - Patients with a history of hepatitis C virus (HCV) infection must have been treated and cured. For patients with HCV infection who are currently on treatment, they are eligible if they have an undetectable HCV viral load - Patients 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 - 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 have experienced complete response, partial response, or stable disease on restaging CT scans by imRECIST that is maintained on restaging scans obtained at week 52 (+/- 2 weeks) from start of initial anti-PD-1 therapy - Patient must have completed an FDG-PET/CT scan at week 52 (+/- 2 weeks) from start of initial anti-PD-1 therapy - Patients with PET/CT positive for hypermetabolic lesions: If a core needle, punch or excisional biopsy and pathological review of a representative lesion was not performed prior to pre-registration (Step 0) must either: - Be amenable to undergo a biopsy. Patient must not be on anticoagulation therapy or, if on anti-coagulation therapy, patient must be able to hold treatment for a biopsy procedure (core needle, punch or excisional biopsy). Anti-coagulation therapy is defined as low molecular weight heparin, warfarin, factor Xa inhibitor, or direct thrombin inhibitor - Have documentation of inability to perform the biopsy due to feasibility or safety concerns - Leukocytes >= 3,000/mcL (obtained =< 4 weeks prior to protocol registration) - Absolute neutrophil count >= 1,500/mcL (obtained =< 4 weeks prior to protocol registration) - Platelets >= 100,000/mcL (obtained =< 4 weeks prior to protocol registration) - Total bilirubin =< institutional upper limit of normal (ULN) (patients with history of Gilbert's syndrome are permitted to have a total bilirubin > 1.5 x institutional ULN) (obtained =< 4 weeks prior to protocol registration) - Aspartate aminotransferase (AST) (serum glutamic-oxaloacetic transaminase [SGOT])/alanine aminotransferase (ALT) (serum glutamate pyruvate transaminase [SGPT]) =< 2.5 x institutional ULN (obtained =< 4 weeks prior to protocol registration) - Creatinine =< 1.5 x institutional ULN (obtained =< 4 weeks prior to protocol registration) - STEP 1 REGISTRATION INCLUSION CRITERIA - Patient met all eligibility criteria outlined above - Patient must register to Step 1 within 4 weeks of registration to Step 0 - Patients must meet one of the following criteria: - Patient had no positive hypermetabolic lesions on the week 52 FDG-PET/CT. - Patients with positive hypermetabolic lesion(s) on the week 52 FDG-PET/CT (positive hypermetabolic = standard uptake volume [SUV] > pooled mediastinal blood), one of the following must have occurred: - A representative lesion was biopsied (core needle, punch or excisional biopsy) within 14 days of registration to Step 0 and subsequent pathology review performed to determine the presence or absence of viable tumor - Documentation is present that the patient is not able to undergo biopsy of a hypermetabolic lesion due to feasibility or safety concerns, i.e., the lesion location that is not amenable to biopsy Exclusion Criteria: - STEP 0 PRE-REGISTRATION EXCLUSION CRITERIA - Patient must not be receiving concurrent anti-tumor therapies in addition to the standard of care anti-PD-1 regimens. Patients who are receiving bisphosphonates and RANKL inhibitors for management of bone metastases are eligible - Patient must not have brain metastases - Women must not be pregnant or breast-feeding due to potential harm to an unborn fetus and possible risk for adverse events in nursing infants with the anti-PD-1 regimens being used. All females of childbearing potential must have a blood test or urine study within 14 days prior to registration 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 conceive or father children by using accepted and effective method(s) of contraception or by abstaining from sexual intercourse from the time of study registration and continuing until at least 5 months after the last dose of anti-PD-1 treatment for female patients and for at least 7 months after the last dose of anti-PD-1 treatment for male patients who are sexually active with a women of childbearing potential (WOCBP)

