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NCT Number: NCT07812467

Rimegepant-Sensitized Neoadjuvant Chemoimmunotherapy for Oral or Oropharyngeal Squamous Cell Carcinoma

This study will evaluate whether adding rimegepant to standard neoadjuvant chemoimmunotherapy can improve treatment response in patients with primary or recurrent oral or oropharyngeal squamous cell carcinoma who are planned to undergo surgery.

Rimegepant blocks the receptor for calcitonin gene-related peptide, also known as CGRP. CGRP signaling may affect the tumor immune environment and the response of tumors to anticancer treatment.

The study includes an initial safety run-in stage involving 20 participants, followed by a randomized controlled stage involving 200 participants. During the randomized stage, participants will be assigned in a 1:1 ratio to receive standard neoadjuvant chemoimmunotherapy either with or without rimegepant. All participants will receive two cycles of neoadjuvant treatment followed by definitive or intended curative surgery.

The main outcome is the major pathological response rate, defined as 10% or less residual viable tumor in the surgical specimen. Other outcomes include pathological complete response, objective response, event-free survival, overall survival, changes in pain and quality of life, and treatment safety.

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Key information

Conditions

Oral Squamous Cell Carcinoma (OSCC) Carcinoma Carcinoma, Squamous Cell Head and Neck Neoplasms Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Glandular and Epithelial Oropharyngeal Squamous Cell Carcinoma (OPSCC) Squamous Cell Carcinoma of Head and Neck

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Age 18 to 75 years, regardless of sex.
  • Histologically or cytologically confirmed oral or oropharyngeal squamous cell carcinoma, including primary disease or recurrent disease after previous treatment that is considered amenable to repeat curative-intent resection.
  • Planned to receive neoadjuvant chemoimmunotherapy followed by surgery after multidisciplinary evaluation.
  • At least one evaluable lesion according to Response Evaluation Criteria in Solid Tumors version 1.1.
  • Eastern Cooperative Oncology Group performance status of 0 or 1.
  • Adequate major organ function.
  • Voluntary participation and provision of written informed consent.

Exclusion criteria

  • Severe cardiac, hepatic, or renal dysfunction.
  • Active autoimmune disease.
  • Pregnancy or breastfeeding.
  • Known allergy or hypersensitivity to rimegepant or any component of the planned neoadjuvant treatment.
  • Any condition that, in the investigator's judgment, makes the participant unsuitable for enrollment.

Treatment and study plan

Rimegepant

Drug

Rimegepant 75 mg will be administered orally every other day from the initiation until the completion of neoadjuvant chemoimmunotherapy.

Tislelizumab

Drug

Tislelizumab 200 mg will be administered by intravenous infusion on Day 1 of each 3-week treatment cycle for two cycles.

Nab-paclitaxel

Drug

Nab-paclitaxel 260 mg/m² will be administered by intravenous infusion on Day 2 of each 3-week treatment cycle for two cycles.

Cisplatin

Drug

A total dose of cisplatin 75 mg/m² will be administered intravenously over Days 2 and 3 of each 3-week treatment cycle for two cycles.

Primary outcomes

  1. Major Pathological Response Rate

    Time frame: At pathological assessment of the definitive surgical specimen after completion of two 3-week cycles of neoadjuvant treatment

    Percentage of participants with 10% or less residual viable tumor cells in the resected primary or recurrent tumor specimen after neoadjuvant treatment. For the randomized efficacy analysis, participants who do not undergo surgery or whose surgical specimens are not evaluable for pathological response will be considered not to have achieved major pathological response. Results will also be reported separately for participants with primary and recurrent disease.

Secondary outcomes

  1. Pathological Complete Response Rate

    Time frame: At pathological assessment of the definitive surgical specimen after completion of two 3-week cycles of neoadjuvant treatment

    Percentage of participants with no residual viable tumor cells in the resected primary or recurrent tumor specimen after neoadjuvant treatment, using the same pathological assessment scope as that used for major pathological response. Participants who do not undergo surgery or whose surgical specimens are not evaluable for pathological response will be considered not to have achieved pathological complete response in the randomized efficacy analysis.

