Pembrolizumab Compared to Standard of Care Observation in Treating Patients with Completely Resected Stage I-III Merkel Cell Cancer

Status: Active

Description

This phase III trial studies how well pembrolizumab works compared to standard of care observation in treating patients with stage I-III Merkel cell cancer that has been completely removed by surgery. 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.

Eligibility Criteria

Inclusion Criteria

  • Patients must have an Eastern Cooperative Oncology Group (ECOG) performance status: 0, 1, or 2 (Those patients who are wheel chair bound due to congenital or traumatic events more than one year before the diagnosis of Merkel cell carcinoma may be considered.)
  • Women must not be pregnant or breast-feeding due to the unknown effects of the study drug in this setting. All women of childbearing potential must have a blood test or urine study within 2 weeks prior to registration to rule out pregnancy. A female of childbearing potential is 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, if receiving MK-3475 (pembrolizumab) or radiation therapy, and sexually active males must use an accepted and effective method of contraception or to abstain from sex from time of registration, while on study treatment, and continue for 120 days after the last dose of study treatment.
  • Patient must have a histological confirmation of diagnosis of Merkel cell carcinoma (MCC), pathologic stages (American Joint Committee on Cancer [AJCC] version 8) I-IIIb. * Stage I patients with negative sentinel lymph node biopsy are ineligible. Patients who have a positive biopsy or for whom no biopsy was done are eligible. * Patients with distant metastatic disease (stage IV) are not eligible. * The primary tumor must have negative margins.
  • Patients with all macroscopic Merkel cell carcinoma (either identified by physical exam or imaging) have been completely resected by surgery within 8 weeks before enrollment.
  • All patients must have disease-free status documented by a complete physical examination and conventional imaging studies within 4 weeks prior to randomization.
  • Patient must have no currently present metastases (as confirmed by standard imaging studies).
  • Patient must have no previous systemic therapy or radiation therapy for Merkel cell carcinoma.
  • Patients with inoperable disease who have received radiation are not eligible.
  • White blood count >= 2000/uL (within 4 weeks prior to randomization).
  • Absolute neutrophil count (ANC) >= 1000/Ul (within 4 weeks prior to randomization).
  • Platelets >= 75 x 103/uL (within 4 weeks prior to randomization).
  • Hemoglobin >= 8 g/dL (>= 80 g/L; may be transfused) (within 4 weeks prior to randomization).
  • Creatinine =< 2.0 x upper limit of normal (ULN) (within 4 weeks prior to randomization).
  • Aspartate aminotransferase (AST)/alanine aminotransferase (ALT) =< 2.5 x ULN (within 4 weeks prior to randomization).
  • Total bilirubin =< 2.0 x ULN, (except patients with Gilbert's syndrome, who must have a total bilirubin less than 3.0 mg/dL) (within 4 weeks prior to randomization).
  • Patients who are human immunodeficiency virus (HIV)+ with undetectable HIV viral load are eligible provided they meet all other protocol criteria for participation.
  • Patients with hepatitis B virus (HBV) or hepatitis C virus (HCV) infection are eligible provided viral loads are undetectable. Patients on suppressive therapy are eligible.
  • Patients must not be on active immunosuppression, have a history of life threatening virus, have had other (beside non-melanoma skin cancers, or recent indolent cancers e.g.: resected low grade prostate cancer) cancer diagnoses in the last two years, or have had immunotherapy of any kind within the last 2 years.
  • Patients must not have a history of (non-infectious) pneumonitis that required steroids or has current pneumonitis.
  • Operative notes from patient’s surgical resection must be accessible.

Locations & Contacts

Arizona

Tucson
The University of Arizona Medical Center-University Campus
Status: Active
Contact: Site Public Contact
Phone: 520-626-9008
University of Arizona Cancer Center-North Campus
Status: Active
Contact: Site Public Contact
Phone: 800-327-2873

California

Los Angeles
Los Angeles County-USC Medical Center
Status: Active
Contact: Site Public Contact
Phone: 323-865-0451
USC / Norris Comprehensive Cancer Center
Status: Active
Contact: Site Public Contact
Phone: 323-865-0451
Newport Beach
USC Norris Oncology / Hematology-Newport Beach
Status: Active
Contact: Site Public Contact
Phone: 323-865-0451
Pasadena
Keck Medical Center of USC Pasadena
Status: Active
Contact: Site Public Contact
Phone: 323-865-0451

