A Study of Dostarlimab vs Placebo After Chemoradiation in Adult Participants With Locally Advanced Unresected Head and Neck Squamous Cell Carcinoma
- Conditions
- Health Condition 1: C148- Malignant neoplasm of overlappingsites of lip, oral cavity and pharynx
- Registration Number
- CTRI/2024/06/068865
- Lead Sponsor
- GlaxoSmithKline Research & Development Limited
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Open to Recruitment
- Sex
- Not specified
- Target Recruitment
- 0
Participants are eligible to be included in the study only if all of the following criteria apply:
1. Has newly diagnosed unresected 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 tissue demonstrating:
PD-L1 positive tumor status
If the primary tumor site is oropharyngeal carcinoma, the participant must have p16 IHC testing.
3. Has an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
4. Has adequate organ function.
Participants are excluded from the study if any of the following criteria apply:
1. Has received prior radiation therapy, systemic therapy, targeted therapy, or radical surgery for management of head and neck cancer not considered part of CRT.
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.
3. Has undergone any major surgical procedure or experienced significant traumatic injury within 28 days prior to enrolment.
4. Has any history of interstitial lung disease or pneumonitis (past or current).
5. Has cirrhosis or current unstable liver biliary disease per investigator assessment defined by the presence of ascites, encephalopathy, coagulopathy, hypoalbuminemia, esophageal/gastric varices, or persistent jaundice.
6. 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.
7. 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.
8. 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, CD134).
9. 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.
10. 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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Event-free Survival (EFS) Assessed by Blinded Independent Central Review (BICR)Timepoint: Up to approximately 5 years
- Secondary Outcome Measures
Name Time Method Event-free Survival (EFS) assessed by investigatorTimepoint: Up to approximately 5 years;Number of Participants with Anti-Drug Antibodies against DostarlimabTimepoint: Up to approximately 15 months;Number of participants with clinically significant changes in laboratory, vital signs, and safety assessment parametersTimepoint: Up to approximately 5 years;Number of Participants with TEAEs and SAEs leading to dose delays, withdrawals or deathTimepoint: Up to approximately 5 years;Number of Participants with treatment emergent adverse events (TEAEs), Immune-mediated TEAEs, and serious adverse events (SAEs) by severityTimepoint: Up to approximately 5 years;Overall Survival (OS)Timepoint: Up to approximately 5 years;Serum Concentration of DostarlimabTimepoint: Up to approximately 15 months;Serum Concentration of Dostarlimab at End of Infusion (C-EoI)Timepoint: Up to approximately 15 months;Serum Predose trough concentration (Ctrough) of DostarlimabTimepoint: Up to approximately 15 months