Phase 12 Study of Modi-1 Moditope Vaccine Alone or with Checkpoint Inhibitors for Advanced Breast, Head and Neck, Ovarian, or Renal Cancer

What this Trial Is About

Researchers are evaluating the safety, tolerability, immune response, and early effects of the Modi-1 Moditope vaccine in patients with advanced triple negative breast cancer, advanced or unresectable human papillomavirus-negative squamous cell carcinoma of the head and neck, high grade serous ovarian carcinoma, or renal cell carcinoma. This open-label Phase 12 study also explores Modi-1 Moditope in combination with checkpoint inhibitors like pembrolizumab or nivolumab, including an exploratory neoadjuvant group for head and neck cancer patients undergoing surgery with curative intent. The Modi-1 Moditope vaccine is given intradermally using the MicronJet600 microneedle device. Participants receive Modi-1 Moditope either alone or combined with standard checkpoint inhibitor treatments such as pembrolizumab, nivolumab, or ipilimumab, depending on their cancer type and treatment setting. The exploratory cohort for head and neck cancer patients includes Modi-1 with or without pembrolizumab before surgical tumor removal. The trial plans to enroll 168 participants across multiple UK centers. Participants will undergo regular safety and laboratory assessments for 12 weeks after their final dose, including monitoring of immune cell responses and imaging to evaluate tumor changes. In the neoadjuvant group, pathological and immune responses will be assessed after surgery over 6 weeks. Researchers will track overall survival, progression-free survival, and adverse events. Participants must comply with scheduled visits and tests throughout the study duration, which includes treatment and follow-up periods.

Modi-1 Moditope in Breast, Head and Neck, Ovarian, or Renal Cancer