Study Design


Related Conditions & MeSH terms


Intervention

Biological:
Ipilimumab
Given IV
Nivolumab
Given IV
Other:
Patient Observation
Undergo active surveillance
Biological:
Pembrolizumab
Given IV

Locations

Country Name City State
United States Hickman Cancer Center Adrian Michigan
United States Riverwood Healthcare Center Aitkin Minnesota
United States Lehigh Valley Hospital-Cedar Crest Allentown Pennsylvania
United States Saint Anthony's Health Alton Illinois
United States Mary Greeley Medical Center Ames Iowa
United States McFarland Clinic PC - Ames Ames Iowa
United States Saint Joseph Mercy Hospital Ann Arbor Michigan
United States Mission Hope Medical Oncology - Arroyo Grande Arroyo Grande California
United States Duluth Clinic Ashland Ashland Wisconsin
United States Northwest Wisconsin Cancer Center Ashland Wisconsin
United States Emory University Hospital/Winship Cancer Institute Atlanta Georgia
United States Rocky Mountain Cancer Centers-Aurora Aurora Colorado
United States Rush - Copley Medical Center Aurora Illinois
United States The Medical Center of Aurora Aurora Colorado
United States UM Sylvester Comprehensive Cancer Center at Aventura Aventura Florida
United States Saint Louis Cancer and Breast Institute-Ballwin Ballwin Missouri
United States MedStar Franklin Square Medical Center/Weinberg Cancer Institute Baltimore Maryland
United States Flaget Memorial Hospital Bardstown Kentucky
United States Memorial Sloan Kettering Basking Ridge Basking Ridge New Jersey
United States Bronson Battle Creek Battle Creek Michigan
United States Essentia Health - Baxter Clinic Baxter Minnesota
United States Indu and Raj Soin Medical Center Beavercreek Ohio
United States Strecker Cancer Center-Belpre Belpre Ohio
United States Sanford Joe Lueken Cancer Center Bemidji Minnesota
United States Central Vermont Medical Center/National Life Cancer Treatment Berlin Vermont
United States Lehigh Valley Hospital - Muhlenberg Bethlehem Pennsylvania
United States Sanford Bismarck Medical Center Bismarck North Dakota
United States Illinois CancerCare-Bloomington Bloomington Illinois
United States Saint Elizabeth Boardman Hospital Boardman Ohio
United States Central Care Cancer Center - Bolivar Bolivar Missouri
United States McFarland Clinic PC-Boone Boone Iowa
United States Boston Medical Center Boston Massachusetts
United States Boulder Community Foothills Hospital Boulder Colorado
United States Rocky Mountain Cancer Centers-Boulder Boulder Colorado
United States Essentia Health Saint Joseph's Medical Center Brainerd Minnesota
United States Cox Cancer Center Branson Branson Missouri
United States Harrison HealthPartners Hematology and Oncology-Bremerton Bremerton Washington
United States Harrison Medical Center Bremerton Washington
United States Saint Joseph Mercy Brighton Brighton Michigan
United States Trinity Health IHA Medical Group Hematology Oncology - Brighton Brighton Michigan
United States Saint Joseph Regional Cancer Center Bryan Texas
United States Roswell Park Cancer Institute Buffalo New York
United States Highline Medical Center-Main Campus Burien Washington
United States University of Vermont and State Agricultural College Burlington Vermont
United States University of Vermont Medical Center Burlington Vermont
United States Illinois CancerCare-Canton Canton Illinois
United States Saint Joseph Mercy Canton Canton Michigan
United States Trinity Health IHA Medical Group Hematology Oncology - Canton Canton Michigan
United States Saint Francis Medical Center Cape Girardeau Missouri
United States Southeast Cancer Center Cape Girardeau Missouri
United States Memorial Hospital of Carbondale Carbondale Illinois
United States Caro Cancer Center Caro Michigan
United States Saint Anthony Regional Hospital Carroll Iowa
United States SIH Cancer Institute Carterville Illinois
United States Illinois CancerCare-Carthage Carthage Illinois
