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

NCT05329532 PHASE1, PHASE2 RECRUITING

The main objectives of this study are to assess the safety, tolerability, immunological activity, and preliminary efficacy of the Modi-1 Moditope vaccine, both as monotherapy and in combination with a checkpoint inhibitor (CPI) such as pembrolizumab or nivolumab with or without Ipilimumab (where these are standard of care in a non-neoadjuvant setting), in patients with advanced triple negative breast cancer (TNBC), advanced/unresectable human papillomavirus-negative squamous cell carcinoma of the head and neck (SCCHN), high grade serous ovarian carcinoma (HGSOC), or renal cell carcinoma (RCC). Modi-1 Moditope will also be investigated in the neoadjuvant setting for patients with SCCHN undergoing curative intent surgical resection in combination with pembrolizumab versus the Modi-1 alone.

Details

Lead sponsor	Scancell Ltd
Phase	PHASE1, PHASE2
Status	RECRUITING
Enrolment	168
Start date	Thu Apr 07 2022 00:00:00 GMT+0000 (Coordinated Universal Time)
Completion	Thu Jul 01 2027 00:00:00 GMT+0000 (Coordinated Universal Time)

Conditions

• Triple Negative Breast Cancer
• Renal Cell Cancer
• High Grade Ovarian Serous Adenocarcinoma
• Squamous Cell Carcinoma of the Head and Neck

Interventions

• Modi-1 Moditope
• Pembrolizumab
• MicronJet600™ microneedle device (NanoPass)

Countries

United Kingdom