A Phase 2 interventional study of Rimegepant and Tislelizumab in Oral Squamous Cell Carcinoma (OSCC) and Oropharyngeal Squamous Cell Carcinoma (OPSCC), sponsored by Shanghai Zhongshan Hospital. Not yet recruiting at 1 site in China. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2026-09-10.
Sponsored by Shanghai Zhongshan Hospital · Phase 2, Interventional, and Treatment
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.
Exclusion Criteria:
Twenty participants will receive rimegepant plus standard neoadjuvant chemoimmunotherapy for two 3-week cycles, followed by definitive or intended curative surgery. Safety and tolerability will be evaluated before initiation of the randomized stage.
Drug: Rimegepant · Drug: Tislelizumab · Drug: Nab-paclitaxel · Drug: Cisplatin
Participants randomized to this arm will receive rimegepant plus standard neoadjuvant chemoimmunotherapy for two 3-week cycles, followed by definitive or intended curative surgery.
Drug: Rimegepant · Drug: Tislelizumab · Drug: Nab-paclitaxel · Drug: Cisplatin
Participants randomized to this arm will receive standard neoadjuvant chemoimmunotherapy alone for two 3-week cycles, followed by definitive or intended curative surgery.
Drug: Tislelizumab · Drug: Nab-paclitaxel · Drug: Cisplatin
Rimegepant 75 mg will be administered orally every other day from the initiation until the completion of neoadjuvant chemoimmunotherapy.
Tislelizumab 200 mg will be administered by intravenous infusion on Day 1 of each 3-week treatment cycle for two cycles.
Nab-paclitaxel 260 mg/m² will be administered by intravenous infusion on Day 2 of each 3-week treatment cycle for two cycles.
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.
Major Pathological Response Rate
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.
Time frame: At pathological assessment of the definitive surgical specimen after completion of two 3-week cycles of neoadjuvant treatment
Pathological Complete Response Rate
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.
Time frame: At pathological assessment of the definitive surgical specimen after completion of two 3-week cycles of neoadjuvant treatment
Objective Response Rate
Percentage of participants with a complete response or partial response according to Response Evaluation Criteria in Solid Tumors version 1.1.
Time frame: From baseline to preoperative radiographic assessment after completion of two 3-week cycles of neoadjuvant treatment
Event-Free Survival
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.
Time frame: From randomization to the first event or censoring, assessed up to 5 years
Overall Survival
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.
Time frame: From randomization until death or censoring, assessed up to 5 years
Change From Baseline in Pain Score
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.
Time frame: At baseline, at the end of each neoadjuvant treatment cycle, and at the preoperative assessment
Change From Baseline in Quality of Life
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.
Time frame: At baseline, at the end of each neoadjuvant treatment cycle, and at the preoperative assessment
Incidence of Treatment-Emergent Adverse Events
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.
Time frame: From signing informed consent through 90 days after the last dose of study treatment
Change From Baseline in Peripheral Blood Immune Cell Subset Proportions Assessed by Multiparameter Flow Cytometry
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.
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
Change From Baseline in Tumor-Infiltrating Immune Cell Subset Proportions Assessed by Single-Cell RNA Sequencing
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.
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
CGRP Pathway Biomarkers
Changes in the expression of biomarkers related to the calcitonin gene-related peptide signaling pathway in tumor tissue and/or peripheral blood.
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
Plan to share: No — Individual participant data are not currently planned to be shared. The study involves sensitive clinical, pathological, and human genetic resource data. Any future sharing of de-identified participant-level data would require additional institutional ethics review, compliance with applicable Chinese regulations on human genetic resources and data security, and appropriate data use agreements. The registry record will be updated if the sharing plan changes.
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Squamous Cell Carcinoma of Head and Neck→
Shanghai Zhongshan Hospital