United States Rocky Mountain Cancer Centers - Centennial Centennial Colorado
United States Dayton Physicians LLC-Miami Valley South Centerville Ohio
United States Miami Valley Hospital South Centerville Ohio
United States Centralia Oncology Clinic Centralia Illinois
United States University of Virginia Cancer Center Charlottesville Virginia
United States Saint Joseph Mercy Chelsea Chelsea Michigan
United States Trinity Health IHA Medical Group Hematology Oncology - Chelsea Hospital Chelsea Michigan
United States Cheyenne Regional Medical Center-West Cheyenne Wyoming
United States Northwestern University Chicago Illinois
United States Adena Regional Medical Center Chillicothe Ohio
United States Marshfield Clinic-Chippewa Center Chippewa Falls Wisconsin
United States Bethesda North Hospital Cincinnati Ohio
United States Good Samaritan Hospital - Cincinnati Cincinnati Ohio
United States Oncology Hematology Care Inc-Kenwood Cincinnati Ohio
United States TriHealth Cancer Institute-Anderson Cincinnati Ohio
United States TriHealth Cancer Institute-Westside Cincinnati Ohio
United States University of Cincinnati Cancer Center-UC Medical Center Cincinnati Ohio
United States Hematology Oncology Consultants-Clarkston Clarkston Michigan
United States Newland Medical Associates-Clarkston Clarkston Michigan
United States Medical Oncology and Hematology Associates-West Des Moines Clive Iowa
United States Mercy Cancer Center-West Lakes Clive Iowa
United States Penrose-Saint Francis Healthcare Colorado Springs Colorado
United States Rocky Mountain Cancer Centers-Penrose Colorado Springs Colorado
United States Saint Francis Cancer Center Colorado Springs Colorado
United States Columbus Oncology and Hematology Associates Inc Columbus Ohio
United States Doctors Hospital Columbus Ohio
United States Grant Medical Center Columbus Ohio
United States Mount Carmel East Hospital Columbus Ohio
United States Mount Carmel Health Center West Columbus Ohio
United States Ohio State University Comprehensive Cancer Center Columbus Ohio
United States Riverside Methodist Hospital Columbus Ohio
United States The Mark H Zangmeister Center Columbus Ohio
United States Memorial Sloan Kettering Commack Commack New York
United States UM Sylvester Comprehensive Cancer Center at Coral Gables Coral Gables Florida
United States Commonwealth Cancer Center-Corbin Corbin Kentucky
United States Alegent Health Mercy Hospital Council Bluffs Iowa
United States Greater Regional Medical Center Creston Iowa
United States Siteman Cancer Center at West County Hospital Creve Coeur Missouri
United States Carle on Vermilion Danville Illinois
United States Geisinger Medical Center Danville Pennsylvania
United States Dayton Physician LLC-Miami Valley Hospital North Dayton Ohio
United States Miami Valley Hospital Dayton Ohio
United States Miami Valley Hospital North Dayton Ohio
United States Cancer Care Specialists of Illinois - Decatur Decatur Illinois
United States Decatur Memorial Hospital Decatur Illinois
United States Essentia Health - Deer River Clinic Deer River Minnesota
United States UM Sylvester Comprehensive Cancer Center at Deerfield Beach Deerfield Beach Florida
United States Delaware Health Center-Grady Cancer Center Delaware Ohio
United States Grady Memorial Hospital Delaware Ohio
United States Colorado Blood Cancer Institute Denver Colorado
United States Porter Adventist Hospital Denver Colorado
United States Presbyterian - Saint Lukes Medical Center - Health One Denver Colorado
United States Rocky Mountain Cancer Centers-Midtown Denver Colorado
United States Rocky Mountain Cancer Centers-Rose Denver Colorado
United States Rose Medical Center Denver Colorado
United States The Women's Imaging Center Denver Colorado
United States Western Surgical Care Denver Colorado
United States Broadlawns Medical Center Des Moines Iowa
United States Iowa Lutheran Hospital Des Moines Iowa
United States Iowa Methodist Medical Center Des Moines Iowa
United States Medical Oncology and Hematology Associates-Des Moines Des Moines Iowa