Georgia

Savannah
Lewis Cancer and Research Pavilion at Saint Joseph's / Candler
Status: Active
Contact: Site Public Contact
Email: ecog.rss@jimmy.harvard.edu
Summit Cancer Care-Candler
Status: Active
Contact: Site Public Contact
Email: ecog.rss@jimmy.harvard.edu

Idaho

Boise
Saint Alphonsus Cancer Care Center-Boise
Status: Active
Contact: Site Public Contact
Phone: 734-712-3671
Email: stephanie.couch@stjoeshealth.org
Caldwell
Saint Alphonsus Cancer Care Center-Caldwell
Status: Active
Contact: Site Public Contact
Phone: 734-712-3671
Email: stephanie.couch@stjoeshealth.org
Coeur D'Alene
Kootenai Medical Center
Status: Active
Contact: Site Public Contact
Phone: 406-969-6060
Email: mccinfo@mtcancer.org
Emmett
Walter Knox Memorial Hospital
Status: Active
Contact: Site Public Contact
Phone: 734-712-3671
Email: stephanie.couch@stjoeshealth.org
Meridian
Idaho Urologic Institute-Meridian
Status: Active
Contact: Site Public Contact
Phone: 734-712-3671
Email: stephanie.couch@stjoeshealth.org
Nampa
Saint Alphonsus Medical Center-Nampa
Status: Active
Contact: Site Public Contact
Phone: 734-712-3671
Email: stephanie.couch@stjoeshealth.org
Post Falls
Kootenai Cancer Center
Status: Active
Contact: Site Public Contact
Phone: 406-969-6060
Email: mccinfo@mtcancer.org
Sandpoint
Kootenai Cancer Clinic
Status: Active
Contact: Site Public Contact
Phone: 406-969-6060
Email: mccinfo@mtcancer.org

