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Chemoradiotherapy arm

Phase 2

Oropharyngeal Squamous Cell Carcinoma | Small molecule | Oncology |AstraZeneca PLC|Last Updated: Aug 8, 2025

Development status

Highest phase Phase 2
Registered trials 1 across 1 sponsor since Aug 2018

Success Probability

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Market & Valuation

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Trial Design

RandomizedCONTROLLEDDMCBiomarker
Total Trials1
Total Enrollment11

FDA Designations

No designations recorded

Clinical trial landscape

Chemoradiotherapy arm · 1 trial · 1 indication

Phase 2 1
NCT03623646Cisplatin or ImmunoTHerapy in Association With Definitive Radiotherapy in HPV-related oropharyngEal Squamous Cell Carcinoma: a Randomized Phase II Trial.Oropharyngeal Squamous Cell Carcinoma
COMPLETED11 Analytics
PHASE2COMPLETED
Cisplatin or ImmunoTHerapy in Association With Definitive Radiotherapy in HPV-related oropharyngEal Squamous Cell Carcinoma: a Randomized Phase II Trial.
Oropharyngeal Squamous Cell Carcinoma
NCT0362364611
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Study Endpoints

Primary Endpoints

The rate of patients alive without progression at 12 months.
12 months for each patient

Secondary Endpoints

Progression-free survival.
24 months for each patient
Overall survival.
24 months for each patient
Safety will be evaluated using National Cancer Institute Common Toxicity Criteria Adverse Event (NCI-CTCAE) version 4.03.
24 months for each patient
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Study Design & Arms

AllocationRANDOMIZED
MaskingNONE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Arm A (standard arm): Chemoradiotherapy armOTHER -
Arm B (Experimental arm): Immunotherapy + Radiotherapy armEXPERIMENTAL -

Interventions

NameTypeDescription
Chemoradiotherapy armDRUGRadiation Therapy in combination with Chemotherapy (Cisplatin)
Immunotherapy + Radiotherapy armDRUGRadiation Therapy in combination with Immunotherapy drug (Durvalumab)
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Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites2

Inclusion Criteria: 1. Newly diagnosed, histologically proven squamous cell carcinoma of oropharynx T1 N1-N2 or T2-T3 N0 to N2 (AJCC 2018) 2. HPV positive status (positive staining for p16 in immunochemistry) 3. Presence of at least one measurable lesion according to RECIST v1.1 criteria (longest d...

Countries:France
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