United States Medical Oncology and Hematology Associates-Laurel Des Moines Iowa
United States Mercy Medical Center - Des Moines Des Moines Iowa
United States Ascension Saint John Hospital Detroit Michigan
United States Essentia Health Saint Mary's - Detroit Lakes Clinic Detroit Lakes Minnesota
United States Illinois CancerCare-Dixon Dixon Illinois
United States Columbus Oncology and Hematology Associates Dublin Ohio
United States Dublin Methodist Hospital Dublin Ohio
United States Essentia Health Cancer Center Duluth Minnesota
United States Essentia Health Saint Mary's Medical Center Duluth Minnesota
United States Miller-Dwan Hospital Duluth Minnesota
United States Mercy Medical Center Durango Colorado
United States Southwest Oncology PC Durango Colorado
United States Great Lakes Cancer Management Specialists-Doctors Park East China Township Michigan
United States Pocono Medical Center East Stroudsburg Pennsylvania
United States Marshfield Medical Center-EC Cancer Center Eau Claire Wisconsin
United States Carle Physician Group-Effingham Effingham Illinois
United States Crossroads Cancer Center Effingham Illinois
United States Essentia Health - Ely Clinic Ely Minnesota
United States Mountain Blue Cancer Care Center - Swedish Englewood Colorado
United States Rocky Mountain Cancer Centers - Swedish Englewood Colorado
United States Swedish Medical Center Englewood Colorado
United States The Melanoma and Skin Cancer Institute Englewood Colorado
United States Saint Elizabeth Hospital Enumclaw Washington
United States Illinois CancerCare-Eureka Eureka Illinois
United States Fairbanks Memorial Hospital Fairbanks Alaska
United States Essentia Health Cancer Center-South University Clinic Fargo North Dakota
United States Sanford Broadway Medical Center Fargo North Dakota
United States Sanford Medical Center Fargo Fargo North Dakota
United States Sanford Roger Maris Cancer Center Fargo North Dakota
United States Sanford South University Medical Center Fargo North Dakota
United States Southpointe-Sanford Medical Center Fargo Fargo North Dakota
United States Parkland Health Center - Farmington Farmington Missouri
United States Saint Francis Hospital Federal Way Washington
United States Lake Region Healthcare Corporation-Cancer Care Fergus Falls Minnesota
United States Armes Family Cancer Center Findlay Ohio
United States Blanchard Valley Hospital Findlay Ohio
United States Orion Cancer Care Findlay Ohio
United States Genesee Cancer and Blood Disease Treatment Center Flint Michigan
United States Genesee Hematology Oncology PC Flint Michigan
United States Genesys Hurley Cancer Institute Flint Michigan
United States Hurley Medical Center Flint Michigan
United States McFarland Clinic PC-Trinity Cancer Center Fort Dodge Iowa
United States Trinity Regional Medical Center Fort Dodge Iowa
United States Holy Cross Hospital Fort Lauderdale Florida
United States Mercy Hospital Fort Smith Fort Smith Arkansas
United States Essentia Health - Fosston Fosston Minnesota
United States Atrium Medical Center-Middletown Regional Hospital Franklin Ohio
United States Dayton Physicians LLC-Atrium Franklin Ohio
United States Gibbs Cancer Center-Gaffney Gaffney South Carolina
United States Central Ohio Breast and Endocrine Surgery Gahanna Ohio
United States Illinois CancerCare-Galesburg Galesburg Illinois
United States Western Illinois Cancer Treatment Center Galesburg Illinois
United States Central Care Cancer Center - Garden City Garden City Kansas
United States Glens Falls Hospital Glens Falls New York
United States CHI Health Saint Francis Grand Island Nebraska
United States Helen DeVos Children's Hospital at Spectrum Health Grand Rapids Michigan
United States Mercy Health Saint Mary's Grand Rapids Michigan
United States Spectrum Health at Butterworth Campus Grand Rapids Michigan
United States Central Care Cancer Center - Great Bend Great Bend Kansas
United States Dayton Physicians LLC-Wayne Greenville Ohio
United States Wayne Hospital Greenville Ohio
United States Gibbs Cancer Center-Pelham Greer South Carolina
