A Phase 2 interventional study of Biospecimen Collection and Carboplatin in Advanced Laryngeal Squamous Cell Carcinoma, Hypopharyngeal Squamous Cell Carcinoma and Stage III Laryngeal Cancer AJCC v8, sponsored by Mayo Clinic. Not yet recruiting at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-11-09.
Sponsored by Mayo Clinic · Phase 2, Interventional, and Treatment
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.
2,018 studies on the registry are indexed under Squamous Cell Carcinoma of Head and Neck; 573 are open to participants now.
This study's planned enrollment of 50 is close to the median of 48 across 1,653 interventional studies indexed under Squamous Cell Carcinoma of Head and Neck.
Browse Squamous Cell Carcinoma of Head and Neck studies →Mayo Clinic is the lead sponsor of 3,269 studies on the registry; 672 are open to participants now.
Of its 452 completed or terminated interventional studies of FDA-regulated products, 321 (71%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Any of the following:
Uncontrolled intercurrent illness including, but not limited to:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.
Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
ECOG performance status
A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.
Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Childbearing potential
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Metastases
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Autoimmune disease
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Patients receive induction therapy with carboplatin, paclitaxel IV and pembrolizumab IV over 30 minutes every 3 weeks for up to 2-3 cycles. After induction, patients undergo standard of care laryngectomy followed by adjuvant RT and chemotherapy if indicated. Additionally, patients undergo blood and drain fluid sample collection, CT, and PET/CT throughout the study.
Procedure: Biospecimen Collection · Drug: Carboplatin · Drug: Chemotherapy · Procedure: Computed Tomography · Other: Electronic Health Record Review · Procedure: Laryngectomy · Drug: Paclitaxel · Biological: Pembrolizumab · Procedure: Positron Emission Tomography · Other: Questionnaire Administration · Radiation: Radiation Therapy
Patients receive induction therapy with carboplatin, paclitaxel IV and pembrolizumab IV over 30 minutes every 3 weeks for up to 2-3 cycles. After induction, patients undergo IMRT or intensity modulated proton therapy QD on Monday-Friday weekly for up to 18 treatment fractions. Patient may also receive cisplatin IV over 30 minutes to 4 hours weekly during radiation therapy. Additionally, patients undergo blood sample collection, CT, and PET/CT throughout the study.
Procedure: Biospecimen Collection · Drug: Carboplatin · Drug: Cisplatin · Procedure: Computed Tomography · Other: Electronic Health Record Review · Procedure: Intensity-Modulated Proton Therapy · Radiation: Intensity-Modulated Radiation Therapy · Drug: Paclitaxel · Biological: Pembrolizumab · Procedure: Positron Emission Tomography · Other: Questionnaire Administration
Undergo blood and drain fluid sample collection
Also known as: Biological Sample Collection, Biospecimen Collected, Sample Collection, Specimen Collection
Given IV
Also known as: Blastocarb, Carboplat, Carboplatin Hexal, Carboplatino, Carboplatinum, Carbosin, Carbosol, Carbotec, CBDCA, Displata, Ercar, JM-8, JM8, Nealorin, Novoplatinum, Paraplatin, Paraplatin AQ, Paraplatine, Platinwas, Ribocarbo
Given chemotherapy
Also known as: Chemo, Chemotherapy (NOS), Chemotherapy, Cancer, General
Given IV
Also known as: Abiplatin, Blastolem, Briplatin, CDDP, Cis-diammine-dichloroplatinum, Cis-diamminedichloridoplatinum, Cis-diamminedichloro Platinum (II), Cis-diamminedichloroplatinum, Cis-dichloroammine Platinum (II), Cis-platinous Diamine Dichloride, Cis-platinum, Cis-platinum II, Cis-platinum II Diamine Dichloride, Cismaplat, Cisplatina, Cisplatinum, Cisplatyl, Citoplatino, Citosin, Cysplatyna, DDP, Lederplatin, Metaplatin, Neoplatin, Peyrone's Chloride, Peyrone's Salt, Placis, Plastistil, Platamine, Platiblastin, Platiblastin-S, Platinex, Platinol, Platinol- AQ, Platinol-AQ, Platinol-AQ VHA Plus, Platinoxan, Platinum, Platinum Diamminodichloride, Platiran, Platistin, Platosin
Undergo CT and PET/CT
Also known as: CAT, CAT Scan, Computed Axial Tomography, Computerized Axial Tomography, Computerized axial tomography (procedure), Computerized Tomography, Computerized Tomography (CT) scan, CT, CT Scan, Diagnostic CAT Scan, Diagnostic CAT Scan Service Type, tomography
