Melanoma (Skin Cancer)

EA6194



A Study Evaluating Whether Pembrolizumab Alone or in Combination with CMP-001 Improves Efficacy in Patients with Operable Melanoma

STATUS: Active


This phase II trial studies the effect of pembrolizumab alone or in combination with CMP-001 in treating patients with melanoma that can be treated by surgery (operable). Immunotherapy with monoclonal antibodies, such as pembrolizumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Immunotherapy with CMP-001 may induce changes in body's immune system and may interfere with the ability of tumor cells to grow and spread. The addition of CMP-001 to pembrolizumab could improve the ability of the immune system to shrink tumors and to prevent them from returning.
  • Patient must be >= 18 years of age

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

  • Patient must have a histologic diagnosis of melanoma belonging to the following American Joint Committee on Cancer (AJCC) 8th edition TNM stages: * T0, Tx or T1-4; and * N2b, N2c, N3b or N3c

  • Patients may have a presentation with primary melanoma with concurrent regional nodal and/or in-transit metastasis; or patients may have a history of primary melanoma or unknown primary melanoma presenting with clinically detected regional nodal and/or in-transit recurrence; and may belong to any of the following groups: * Primary cutaneous melanoma with clinically apparent regional lymph node metastases and/or in-transit metastases * Clinically detected recurrent melanoma at the proximal regional lymph node(s) basin * Primary cutaneous melanoma with concurrent nodal disease involving a single regional nodal group * Clinically detected nodal melanoma (if single site) arising from an unknown primary * In-transit cutaneous metastases with or without regional lymph node involvement permitted if considered potentially surgically resectable at baseline ** NOTE: Patients with mucosal and/or uveal melanoma are not eligible for the study

  • Patient must be a candidate for definitive surgery and have met with the treating surgical oncologist prior to randomization

  • Patient must not have received any live vaccine within 30 days prior to randomization and while participating in the study. Live vaccines include, but are not limited to, the following: measles, mumps, rubella, chicken pox, yellow fever, rabies, Bacillus Calmette-Guerin (BCG), and typhoid (oral) vaccine. Patients are permitted to receive inactivated vaccines and any non-live vaccines including those for the seasonal influenza and COVID-19 (Note: intranasal influenza vaccines, such as Flu-Mist are live attenuated vaccines and are not allowed). If possible, it is recommended to separate study drug administration from vaccine administration by about a week (primarily, in order to minimize an overlap of adverse events)

  • Patient must have the presence of injectable and measurable disease based on Response Evaluation Criteria in Solid Tumors (RECIST) 1.1, documented by scans obtained within 4 weeks prior to randomization * NOTE: Injectable disease is defined as an accessible lesion in the skin, subcutaneous tissue or lymph nodes (LN) close to the skin and palpable by physical examination or approachable with ultrasound guidance

  • Absolute neutrophil count (ANC) >= 1,500 /mcL (obtained within 4 weeks prior to randomization)

  • Hemoglobin (Hgb) >= 9 g/dL or >= 5.6 mmol/L (obtained within 4 weeks prior to randomization)

  • Platelets >= 100,000 / mcL (obtained within 4 weeks prior to randomization)

  • Serum creatinine =< 1.5 x upper limit of normal (ULN) or measured or calculated creatinine clearance > 60 mL/min (glomerular filtration rate [GFR] can also be used in place of creatinine or creatinine clearance [CrCl] for patients with creatinine levels > 1.5 x institutional ULN) (obtained within 4 weeks prior to randomization)

  • Serum total bilirubin =< 1.5 x ULN; for total bilirubin levels > 1.5 x ULN, but =< 3 x ULN, the direct bilirubin must be =< the ULN (obtained within 4 weeks prior to randomization)

  • Aspartate aminotransferase (AST) (serum glutamic-oxaloacetic transaminase [SGOT]) and alanine aminotransferase (ALT) (serum glutamate pyruvate transaminase [SGPT]) =< 2.5 x ULN (obtained within 4 weeks prior to randomization)

