Comparing Dostarlimab to Placebo after Chemoradiation for Head and Neck Cancer

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study evaluates the safety and effectiveness of Dostarlimab, an immunotherapy drug, compared to a placebo in adults with locally advanced unresected head and neck squamous cell carcinoma (HNSCC) who have completed chemoradiation. Participants must have a confirmed diagnosis of HNSCC and meet specific criteria regarding tumor status and performance levels. The study aims to determine if Dostarlimab can improve outcomes for these patients after their initial treatment.

Why it matters

Who can join: the full rules

Inclusion Criteria:

Participants are eligible to be included in the study only if all of the following criteria apply:

* 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.
* Has provided acceptable core or excisional biopsy obtained prior to CRT:

  * PD-L1 positive tumor status
  * If the primary tumor site is oropharyngeal carcinoma, the participant must have p16 immunohistochemistry (IHC) testing.
* Has an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
* Has adequate organ function.

Exclusion Criteria:

Participants are excluded from the study if any of the following criteria apply:

* 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.
* 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.
* 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.
* Has undergone any major surgical procedure or experienced significant traumatic injury that has not resolved by the time of randomization.
* Has any history of interstitial lung disease or pneumonitis (past or current).
* 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.
* 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.
* 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.
* 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 \[e.g., Cytotoxic T-lymphocyte associated protein 4 (CTLA4), OX-40, CD137\]
* 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.
* 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.

Where it's running

• GSK Investigational Site
  Jonesboro, Arkansas, United States Recruiting
• GSK Investigational Site
  Los Angeles, California, United States Recruiting
• GSK Investigational Site
  Solvang, California, United States Recruiting
• GSK Investigational Site
  Stockton, California, United States Recruiting
• GSK Investigational Site
  Torrance, California, United States Recruiting
• GSK Investigational Site
  Farmington, Connecticut, United States Recruiting

+227 more sites. See ClinicalTrials.gov for the full list.

Study contacts

• Study coordinator: US GSK Clinical Trials Call Center
• Email: GSKClinicalSupportHD@gsk.com
• Phone: 877-379-3718

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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  It tests an antibody–drug conjugate called GSK5764227 by itself or with the immunotherapy dostarlimab in adults with recurrent or metastatic head and neck squamous cell carcinoma who have received prior treatments.

  Recruiting Phase 2 University Health Network, Toronto · Toronto, Ontario · NCT07408063

• Dostarlimab with cisplatin, etoposide, and radiotherapy for small cell neuroendocrine cervical cancer

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  Recruiting Phase 2 Chang Gung Memorial Hospital · Taoyuan, Taiwan · NCT07336147

• Neoadjuvant dostarlimab for locally advanced dMMR/MSI‑H rectal cancer in routine practice

  This project will try neoadjuvant dostarlimab in adults with dMMR/MSI‑H stage II–III rectal cancer to see how well it works and how safe it is in real-world clinical care.

  Recruiting National Cancer Institute, Naples · Naples and 1 other locations · NCT07269249

• Dostarlimab with carboplatin–paclitaxel for advanced or recurrent endometrial cancer in Chinese patients with dMMR/MSI-H

  This Phase 2 trial will test whether adding dostarlimab to carboplatin and paclitaxel helps Chinese patients with advanced or recurrent dMMR/MSI‑H endometrial cancer respond to treatment and tolerate the combination.

  Recruiting Phase 2 GlaxoSmithKline · Jinan, Shandong · NCT07108270

• Neoadjuvant dostarlimab before surgery for resectable stage III pMMR/MSS colon cancer

  This will test whether two pre-surgery infusions of the PD-1 drug dostarlimab help people with resectable stage III pMMR/MSS colon cancer.

  Recruiting Phase 2 Universitaire Ziekenhuizen KU Leuven · Leuven · NCT06830239

• Neoadjuvant immunotherapy and radiotherapy for advanced rectal cancer

  This study is testing if combining a new immunotherapy drug with short radiation treatment can help people with advanced rectal cancer avoid surgery and improve their chances of staying cancer-free.

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.