NCT07923877Not yet recruitingPhase 2
Induction Chemoimmunotherapy to Prevent Laryngectomy in Advanced Laryngeal Cancer and Hypopharyngeal Cancer
Induction Bio-Selection Organ Preservation for Advanced Laryngeal Cancer (IBOP)
Source: ClinicalTrials.gov · Last updated 9 Nov 2026
Brief summary (registry, in English)
This phase II trial tests the effect of early (induction) standard chemoimmunotherapy with carboplatin, paclitaxel and pembrolizumab in preventing more extensive surgery to remove the voice box (laryngectomy), in patients with laryngeal squamous cell cancer that may have spread from where it first started to nearby tissue, lymph nodes, or distant parts of the body (advanced) or hypopharyngeal cancer of any stage. Carboplatin is in a class of medications known as platinum-containing compounds. It works in a way similar to the anticancer drug cisplatin, but may be better tolerated than cisplatin. Carboplatin works by killing, stopping or slowing the growth of tumor cells. Paclitaxel is in a class of medications called antimicrotubule agents. It stops tumor cells from growing and dividing and may kill them. Immunotherapy with monoclonal antibodies, such as pembrolizumab, may help the body's immune system attack the tumor, and may interfere with the ability of tumor cells to grow and spread. Response to treatment with chemoimmunotherapy may help guide further treatment, such as radiation therapy with or without cisplatin. Intensity-modulated radiation therapy (IMRT) is a type of 3-dimensional radiation therapy that uses computer-generated images to show the size and shape of the tumor. Thin beams of radiation of different intensities are aimed at the tumor from many angles. This type of radiation therapy reduces the damage to healthy tissue near the tumor. Intensity-modulated proton therapy is a type of proton beam radiation therapy that uses precise proton beams to target tumors while sparing the surrounding healthy tissue. Cisplatin is in a class of medications known as platinum-containing compounds. It works by killing, stopping or slowing the growth of tumor cells. Giving induction chemoimmunotherapy with carboplatin, paclitaxel and pembrolizumab may be an effective strategy to prevent more invasive treatments, such as a laryngectomy, while improving both survival and quality of life in patients with advanced laryngeal squamous cell carcinoma and hypopharyngeal squamous cell carcinoma.
- Status (registry)
- Not yet recruiting
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 50 (estimated)
- First submitted
- 29 Oct 2026
- Start date
- 1 Nov 2026
- Primary completion date
- 28 Feb 2031
- Lead sponsor
- Mayo Clinic
- Diseases
- Head and neck cancer
- NCT number
- NCT07923877
What you commit to
- Study type: Interventional · Phase 2
- Planned participants: 50
- From 1 Nov 2026 to the primary completion date, 28 Feb 2031
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study design.
AI-kivonat: who the study is looking for
Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for adults with squamous cell cancer of the larynx (voice box) or hypopharynx. It tests chemoimmunotherapy first, to try to avoid removing the voice box.
- Age
- 18 years or older
- Sex
- All sexes can join
- Disease stage
- Squamous cell cancer of the larynx that is cT2N+ or cT3-4N any, or any hypopharynx cancer of any stage. No distant spread (M0) on PET/CT or PET. New diagnosis, or earlier endoscopic resection only.
- Earlier treatment
- No earlier drug treatment for this cancer. No earlier radiation to the head and neck, except 30 Gy or less.
Main reasons for not taking part
- Pregnant or nursing, or unwilling to use adequate contraception
- Heart attack in the last 6 months, or uncontrolled illness such as active infection or heart failure
- Another cancer whose treatment could interfere with this trial
- Active autoimmune disease or other reason not to receive immunotherapy
- ECOG performance status above 2
Read by machine on 10 Nov 2026.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Co-morbid systemic illnesses or other severe concurrent diseases which, in the judgment of the investigator, would make the patient inappropriate for entry into this study or interfere significantly with the proper assessment of safety and toxicity of the prescribed regimens
- Prior radiation to the head and neck area with exception of ≤ 30 Gy
- Any patient who has concurrent illness that would make them ineligible for chemotherapy per medical oncology evaluation
- Prior systemic treatment specifically for this larynx/hypopharynx cancer
- Any contraindications to receiving immunotherapy such as active autoimmune disease, recent organ transplantation deemed too risky for immunotherapy use, or other medical conditions that would make the patient ineligible for immunotherapy as deemed per medical oncology
Other illness
- Uncontrolled intercurrent illness including, but not limited to:
- Ongoing or active infection
- Symptomatic congestive heart failure
- Unstable angina pectoris
- Cardiac arrhythmia
- Or psychiatric illness/social situations that would limit compliance with study requirements
- History of myocardial infarction ≤ 6 months, or congestive heart failure requiring use of ongoing maintenance therapy for life-threatening ventricular arrhythmias
- Any malignancy for which the treatment may interfere with ability to deliver treatment paradigm on trial
Other
- Any of the following:
- Pregnant persons
- Nursing persons
- Persons of childbearing potential (and persons able to father a child) who are unwilling to employ adequate contraception
Who the study is looking for
- Age ≥ 18 years
- Histological confirmation of squamous cell carcinoma of larynx or hypopharynx. Larynx squamous cell carcinoma is ≥ cT2N+ or cT3-4N any, or any hypopharynx cancer regardless of stage. Individuals with a new diagnosis or who were previously treated with endoscopic resections alone are eligible
- Eastern Cooperative Oncology Group (ECOG) performance status (PS) ≤ 2
- Negative pregnancy test done ≤ 7 days prior to registration, for persons of childbearing potential only
- Ability to complete questionnaire(s) by themselves or with assistance
- Provide written informed consent
- Willing to return to enrolling institution for follow-up (during the active monitoring and follow-up phase of the study)
- Willing to provide mandatory tissue and/or blood samples for correlative research purposes
- Confirmation of no evidence of distant metastasis (M0 as defined in American Joint Committee on Cancer [AJCC] 8th edition) by PET/CT or PET
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Mayo Clinic in Rochester | Rochester | United States | Unknown status |
The registry text, word for word
This page is information, not medical advice. Discuss any trial with your doctor.