United States Academic Hematology Oncology Specialists Grosse Pointe Woods Michigan
United States Great Lakes Cancer Management Specialists-Van Elslander Cancer Center Grosse Pointe Woods Michigan
United States Michigan Breast Specialists-Grosse Pointe Woods Grosse Pointe Woods Michigan
United States Mount Carmel Grove City Hospital Grove City Ohio
United States Hackensack University Medical Center Hackensack New Jersey
United States Memorial Sloan Kettering Westchester Harrison New York
United States Essentia Health-Hayward Clinic Hayward Wisconsin
United States Geisinger Medical Center-Cancer Center Hazleton Hazleton Pennsylvania
United States Lehigh Valley Hospital-Hazleton Hazleton Pennsylvania
United States Penn State Milton S Hershey Medical Center Hershey Pennsylvania
United States Essentia Health Hibbing Clinic Hibbing Minnesota
United States CHI Saint Vincent Cancer Center Hot Springs Hot Springs Arkansas
United States Essentia Health - International Falls Clinic International Falls Minnesota
United States Essentia Health - Jamestown Clinic Jamestown North Dakota
United States McFarland Clinic PC-Jefferson Jefferson Iowa
United States Capital Region Southwest Campus Jefferson City Missouri
United States Freeman Health System Joplin Missouri
United States Mercy Hospital Joplin Joplin Missouri
United States Ascension Borgess Cancer Center Kalamazoo Michigan
United States Borgess Medical Center Kalamazoo Michigan
United States Bronson Methodist Hospital Kalamazoo Michigan
United States West Michigan Cancer Center Kalamazoo Michigan
United States CHI Health Good Samaritan Kearney Nebraska
United States Greater Dayton Cancer Center Kettering Ohio
United States Kettering Medical Center Kettering Ohio
United States Illinois CancerCare-Kewanee Clinic Kewanee Illinois
United States Marshfield Clinic - Ladysmith Center Ladysmith Wisconsin
United States Northwestern Medicine Lake Forest Hospital Lake Forest Illinois
United States Rocky Mountain Cancer Centers-Lakewood Lakewood Colorado
United States Saint Anthony Hospital Lakewood Colorado
United States Saint Clare Hospital Lakewood Washington
United States Fairfield Medical Center Lancaster Ohio
United States Sparrow Hospital Lansing Michigan
United States Geisinger Medical Oncology-Lewisburg Lewisburg Pennsylvania
United States Saint Joseph Hospital East Lexington Kentucky
United States Saint Joseph Radiation Oncology Resource Center Lexington Kentucky
United States Saint Rita's Medical Center Lima Ohio
United States Saint Elizabeth Regional Medical Center Lincoln Nebraska
United States University of Arkansas for Medical Sciences Little Rock Arkansas
United States Littleton Adventist Hospital Littleton Colorado
United States Rocky Mountain Cancer Centers-Littleton Littleton Colorado
United States Hope Cancer Clinic Livonia Michigan
United States Trinity Health Saint Mary Mercy Livonia Hospital Livonia Michigan
United States Saint Joseph London London Kentucky
United States Rocky Mountain Cancer Centers-Sky Ridge Lone Tree Colorado
United States Sky Ridge Medical Center Lone Tree Colorado
United States Longmont United Hospital Longmont Colorado
United States Rocky Mountain Cancer Centers-Longmont Longmont Colorado
United States Cedars Sinai Medical Center Los Angeles California
United States Jewish Hospital Louisville Kentucky
United States Saints Mary and Elizabeth Hospital Louisville Kentucky
United States UofL Health Medical Center Northeast Louisville Kentucky
United States Great Lakes Cancer Management Specialists-Macomb Medical Campus Macomb Michigan
United States Illinois CancerCare-Macomb Macomb Illinois
United States Michigan Breast Specialists-Macomb Township Macomb Michigan
United States OhioHealth Mansfield Hospital Mansfield Ohio
United States Marietta Memorial Hospital Marietta Ohio
United States OhioHealth Marion General Hospital Marion Ohio
United States Saint Mary's Oncology/Hematology Associates of Marlette Marlette Michigan
United States McFarland Clinic PC-Marshalltown Marshalltown Iowa
