Last updated on April 2019

Pembrolizumab in Treating Patients With Desmoplastic Melanoma That Can or Cannot Be Removed by Surgery


Brief description of study

This pilot phase II trial studies how well pembrolizumab works in treating patients with desmoplastic melanoma (DM) that can or cannot be removed by surgery. Monoclonal antibodies, like pembrolizumab, may block specific proteins which may strengthen the immune system and control tumor growth.

Detailed Study Description

PRIMARY OBJECTIVES:

I. To evaluate the pathologic complete response rate (pCR) in patients with resectable desmoplastic melanoma treated with neoadjuvant MK-3475 (pembrolizumab). (Cohort A) II. To evaluate the complete response rate (confirmed and unconfirmed) in patients with unresectable desmoplastic melanoma treated with MK-3475 (pembrolizumab). (Cohort B)

SECONDARY OBJECTIVES:

I. To estimate the 9 week response rate (RR) (unconfirmed complete and partial responses) among patients with measurable disease. (Cohort A) II. To estimate the median overall survival (OS). (Cohort A) III. To evaluate safety and tolerability of MK-3475 (pembrolizumab) in the neoadjuvant setting. (Cohort A) IV. To estimate the median progression-free survival (PFS). (Cohort B) V. To estimate the median overall survival (OS). (Cohort B) VI. To evaluate safety and tolerability of MK-3475 (pembrolizumab) in this setting. (Cohort B)

TERTIARY OBJECTIVES:

I. To evaluate the hypothesis that higher mutational load in the patient derived baseline tumor biopsy samples is associated with higher pathologic complete response (pCR).

II. To evaluate T cell infiltration into the tumors in DM patients and correlate with response to programmed cell death protein 1 (PD-1) blockade.

III. To evaluate the clonality of tumor infiltrating T cells in DM patients and correlate with response to PD-1 blockade.

IV. To evaluate adaptive immune resistant mechanism in DM tumors.

OUTLINE: Patients are assigned to 1 of 2 cohorts.

COHORT A: Patients receive pembrolizumab intravenously (IV) over 30 minutes on day 1. Treatment repeats every 21 days for up to 3 courses. Patients with potentially resectable disease undergo surgery. Patients with tumor progression and unresectable disease may receive one additional course of pembrolizumab.

COHORT B: Patients with unresectable disease receive pembrolizumab IV over 30 minutes on day

  1. Treatment repeats every 21 days for up to 34 courses in the absence of disease progression or toxicity.

After completion of study treatment, patients are followed up at 6 and 12 weeks, then every 3 months for 1 year, and every 6 months for 4 years.

Clinical Study Identifier: NCT02775851

Contact Investigators or Research Sites near you

Start Over

Epic Care-Dublin

Dublin, CA United States
  Connect »

Bay Area Breast Surgeons Inc

Emeryville, CA United States
  Connect »

Bay Area Tumor Institute

Oakland, CA United States
  Connect »

Grand Valley Oncology

Grand Junction, CO United States
  Connect »

Holy Cross Hospital

Fort Lauderdale, FL United States
  Connect »

Mount Sinai Medical Center

Miami Beach, FL United States
  Connect »

Moffitt Cancer Center

Tampa, FL United States
  Connect »

Summit Cancer Care-Candler

Savannah, GA United States
  Connect »

Kootenai Medical Center

Coeur d'Alene, ID United States
  Connect »

Kootenai Cancer Center

Post Falls, ID United States
  Connect »

Kootenai Cancer Clinic

Sandpoint, ID United States
  Connect »

Northwestern University

Chicago, IL United States
  Connect »

Carle on Vermilion

Danville, IL United States
  Connect »

Carle Cancer Center

Urbana, IL United States
  Connect »

Rush-Copley Healthcare Center

Yorkville, IL United States
  Connect »

Deaconess Clinic Downtown

Evansville, IN United States
  Connect »

Monroe Cancer Center

Monroe, MI United States
  Connect »

Fairview Ridges Hospital

Burnsville, MN United States
  Connect »

Mercy Hospital

Coon Rapids, MN United States
  Connect »

Unity Hospital

Fridley, MN United States
  Connect »

Abbott-Northwestern Hospital

Minneapolis, MN United States
  Connect »

Hennepin County Medical Center

Minneapolis, MN United States
  Connect »

Health Partners Inc

Minneapolis, MN United States
  Connect »

New Ulm Medical Center

New Ulm, MN United States
  Connect »