  2. Objective Response Rate

    Time frame: From baseline to preoperative radiographic assessment after completion of two 3-week cycles of neoadjuvant treatment

    Percentage of participants with a complete response or partial response according to Response Evaluation Criteria in Solid Tumors version 1.1.

  3. Event-Free Survival

    Time frame: From randomization to the first event or censoring, assessed up to 5 years

    Event-free survival is defined as the time from randomization to the first occurrence of any of the following: disease progression during neoadjuvant treatment that precludes the planned definitive or intended curative surgery; locoregional recurrence or progression after surgery; distant metastasis or distant disease progression; or death from any cause. Participants without an event will be censored at the date of the last assessment confirming that they remained event-free.

  4. Overall Survival

    Time frame: From randomization until death or censoring, assessed up to 5 years

    Overall survival is defined as the time from randomization to death from any cause. Participants who are alive at the time of analysis will be censored at the date they were last known to be alive.

  5. Change From Baseline in Pain Score

    Time frame: At baseline, at the end of each neoadjuvant treatment cycle, and at the preoperative assessment

    Change from baseline in pain severity as assessed using the McGill Pain Questionnaire. Changes in pain scores will be compared between treatment groups at protocol-specified assessment time points.

  6. Change From Baseline in Quality of Life

    Time frame: At baseline, at the end of each neoadjuvant treatment cycle, and at the preoperative assessment

    Change from baseline in quality-of-life scores assessed using the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Core 30.

  7. Incidence of Treatment-Emergent Adverse Events

    Time frame: From signing informed consent through 90 days after the last dose of study treatment

    Incidence, type, and severity of treatment-emergent adverse events and serious adverse events, graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events version 5.0.

Other outcomes

  1. Change From Baseline in Peripheral Blood Immune Cell Subset Proportions Assessed by Multiparameter Flow Cytometry

    Time frame: At baseline; at the end of Cycle 1 (Day 21); at the end of Cycle 2 (Day 42); and on the day of definitive surgery before anesthesia

    Multiparameter flow cytometry will be used to quantify major immune cell subsets in peripheral blood mononuclear cells, including CD4+ T cells, CD8+ T cells, B cells, natural killer cells, and monocytes. Each immune cell subset will be reported as a percentage of total viable peripheral blood mononuclear cells. Changes from baseline will be reported in percentage points at each post-baseline assessment.

  2. Change From Baseline in Tumor-Infiltrating Immune Cell Subset Proportions Assessed by Single-Cell RNA Sequencing

    Time frame: At baseline, using the pretreatment biopsy obtained before Cycle 1, and at definitive surgery after completion of two 21-day cycles of neoadjuvant treatment

    Single-cell RNA sequencing will be used to quantify tumor-infiltrating immune cell subsets in paired pretreatment biopsy and definitive surgical specimens, including T cells, B cells, natural killer cells, macrophages, and other myeloid cells. Each immune cell subset will be reported as a percentage of all viable cells captured in the corresponding specimen. Changes from baseline will be reported in percentage points.

  3. CGRP Pathway Biomarkers

    Time frame: At baseline, using peripheral blood and the pretreatment tumor biopsy obtained before Cycle 1, and at definitive surgery after completion of two 21-day cycles of neoadjuvant treatment

    Changes in the expression of biomarkers related to the calcitonin gene-related peptide signaling pathway in tumor tissue and/or peripheral blood.

Study contacts

Contact information is provided by the study sponsor or research team.

Yu Zhang

CONTACT

[email protected]

+86-13818927554

Sponsors and collaborators

Lead sponsor

Shanghai Zhongshan Hospital

Other

Collaborators

  • Pfizer

Registry information

Official study title

A Phase II Randomized Controlled Clinical Trial of Rimegepant-Sensitized Neoadjuvant Chemoimmunotherapy in Patients With Oral/Oropharyngeal Squamous Cell Carcinoma

Important dates

Study start
2026
Primary completion
2028
Study completion
2033
First posted
Sep 10, 2026
Registry last updated
Sep 10, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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