Skip to Content
800-533-8762
  • Careers
  • Newsroom
  • Health Care Professionals
  • About Us
  • Contact Us
UPMC
  • Find a Doctor
  • Services
    • Frequently Searched Services
    • Frequently Searched Services
      Allergy & Immunology Behavioral & Mental Health Cancer Ear, Nose & Throat Endocrinology Gastroenterology Heart & Vascular Imaging Neurosciences Orthopaedics
      Physical Rehabilitation Plastic & Reconstructive Surgery Primary Care Senior Services Sports Medicine Telemedicine Transplant Surgery Walk-In Care Weight Management Women’s Health
      See all Services
    • Services by Region
    • Find a UPMC health care facility close to you quickly by browsing by region.
      UPMC in Western Pa. Western Pa. and New York
      UPMC in Central Pa. Central Pa.
      UPMC in North Central Pa. North Central Pa.
      UPMC in Western Md. Maryland & West Virginia
    • See All Services
  • Locations
    • Locations by Type
    • Locations by Type
      UPMC hospitals
      Hospitals
      Physical Therapy
      Physical Therapy
      Urgent care
      Walk-In Care
      UPMC Outpatient Centers
      Outpatient Centers
      UPMC Imaging Services
      Imaging
      Community Health Centers
      Community Health Centers
      See All Locations
    • Locations by Region
    • Locations by Region
      UPMC in Southwest Pa. Southwest Pa.
      UPMC in North Central Pa. North Central Pa.
      UPMC in Northwest Pa and Ny. Northwest Pa. & Western N.Y.
      UPMC in West Central Pa. West Central Pa.
      UPMC in Central Pa. Central Pa.
      UPMC in Western Md. Maryland & West Virginia
    • See All Locations
  • Patients & Visitors
    • Patient & Visitor Resources
    • Patient & Visitor Resources
      Patients and Visitors Resources Pay a Bill Classes & Events Medical Records Health Library Patient Information
      Patient Portals Privacy Information Shared Decision Making Traveling Patients Visitor Information
      Man uses mobile phone
      Pay a Bill
      Nurse reviews medical chart
      Request Medical Records
  • Patient Portals
  • Find Covid-19 updates
  • Schedule an appointment
  • Request medical records
  • Pay a bill
  • Learn about financial assistance
  • Find classes & events
  • Send a patient an eCard
  • Make a donation
  • Volunteer
  • Read HealthBeat blog
  • Explore UPMC Careers
Skip to Content
UPMC
  • Patient Portals
  • For Patients & Visitors
    • Find a Doctor
    • Locations
    • Patient & Visitor Resources
    • Pay a Bill
    • Services
    • More
      • Medical Records
      • Financial Assistance
      • Classes & Events
      • HealthBeat Blog
      • Health Library
  • About UPMC
    • Why UPMC
    • Facts & Stats
    • Supply Chain Management
    • Community Commitment
    • More
      • Financials
      • Support UPMC
      • UPMC Apps
      • UPMC Enterprises
      • UPMC International
  • For Health Care Professionals
    • Physician Information
    • Resources
    • Education & Training
    • Departments
    • Credentialing
  • Careers
  • Contact Us
  • Newsroom
  • UPMC >
  • Media Relations >
  • News Releases >
  • 091821 Pembrolizumab Melanoma
Media Relations
News Releases
Central Pa. News
North Central Pa. News
Contact Us
Experts
Community-Focused News
Media Kits
Media RSS
Media Relations
News Releases
Central Pa. News
North Central Pa. News
Contact Us
Experts
Community-Focused News
Media Kits
Media RSS

Chat Keywords List

  • cancel or exit: Stops your conversation
  • start over: Restarts your current scenario
  • help: Shows what this bot can do
  • terms: Shows terms of use and privacy statement
  • feedback: Give us feedback
Continue
Chat with UPMC
RESTART
MENU
CLOSE

Immunotherapy Drug Benefits Patients with High-Risk Local Melanomas

For Journalists

Asher Jones
Manager, Science Writing
412-647-3555
jonesag@upmc.edu

Cynthia Patton
Director
412-415-6085
pattonc4@upmc.edu

Want to Make an Appointment or Need Patient Information?
Contact UPMC at

1-800-533-8762.