  • International normalized ratio (INR) or prothrombin time (PT) =< 1.5 x ULN unless patient is receiving anticoagulant therapy as long as PT or partial thromboplastin time (PTT) is within therapeutic range of intended use of anticoagulants (obtained within 4 weeks prior to randomization)

  • Activated partial thromboplastin time (aPTT) =< 1.5 x ULN unless patient is receiving anticoagulant therapy as long as PT or PTT is within therapeutic range of intended use of anticoagulants (obtained within 4 weeks prior to randomization)

  • Patients 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 patients of childbearing potential must have a blood test or urine study within 14 days prior to randomization to rule out pregnancy. A urine or serum pregnancy test must be repeated within 72 hours prior to receiving the first dose of pembrolizumab if the test done for eligibility/randomization is done outside of this 72 hour window. If the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required. A patient of childbearing potential is defined as anyone, 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)

  • Patients must not expect to conceive or father children by using accepted and effective method(s) of contraception or abstaining from sexual intercourse from time of randomization, while on study treatment, and continue for 26 weeks after the last dose of protocol treatment

  • 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

  • Patient must not have received prior systemic therapy for melanoma including systemic therapy with an anti-PD-1, anti-PD-L1, anti-CTLA-4, BRAF/MEK inhibitor combination and/or TLR-9 agonist

  • Patient must not have a diagnosis of immunodeficiency or be receiving systemic steroid therapy or any other form of immunosuppressive therapy within 7 days prior to randomization, except as noted here * Patients who are currently receiving steroids at a dose of prednisone =< 5 mg daily (or equivalent) are permitted to enroll * Patients who require topical, ophthalmologic and inhalational steroids are permitted to enroll * Patients with hypothyroidism who are stable on hormone replacement are permitted to enroll * Patients who require active immunosuppression with corticosteroids at a dose of prednisone > 5 mg daily (or equivalent) for any reason are ineligible * Patients with adrenal insufficiency are ineligible * Patients who have developed autoimmune disorders of grade 4 while on prior immunotherapy are not permitted to enroll on this study. Patients who developed autoimmune disorders of grade =< 3 may enroll if the disorder has resolved to grade =< 1 and the patient has been off systemic corticosteroids at doses > 5 mg for at least 2 weeks prior to 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

  • Patients with a history of brain metastases are not eligible for this study as they do not meet the eligibility staging criteria

  • 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 not have had an allogeneic tissue/solid organ transplant

  • Patient must not have a history of (non-infectious) pneumonitis that required steroids or current pneumonitis

  • Patient must not have severe hypersensitivity (>= grade 3) to pembrolizumab and/or any of its excipients

  • Patient must not have an active infection requiring systemic therapy

  • Patient must not have a known psychiatric or substance abuse disorder that would interfere with the patient’s ability to cooperate with the requirements of the study

United States
AK
Anchorage
Alaska Breast Care and Surgery LLC
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Email: AKPAMC.OncologyResearchSupport@providence.org

Alaska Oncology and Hematology LLC
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Email: AKPAMC.OncologyResearchSupport@providence.org

Alaska Women's Cancer Care
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Email: AKPAMC.OncologyResearchSupport@providence.org

Anchorage Associates in Radiation Medicine
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Email: AKPAMC.OncologyResearchSupport@providence.org

Anchorage Oncology Centre
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Email: AKPAMC.OncologyResearchSupport@providence.org

Katmai Oncology Group
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Email: AKPAMC.OncologyResearchSupport@providence.org

Providence Alaska Medical Center
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Email: AKPAMC.OncologyResearchSupport@providence.org

Fairbanks
Fairbanks Memorial Hospital
Status: ACTIVE
Contact: Site Public Contact
Email: Veronica.Stevenson@foundationhealth.org

AR
Ft. Smith
Mercy Hospital Fort Smith
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact

CA
Burbank
Providence Saint Joseph Medical Center / Disney Family Cancer Center
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Email: Najee.Boucher@providence.org

Dublin
Epic Care-Dublin
Status: ACTIVE
Contact: Site Public Contact

Emeryville
Bay Area Breast Surgeons Inc
Status: ACTIVE
Contact: Site Public Contact

