A Phase 3 Study of Dostarlimab as Sequential Therapy After Chemoradiotherapy Compared to Placebo in Adult Participants with Locally Advanced, Unresectable Squamous Cell Carcinoma of the Head and Neck (JADE)
Zusammenfassung der Studie
This study investigates the efficacy and safety of the investigational drug Dostarlimab (PD-1 inhibitor) in adult participants with locally advanced, unresectable squamous cell carcinoma of the head and neck (also referred to as head and neck cancer). After the recommended treatment with a combination of radiation therapy and chemotherapy (chemoradiotherapy) has been completed, the screening phase begins to determine if the patient is eligible for this study. If all requirements are met, study participants will be randomly assigned to 2 groups: - Group A: Experimental group, receives Dostarlimab - Group B: Control group, receives a placebo (an identically appearing substance without active ingredient, e.g., saline). In the treatment phase (approximately 1 year), study participants will receive an intravenous infusion of either Dostarlimab or placebo for up to 11 doses (also called cycles). The first 4 cycles are administered every 3 weeks, and the following 7 cycles every 6 weeks. This is followed by a follow-up phase (approximately 4 years), during which further examinations will be conducted to determine if the cancer has recurred or worsened. The aim of the study is to investigate whether Dostarlimab can delay or reduce the risk of recurrence of head and neck cancer compared to placebo.
(BASEC)
Untersuchte Intervention
The investigational drug Dostarlimab belongs to the class of medications known as PD-1 inhibitors (PD-1 blockers; programmed cell death-1). On certain cells of the immune system (the T cells), there is a protein called PD-1 (a protein substance). Cancer cells in the body produce a protein called PD-L1 (programmed death-ligand 1). PD-L1 can interact with PD-1 and thereby inhibit immune cells. Dostarlimab, as a PD-1 inhibitor, can block this interaction and enable the immune system to attack cancer cells again.
(BASEC)
Untersuchte Krankheit(en)
Locally advanced, unresectable squamous cell carcinoma of the head and neck (also referred to as head and neck cancer).
(BASEC)
1. The study participant is over 18 years old and has a specific type of head and neck cancer that cannot be surgically removed. The cancer is newly diagnosed and located in the mouth, throat, or larynx. The participant has completed treatment with a combination of chemotherapy and radiation therapy, aiming to cure the cancer, and there are no signs that the cancer has spread to other parts of the body (no metastases). 2. The disease falls into one of the categories described in the protocol, according to the location of the cancer (throat and larynx) and the status of a protein called p16. The participant has provided a tissue sample from a biopsy showing that the tumor has a specific marker called PD-L1 with a value of 1 or higher. 3. The participant has completed the required amount of chemotherapy and radiation therapy according to the study guidelines. (BASEC)
Ausschlusskriterien
1. Has a type of cancer in the head or neck area, but not in the throat, larynx, lower throat, or mouth. This includes cancers in areas such as the upper part of the throat, the sinuses, other areas near the nose, or other unknown areas in the head and neck region. 2. Has received prior treatments for head and neck cancer that are not part of a combined treatment of chemotherapy and radiation therapy (chemoradiotherapy). These treatments may include sole radiation, drug treatments, or surgeries. 3. Currently has side effects from previous combined chemotherapy and radiation therapy (chemoradiotherapy) that are greater than moderate (more than grade 2 on a standard scale). Participants with stable or persistent side effects (e.g., hearing loss, nerve damage) may still participate after consultation with the central study team. (BASEC)
Studienstandort
Basel, Freiburg, Genf, Lausanne, Zürich
(BASEC)
Sponsor
GlaxoSmithKline AG
(BASEC)
Kontakt für weitere Auskünfte zur Studie
Kontaktperson Schweiz
Dr. Tomas Brezina
+41 43 253 28 87
Tomas.Brezina@clutterusz.chUniversitätsspital Zürich Klinik für Med. Onkologie und Hämatologie
(BASEC)
Wissenschaftliche Auskünfte
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Name der bewilligenden Ethikkommission (bei multizentrischen Studien nur die Leitkommission)
Ethikkommission Zürich
(BASEC)
Datum der Bewilligung durch die Ethikkommission
19.08.2025
(BASEC)
ICTRP Studien-ID
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Offizieller Titel (Genehmigt von der Ethikkommission)
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 (JADE) (BASEC)
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Untersuchte Krankheit(en)
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Untersuchte Intervention
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Ergebnisse der Studie
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