Evaluation of the Efficacy and Safety of Nivolumab Neoadjuvant Treatment of Patients With Locally Advanced Oral Squamous Cell Carcinoma

Sponsor
Prof. Lars Olaf Cardell
Study ID
NCT07514767
Phase
PHASE2
Status
Not Yet Recruiting

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Conditions

  • Oral Squamous Cell Carcinoma (OSCC)

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Nivolumab (240 mg) — DRUG
    Nivolumab at day 1 and day 15 prior to the curative standard of care surgery.

Study Details

This is a Phase II, single-centre, non-randomized, single-arm clinical trial to investigate the efficacy and safety of neoadjuvant nivolumab therapy in adult participants with resectable, locoregionally advanced Oral Squamous Cell Carcinoma (OSCC) tumors. Identification of predictive molecular biomarkers of tumor response to treatment will also be performed.

Key Dates

Start date
May 1, 2026
Status verified
Apr 2026
Primary completion
Sep 30, 2028
Completion
Sep 30, 2033

Study Design

Enrollment
60 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Neoadjuvant treatment
    Drug:Nivolumab

Primary Outcome Measure

Frequency of response [ Time Frame: From start of neoadjuvant treatment to end of neoadjuvant treatment (before surgery), up to approximately 4 weeks ]

Central Contacts