United States Marshfield Medical Center-Marshfield Marshfield Wisconsin
United States Carle Physician Group-Mattoon/Charleston Mattoon Illinois
United States UM Sylvester Comprehensive Cancer Center at Kendall Miami Florida
United States University of Miami Miller School of Medicine-Sylvester Cancer Center Miami Florida
United States Memorial Sloan Kettering Monmouth Middletown New Jersey
United States Marshfield Clinic-Minocqua Center Minocqua Wisconsin
United States Toledo Clinic Cancer Centers-Monroe Monroe Michigan
United States Memorial Sloan Kettering Bergen Montvale New Jersey
United States Essentia Health - Moose Lake Clinic Moose Lake Minnesota
United States Good Samaritan Regional Health Center Mount Vernon Illinois
United States Knox Community Hospital Mount Vernon Ohio
United States ProHealth D N Greenwald Center Mukwonago Wisconsin
United States Mercy Health Mercy Campus Muskegon Michigan
United States Laura and Isaac Perlmutter Cancer Center at NYU Langone New York New York
United States Memorial Sloan Kettering Cancer Center New York New York
United States Licking Memorial Hospital Newark Ohio
United States Newark Radiation Oncology Newark Ohio
United States Lakeland Hospital Niles Niles Michigan
United States Cancer and Hematology Centers of Western Michigan - Norton Shores Norton Shores Michigan
United States Cancer Care Center of O'Fallon O'Fallon Illinois
United States ProHealth Oconomowoc Memorial Hospital Oconomowoc Wisconsin
United States Mercy Hospital Oklahoma City Oklahoma City Oklahoma
United States University of Oklahoma Health Sciences Center Oklahoma City Oklahoma
United States Alegent Health Bergan Mercy Medical Center Omaha Nebraska
United States Alegent Health Immanuel Medical Center Omaha Nebraska
United States Alegent Health Lakeside Hospital Omaha Nebraska
United States Creighton University Medical Center Omaha Nebraska
United States Illinois CancerCare-Ottawa Clinic Ottawa Illinois
United States Midlands Community Hospital Papillion Nebraska
United States Essentia Health - Park Rapids Park Rapids Minnesota
United States Parker Adventist Hospital Parker Colorado
United States Illinois CancerCare-Pekin Pekin Illinois
United States Illinois CancerCare-Peoria Peoria Illinois
United States Methodist Medical Center of Illinois Peoria Illinois
United States Mercy Health Perrysburg Cancer Center Perrysburg Ohio
United States Illinois CancerCare-Peru Peru Illinois
United States Valley Radiation Oncology Peru Illinois
United States Cancer Center at Saint Joseph's Phoenix Arizona
United States UM Sylvester Comprehensive Cancer Center at Plantation Plantation Florida
United States 21st Century Oncology-Pontiac Pontiac Michigan
United States Hope Cancer Center Pontiac Michigan
United States Newland Medical Associates-Pontiac Pontiac Michigan
United States Saint Joseph Mercy Oakland Pontiac Michigan
United States Jefferson Healthcare Port Townsend Washington
United States Southern Ohio Medical Center Portsmouth Ohio
United States Geisinger Cancer Services-Pottsville Pottsville Pennsylvania
United States Harrison HealthPartners Hematology and Oncology-Poulsbo Poulsbo Washington
United States Illinois CancerCare-Princeton Princeton Illinois
United States Saint Mary Corwin Medical Center Pueblo Colorado
United States Spectrum Health Reed City Hospital Reed City Michigan
United States Marshfield Medical Center-Rice Lake Rice Lake Wisconsin
United States Reid Health Richmond Indiana
United States Great Lakes Cancer Management Specialists-Rochester Hills Rochester Hills Michigan
United States Delbert Day Cancer Institute at PCRMC Rolla Missouri
United States Mercy Clinic-Rolla-Cancer and Hematology Rolla Missouri
United States Ascension Saint Mary's Hospital Saginaw Michigan
United States Oncology Hematology Associates of Saginaw Valley PC Saginaw Michigan
United States Heartland Regional Medical Center Saint Joseph Missouri
United States Lakeland Medical Center Saint Joseph Saint Joseph Michigan
United States Marie Yeager Cancer Center Saint Joseph Michigan
United States Mercy Hospital Saint Louis Saint Louis Missouri