Epic Care Partners in Cancer Care
Status: ACTIVE
Contact: Site Public Contact

Martinez
Contra Costa Regional Medical Center
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact

Oakland
Alta Bates Summit Medical Center - Summit Campus
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact

Bay Area Tumor Institute
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Email: lradke@bati.org

Walnut Creek
Epic Care Cyberknife Center
Status: ACTIVE
Contact: Site Public Contact
Email: somega@bati.org

CO
Aurora
Rocky Mountain Cancer Centers-Aurora
Status: ACTIVE
Contact: Site Public Contact
Email: info@westernstatesncorp.org

The Medical Center of Aurora
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Email: info@westernstatesncorp.org

Boulder
Rocky Mountain Cancer Centers-Boulder
Status: ACTIVE
Contact: Site Public Contact
Email: info@westernstatesncorp.org

Centennial
Rocky Mountain Cancer Centers - Centennial
Status: ACTIVE
Contact: Site Public Contact
Email: info@westernstatesncorp.org

Denver
Presbyterian - Saint Lukes Medical Center - Health One
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Email: info@westernstatesncorp.org

Rocky Mountain Cancer Centers-Midtown
Status: ACTIVE
Contact: Site Public Contact
Email: info@westernstatesncorp.org

Rocky Mountain Cancer Centers-Rose
Status: ACTIVE
Contact: Site Public Contact
Email: info@westernstatesncorp.org

Englewood
Mountain Blue Cancer Care Center - Swedish
Status: ACTIVE
Contact: Site Public Contact
Email: info@westernstatesncorp.org

Swedish Medical Center
Status: ACTIVE
Contact: Site Public Contact
Email: info@westernstatesncorp.org

The Melanoma and Skin Cancer Institute
Status: ACTIVE
Contact: Site Public Contact
Email: ryan.weight@theskincancerinstitute.com

Greeley
North Colorado Medical Center
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Email: info@westernstatesncorp.org

Littleton
Rocky Mountain Cancer Centers-Littleton
Status: ACTIVE
Contact: Site Public Contact
Email: info@westernstatesncorp.org

Lone Tree
Rocky Mountain Cancer Centers-Sky Ridge
Status: ACTIVE
Contact: Site Public Contact
Email: info@westernstatesncorp.org

Sky Ridge Medical Center
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Email: info@westernstatesncorp.org

Loveland
McKee Medical Center
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Email: info@westernstatesncorp.org

Thornton
Rocky Mountain Cancer Centers-Thornton
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Email: info@westernstatesncorp.org

FL
Miami
University of Miami Miller School of Medicine-Sylvester Cancer Center
Status: ACTIVE
Contact: Site Public Contact

IA
Ames
Mary Greeley Medical Center
Status: ACTIVE
Contact: Site Public Contact

McFarland Clinic PC - Ames
Status: ACTIVE
Contact: Site Public Contact
Email: ksoder@mcfarlandclinic.com

Boone
McFarland Clinic PC-Boone
Status: ACTIVE
Contact: Site Public Contact

Fort Dodge
McFarland Clinic PC-Trinity Cancer Center
Status: ACTIVE
Contact: Site Public Contact

Jefferson
McFarland Clinic PC-Jefferson
Status: ACTIVE
Contact: Site Public Contact

Marshalltown
McFarland Clinic PC-Marshalltown
Status: ACTIVE
Contact: Site Public Contact

ID
Boise
Saint Luke's Cancer Institute - Boise
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Email: eslinget@slhs.org

Fruitland
Saint Luke's Cancer Institute - Fruitland
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Email: eslinget@slhs.org

Meridian
Saint Luke's Cancer Institute - Meridian
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Email: eslinget@slhs.org

Nampa
Saint Luke's Cancer Institute - Nampa
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Email: eslinget@slhs.org

Twin Falls
Saint Luke's Cancer Institute - Twin Falls
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Email: eslinget@slhs.org

IL
Bloomington
Illinois CancerCare-Bloomington
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Email: andersonj@illinoiscancercare.com

Canton
Illinois CancerCare-Canton
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Email: andersonj@illinoiscancercare.com