Illinois

Aurora
Rush - Copley Medical Center
Status: Active
Contact: Site Public Contact
Phone: 630-978-6212
Email: Cancer.Research@rushcopley.com
Bloomington
Illinois CancerCare-Bloomington
Status: Active
Contact: Site Public Contact
Phone: 309-243-3605
Email: andersonj@illinoiscancercare.com
Canton
Illinois CancerCare-Canton
Status: Active
Contact: Site Public Contact
Phone: 309-243-3605
Email: andersonj@illinoiscancercare.com
Carbondale
Memorial Hospital of Carbondale
Status: Active
Contact: Site Public Contact
Phone: 618-457-5200
Email: clinical.research@sih.net
Carterville
SIH Cancer Institute
Status: Active
Contact: Site Public Contact
Phone: 618-985-3333
Email: clinical.research@sih.net
Carthage
Illinois CancerCare-Carthage
Status: Active
Contact: Site Public Contact
Phone: 309-243-3605
Email: andersonj@illinoiscancercare.com
Centralia
Centralia Oncology Clinic
Status: Active
Contact: Site Public Contact
Phone: 217-876-4740
Email: rhamrick@dmhhs.org
Chicago
Northwestern University
Status: Active
Contact: Site Public Contact
Phone: 312-695-1301
Email: cancer@northwestern.edu
Danville
Carle on Vermilion
Status: Active
Contact: Site Public Contact
Phone: 800-446-5532
Email: Research@carle.com
Decatur
Cancer Care Specialists of Illinois - Decatur
Status: Active
Contact: Site Public Contact
Phone: 217-876-4740
Email: kcheek@dmhhs.org
Decatur Memorial Hospital
Status: Active
Contact: Site Public Contact
Phone: 217-876-4740
Email: rhamrick@dmhhs.org
Effingham
Carle Physician Group-Effingham
Status: Active
Contact: Site Public Contact
Phone: 800-446-5532
Email: Research@carle.com
Crossroads Cancer Center
Status: Active
Contact: Site Public Contact
Phone: 217-876-4740
Email: rhamrick@dmhhs.org
Eureka
Illinois CancerCare-Eureka
Status: Active
Contact: Site Public Contact
Phone: 309-243-3605
Email: andersonj@illinoiscancercare.com
Galesburg
Illinois CancerCare-Galesburg
Status: Active
Contact: Site Public Contact
Phone: 309-243-3605
Email: andersonj@illinoiscancercare.com
Western Illinois Cancer Treatment Center
Status: Active
Contact: Site Public Contact
Phone: 309-344-2831
Kewanee
Illinois CancerCare-Kewanee Clinic
Status: Active
Contact: Site Public Contact
Phone: 309-243-3605
Email: andersonj@illinoiscancercare.com
Lake Forest
Northwestern Medicine Lake Forest Hospital
Status: Active
Contact: Site Public Contact
Email: cancertrials@northwestern.edu
Macomb
Illinois CancerCare-Macomb
Status: Active
Contact: Site Public Contact
Phone: 309-243-3605
Email: andersonj@illinoiscancercare.com
Mattoon
Carle Physician Group-Mattoon / Charleston
Status: Active
Contact: Site Public Contact
Phone: 800-446-5532
Email: Research@carle.com
Ottawa
Illinois CancerCare-Ottawa Clinic
Status: Active
Contact: Site Public Contact
Phone: 309-243-3605
Email: andersonj@illinoiscancercare.com
Pekin
Illinois CancerCare-Pekin
Status: Active
Contact: Site Public Contact
Phone: 309-243-3605
Email: andersonj@illinoiscancercare.com
Peoria
Illinois CancerCare-Peoria
Status: Active
Contact: Site Public Contact
Phone: 309-243-3605
Email: andersonj@illinoiscancercare.com
Methodist Medical Center of Illinois
Status: Active
Contact: Site Public Contact
Phone: 309-243-3605
Email: andersonj@illinoiscancercare.com
Peru
Illinois CancerCare-Peru
Status: Active
Contact: Site Public Contact
Phone: 309-243-3605
Email: andersonj@illinoiscancercare.com
Valley Radiation Oncology
Status: Active
Contact: Site Public Contact
Phone: 815-664-4141
Princeton
Illinois CancerCare-Princeton
Status: Active
Contact: Site Public Contact
Phone: 309-243-3605
Email: andersonj@illinoiscancercare.com
Springfield
Memorial Medical Center
Status: Active
Contact: Site Public Contact
Phone: 217-788-3528
Southern Illinois University School of Medicine
Status: Active
Contact: Site Public Contact
Phone: 217-545-7929
Springfield Clinic
Status: Active
Contact: Site Public Contact
Phone: 800-444-7541
Swansea
Cancer Care Specialists of Illinois-Swansea
Status: Active
Contact: Site Public Contact
Phone: 217-876-4740
Email: rhamrick@dmhhs.org
Southwest Illinois Health Services LLP
Status: Active
Contact: Site Public Contact
Phone: 618-236-1000
Email: lynns@thecancercenter.com
Urbana
Carle Cancer Center
Status: Active
Contact: Site Public Contact
Phone: 800-446-5532
Email: Research@carle.com
The Carle Foundation Hospital
Status: Active
Contact: Site Public Contact
Phone: 800-446-5532
Email: Research@carle.com
Yorkville
Rush-Copley Healthcare Center
Status: Active
Contact: Site Public Contact
Phone: 630-978-6212
Email: Cancer.Research@rushcopley.com

Iowa

Des Moines
Broadlawns Medical Center
Status: Active
Contact: Site Public Contact
Phone: 515-282-2200
Iowa Lutheran Hospital
Status: Active
Contact: Site Public Contact
Phone: 515-241-8704
Iowa Methodist Medical Center
Status: Active
Contact: Site Public Contact
Phone: 515-241-6727
Medical Oncology and Hematology Associates-Des Moines
Status: Active
Contact: Site Public Contact
Phone: 515-282-2921
Fort Dodge
Trinity Regional Medical Center
Status: Active
Contact: Site Public Contact
Phone: 515-574-8302
West Des Moines
Methodist West Hospital
Status: Active
Contact: Site Public Contact
Phone: 515-343-1000