United States Mercy Hospital South Saint Louis Missouri
United States Missouri Baptist Medical Center Saint Louis Missouri
United States Saint Louis Cancer and Breast Institute-South City Saint Louis Missouri
United States Siteman Cancer Center at Christian Hospital Saint Louis Missouri
United States Siteman Cancer Center-South County Saint Louis Missouri
United States Washington University School of Medicine Saint Louis Missouri
United States Siteman Cancer Center at Saint Peters Hospital Saint Peters Missouri
United States Sainte Genevieve County Memorial Hospital Sainte Genevieve Missouri
United States Huntsman Cancer Institute/University of Utah Salt Lake City Utah
United States Pacific Central Coast Health Center-San Luis Obispo San Luis Obispo California
United States Essentia Health Sandstone Sandstone Minnesota
United States Mission Hope Medical Oncology - Santa Maria Santa Maria California
United States Lewis Cancer and Research Pavilion at Saint Joseph's/Candler Savannah Georgia
United States Community Medical Center Scranton Pennsylvania
United States Jewish Hospital Medical Center South Shepherdsville Kentucky
United States Sanford Cancer Center Oncology Clinic Sioux Falls South Dakota
United States Sanford USD Medical Center - Sioux Falls Sioux Falls South Dakota
United States North Grove Medical Park Spartanburg South Carolina
United States Spartanburg Medical Center Spartanburg South Carolina
United States Spartanburg Medical Center - Mary Black Campus Spartanburg South Carolina
United States Essentia Health-Spooner Clinic Spooner Wisconsin
United States CoxHealth South Hospital Springfield Missouri
United States Memorial Medical Center Springfield Illinois
United States Mercy Hospital Springfield Springfield Missouri
United States Southern Illinois University School of Medicine Springfield Illinois
United States Springfield Clinic Springfield Illinois
United States Springfield Regional Cancer Center Springfield Ohio
United States Springfield Regional Medical Center Springfield Ohio
United States Bhadresh Nayak MD PC-Sterling Heights Sterling Heights Michigan
United States Marshfield Medical Center-River Region at Stevens Point Stevens Point Wisconsin
United States Missouri Baptist Sullivan Hospital Sullivan Missouri
United States Missouri Baptist Outpatient Center-Sunset Hills Sunset Hills Missouri
United States Essentia Health Saint Mary's Hospital - Superior Superior Wisconsin
United States Southwest Illinois Health Services LLP Swansea Illinois
United States Franciscan Research Center-Northwest Medical Plaza Tacoma Washington
United States Northwest Medical Specialties PLLC Tacoma Washington
United States Ascension Saint Joseph Hospital Tawas City Michigan
United States Sanford Thief River Falls Medical Center Thief River Falls Minnesota
United States Rocky Mountain Cancer Centers-Thornton Thornton Colorado
United States Mercy Health - Saint Anne Hospital Toledo Ohio
United States Saint Vincent Mercy Medical Center Toledo Ohio
United States Toledo Clinic Cancer Centers-Toledo Toledo Ohio
United States Munson Medical Center Traverse City Michigan
United States Dayton Physicians LLC-Upper Valley Troy Ohio
United States Upper Valley Medical Center Troy Ohio
United States MGC Hematology Oncology-Union Union South Carolina
United States Memorial Sloan Kettering Nassau Uniondale New York
United States Carle Cancer Center Urbana Illinois
United States The Carle Foundation Hospital Urbana Illinois
United States Essentia Health Virginia Clinic Virginia Minnesota
United States Advanced Breast Care Center PLLC Warren Michigan
United States Great Lakes Cancer Management Specialists-Macomb Professional Building Warren Michigan
United States Macomb Hematology Oncology PC Warren Michigan
United States Michigan Breast Specialists-Warren Warren Michigan
United States Saint John Macomb-Oakland Hospital Warren Michigan
United States Saint Joseph Warren Hospital Warren Ohio
United States Illinois CancerCare - Washington Washington Illinois