Carbondale
Memorial Hospital of Carbondale
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Email: clinical.research@sih.net

Carterville
SIH Cancer Institute
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Email: clinical.research@sih.net

Carthage
Illinois CancerCare-Carthage
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Email: andersonj@illinoiscancercare.com

Centralia
Centralia Oncology Clinic
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Email: morganthaler.jodi@mhsil.com

Decatur
Cancer Care Specialists of Illinois - Decatur
Status: ACTIVE
Contact: Site Public Contact
Email: morganthaler.jodi@mhsil.com

Decatur Memorial Hospital
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Email: morganthaler.jodi@mhsil.com

Dixon
Illinois CancerCare-Dixon
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact

Effingham
Crossroads Cancer Center
Status: ACTIVE
Contact: Site Public Contact
Email: morganthaler.jodi@mhsil.com

Eureka
Illinois CancerCare-Eureka
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Email: andersonj@illinoiscancercare.com

Galesburg
Illinois CancerCare-Galesburg
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Email: andersonj@illinoiscancercare.com

Western Illinois Cancer Treatment Center
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact

Kewanee
Illinois CancerCare-Kewanee Clinic
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Email: andersonj@illinoiscancercare.com

Macomb
Illinois CancerCare-Macomb
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Email: andersonj@illinoiscancercare.com

Mount Vernon
Good Samaritan Regional Health Center
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact

O'Fallon
Cancer Care Center of O'Fallon
Status: ACTIVE
Contact: Site Public Contact
Email: morganthaler.jodi@mhsil.com

Ottawa
Illinois CancerCare-Ottawa Clinic
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Email: andersonj@illinoiscancercare.com

Pekin
Illinois CancerCare-Pekin
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Email: andersonj@illinoiscancercare.com

Peoria
Illinois CancerCare-Peoria
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Email: andersonj@illinoiscancercare.com

Methodist Medical Center of Illinois
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Email: andersonj@illinoiscancercare.com

Peru
Illinois CancerCare-Peru
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Email: andersonj@illinoiscancercare.com

Valley Radiation Oncology
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact

Princeton
Illinois CancerCare-Princeton
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Email: andersonj@illinoiscancercare.com

Springfield
Memorial Medical Center
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Email: pallante.beth@mhsil.com

Southern Illinois University School of Medicine
Status: ACTIVE
Contact: Site Public Contact

Springfield Clinic
Status: ACTIVE
Contact: Site Public Contact

Washington
Illinois CancerCare - Washington
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Email: andersonj@illinoiscancercare.com

IN
Richmond
Reid Health
Status: ACTIVE
Contact: Site Public Contact
Email: clinical.trials@daytonncorp.org

KS
Garden City
Central Care Cancer Center - Garden City
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Email: aroland@kccop.org

Great Bend
Central Care Cancer Center - Great Bend
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Email: aroland@kccop.org

MI
Battle Creek
Bronson Battle Creek
Status: ACTIVE
Contact: Site Public Contact
Email: crcwm-regulatory@crcwm.org

Grand Rapids
Helen DeVos Children's Hospital at Spectrum Health
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Email: crcwm-regulatory@crcwm.org

Mercy Health Saint Mary's
Status: ACTIVE
Contact: Site Public Contact
Email: crcwm-regulatory@crcwm.org

Spectrum Health at Butterworth Campus
Status: ACTIVE
Contact: Site Public Contact
Email: crcwm-regulatory@crcwm.org

Kalamazoo
Ascension Borgess Cancer Center
Status: ACTIVE
Contact: Site Public Contact
Email: crcwm-regulatory@crcwm.org

Borgess Medical Center
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Email: crcwm-regulatory@crcwm.org

Bronson Methodist Hospital
Status: ACTIVE
Contact: Site Public Contact
Email: crcwm-regulatory@crcwm.org

West Michigan Cancer Center
Status: ACTIVE
Contact: Site Public Contact
Email: crcwm-regulatory@crcwm.org

Muskegon
Mercy Health Mercy Campus
Status: ACTIVE
Contact: Site Public Contact
Email: crcwm-regulatory@crcwm.org

Niles
Lakeland Hospital Niles
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact

