RecruitingSquamous Cell CarcinomaHead and Neck Cancer Squamous Cell CarcinomaHead and Neck Cancer
PDT For Induction Therapy For Head And Neck Cancer
Eligible age
18+ yrs
Accepts
All genders
Locations
1 state
Healthy volunteers
No
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About this study
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).
Sponsor: Massachusetts General Hospital
You may qualify if…
- ✓ Participants must have a new diagnosis of histologically or cytologically confirmed squamous cell carcinoma (SCC) of the oral cavity, oropharynx, hypopharynx, larynx, nasopharynx, sinonasal cavities or unknown primary HNSCC.
- ✓ Participants with HPV-independent SCC or HNSCC or other head and neck subsites must have stage III or non-metastatic stage IV at the time of diagnosis. Participants with HPV-associated oropharynx SCC must have stage II or stage III disease.
- ✓ Participants must be determined by the investigator to be candidates for induction systemic therapy due to reasons such as the extent of primary tumor at the time of diagnosis, rate of progression, symptom burden or potential benefit of cytoreduction prior to definitive local therapy.
- ✓ CPS ≥ 1%
- ✓ Age ≥18 years. Because no dosing or adverse event data are currently available on the use of toripalimab in combination with cisplatin and docetaxel in participants \<18 years of age, children are excluded from this study, but will be eligible for future pediatric trials.
- ✓ ECOG performance status ≤ 1
- ✓ Life expectancy of greater than 12 weeks.
- ✓ Participants must meet the following organ and marrow function as defined below:
You may not qualify if…
- ✕ Diagnosis of EBV-associated nasopharynx squamous cell carcinoma
- ✕ Strong clinical suspicion or histologic confirmation of cutaneous squamous cell carcinoma
- ✕ Histology other than squamous cell carcinoma.
- ✕ Proven distant metastases (below the clavicle) by clinical or radiographic measures.
- ✕ Prior radiotherapy to the head and/or neck with the exception of radiation for cutaneous malignancies involving radiation fields that do not overlap with areas of current disease involvement.
- ✕ Pre-existing peripheral neuropathy CTCAE grade 2 or higher
- ✕ Participants who are receiving any other investigational agents for this condition.
- ✕ History of allergic reactions attributed to compounds of similar chemical or biologic composition to toripalimab, cisplatin or docetaxel.
Where it's recruiting
Massachusetts
Boston
Source: ClinicalTrials.gov · NCT07214987 · last updated 2026-07-14