United States MedStar Georgetown University Hospital Washington District of Columbia
United States MedStar Washington Hospital Center Washington District of Columbia
United States Mercy Hospital Washington Washington Missouri
United States ProHealth Waukesha Memorial Hospital Waukesha Wisconsin
United States UW Cancer Center at ProHealth Care Waukesha Wisconsin
United States Marshfield Clinic-Wausau Center Wausau Wisconsin
United States Saint Mary's Oncology/Hematology Associates of West Branch West Branch Michigan
United States University of Cincinnati Cancer Center-West Chester West Chester Ohio
United States Mercy Medical Center-West Lakes West Des Moines Iowa
United States Methodist West Hospital West Des Moines Iowa
United States Saint Ann's Hospital Westerville Ohio
United States Marshfield Medical Center - Weston Weston Wisconsin
United States Geisinger Wyoming Valley/Henry Cancer Center Wilkes-Barre Pennsylvania
United States Marshfield Clinic - Wisconsin Rapids Center Wisconsin Rapids Wisconsin
United States Sanford Cancer Center Worthington Worthington Minnesota
United States Metro Health Hospital Wyoming Michigan
United States Rush-Copley Healthcare Center Yorkville Illinois
United States Saint Elizabeth Youngstown Hospital Youngstown Ohio
United States Huron Gastroenterology PC Ypsilanti Michigan
United States Trinity Health IHA Medical Group Hematology Oncology Ann Arbor Campus Ypsilanti Michigan
United States Genesis Healthcare System Cancer Care Center Zanesville Ohio

Sponsors (2)

Lead Sponsor Collaborator
ECOG-ACRIN Cancer Research Group National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Other Determine FDG-PET/CT positivity between the local site read and central review Determining agreement between local and central review of FDG-PET/CT positivity Up to 5 years
Other Metabolic response on serial FDG-PET/CT Metabolic response by serial FDG-PET/CT scan from baseline to 12 month time-point (Arm A) will be associated with EFS (Arm A) and with EFS (Arm B). Baseline to 12 months of anti-PD-1 therapy
Other Metabolic response on serial FDG-PET/CT Metabolic response by serial FDG-PET/CT scan from the 12 month to 24 month time points (Arm B) will be associated with EFS (Arm A) and with EFS (Arm B). 12 months to 24 months after start of anti-PD-1 therapy
Other Banking samples for future biomarker studies Will bank tumor samples and peripheral blood for future biomarker studies. Up to 5 years
Primary Event free survival (EFS) rate (Arm A) Event is defined as recurrence, progression or melanoma-specific death. The distribution of EFS will be evaluated using the method of Kaplan-Meier. At 12 months
Secondary Rates of pathologic response (Arm B) Will be defined as the absence of residual viable melanoma in the resected metastasis site as assessed on local pathology review. Pathologic response rate will be estimated in patients with tumor biopsies where positive hypermetabolic activity was present on FDG-PET/CT scan after 12 month of anti-PD-1 therapy on Arm B. 95% confidence intervals (CIs) will be provided for all estimated rates. After 12 months of anti-PD-1 therapy
Secondary EFS The distribution of EFS will be evaluated using the method of Kaplan-Meier. At 24 months
Secondary Overall survival Overall 24 month EFS for patients in Arm B will be summarized. At 24 months
Secondary Percentage of patients who remain on treatment beyond 12 months Will determine the percentage of patients who remain on treatment beyond 12 months because of positive fludeoxyglucose F-18 (FDG)-positron emission tomography (PET)/computed tomography (CT) scan and positive biopsy for residual disease (or unable to obtain a biopsy). Up to 5 years
Secondary Incidence rates of treatment-related adverse events -12 months from start of treatment in patients who discontinue anti-PD-1 therapy at 12 months (Arm A) and in patients who continue anti-PD-1 therapy beyond 12 months (Arm B) 95% CIs will be provided for all estimated rates. Up to 5 years
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