Go to Find a Doctor to search for a UPMC doctor.

UPMC Hillman CC

9/18/2021

PITTSBURGH – An immunotherapy called pembrolizumab reduced cancer recurrence after surgery in patients with stage IIb and IIc melanoma, according to the results of an international, randomized phase III clinical trial led by UPMC Hillman Cancer Center. These results indicate that this immunotherapy treatment—which currently is approved only for stage III and IV melanomas—may be appropriate for patients with earlier stages of melanoma.

 

Jason Luke releaseThe study was led by Jason Luke, M.D., director of the Cancer Immunotherapeutics Center at UPMC Hillman and associate professor of medicine at the University of Pittsburgh School of Medicine. He delivered the results on behalf of a leading international group of melanoma oncologists, including John Kirkwood, M.D., also of UPMC Hillman, as well as the study sponsor Merck, during a presentation today at ESMO Congress 2021.

Update, April 1, 2022: The research described in this release has now been published in a peer-reviewed journal, The Lancet.

 

“Patients with stage IIb and IIc melanomas have a high level of risk for the disease coming back after surgery,” said Luke. “This is a very important clinical trial as it shows that pembrolizumab reduces that risk. Based on these results, I believe that we should be offering patients in this situation the opportunity to get this treatment after surgery.”

 

Pembrolizumab often is used as adjuvant immunotherapy following surgical removal of stage III melanomas, in which the cancer has spread to lymph nodes, and for treatment of metastatic stage IV melanomas. But the U.S. Food and Drug Administration (FDA) has not yet approved the drug for patients with earlier stages, such as IIb and IIc melanomas—invasive tumors that extend deep into the skin or have broken the overlying skin, which is known as ulceration. 

 

“In most cancers, it’s automatically worse if the cancer moves beyond the primary location to the lymph nodes. But melanoma is idiosyncratic in that the risk of long-term relapse and death is similar among patients with stage IIIa and IIIb melanoma, with lymph node involvement, compared with stage IIb and IIc, which lack lymph node involvement,” said Luke. “So, in a sense it has been unfair that these patients couldn’t get pembrolizumab because they were excluded from initial trials. With this trial, we hoped to right that wrong.”

 

The multi-country KEYNOTE-716 trial enrolled 976 patients with stage IIb or IIc melanomas. After surgery, 487 patients received intravenous pembrolizumab and 489 received a placebo every three weeks for one year. Patients were monitored for cancer recurrence via computed tomography scans and magnetic resonance imaging.

 

The researchers found that patients who received the drug had a 35% lower risk of death or melanoma relapse compared to those who got the placebo.

 

On the basis of these findings, Merck has submitted an application to the FDA for treatment of stage IIb and IIc melanoma with pembrolizumab, which is undergoing priority review.

 

Update, Dec. 3, 2021: The FDA approved pembrolizumab for patients aged 12 years or older with stage IIB or IIC melanoma following surgery.

 

At a median follow-up time of 14.4 months, 136 patients had disease recurrence or died: 54 in the pembrolizumab group and 82 in the placebo group. 

 

“The fact that patients in this trial had very rapid recurrences in distant organs—which is metastatic cancer—drives home the point that stage IIb and IIc melanomas are high risk,” said Luke. “There has been the idea that because these cancers don’t involve the lymph nodes, they’re not such a big deal. But that’s clearly wrong.”

 

The KEYNOTE-716 trial is ongoing, and the researchers will continue to monitor participants for cancer recurrence or death. 

 

“The trial is still very early, and we expect to see the benefit of pembrolizumab increase above 35% over time,” said Luke.

 

In part two of the trial, patients in the placebo group who had their cancer return will be offered pembrolizumab. This will help clinicians figure out whether it is better to give the treatment right after melanoma surgery or wait until the cancer returns. 

 

About 18% of participants receiving pembrolizumab experienced significant adverse effects that required long-term hormone replacement. According to Luke, this level of drug safety was expected based on previous trials, and they did not observe new or unexpected side effects.

