New drug cocktail shows promise for tough head and neck cancer
NCT ID NCT05459129
First seen Jun 26, 2026 · Last updated Jun 26, 2026
Summary
This early-phase study tested combinations of immunotherapy drugs (atezolizumab and tiragolumab) plus chemotherapy (carboplatin and paclitaxel) in 12 people with advanced head and neck cancer that had not been treated before. The goal was to see if these combinations could completely eliminate the tumor before surgery. The study is complete, but results are still being analyzed to determine how well the treatments worked.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Atezolizumab, Tiragolumab, Carboplatin, Paclitaxel
- What this could lead to
- If successful, this could point toward more effective treatment combinations for advanced head and neck cancer.
- What could go wrong
- This is an early-phase trial with only 12 participants, so results are preliminary. The drug combinations may cause side effects and may not work for everyone.
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 1/2
Runs two stages together: safety and dose first, then whether the treatment works.
- Participants
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12 people
The number who actually took part.
- Started
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Apr 2023
- Finished
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Aug 2024
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
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: * Eastern Cooperative Oncology Group Performance Status of 0 or 1 * Histologically confirmed, resectable Stage III-IVA SCCHN * Eligible candidate for R0 resection with curative intent at the time of screening * HPV-negative test for oropharyngeal carcinoma, as determined locally by p16 immunohistochemistry (IHC), in situ hybridization, or polymerase chain reaction-based assay * Measurable disease (at least one target lesion), as assessed according to RECIST v1.1 * PD-L1 expression, defined as a combined positive score (CPS) \>= 1 * Adequate hematologic and end-organ function * Negative HIV test with the following exception: patients with a positive HIV test at screening are eligible provided they are stable on anti-retroviral therapy, have a CD4 count \>= 200/μL, and have an undetectable viral load. * Negative hepatitis B surface antigen (HBsAg) test at screening * Positive hepatitis B surface antibody (HBsAb) test at screening, or negative HBsAb at screening accompanied by either of the following: Negative total hepatitis B core antibody (HBcAb), Positive total hepatitis B core antibody (HBcAb) followed by a negative quantitative hepatitis B virus (HBV) DNA. Exclusion Criteria: * HPV-positive oropharyngeal cancer, as determined locally by p16 IHC, in situ hybridization, or by polymerase chain reactions-based assay * Distantly metastasized SCCHN * Any prior therapy for SCCHN, including immunotherapy, chemotherapy, or RT * Prior treatment with any of the protocol-specified study treatments * Treatment with investigational therapy within 42 days prior to initiation of study treatment * Treatment with systemic immunostimulatory agents within 4 weeks or 5 drug-elimination half-lives (whichever is longer) prior to initiation of study treatment * Prior allogeneic stem cell or solid organ transplantation * Treatment with systemic immunosuppressive medication within 2 weeks prior to initiation of study treatment * Treatment with a live, attenuated vaccine within 4 weeks prior to initiation of study treatment, or anticipation of need for such a vaccine during study treatment or within 5 months after the final dose of study treatment * Active or history of autoimmune disease or immune deficiency * History of idiopathic pulmonary fibrosis, organizing pneumonia, drug-induced pneumonitis, or idiopathic pneumonitis, or evidence of active pneumonitis on screening chest computed tomography (CT scan) * History of malignancy other than SCCHN within 5 years prior to screening, with the exception of malignancies with a negligible risk of metastasis or death (e.g., 5 -year OS rate\>90%) * Active tuberculosis * Severe infection within 4 weeks prior to initiation of study treatment * Treatment with therapeutic or prophylactic oral or intravenous (IV) antibiotics within 2 weeks prior to initiation of study treatment * Significant cardiovascular disease such a New York Heart Association cardiac disease (Class II or greater), myocardial infarction or cerebrovascular accident within 3 months prior to initiation of study treatment, unstable arrhytmia, or unstable angina * Major surgical procedure, other than for diagnosis, within 4 weeks prior to study initiation of study treatment, or anticipation of need for a major surgical procedure other than tumor resection, during the study * Any of other disease, metabolic dysfunction, physical examination finding, or clinical laboratory finding that contraindicates the use of investigational drug, may affect the interpretation of the results, impair the ability of the patient to participate in the study, or renders the patient at high risk form treatment complications * History of severe allergic reactions to chimeric or humanized antibodies or fusion proteins * Known hypersensitivity to Chinese hamster ovary cell products or recombinant human antibodies * Known allergy or hypersensitivity to any of the study drugs or their excipients * Known intolerance to any of the drugs required for premedication * Pregnancy or breastfeeding, or intention of becoming pregnant during the study * Eligible only for the control arm * Active EBV infection or known or suspected chronic EBV infection at screening Specific Exclusion Criteria for Atezo+Tira+CP: * Known severe allergy or hypersensitivity to placlitaxel, platinum or platinum-containing compounds * Known history of severe hypersensitivity to products containing Cremophor EL * Creatinine clearance \<45m./min (Calculated using the Cockcroft-Gault formula)
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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.
Contacts and locations
Locations
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Asan Medical Center
Seoul, 05505, South Korea
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City of Hope
Duarte, California, 91010, United States
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Hadassah University Hospital - Ein Kerem
Jerusaelm, 9112001, Israel
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Severance Hospital - Yonsei Cancer Center
Seoul, 03722, South Korea
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Thomas Jefferson University Hospital
Philadelphia, Pennsylvania, 19107, United States
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University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, 15213, United States
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Other studies related to the condition(s) this trial covers.
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