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

NCT06256588 | Recruiting Phase 3 DMC FDA Drug

• 2 other identifiers: 2215302023-508613-17
• Study Type: interventional
• Target: 864
• Locations: 27 countries
• Sites: 240

Brief Summary

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)

Conditions

Neoplasms, Head and Neck

Keywords

JEMPERLI; Dostarlimab; Placebo; Chemoradiation; HNSCC

Outcome Measures

Primary Outcomes (1)

• Event-free Survival (EFS) Assessed by Blinded Independent Central Review (BICR)

  Event Free Survival (EFS) is defined as the time from the date of randomization to the date of an event, where an event is defined as locoregional progression or recurrence, or distant metastasis per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 as per BICR; Salvage surgery at the primary tumor site; Neck dissection or surgery performed \>20 weeks after completion of Concomitant Chemoradiotherapy (CRT) when invasive cancer is present or Death from any cause.

  Up to approximately 5 years

Secondary Outcomes (9)

• Overall Survival (OS)

  Up to approximately 5 years

• Event-free Survival (EFS) assessed by investigator

  Up to approximately 5 years

• Number of Participants with treatment emergent adverse events (TEAEs), Immune-mediated TEAEs, and serious adverse events (SAEs) by severity

  Up to approximately 5 years

• Number of Participants with TEAEs and SAEs leading to dose delays, withdrawals or death

  Up to approximately 5 years

• Number of participants with clinically significant changes in laboratory, vital signs, and safety assessment parameters

  Up to approximately 5 years

Study Arms (2)

Arm A: Dostarlimab

EXPERIMENTAL

Drug: Dostarlimab

Arm B: Placebo

PLACEBO COMPARATOR

Drug: Placebo

Interventions

Dostarlimab DRUG

Dostarlimab will be administered as an intravenous (IV) infusion

Arm A: Dostarlimab

Placebo DRUG

Placebo will be administered as an IV infusion

Arm B: Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify 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 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.

You may not qualify 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 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 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.

Sponsors & Collaborators

• GlaxoSmithKline: lead

Study Sites (240)

GSK Investigational Site

Jonesboro, Arkansas, 72401, United States

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Los Angeles, California, 90095, United States

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Solvang, California, 93463, United States

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Stockton, California, 95204, United States

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Torrance, California, 90505, United States

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Farmington, Connecticut, 06030-1628, United States

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New Haven, Connecticut, 06520, United States

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Washington D.C., District of Columbia, 20010, United States

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St. Petersburg, Florida, 33709, United States

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Tamarac, Florida, 33321, United States

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Atlanta, Georgia, 30322, United States

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Fort Wayne, Indiana, 46804, United States

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Iowa City, Iowa, 52242, United States

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Lexington, Kentucky, 40536, United States

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Columbia, Maryland, 21044, United States

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Worcester, Massachusetts, 01655-0002, United States

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St Louis, Missouri, 63110, United States

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Omaha, Nebraska, 68114, United States

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New York, New York, 10032, United States

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Cincinnati, Ohio, 45219, United States

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Charleston, South Carolina, 29425, United States

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Greenville, South Carolina, 29607, United States

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Chattanooga, Tennessee, 37404, United States

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Germantown, Tennessee, 38138, United States

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Nashville, Tennessee, 37203, United States

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Fort Worth, Texas, 76104, United States

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Fredericksburg, Virginia, 22408, United States

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Wytheville, Virginia, 24382, United States

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Tacoma, Washington, 98405, United States

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Buenos Aires, 1023, Argentina

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Buenos Aires, C1425, Argentina

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Buenos Aires, C1437GZT, Argentina

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Ciudad Autonoma de Buenos Aire, 1426, Argentina

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Córdoba, 5000, Argentina

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Rosario, S2002, Argentina

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San Juan, J5400, Argentina

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San Miguel de Tucumán, T4000GTB, Argentina

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Viedma, R8500ACE, Argentina

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Blacktown, New South Wales, 2148, Australia

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GSK Investigational Site

Douglas, Queensland, 4814, Australia

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GSK Investigational Site

Herston, Queensland, 4029, Australia

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Ballarat, Victoria, 3350, Australia

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Geelong, Victoria, 3220, Australia

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Melbourne, Victoria, 3004, Australia

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Brussels, 1200, Belgium

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Charleroi, 6060, Belgium

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Edegem, 2650, Belgium

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Ghent, 9000, Belgium

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Yvoir, 5530, Belgium

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Barretos, 14784-400, Brazil

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Belo Horizonte, 30110-022, Brazil

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Florianópolis, 88020-210, Brazil

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Ijuí, 98700-000, Brazil

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Jaú, 17210-120, Brazil

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Joinville, 89201-260, Brazil

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Natal, 59075-740, Brazil

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Porto Alegre, 90610-000, Brazil

