Could immunotherapy spare throat cancer patients from losing their voice?
NCT ID NCT07423078
First seen Jun 26, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This phase 2 trial is testing whether adding the immunotherapy drug toripalimab to standard chemotherapy can help people with advanced laryngeal or hypopharyngeal cancer avoid having their voice box removed. The study will enroll 87 adults whose cancer has not been treated before. Researchers will track how many patients are alive and cancer-free after one year, and how many keep their larynx.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Toripalimab (a type of immunotherapy) combined with chemotherapy (carboplatin or cisplatin and paclitaxel)
- What this could lead to
- If successful, this could offer a way to treat advanced laryngeal cancer without removing the voice box, preserving speech and swallowing.
- What could go wrong
- This is a small, early-phase trial, so results may not apply broadly. The combination therapy may cause side effects like immune reactions or nerve damage.
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 87 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Apr 2026
- Expected to finish
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Apr 2031
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: 1. Pathologically confirmed and previously untreated squamous cell carcinoma of the larynx or hypopharynx 2. AJCC 8th Edition Stage III - IV disease (T1-T2/N1-N3, T3-T4/N0-N3) 3. Disease (primary \& nodal) must be potentially surgically resectable and curable with conventional surgery and CRT 4. ECOG PS 0 - 2 5. Sexually active fertile subjects and their partners must agree to use highly effective method of contraception prior to study entry, during the course of the study, and for 1 year after the last dose of treatment (whichever is later). An additional contraceptive method, such as a barrier method (e.g., condom), is required. In addition, men must agree not to donate sperm and women must agree not to donate eggs (ova, oocyte) for the purpose of reproduction during these same periods. 6. Female subjects of childbearing potential must not be pregnant or breastfeeding at screening. Female subjects are considered to be of childbearing potential unless one of the following criteria is met: Permanent sterilization (hysterectomy, bilateral salpingectomy, or bilateral oophorectomy) or documented postmenopausal status (defined as 12 months of amenorrhea in a woman \> 45 years-of-age in the absence of other biological or physiological causes). Note: Documentation may include review of medical records, medical examination, or medical history interview by study site staff. 7. Must have normal organ and marrow function as defined below: * Hemoglobin ≥ 9.0 g/dL * Absolute neutrophil count ≥ 1,500/mcL * Platelet count ≥ 100,000/mcL * Total bilirubin ≤ 1.5 X the institutional upper limit of normal (ULN) * AST (SGOT) ≤ 2.5 X institutional upper limit of normal (ULN) * ALT (SGPT) ≤ 2.5 X institutional ULN * Creatinine clearance ≥ 40 mL/min/1.73 m2 for patients with a creatinine level above institutional normal 8. Must have the ability to understand and the willingness to sign a written informed consent document. Exclusion Criteria: 1. Prior treatment for head and neck cancer 2. Unresectable laryngeal or hypopharyngeal squamous cell carcinoma 3. Distant metastatic disease 4. Has an active autoimmune disease requiring systemic treatment within the past 3 months, or a syndrome that requires ongoing systemic steroids or immunosuppressive agents. Subjects with vitiligo, Grave's disease, or psoriasis not requiring systemic therapy or resolved childhood asthma/atopy would be an exception to this rule. Subjects that require intermittent use of bronchodilators or local steroid injections would not be excluded from the study. Subjects with hypothyroidism or Sjogren's syndrome will not be excluded from the study. 5. Has a history of non-infectious pneumonitis that required steroids, evidence of interstitial lung disease, or currently active non-infectious pneumonitis. 6. Known allergy or hypersensitivity to carboplatin or cisplatin, toripalimab, or paclitaxel. 7. Prior malignancy within 2 years that in the investigator's opinion would be likely to affect the outcomes for the patient. 8. Peripheral sensory neuropathy \> grade 2 by CTCAE v5.0 9. Has a history or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the trial, interfere with the subject's participation for the full duration of the trial, or is not in the best interest of the subject to participate, in the opinion of the treating investigator. 10. Has acute or chronic active hepatitis B and C virus infection or known history of untreated hepatitis B (defined as hepatitis B surface antigen \[HBsAg\] reactive) or known active hepatitis C virus (HCV) (defined as HCV RNA \[qualitative\]) or HIV infection (see note). 1. Note: No testing for Hepatitis B, Hepatitis C, or HIV is required unless mandated by local health authority or clinically indicated. 2. Note: Participants with a history of HIV infection are considered eligible if CD4+ T cell counts are ≥350 cells/µL and the patient has had no opportunistic infections in the last 12 months.
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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
1 site. 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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UPMC Hillman Cancer
RECRUITINGPittsburgh, Pennsylvania, 15213, United States
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