 

Additional authors of the study include Piotr Rutkowski, M.D., Ph.D., Maria Sklodowska-Curie National Research Institute of Oncology, Warsaw, Poland; Paola Queirolo, M.D., Istituto Europeo di Oncologia - IRCCS, Milano, Italy; Michele Del Vecchio, M.D., Fondazione IRCCS Istituto Nazionale dei Tumori, Milano, Italy; Jacek Mackiewicz, M.D., Ph.D., Poznan University of Medical Sciences and Greater Poland Cancer Center, Poznan, Poland; Vanna Chiarion-Sileni, M.D., Istituto Oncologico Veneto, IOV-IRCCS, Padova, Italy; Luis de la Cruz Merino, M.D., Hospital Universitario Virgen Macarena and Universidad de Sevilla, Sevilla, Spain; Muhammad A. Khattak, M.D., Fiona Stanley Hospital and Edith Cowan University, Perth, Australia; Dirk Schadendorf, M.D., Ph.D., University Hospital Essen and German Cancer Consortium Partner Site, Essen, Germany; Georgina V. Long, M.D., Ph.D., Melanoma Institute Australia, The University of Sydney and Royal North Shore and Mater Hospitals, Sydney, Australia; Paolo A. Ascierto, M.D., Istituto Nazionale Tumori IRCCS Fondazione Pascale, Naples, Italy; Mario Mandala, M.D., University of Perugia, Perugia, Italy; Federica De Galitiis, M.D., Dermopathic Institute of the Immaculate IDI-IRCCS, Rome, Italy; Andrew Haydon, M.D., Alfred Hospital, Monash University, Melbourne, Australia; Reinhard Dummer, M.D., University Hospital Zürich Skin Cancer Center, Zürich, Switzerland; Jean-Jacques Grob, M.D., AP-HM Hospital, Aix-Marseille University, Marseille, France; Caroline Robert, M.D., Ph.D., Institut Gustave Roussy, Villejuif, France and Paris-Saclay University, Villejuif, France; Vernon K. Sondak, M.D., H. Lee Moffitt Cancer Center and Research Institute, Tampa, Fla.; Richard A. Scolyer, M.D., Melanoma Institute Australia, The University of Sydney and Royal Prince Alfred Hospital and NSW Health Pathology, Sydney, Australia; John M. Kirkwood; M.D., UPMC Hillman Cancer Center; Ke Chen, M.S., Scott J. Diede, M.D., Ph.D., Sama Ahsan, M.D., and Nageatte Ibrahim, M.D., all of Merck & Co. Inc., Kenilworth, NJ; Alexander M.M. Eggermont, M.D., Ph.D., Medical Center Utrecht and Princess Máxima Center, Utrecht, Netherlands; and the KEYNOTE-716 investigators.

 

The clinical trial was funded by Merck Sharp & Dohme Corp. 
PHOTO INFO: (click image for high-res version)

 

CREDIT: UPMC

CAPTION: Jason Luke, M.D.

UPMC
200 Lothrop Street Pittsburgh, PA 15213

412-647-8762 800-533-8762

Patients And Visitors
  • Find a Doctor
  • Locations
  • Pay a Bill
  • Patient & Visitor Resources
  • Disabilities Resource Center
  • Services
  • Medical Records
  • No Surprises Act
  • Price Transparency
  • Financial Assistance
  • Classes & Events
  • Health Library
Health Care Professionals
  • Physician Information
  • Resources
  • Education & Training
  • Departments
  • Credentialing
Newsroom
  • Newsroom Home
  • Inside Life Changing Medicine Blog
  • News Releases
About
  • Why UPMC
  • Facts & Stats
  • Supply Chain Management
  • Community Commitment
  • Financials
  • Supporting UPMC
  • HealthBeat Blog
  • UPMC Apps
  • UPMC Enterprises
  • UPMC Health Plan
  • UPMC International
  • Nondiscrimination Policy
Life changing is...
Follow UPMC
  • Contact Us
  • Website/Email Terms of Use
  • Medical Advice Disclaimer
  • Privacy Information
  • Active Privacy Alerts
  • Sitemap
© 2025 UPMC I Affiliated with the University of Pittsburgh Schools of the Health Sciences Supplemental content provided by Healthwise, Incorporated. To learn more, visit healthwise.org
Find Care
Providers
Video Visit
Portal Login