Ancillary studies
Undergo intensity-modulated proton therapy
Also known as: IMPT
Undergo IMRT
Also known as: IMRT, Intensity modulated radiation therapy (procedure), Intensity Modulated RT, Intensity-Modulated Radiotherapy, Radiation, Intensity-Modulated Radiotherapy
Undergo laryngectomy
Given IV
Also known as: Anzatax, Asotax, Bristaxol, Praxel, Taxol, Taxol Konzentrat
Given IV
Also known as: BCD-201, GME 751, GME751, Keytruda, Lambrolizumab, MK 3475, MK-3475, MK3475, Pembrolizumab Biosimilar BCD-201, Pembrolizumab Biosimilar GME751, Pembrolizumab Biosimilar QL2107, Pembrolizumab Biosimilar RPH-075, Pembrolizumab Biosimilar SB27, QL2107, RPH 075, RPH-075, RPH075, SB 27, SB-27, SB27, SCH 900475, SCH-900475, SCH900475
Undergo PET/CT
Also known as: Medical Imaging, Positron Emission Tomography, PET, PET Scan, Positron emission tomography (procedure), Positron Emission Tomography Scan, Positron-Emission Tomography, PT
Ancillary studies
Undergo adjuvant RT
Also known as: Cancer Radiotherapy, Energy Type, ENERGY_TYPE, Irradiate, Irradiated, Irradiation, Radiation, Radiation Therapy, NOS, Radiotherapeutics, Radiotherapy, RT, Therapy, Radiation
Laryngectomy free survival (LFS)
Defined as the time from registration to the earliest of laryngectomy or death from any cause, whichever occurs first
Time frame: Up to 2 years
Overall survival (OS)
Defined as the time from registration to death from any cause
Time frame: Up to 2 years
Progression-free survival (PFS)
Defined as the time from registration to the first occurrence of disease progression or death, whichever occurs first
Time frame: Up to 2 years
LFS among induction responders
Will be evaluated among patients with a functional larynx after induction therapy who proceed to definitive radiation-based treatment. LFS is defined as the time from registration to the earliest of laryngectomy or death from any cause, whichever occurs first
Time frame: Up to 2 years
Pathologic response rate of laryngectomy patients only
Will define pathologic complete response (pCR) as the absence of residual invasive carcinoma in the laryngectomy specimen and all resected regional lymph nodes. Will document partial pathologic responses for those who have residual tumor, such as major pathologic response (MPR) defined as ≤ 10% viable tumor cells remaining in the resected tissue (indicating an almost complete tumor kill), or incomplete pathologic response defined as cases with more than 10% residual tumor (any case that is not pCR or MPR). pCR will be a dichotomous outcome (pCR versus no pCR) for analysis purpose, and the number of patients who achieve pCR and the pCR rate among those who had surgery will be reported. MPR will be reported in a similar manner.
Time frame: Up to 2 years
Partial pathologic response rate of laryngectomy patients only
Will define partial pathologic responses for those who have residual tumor, such as major pathologic response (MPR), as ≤ 10% viable tumor cells remaining in the resected tissue (indicating an almost complete tumor kill), or incomplete pathologic response defined as cases with more than 10% residual tumor (any case that is not pCR or MPR). MPR will be a dichotomous outcome (MPR versus no MPR) for analysis purpose, and the number of patients who achieve MPR and the MPR rate among those who had surgery will be reported.
Time frame: Up to 2 years
Radiographic response for all patients after induction
Will be evaluated using Response Evaluation Criteria in Solid Tumors (RECIST) 1.1. Complete response (CR), partial response (PR), progressive disease (PD), and stable disease (SD) will be determined for each patient by comparing the post-induction to the pre-induction scan.
Time frame: After induction, assessed up to 2 years
Radiographic objective response rate
Will be evaluated using RECIST 1.1. Objective response defined as the proportion of patients achieving either CR or PR on imaging.
Time frame: Up to 2 years
Radiographic disease control rate
Will be evaluated using RECIST 1.1. Disease control defined as the proportion of patients who achieved CR, PR, or maintained SD.
Time frame: Up to 2 years
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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Studies of the drug tested here: Cisplatin
Squamous Cell Carcinoma of Head and Neck →