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Salvador, 41253-190, Brazil

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Salvador, 41950-640, Brazil

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São José do Rio Preto, 15090-200, Brazil

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São Paulo, 01246-000, Brazil

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Vitória, 29043-260, Brazil

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Hamilton, Ontario, L8V 5C2, Canada

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Toronto, Ontario, M5G 2M9, Canada

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Montreal, Quebec, H3T 1E2, Canada

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Chongqing, Chongqing Municipality, 400030, China

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Beijing, 100036, China

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Changsha, 410013, China

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Changzhou, 213032, China

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Chengdu, 610000, China

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Chengdu, 610041, China

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Dongguan, 523059, China

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Fuzhou, 350005, China

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Fuzhou, 350014, China

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Guangzhou, 510503, China

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Hangzhou, 310003, China

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Hangzhou, 310022, China

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Hefei, 230001, China

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Hengyang, 421000, China

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Jinan, 250117, China

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Linyi, 276002, China

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Nanchang, 330006, China

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Nanchang, 330029, China

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Nanning, 530021, China

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Shanghai, 200032, China

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Taiyuan, 030013, China

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Wuhan, 430030, China

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Wuhan, 430079, China

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Xiamen, 361004, China

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Zhengzhou, 450052, China

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Zhuhai, 519001, China

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Olomouc, 779 00, Czechia

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Prague, 10034, Czechia

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Prague, 150 08, Czechia

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Prague, 180 81, Czechia

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Zlín, 76275, Czechia

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Caen, 14075, France

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Dijon, 21079, France

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Marseille, 13005, France

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Poitiers, 86021, France

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Quimper, 29000, France

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Rennes, 35042, France

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Rouen, 76038, France

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GSK Investigational Site

Vandœuvre-lès-Nancy, 54519, France

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Augsburg, 86156, Germany

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Berlin, 12351, Germany

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Berlin, 13353, Germany

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Erlangen, 91054, Germany

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Essen, 45147, Germany

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Giessen, 35392, Germany

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Hamburg, 22087, Germany

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Neuruppin, 16816, Germany

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Straubing, 94315, Germany

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Athens, 115 22, Greece

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Athens, 12462, Greece

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Larissa, 41100, Greece

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Thessaloniki, 564 29, Greece

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Győr, 9023, Hungary

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Kaposvár, 7400, Hungary

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Nyíregyháza, H-4400, Hungary

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Bengaluru, 560066, India

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Bhubaneswar, 751019, India

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Hyderabad, 500004, India

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Mumbai, 400012, India

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GSK Investigational Site

Nashik, 422002, India

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GSK Investigational Site

Nehru Nagar Belagavi Karnataka 590010, 590010, India

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Surat, 395002, India

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Vijayawada, 520002, India

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Ashdod, 7747629, Israel

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Haifa, 3109601, Israel

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Jerusalem, 9112001, Israel

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Tel Aviv, 64239, Israel

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GSK Investigational Site

Bologna, 40139, Italy

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Milan, 20133, Italy

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Milan, 20141, Italy

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Napoli, 80131, Italy

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Pavia, 27100, Italy

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Prato, 59100, Italy

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Roma, 00161, Italy

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Roma, 00168, Italy

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Rozzano MI, 20089, Italy

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Savona, 17100, Italy

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GSK Investigational Site

Aichi, 464-8681, Japan

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Aomori, 036-8563, Japan

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Chiba, 260-8717, Japan

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Chiba, 277-8577, Japan

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Ehime, 791-0280, Japan

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Fukuoka, 812-8582, Japan

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Gunma, 371-8511, Japan

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Hokkaido, 060-8648, Japan

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Hyōgo, 650-0017, Japan

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Hyōgo, 673-8558, Japan

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Kagoshima, 890-8520, Japan

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Kanagawa, 236-0004, Japan

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Kanagawa, 259-1193, Japan

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Kyoto, 612-8555, Japan

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Miyagi, 981-1293, Japan

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Niigata, 951-8520, Japan

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Numakunai, 028-3695, Japan

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Osaka, 541-8567, Japan

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Saitama, 350-1298, Japan

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Shizuoka, 411-8777, Japan

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Tokyo, 105-8471, Japan

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Tokyo, 113-8519, Japan

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Tokyo, 152-8902, Japan

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Tokyo, 160-0023, Japan

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Tottori, 683-8504, Japan

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GSK Investigational Site

Guadalajara, 44650, Mexico

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Mexico City, 06760, Mexico

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Mexico City, 11510, Mexico

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Oaxaca City, 68020, Mexico

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GSK Investigational Site

Bergen, 5021, Norway

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Oslo, 0379, Norway

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Troms, 9038, Norway

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Bielsko-Biala, 43-300, Poland

