RECRUITING

A Study of Dostarlimab vs Placebo After Chemoradiation in Adult Participants With Locally Advanced Unresected Head and Neck Squamous Cell Carcinoma

Talk to us

Conditions

Neoplasms, Head and NeckJEMPERLIDostarlimabPlaceboChemoradiationHNSCC

Quick Navigation

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

The goal of this study is to assess the safety and effectiveness of Dostarlimab compared to Placebo in adult participants with Head and Neck Squamous Cell Carcinoma (HNSCC)

Official Title

A Randomized, Double-blind, Placebo-controlled Phase 3 Study to Evaluate Dostarlimab as Sequential Therapy After Chemoradiation in Participants With Locally Advanced Unresected Head and Neck Squamous Cell Carcinoma

Quick Facts

Study Start:2024-03-21
Study Completion:2029-10-26
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06256588

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Has newly diagnosed unresected Locally Advanced (LA) histologically confirmed HNSCC of the oral cavity, oropharynx, hypopharynx or larynx and completed cisplatin plus radiotherapy (termed "CRT" in this protocol) with curative intent and has no evidence of distant metastatic disease.
  2. * Has provided acceptable core or excisional biopsy obtained prior to CRT:
  3. * PD-L1 positive tumor status
  4. * If the primary tumor site is oropharyngeal carcinoma, the participant must have p16 immunohistochemistry (IHC) testing.
  5. * Has an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
  6. * Has adequate organ function.
  1. * Has received prior radiation therapy (RT), systemic therapy, targeted therapy, or surgery for management of head and neck cancer not considered part of CRT. Participants receiving induction chemotherapy are excluded. CRT combinations with components other than cisplatin and RT (e.g., experimental agents, including radiosensitizers/radioprotectants, cetuximab) are not eligible.
  2. * Has cancer outside of the oropharynx, larynx, hypopharynx or oral cavity, such as nasopharyngeal, sinus, other para-nasal, or other unknown primary head and neck cancer. Has more than one primary HNSCC tumor.
  3. * Has experienced any of the following with prior immunotherapy: any immune-related adverse event (irAE) of Grade ≥3, immune-related severe neurologic events of any grade (e.g., myasthenic syndrome/myasthenia gravis, encephalitis, Guillain-Barré Syndrome, or transverse myelitis), exfoliative dermatitis of any grade (Stevens-Johnson Syndrome, toxic epidermal necrolysis, or Drug Rash with Eosinophilia and Systemic Symptoms \[DRESS\] syndrome), or myocarditis of any grade. Non-clinically significant laboratory abnormalities are not exclusionary.
  4. * Has undergone any major surgical procedure or experienced significant traumatic injury that has not resolved by the time of randomization.
  5. * Has any history of interstitial lung disease or pneumonitis (past or current).
  6. * Has cirrhosis of any stage or current unstable liver biliary disease per investigator assessment defined by the presence of ascites, encephalopathy, coagulopathy, hypoalbuminemia, esophageal/gastric varices, or persistent jaundice.
  7. * Has a history or current evidence of any medical condition, therapy, or laboratory abnormality that might confound the study results, interfere with their participation for the full duration of the study intervention, or indicate it is not in the best interest of the participant to participate, in the opinion of the investigator.
  8. * Is receiving any other anticancer or experimental therapy. No other experimental therapies (including but not limited to chemotherapy, radiation, hormonal treatment, antibody therapy, immunotherapy, gene therapy, vaccine therapy, or other experimental drugs) of any kind are permitted while the participant is receiving study intervention.
  9. * Previous treatment with anti-PD-1, anti-PD-L1, or anti-PD-L2 agent or an agent directed to another stimulatory or coinhibitory T-cell receptor \[e.g., Cytotoxic T-lymphocyte associated protein 4 (CTLA4), OX-40, CD137\]
  10. * Is pregnant, breastfeeding, or expecting to conceive children within the projected duration of the study, starting with the Screening Visit through 120 days after the last dose of study intervention.
  11. * Has a history of severe allergic and/or anaphylactic reactions to chimeric, human or humanized antibodies, fusion proteins, or known allergies to dostarlimab or its excipients.

Contacts and Locations

Study Contact

US GSK Clinical Trials Call Center
CONTACT
877-379-3718
GSKClinicalSupportHD@gsk.com
EU GSK Clinical Trials Call Center
CONTACT
+44 (0) 20 89904466
GSKClinicalSupportHD@gsk.com

Study Locations (Sites)

GSK Investigational Site
Jonesboro, Arkansas, 72401
United States
GSK Investigational Site
Los Angeles, California, 90095
United States
GSK Investigational Site
Solvang, California, 93463
United States
GSK Investigational Site
Stockton, California, 95204
United States
GSK Investigational Site
Torrance, California, 90505
United States
GSK Investigational Site
Farmington, Connecticut, 06030-1628
United States
GSK Investigational Site
New Haven, Connecticut, 06520
United States
GSK Investigational Site
Washington D.C., District of Columbia, 20010
United States
GSK Investigational Site
St. Petersburg, Florida, 33709
United States
GSK Investigational Site
Tamarac, Florida, 33321
United States
GSK Investigational Site
Atlanta, Georgia, 30322
United States
GSK Investigational Site
Fort Wayne, Indiana, 46804
United States
GSK Investigational Site
Iowa City, Iowa, 52242
United States
GSK Investigational Site
Lexington, Kentucky, 40536
United States
GSK Investigational Site
Columbia, Maryland, 21044
United States
GSK Investigational Site
Worcester, Massachusetts, 01655-0002
United States
GSK Investigational Site
St Louis, Missouri, 63110
United States
GSK Investigational Site
Omaha, Nebraska, 68114
United States
GSK Investigational Site
New York, New York, 10032
United States
GSK Investigational Site
Cincinnati, Ohio, 45219
United States
GSK Investigational Site
Charleston, South Carolina, 29425
United States
GSK Investigational Site
Greenville, South Carolina, 29607
United States
GSK Investigational Site
Chattanooga, Tennessee, 37404
United States
GSK Investigational Site
Germantown, Tennessee, 38138
United States
GSK Investigational Site
Nashville, Tennessee, 37203
United States
GSK Investigational Site
Fort Worth, Texas, 76104
United States
GSK Investigational Site
Fredericksburg, Virginia, 22408
United States
GSK Investigational Site
Wytheville, Virginia, 24382
United States
GSK Investigational Site
Tacoma, Washington, 98405
United States

Collaborators and Investigators

Sponsor: GlaxoSmithKline

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-03-21
Study Completion Date2029-10-26

Study Record Updates

Study Start Date2024-03-21
Study Completion Date2029-10-26

Terms related to this study

Keywords Provided by Researchers

  • JEMPERLI
  • Dostarlimab
  • Placebo
  • Chemoradiation
  • HNSCC

Additional Relevant MeSH Terms

  • Neoplasms, Head and Neck