Minnesota

Bemidji
Sanford Joe Lueken Cancer Center
Status: Active
Contact: Site Public Contact
Phone: 218-333-5000
Burnsville
Fairview Ridges Hospital
Status: Active
Contact: Site Public Contact
Phone: 952-993-1517
Email: mmcorc@healthpartners.com
Coon Rapids
Mercy Hospital
Status: Active
Contact: Site Public Contact
Phone: 952-993-1517
Email: mmcorc@healthpartners.com
Edina
Fairview-Southdale Hospital
Status: Active
Contact: Site Public Contact
Phone: 952-993-1517
Email: mmcorc@healthpartners.com
Fridley
Unity Hospital
Status: Active
Contact: Site Public Contact
Phone: 952-993-1517
Email: mmcorc@healthpartners.com
Maple Grove
Fairview Maple Grove Medical Center
Status: Active
Contact: Site Public Contact
Phone: 952-993-1517
Email: mmcorc@healthpartners.com
Maplewood
Minnesota Oncology Hematology PA-Maplewood
Status: Active
Contact: Site Public Contact
Phone: 952-993-1517
Email: mmcorc@healthpartners.com
Saint John's Hospital - Healtheast
Status: Active
Contact: Site Public Contact
Email: ecog.rss@jimmy.harvard.edu
Minneapolis
Abbott-Northwestern Hospital
Status: Active
Contact: Site Public Contact
Phone: 952-993-1517
Email: mmcorc@healthpartners.com
Health Partners Inc
Status: Active
Contact: Site Public Contact
Phone: 952-993-1517
Email: mmcorc@healthpartners.com
Hennepin County Medical Center
Status: Active
Contact: Site Public Contact
Phone: 952-993-1517
Email: mmcorc@healthpartners.com
Monticello
Monticello Cancer Center
Status: Active
Contact: Site Public Contact
Phone: 952-993-1517
Email: mmcorc@healthpartners.com
New Ulm
New Ulm Medical Center
Status: Active
Contact: Site Public Contact
Phone: 952-993-1517
Email: mmcorc@healthpartners.com
Robbinsdale
North Memorial Medical Health Center
Status: Active
Contact: Site Public Contact
Phone: 952-993-1517
Email: mmcorc@healthpartners.com
Rochester
Mayo Clinic
Status: Active
Contact: Site Public Contact
Phone: 855-776-0015
Saint Louis Park
Park Nicollet Clinic - Saint Louis Park
Status: Active
Contact: Site Public Contact
Phone: 952-993-1517
Email: mmcorc@healthpartners.com
Saint Paul
Regions Hospital
Status: Active
Contact: Site Public Contact
Phone: 952-993-1517
Email: mmcorc@healthpartners.com
United Hospital
Status: Active
Contact: Site Public Contact
Phone: 952-993-1517
Email: mmcorc@healthpartners.com
Stillwater
Lakeview Hospital
Status: Active
Contact: Site Public Contact
Phone: 952-993-1517
Email: mmcorc@healthpartners.com
Thief River Falls
Sanford Thief River Falls Medical Center
Status: Active
Contact: Site Public Contact
Phone: 605-312-3320
Waconia
Ridgeview Medical Center
Status: Active
Contact: Site Public Contact
Phone: 952-993-1517
Email: mmcorc@healthpartners.com
Willmar
Rice Memorial Hospital
Status: Active
Contact: Site Public Contact
Phone: 952-993-1517
Email: mmcorc@healthpartners.com
Woodbury
Minnesota Oncology Hematology PA-Woodbury
Status: Active
Contact: Site Public Contact
Phone: 952-993-1517
Email: mmcorc@healthpartners.com
Worthington
Sanford Cancer Center Worthington
Status: Active
Contact: Site Public Contact
Phone: 605-312-3320
Wyoming
Fairview Lakes Medical Center
Status: Active
Contact: Site Public Contact
Phone: 952-993-1517
Email: mmcorc@healthpartners.com