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Gliwice, 44-102, Poland

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Katowice, 40-514, Poland

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Olsztyn, 10-228, Poland

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Przemyśl, 37-700, Poland

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Siedlce, 08-110, Poland

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Warsaw, 04-141, Poland

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GSK Investigational Site

Coimbra, 3000-075, Portugal

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Faro, 8000-386, Portugal

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Lisbon, 1649-035, Portugal

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Lisbon, 1998-018, Portugal

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GSK Investigational Site

Matosinhos Municipality, 4464-509, Portugal

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Porto, 4200-072, Portugal

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Porto, 4200-319, Portugal

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Vila Nova de Gaia, 4434-502, Portugal

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Bucharest, 013823, Romania

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Bucharest, 020142, Romania

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Craiova, 200508, Romania

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Craiova, 200542, Romania

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Floreşti, 407280, Romania

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Iași, 700483, Romania

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Oradea, 410469, Romania

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Piteşti, 110283, Romania

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Suceava, 720214, Romania

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Timișoara, 300239, Romania

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GSK Investigational Site

Busan, 602-030, South Korea

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GSK Investigational Site

Pusan, 49241, South Korea

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Seoul, 03722, South Korea

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GSK Investigational Site

Seoul, 06351, South Korea

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GSK Investigational Site

Seoul, 110 744, South Korea

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Suwon Gyeonggi-do, 16247, South Korea

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BaracaldoVizcaya, 48903, Spain

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Barcelona, 08023, Spain

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Cartagena Murcia, 30202, Spain

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HebrOn, 08035, Spain

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Jerez de la Frontera, 11407, Spain

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L'Hospitalet de Llobrega, 08908, Spain

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Lugo, 27003, Spain

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Madrid, 28040, Spain

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Madrid, 28041, Spain

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Madrid, 28046, Spain

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Pamplona, 31008, Spain

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Salamanca, 37007, Spain

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Santander, 39008, Spain

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Zaragoza, 50009, Spain

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Gothenburg, SE-413 45, Sweden

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Stockholm, SE-171 64, Sweden

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Uppsala, SE-751 85, Sweden

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Changhua, 500, Taiwan

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Kaohsiung City, 833, Taiwan

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Taichung, 40447, Taiwan

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Taipei, 100, Taiwan

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Adapazarı, Turkey (Türkiye)

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Ankara, 06010, Turkey (Türkiye)

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Ankara, 06100, Turkey (Türkiye)

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GSK Investigational Site

Ankara, 06520, Turkey (Türkiye)

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Antalya, 7050, Turkey (Türkiye)

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Istanbul, 34010, Turkey (Türkiye)

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Istanbul, 34662, Turkey (Türkiye)

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GSK Investigational Site

Istanbul, Şişli, 34384, Turkey (Türkiye)

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Edinburgh, EH4 2XU, United Kingdom

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Gloucester, GL1 3NN, United Kingdom

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London, SW3 6JJ, United Kingdom

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Nottingham, NG5 1PB, United Kingdom

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Sutton, SM2 5PT, United Kingdom

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Wolverhampton, WV10 0QP, United Kingdom

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Related Publications (1)

• Siu LL, Burtness B, Harrington K, Psyrri A, Saba NF, Tahara M, Carlson G, Dhar A, Grimshaw M, Hua L, Iadevaia R, Theti D, Vlahovic G, Machiels JP. JADE: phase 3 study of sequential dostarlimab post chemoradiotherapy in patients with locally advanced unresected HNSCC. Future Oncol. 2026 Jan 30:1-8. doi: 10.1080/14796694.2026.2619653. Online ahead of print.

  PMID: 41612885 DERIVED

MeSH Terms

Conditions

Head and Neck Neoplasms; Squamous Cell Carcinoma of Head and Neck

Interventions

dostarlimab

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Carcinoma, Squamous Cell; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type

Central Study Contacts

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 Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 5, 2024
• First Posted: February 13, 2024
• Study Start: March 21, 2024
• Primary Completion (Estimated): June 30, 2028
• Study Completion (Estimated): October 26, 2029
• Last Updated: September 25, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: Anonymized IPD will be made available within 6 months of publication of primary, key secondary and safety results for studies in product with approved indication(s) or terminated asset(s) across all indications.
• Access Criteria: Anonymized IPD is shared with researchers whose proposals are approved by an Independent Review Panel and after a Data Sharing Agreement is in place. Access is provided for an initial period of 12 months but an extension may be granted, when justified, for up to 6 months.

Locations

DE (9); IT (10); RO (10); PT (8); SE (3); BE (5); JP (25); ES (14); HU (3); IL (4); GB (6); CA (3); KR (6); CZ (5); AR (9); US (29); GR (4); ME (4); PL (7); TW (4); FR (8); TU (8); CN (26); NO (3); IN (8); BR (13); AU (6)