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Compares treatment options for Neoplasms, Head and Neck
Official title A Study of Dostarlimab vs Placebo After Chemoradiation in Adult Participants With Locally Advanced Unresected Head and Neck Squamous Cell Carcinoma
ClinicalTrials.gov ID: NCT06256588
What this study is testing
What is Dostarlimab?
Dostarlimab is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for neoplasms, head and neck.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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)
- Phase 3: a large, late-stage study
- You might receive a placebo (an inactive treatment) instead of the study drug.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- 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...
- 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.
You likely can't join if
- 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...
- Has cancer outside of the oropharynx, larynx, hypopharynx or oral cavity, such as nasopharyngeal, sinus, other para-nasal, or other unknown primary...
- Has experienced any of the following with prior immunotherapy: any immune-related adverse event (irAE) of Grade ≥3, immune-related severe neurologic...
- 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).
See the full eligibility 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...
- 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.
- 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...
- 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...
- 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...
- 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...
- 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...
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Jonesboro, Arkansas, United States
- Los Angeles, California, United States
- Solvang, California, United States
- Stockton, California, United States
- Torrance, California, United States
- Farmington, Connecticut, United States
- New Haven, Connecticut, United States
- Washington D.C., District of Columbia, United States
- St. Petersburg, Florida, United States
- Tamarac, Florida, United States
- Atlanta, Georgia, United States
- Fort Wayne, Indiana, United States
- Iowa City, Iowa, United States
- Lexington, Kentucky, United States
- Columbia, Maryland, United States
- Worcester, Massachusetts, United States
- St Louis, Missouri, United States
- Omaha, Nebraska, United States
- New York, New York, United States
- The Bronx, New York, United States
+ 221 more site(s).
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Jonesboro, Arkansas, United States; Los Angeles, California, United States; Solvang, California, United States; Stockton, California, United States; Torrance, California, United States; Farmington, Connecticut, United States and 235 more location(s). Enter your location above to see the nearest site and check your eligibility.
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BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.