Missouri

Bonne Terre
Parkland Health Center-Bonne Terre
Status: Active
Contact: Site Public Contact
Phone: 314-996-5569
Cape Girardeau
Saint Francis Medical Center
Status: Active
Contact: Site Public Contact
Phone: 573-334-2230
Email: sfmc@sfmc.net
Southeast Cancer Center
Status: Active
Contact: Site Public Contact
Phone: 573-651-5550
Creve Coeur
Siteman Cancer Center at West County Hospital
Status: Active
Contact: Site Public Contact
Phone: 800-600-3606
Email: info@siteman.wustl.edu
Jefferson City
Capital Region Southwest Campus
Status: Active
Contact: Site Public Contact
Phone: 573-632-4814
Email: swooden@mail.crmc.org
Saint Louis
Missouri Baptist Medical Center
Status: Active
Contact: Site Public Contact
Phone: 314-996-5569
Siteman Cancer Center at Christian Hospital
Status: Active
Contact: Site Public Contact
Phone: 800-600-3606
Email: info@siteman.wustl.edu
Siteman Cancer Center-South County
Status: Active
Contact: Site Public Contact
Phone: 800-600-3606
Email: info@siteman.wustl.edu
Washington University School of Medicine
Status: Active
Contact: Site Public Contact
Phone: 800-600-3606
Email: info@siteman.wustl.edu
Saint Peters
Siteman Cancer Center at Saint Peters Hospital
Status: Active
Contact: Site Public Contact
Phone: 800-600-3606
Email: info@siteman.wustl.edu
Sainte Genevieve
Sainte Genevieve County Memorial Hospital
Status: Active
Contact: Site Public Contact
Phone: 314-996-5569
Sullivan
Missouri Baptist Sullivan Hospital
Status: Active
Contact: Site Public Contact
Phone: 314-996-5569
Sunset Hills
Missouri Baptist Outpatient Center-Sunset Hills
Status: Active
Contact: Site Public Contact
Phone: 314-996-5569

Montana

Anaconda
Community Hospital of Anaconda
Status: Active
Contact: Site Public Contact
Phone: 406-969-6060
Email: mccinfo@mtcancer.org
Billings
Billings Clinic Cancer Center
Status: Active
Contact: Site Public Contact
Phone: 800-996-2663
Email: research@billingsclinic.org
Bozeman
Bozeman Deaconess Hospital
Status: Active
Contact: Site Public Contact
Phone: 406-969-6060
Email: mccinfo@mtcancer.org
Great Falls
Benefis Healthcare- Sletten Cancer Institute
Status: Active
Contact: Site Public Contact
Phone: 406-969-6060
Email: mccinfo@mtcancer.org
Great Falls Clinic
Status: Active
Contact: Site Public Contact
Phone: 406-969-6060
Email: mccinfo@mtcancer.org
Helena
Saint Peter's Community Hospital
Status: Active
Contact: Site Public Contact
Email: ecog.rss@jimmy.harvard.edu
Kalispell
Kalispell Regional Medical Center
Status: Active
Contact: Site Public Contact
Phone: 406-969-6060
Email: mccinfo@mtcancer.org
Missoula
Community Medical Hospital
Status: Active
Contact: Site Public Contact
Phone: 406-969-6060
Email: mccinfo@mtcancer.org

Nebraska

Omaha
Nebraska Methodist Hospital
Status: Active
Contact: Site Public Contact
Phone: 402-354-5144

New Jersey

Hackensack
Hackensack University Medical Center
Status: Active
Contact: Site Public Contact
Phone: 201-996-2879

North Carolina

Hendersonville
Margaret R Pardee Memorial Hospital
Status: Active
Contact: Site Public Contact
Phone: 828-696-4716
Email: karen.morris@unchealth.unc.edu

North Dakota

Bismarck
Sanford Bismarck Medical Center
Status: Active
Contact: Site Public Contact
Phone: 701-323-5760
Email: tamara.fischer@sanfordhealth.org
Fargo
Roger Maris Cancer Center
Status: Active
Contact: Site Public Contact
Phone: 701-234-6161
Sanford Broadway Medical Center
Status: Active
Contact: Site Public Contact
Phone: 800-437-4010
Sanford Medical Center Fargo
Status: Active
Contact: Site Public Contact
Phone: 800-437-4010
Sanford South University Medical Center
Status: Active
Contact: Site Public Contact
Phone: 701-234-6161

Ohio

Cleveland
Cleveland Clinic Foundation
Status: Active
Contact: Site Public Contact
Phone: 866-223-8100
Email: CancerAnswer@ccf.org
MetroHealth Medical Center
Status: Active
Contact: Site Public Contact
Phone: 216-778-8526
Email: dstrater@metrohealth.org
Sandusky
North Coast Cancer Care
Status: Active
Contact: Site Public Contact
Phone: 866-223-8100
Email: CancerAnswer@ccf.org
Strongsville
Cleveland Clinic Cancer Center Strongsville
Status: Active
Contact: Site Public Contact
Phone: 866-223-8100
Email: CancerAnswer@ccf.org
Wooster
Cleveland Clinic Wooster Family Health and Surgery Center
Status: Active
Contact: Site Public Contact
Phone: 866-223-8100
Email: CancerAnswer@ccf.org