Norton Shores
Cancer and Hematology Centers of Western Michigan - Norton Shores
Status: ACTIVE
Contact: Site Public Contact
Email: connie.szczepanek@crcwm.org

Reed City
Spectrum Health Reed City Hospital
Status: ACTIVE
Contact: Site Public Contact
Email: crcwm-regulatory@crcwm.org

Saint Joseph
Lakeland Medical Center Saint Joseph
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Email: crcwm-regulatory@crcwm.org

Marie Yeager Cancer Center
Status: ACTIVE
Contact: Site Public Contact
Email: crcwm-regulatory@crcwm.org

Traverse City
Munson Medical Center
Status: ACTIVE
Contact: Site Public Contact
Email: crcwm-regulatory@crcwm.org

Wyoming
Metro Health Hospital
Status: ACTIVE
Contact: Site Public Contact
Email: crcwm-regulatory@crcwm.org

MO
Ballwin
Saint Louis Cancer and Breast Institute-Ballwin
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact

Bolivar
Central Care Cancer Center - Bolivar
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Email: aroland@kccop.org

Cape Girardeau
Saint Francis Medical Center
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Email: sfmc@sfmc.net

Southeast Cancer Center
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact

Farmington
Parkland Health Center - Farmington
Status: ACTIVE
Contact: Site Public Contact

Jefferson City
Capital Region Southwest Campus
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Email: swooden@mail.crmc.org

Joplin
Freeman Health System
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Email: LJCrockett@freemanhealth.com

Mercy Hospital Joplin
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Email: esmeralda.carrillo@mercy.net

Rolla
Delbert Day Cancer Institute at PCRMC
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Email: research@phelpshealth.org

Mercy Clinic-Rolla-Cancer and Hematology
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact

Saint Joseph
Heartland Regional Medical Center
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Email: linda.schumacher@mymlc.com

Saint Louis
Mercy Hospital Saint Louis
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact

Mercy Hospital South
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Email: janet.lesko@mercy.net

Missouri Baptist Medical Center
Status: ACTIVE
Contact: Site Public Contact

Sainte Genevieve
Sainte Genevieve County Memorial Hospital
Status: ACTIVE
Contact: Site Public Contact

Springfield
CoxHealth South Hospital
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact

Mercy Hospital Springfield
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact

Sullivan
Missouri Baptist Sullivan Hospital
Status: ACTIVE
Contact: Site Public Contact

Sunset Hills
Missouri Baptist Outpatient Center-Sunset Hills
Status: ACTIVE
Contact: Site Public Contact

MT
Missoula
Saint Patrick Hospital - Community Hospital
Status: ACTIVE
Contact: Site Public Contact
Email: amy.hanneman@providence.org

OH
Beavercreek
Indu and Raj Soin Medical Center
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Email: clinical.trials@daytonncorp.org

Centerville
Dayton Physicians LLC-Miami Valley South
Status: ACTIVE
Contact: Site Public Contact
Email: clinical.trials@daytonncorp.org

Miami Valley Hospital South
Status: ACTIVE
Contact: Site Public Contact
Email: clinical.trials@daytonncorp.org

Cincinnati
Oncology Hematology Care Inc-Kenwood
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Email: clinical.trials@daytonncorp.org

Dayton
Dayton Physician LLC-Miami Valley Hospital North
Status: ACTIVE
Contact: Site Public Contact
Email: clinical.trials@daytonncorp.org

Miami Valley Hospital
Status: ACTIVE
Contact: Site Public Contact
Email: clinical.trials@daytonncorp.org

Miami Valley Hospital North
Status: ACTIVE
Contact: Site Public Contact
Email: clinical.trials@daytonncorp.org

Findlay
Armes Family Cancer Center
Status: ACTIVE
Contact: Site Public Contact
Email: clinical.trials@daytonncorp.org

Blanchard Valley Hospital
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Email: clinical.trials@daytonncorp.org

Orion Cancer Care
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Email: clinical.trials@daytonncorp.org

Franklin
Atrium Medical Center-Middletown Regional Hospital
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Email: clinical.trials@daytonncorp.org