Park Nicollet Clinic - Saint Louis Park

Saint Louis Park, MN United States
  Connect »

Regions Hospital

Saint Paul, MN United States
  Connect »

United Hospital

Saint Paul, MN United States
  Connect »

Lakeview Hospital

Stillwater, MN United States
  Connect »

Ridgeview Medical Center

Waconia, MN United States
  Connect »

Rice Memorial Hospital

Willmar, MN United States
  Connect »

Cox Cancer Center Branson

Branson, MO United States
  Connect »

Freeman Health System

Joplin, MO United States
  Connect »

Mercy Hospital Joplin

Joplin, MO United States
  Connect »

Heartland Regional Medical Center

Saint Joseph, MO United States
  Connect »

Mercy Hospital Saint Louis

Saint Louis, MO United States
  Connect »

Mercy Hospital Springfield

Springfield, MO United States
  Connect »

CoxHealth South Hospital

Springfield, MO United States
  Connect »

Mercy Hospital Washington

Washington, MO United States
  Connect »

Bozeman Deaconess Hospital

Bozeman, MT United States
  Connect »

Great Falls Clinic

Great Falls, MT United States
  Connect »

Community Medical Hospital

Missoula, MT United States
  Connect »

Wayne Memorial Hospital

Goldsboro, NC United States
  Connect »

Onslow Memorial Hospital

Jacksonville, NC United States
  Connect »

Adena Regional Medical Center

Chillicothe, OH United States
  Connect »

Mount Carmel East Hospital

Columbus, OH United States
  Connect »

Riverside Methodist Hospital

Columbus, OH United States
  Connect »

Grant Medical Center

Columbus, OH United States
  Connect »

Doctors Hospital

Columbus, OH United States
  Connect »

Delaware Radiation Oncology

Delaware, OH United States
  Connect »

Grady Memorial Hospital

Delaware, OH United States
  Connect »

Fairfield Medical Center

Lancaster, OH United States
  Connect »

OhioHealth Mansfield Hospital

Mansfield, OH United States
  Connect »

Marietta Memorial Hospital

Marietta, OH United States
  Connect »

Knox Community Hospital

Mount Vernon, OH United States
  Connect »

Licking Memorial Hospital

Newark, OH United States
  Connect »

Newark Radiation Oncology

Newark, OH United States
  Connect »

Southern Ohio Medical Center

Portsmouth, OH United States
  Connect »

Saint Ann's Hospital

Westerville, OH United States
  Connect »

Mercy Hospital Oklahoma City

Oklahoma City, OK United States
  Connect »

Sandra L Maxwell Cancer Center

Cedar City, UT United States
  Connect »

Farmington Health Center

Farmington, UT United States
  Connect »

Logan Regional Hospital

Logan, UT United States
  Connect »

Riverton Hospital

Riverton, UT United States
  Connect »

LDS Hospital

Salt Lake City, UT United States
  Connect »

South Jordan Health Center

South Jordan, UT United States
  Connect »

Cancer Center of Western Wisconsin

New Richmond, WI United States
  Connect »

Billings Clinic-Cody

Cody, WY United States
  Connect »

Welch Cancer Center

Sheridan, WY United States
  Connect »

Hays Medical Center

Hays, KS United States
  Connect »

Olathe Medical Center

Olathe, KS United States
  Connect »

Via Christi Hospital-Pittsburg

Pittsburg, KS United States
  Connect »

Truman Medical Center

Kansas City, MO United States
  Connect »

Singing River Hospital

Pascagoula, MS United States
  Connect »

Menorah Medical Center

Overland Park, KS United States
  Connect »

Centerpoint Medical Center LLC

Independence, MO United States
  Connect »

Research Medical Center

Kansas City, MO United States
  Connect »

Epic Care Cyberknife Center

Walnut Creek, CA United States
  Connect »

Hartford Hospital

Hartford, CT United States
  Connect »

ProMedica Flower Hospital

Sylvania, OH United States
  Connect »

Monticello Cancer Center

Monticello, MN United States
  Connect »

Mercy Hospital South

Saint Louis, MO United States
  Connect »

City of Hope Rancho Cucamonga

Rancho Cucamonga, CA United States
  Connect »

City of Hope South Pasadena

South Pasadena, CA United States
  Connect »

Recruitment Status: Open


Brief Description Eligibility Contact Research Team


Receive Emails About New Clinical Trials!

Sign up for our FREE service to receive email notifications when clinical trials are posted in the medical category of interest to you.