Oregon

Baker City
Saint Alphonsus Medical Center-Baker City
Status: Active
Contact: Site Public Contact
Phone: 734-712-3671
Email: stephanie.couch@stjoeshealth.org
Ontario
Saint Alphonsus Medical Center-Ontario
Status: Active
Contact: Site Public Contact
Phone: 734-712-3671
Email: stephanie.couch@stjoeshealth.org

Pennsylvania

Philadelphia
ECOG-ACRIN Cancer Research Group
Status: Active
Contact: Brian R. Gastman
Phone: 216-444-6901
Email: gastmab@ccf.org

South Carolina

Gaffney
Gibbs Cancer Center-Gaffney
Status: Active
Contact: Site Public Contact
Phone: 864-560-6104
Email: kmertz-rivera@gibbscc.org
Greer
Gibbs Cancer Center-Pelham
Status: Active
Contact: Site Public Contact
Phone: 864-560-6104
Email: kmertz-rivera@gibbscc.org
Spartanburg
Spartanburg Medical Center
Status: Active
Contact: Site Public Contact
Phone: 864-560-6104
Email: kmertz-rivera@gibbscc.org
Union
MGC Hematology Oncology-Union
Status: Active
Contact: Site Public Contact
Phone: 864-560-6104
Email: kmertz-rivera@gibbscc.org

South Dakota

Sioux Falls
Sanford Cancer Center Oncology Clinic
Status: Active
Contact: Site Public Contact
Phone: 605-312-3320
Sanford USD Medical Center - Sioux Falls
Status: Active
Contact: Site Public Contact
Phone: 605-312-3320
Email: OncologyClinicalTrialsSF@SanfordHealth.org

Wisconsin

Eau Claire
Mayo Clinic Health System-Eau Claire Clinic
Status: Active
Contact: Site Public Contact
Phone: 855-776-0015
Marshfield
Marshfield Medical Center-Marshfield
Status: Active
Contact: Site Public Contact
Phone: 800-782-8581
Email: oncology.clinical.trials@marshfieldresearch.org
New Richmond
Cancer Center of Western Wisconsin
Status: Active
Contact: Site Public Contact
Phone: 952-993-1517
Email: mmcorc@healthpartners.com

Wyoming

Cody
Billings Clinic-Cody
Status: Active
Contact: Site Public Contact
Phone: 800-996-2663
Email: research@billingsclinic.org
Sheridan
Welch Cancer Center
Status: Active
Contact: Site Public Contact
Phone: 406-969-6060
Email: mccinfo@mtcancer.org

Trial Objectives and Outline

PRIMARY OBJECTIVES:

I. To compare overall survival (OS) and recurrence free survival (RFS) as co-primary endpoints across the two arms.

SECONDARY OBJECTIVES:

I. To evaluate adverse events.

II. To evaluate distant metastasis free survival (DMFS).

III. To evaluate the impact of radiation on clinical outcomes (OS, RFS, DMFS).

OUTLINE: Patients are randomized to 1 of 2 arms.

ARM A: Patients receive pembrolizumab intravenously (IV) over 30 minutes on day 1. Treatment repeats every 21 days for up to 17 courses in the absence of disease progression or unacceptable toxicity. Patients may also undergo standard of care radiation therapy within 14 days of day 1, course 1.

ARM B: Patients receive standard of care observation for 17 courses. Patients may also undergo standard of care radiation therapy within 14 days of day 1, course 1.

After completion of study treatment, patients are followed up every 6 months for 4 years.

Trial Phase & Type

Trial Phase

Phase III

Trial Type

Treatment

Lead Organization

Lead Organization
ECOG-ACRIN Cancer Research Group

Principal Investigator
Brian R. Gastman

Trial IDs

Primary ID EA6174
Secondary IDs NCI-2018-02217
Clinicaltrials.gov ID NCT03712605