PDT For Induction Therapy For Head And Neck Cancer
Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorMassachusetts General Hospital
About this trial
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).
Eligibility criteria
Qualifiers
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%
Disqualifiers
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.
Trial design
Treatments tested in this trial
- Toripalimab-tpzi
- Cisplatin
- Docetaxel
Treatment groups
26 Participants
are divided into 1 treatment groupSponsors and collaborators
Massachusetts General Hospital
Lead sponsor
Coherus Oncology, Inc.
Collaborator
Source ClinicalTrials.gov