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PDT Induction Therapy for Head and Neck Cancer

This study is testing a combination of three drugs – Toripalimab-tpzi, Cisplatin, and Docetaxel (PDT) – as an initial treatment for locally advanced head and neck squamous cell carcinoma (HNSCC). Toripalimab-tpzi is an immunotherapy that helps your immune system fight cancer. The main goal is to see how safe this combination is, specifically looking at the proportion of participants who don't experience severe side effects (Grade 3-5 TRAE-free) during the induction therapy. You may be eligible if you have a new diagnosis of certain types of head and neck squamous cell carcinoma and are at least 18 years old. The study aims to enroll 26 participants, and its current status is unclear.

Study design
This is a single-arm Phase II study, meaning all participants receive the same treatment. It plans to enroll 26 participants.
What's involved
Participants will receive treatment for three cycles or until their disease progresses, they have unacceptable side effects, or they withdraw. Each cycle is 21 days.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed for two years from registration.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT07214987

PDT For Induction Therapy For Head And Neck Cancer

Recruiting
PHASE2Ages 18+InterventionalTreatment
Massachusetts General Hospital
~26 participants
Updated 2026-07-14 on ClinicalTrials.gov
What's tested:Toripalimab-tpziCisplatinDocetaxel

At a glance

Recruiting sites
2 of 2 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Proportion Grade 3-5 TRAE-free during induction therapy
Measured over Day 1 of Cycle 1 (each cycle is 21 days) to Day 10 of Cycle 3 (end of induction therapy).

Conditions

Squamous Cell Carcinoma
Head and Neck Cancer Squamous Cell Carcinoma
Head and Neck Cancer

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Head and Neck Squamous Cell CarcinomaHPVProgrammed Cell Death 1 Ligand 1

Where it's being run

2 sites across 1 states
Massachusetts2

Study leadership

  • Thomas Roberts, MD, MBA · PRINCIPAL_INVESTIGATOR · Massachusetts General Hospital

Who to contact

Thomas Roberts, MD, MBA
[email protected]
617-726-5130
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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:
Participants with a prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or efficacy assessment of the investigational regimen are eligible for this trial.
Because immunotherapy agents as well as cisplatin and docetaxel are known to be teratogenic, women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation. Should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this study, she should inform her treating physician immediately. Men treated or enrolled on this protocol must also agree to use adequate contraception prior to the study, for the duration of study participation, and 4 months after completion of toripalimab administration.
Ability to understand and the willingness to sign a written informed consent document.

Exclusion

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.
An autoimmune condition requiring treatment with systemic corticosteroids within the past 30 days. Long-term steroid replacement for patients with adrenal insufficiency is allowed.
Any second malignancy that required antineoplastic therapy in the previous 6 months.
Participants receiving any medications or substances that are moderate or strong inhibitors or inducers of CYP3A4 are ineligible. Because the lists of these agents are constantly changing, it is important to regularly consult a frequently updated medical reference. As part of the enrollment/informed consent procedures, the participant will be counseled on the risk of interactions with other agents, and what to do if new medications need to be prescribed or if the participant is considering a new over-the-counter medicine or herbal product.
Pregnant women are excluded from this study because toripalimab, cisplatin and docetaxel have the potential for teratogenic or abortifacient effects. Because there is an unknown but potential risk for adverse events in nursing infants secondary to treatment of the mother with toripalimab, cisplatin and docetaxel, breastfeeding should be discontinued if the mother is treated with toripalimab. These potential risks may also apply to other agents used in this study.

What this trial measures

  • Proportion Grade 3-5 TRAE-free during induction therapyDay 1 of Cycle 1 (each cycle is 21 days) to Day 10 of Cycle 3 (end of induction therapy).

    Assessed using NCI Common Terminology for Adverse Event (CTCAE) version 5.0. The rate of patients with grade 3+ TRAEs-free during induction therapy will be summarized as a proportion with a corresponding exact 95% confidence interval (CI) (if the trial closes to accrual after the first stage), or a proportion with a corresponding 95% two-stage confidence interval (CI) if the trial closes to accrual after the second stage.