Dayton Physicians LLC-Atrium
Status: ACTIVE
Contact: Site Public Contact
Email: clinical.trials@daytonncorp.org

Greenville
Dayton Physicians LLC-Wayne
Status: ACTIVE
Contact: Site Public Contact
Email: clinical.trials@daytonncorp.org

Wayne Hospital
Status: ACTIVE
Contact: Site Public Contact
Email: clinical.trials@daytonncorp.org

Kettering
Greater Dayton Cancer Center
Status: ACTIVE
Contact: Site Public Contact
Email: clinical.trials@daytonncorp.org

Kettering Medical Center
Status: ACTIVE
Contact: Site Public Contact
Email: clinical.trials@daytonncorp.org

Springfield
Springfield Regional Cancer Center
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Email: clinical.trials@daytonncorp.org

Springfield Regional Medical Center
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Email: clinical.trials@daytonncorp.org

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

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

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

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

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

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

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

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

Portland
Providence Portland Medical Center
Status: ACTIVE
Contact: Site Public Contact
Email: CanRsrchStudies@providence.org

Providence Saint Vincent Medical Center
Status: ACTIVE
Contact: Site Public Contact
Email: CanRsrchStudies@providence.org

PA
Bethlehem
Saint Luke's University Hospital-Bethlehem Campus
Status: ACTIVE
Contact: Site Public Contact

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

VA
Charlottesville
University of Virginia Cancer Center
Status: ACTIVE
Contact: Site Public Contact
Email: uvacancertrials@hscmail.mcc.virginia.edu

Richmond
Virginia Commonwealth University / Massey Cancer Center
Status: ACTIVE
Contact: Site Public Contact
Email: CTOclinops@vcu.edu

WI
Milwaukee
Medical College of Wisconsin
Status: ACTIVE
Contact: Site Public Contact

PRIMARY OBJECTIVE:
I. To evaluate the rate of pathologic complete response (pCR) rate in patients in each arm of the trial.

SECONDARY OBJECTIVES:
I. To evaluate the rate of pathologic near-complete/major response (pMR) of the neoadjuvant therapy in each arm.
II. To evaluate the pathologic response rate of un-injected lesions on the combination arm.
III. To evaluate relapse-free survival (RFS) in each arm.
IV. To evaluate overall survival (OS) in each arm.
V. To evaluate the preoperative radiographic response rate in each arm.
VI. To evaluate safety and toxicity of neoadjuvant therapy in each arm.

OUTLINE: Patients are randomized to 1 of 2 arms.

ARM A:
NEOADJUVANT PHASE: Patients receive pembrolizumab intravenously (IV) over 30 minutes on day 1. Treatment repeats every 21 days for up to 3 cycles in the absence of disease progression or unacceptable toxicity.

SURGERY: Patients undergo surgery 1-2 weeks after completion of neoadjuvant phase.

ADJUVANT PHASE: After recovery from surgery, patients receive pembrolizumab IV over 30 minutes on day 1 of every other cycle. Treatment repeats every 21 days for up to 16 cycles in the absence of disease progression or unacceptable toxicity.

ARM B:
NEOADJUVANT PHASE: Patients receive VLP-encapsulated TLR9 agonist CMP-001 (CMP-001) subcutaneously (SC) on day 1 of cycle 1 and then intratumorally on days 8 and 15 of cycle 1, days 1, 8, and 15 of cycle 2, and day 1 of cycle 3. Patients also receive pembrolizumab IV over 30 minutes on day 8 of each cycle. Treatment repeats every 21 days for up to 3 cycles in the absence of disease progression or unacceptable toxicity.

SURGERY: Patients undergo surgery 1-2 weeks after completion of neoadjuvant phase.

ADJUVANT PHASE: After recovery from surgery, patients receive pembrolizumab IV over 30 minutes on day 1 of every other cycle. Treatment repeats every 21 days for up to 16 cycles in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed up at 30 days and then every 3 months if < 2 years from study entry, every 6 months if 2-5 years from study entry, and every 12 months if > 5 years from study entry for up to 10 years (15 years total follow up).

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


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


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