PDT For Induction Therapy For Head And Neck Cancer

Part of paid clinical trials in Boston, Massachusetts.

Sponsor
Massachusetts General Hospital
Study ID
NCT07214987
Phase
PHASE2
Status
Not Yet Recruiting

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Conditions

Eligibility Criteria

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

Interventions

  • Toripalimab-tpzi — DRUG
    Toripalimab-tpzi is a humanized IgG4 monoclonal antibody specific against human PD-1.
  • Cisplatin — DRUG
    Cisplatin is an injectable chemotherapy agent classified as a platinum-based alkylating agent.
  • Docetaxel — DRUG
    Docetaxel is a taxane chemotherapy agent.

Study Details

This research study is being done to assess the safety and tolerability of toripalimab in combination with cisplatin and docetaxel (PDT) induction therapy for patients with CPS-positive locally advanced head and neck squamous cell carcinoma (HNSCC).

Key Dates

Start date
Mar 9, 2026
Status verified
Jan 2026
Primary completion
Dec 31, 2027
Completion
Sep 1, 2029

Study Design

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

Arms

  • Experimental: PDT (cisplatin + docetaxel + toripalimab) induction therapy
    Toripalimab, cisplatin, and docetaxel will be given once every 21 days, +/- a window of 5 days, by intravenous infusion. On day 1 of each cycle, the pre-determined dose of toripalimab will be administered over about 60 minutes. The pre-determined dose of docetaxel will then be administered over about 1 hour. After docetaxel, the pre-determined dose of cisplatin will be administered over about 1-3 hours. This will continue for up to 3 cycles. Participants may be pre-medicated with drugs to reduce the chance of having a sensitivity reaction to the study treatment. The decision to pursue definitive chemoradiotherapy should be made by a multidisciplinary team specializing in treating head and neck cancers. For patients receiving chemoradiotherapy, the recommended concurrent chemotherapy regimen used with radiotherapy is weekly cisplatin.

Primary Outcome Measure

Proportion Grade 3-5 TRAE-free during induction therapy [ Time Frame: Day 1 of Cycle 1 (each cycle is 21 days) to Day 10 of Cycle 3 (end of induction therapy). ]

Central Contacts

Locations (2)

FacilityCityStateZIPSite coordinators
Dana-Farber Cancer InstituteBostonMassachusetts02215
Michael J Dennis, MD
[email protected]
617-632-3090
Michael J Dennis, MD (PRINCIPAL_INVESTIGATOR)
Massachusetts General HospitalBostonMassachusetts02114
Thomas Roberts, MD, MBA
[email protected]
617-726-5130
Thomas Roberts, MD, MBA (PRINCIPAL_INVESTIGATOR)

Find similar trials in Boston, MA

By condition
Head and neck cancerSkin cancer
By specialty
OncologyENTSkin cancerDermatology
By research site
Dana-Farber Cancer Institute· Boston, MAMassachusetts General Hospital· Boston, MA

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