Induction Chemoimmunotherapy to Prevent Laryngectomy in Advanced Laryngeal Cancer and Hypopharyngeal Cancer
NCT07923877, Phase 2, Not yet recruiting, Mayo Clinic
Trial 10
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
| Field | Value | Source |
|---|---|---|
| Title | Induction Chemoimmunotherapy to Prevent Laryngectomy in Advanced Laryngeal Cancer and Hypopharyngeal Cancer | ClinicalTrials.gov |
| NCT number | NCT07923877 | ClinicalTrials.gov |
| Status | Not yet recruiting | ClinicalTrials.gov |
| Phases | Phase 2 | ClinicalTrials.gov |
| Enrollment | 50 participants, estimated | ClinicalTrials.gov |
| Lead sponsor | Mayo Clinic | ClinicalTrials.gov |
| Conditions | Advanced Laryngeal Squamous Cell Carcinoma, Hypopharyngeal Squamous Cell Carcinoma, Stage III Laryngeal Cancer AJCC v8, Stage IV Laryngeal Cancer AJCC v8 | ClinicalTrials.gov |
| Interventions | Biospecimen Collection, Carboplatin, Chemotherapy, Cisplatin, Computed Tomography, Electronic Health Record Review, Intensity-Modulated Proton Therapy, Intensity-Modulated Radiation Therapy, Laryngectomy, Paclitaxel, Pembrolizumab, Positron Emission Tomography, Questionnaire Administration, Radiation Therapy | ClinicalTrials.gov |
| First posted | 2026-11-09 | ClinicalTrials.gov |
| Last updated | 2026-11-09 | ClinicalTrials.gov |
Registered outcomes 9
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description | Source |
|---|---|---|---|---|
| Primary | Laryngectomy free survival (LFS) | Up to 2 years | Defined as the time from registration to the earliest of laryngectomy or death from any cause, whichever occurs first | ClinicalTrials.gov |
| Secondary | Overall survival (OS) | Up to 2 years | Defined as the time from registration to death from any cause | ClinicalTrials.gov |
| Secondary | Progression-free survival (PFS) | Up to 2 years | Defined as the time from registration to the first occurrence of disease progression or death, whichever occurs first | ClinicalTrials.gov |
| Secondary | LFS among induction responders | Up to 2 years | 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 | ClinicalTrials.gov |
| Secondary | Pathologic response rate of laryngectomy patients only | Up to 2 years | 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. | ClinicalTrials.gov |
| Secondary | Partial pathologic response rate of laryngectomy patients only | Up to 2 years | 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. | ClinicalTrials.gov |
| Secondary | Radiographic response for all patients after induction | After induction, assessed up to 2 years | 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. | ClinicalTrials.gov |
| Secondary | Radiographic objective response rate | Up to 2 years | Will be evaluated using RECIST 1.1. Objective response defined as the proportion of patients achieving either CR or PR on imaging. | ClinicalTrials.gov |
| Secondary | Radiographic disease control rate | Up to 2 years | Will be evaluated using RECIST 1.1. Disease control defined as the proportion of patients who achieved CR, PR, or maintained SD. | ClinicalTrials.gov |
Outcomes 0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as | Source |
|---|
Results by group 0
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units | Source |
|---|
Participant flow 0
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted | Source |
|---|
Adverse events 0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events | Source |
|---|
Adverse event totals 0
The totals the trial posted for each group.
| Total | Group | Affected | At risk | Source |
|---|
Papers 0
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as | Source |
|---|
Grants 0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
| Project | Title | Principal investigators | Organization | Funder | Fiscal years | Source |
|---|
Trial comparisons 0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|
Tests 0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
| Test | Named as | Source |
|---|
Source 5
| Field | Value | Source |
|---|---|---|
| Release | trials-2026-11-12-0.4.0 | ClinicalTrials.gov |
| Release manifest SHA-256 | 0f4a8d8c48aee2a7573ae0fa94ecbeab70c1adbe449bbc95c424bc7d3e97b9d4 | ClinicalTrials.gov |
| Registry capture | 2026-11-12 | ClinicalTrials.gov |
| Results copy, AACT | 2026-03-23 | ClinicalTrials.gov |
| NIH clinical studies file | 2026-11-13 | ClinicalTrials.gov |
Release trials-2026-11-12-0.4.0
ClinicalTrials.gov's posted results, through CTTI's AACT: ClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299 ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
ClinicalTrials.gov: none stated ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
NIH RePORTER's clinical studies and project files: Public domain (NIH RePORTER)