Immunotherapy-Chemo cocktail aims to tame head and neck tumors
NCT ID NCT07214987
First seen Jun 25, 2026 · Last updated Jul 15, 2026 · Updated 3 times
Summary
This phase 2 trial tests whether adding the immunotherapy drug toripalimab to standard chemotherapy (cisplatin and docetaxel) is safe and tolerable as an initial treatment for people with advanced head and neck cancer. The study enrolls 26 adults whose tumors have a certain protein marker (CPS-positive). The goal is to see if this combination can control the disease before patients undergo surgery or radiation, with fewer severe side effects.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- toripalimab (an immunotherapy drug) combined with cisplatin and docetaxel (chemotherapy drugs)
- What this could lead to
- If successful, this combination could become a safer and more effective induction therapy before surgery or radiation, potentially improving outcomes for patients with advanced head and neck cancer.
- What could go wrong
- This is a small, early-phase trial (26 participants) focused on safety and tolerability, not yet on long-term cure. The drug combination may still cause serious side effects, and results may not apply to all patients.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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About 26 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Mar 2026
- Expected to finish
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Sep 2029
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * 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: Hemoglobin ≥8.0 g/dL absolute neutrophil count ≥1500/mcL platelets ≥100,000/mcL total bilirubin ≤ 2 institutional upper limit of normal (ULN) AST(SGOT)/ALT(SGPT) ≤ 2 × institutional ULN creatinine ≤ 2 x institutional ULN OR glomerular filtration rate (GFR) ≥ 45 mL/min/1.73 m2 * 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 Criteria: * 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.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
2 sites. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Dana-Farber Cancer Institute
RECRUITINGBoston, Massachusetts, 02215, United States
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Massachusetts General Hospital
RECRUITINGBoston, Massachusetts, 02114, United States
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- Experimental pill HG146 put to the test against rare head and neck cancer
- Can a dental assistant keep cancer Patients' mouths healthier during radiation?
- Why do Non-Smokers get head and neck cancer? scientists probe tumor DNA
- Re-irradiation plus cetuximab targets head and neck tumors that return
- Sharper tumor maps: PET scans could tighten radiation beams
- Five days of radiation instead of weeks: a new test for head and neck cancer