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

Sponsor
Shanghai Zhongshan Hospital
Study ID
NCT07812467
Phase
PHASE2
Status
Not Yet Recruiting

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Conditions

  • Oral Squamous Cell Carcinoma (OSCC)
  • Oropharyngeal Squamous Cell Carcinoma (OPSCC)

Eligibility Criteria

Sex
ALL
Age
18 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

  • 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.

Study Details

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.

Key Dates

First listed
Sep 10, 2026
Start date
Oct 1, 2026
Status verified
Jul 2026
Primary completion
Oct 31, 2028
Completion
Oct 31, 2033

Study Design

Enrollment
220 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Safety Run-In Combination Arm
    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.
  • Experimental: Randomized Combination Arm
    Participants randomized to this arm will receive rimegepant plus standard neoadjuvant chemoimmunotherapy for two 3-week cycles, followed by definitive or intended curative surgery.
  • Active Comparator: Randomized Control Arm
    Participants randomized to this arm will receive standard neoadjuvant chemoimmunotherapy alone for two 3-week cycles, followed by definitive or intended curative surgery.

Primary Outcome Measure

Major Pathological Response Rate [ Time Frame: At pathological assessment of the definitive surgical specimen after completion of two 3-week cycles of neoadjuvant treatment ]

Central Contacts

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