OncoMatch/Clinical Trials/NCT05329532
Modi-1 Moditope in Breast, Head and Neck, Ovarian, or Renal Cancer
Is NCT05329532 recruiting? Yes, currently enrolling (May 2026). This Phase 1/2 trial studies multiple treatments including Modi-1 Moditope and Pembrolizumab for triple negative breast cancer.
Treatment: Modi-1 Moditope · Pembrolizumab · MicronJet600™ microneedle device (NanoPass) — 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.
Check if I qualifyExtracted eligibility criteria
Cancer type
Triple-Negative Breast Cancer
Breast Carcinoma
Renal Cell Carcinoma
Head and Neck Squamous Cell Carcinoma
Performance status
ECOG 0–1(Restricted strenuous activity)
Lab requirements
Blood counts
absolute neutrophil count ≥1.5 x 10^9/L, platelets ≥100 x 10^9/L, haemoglobin >90 g/L (>5.6 mmol/L), lymphocytes ≥ 1 x 10^9/L
Kidney function
serum creatinine ≤1.5 x upper limit of the normal range (ULN)
Liver function
serum total bilirubin ≤1.5 x ULN, serum transaminases (AST/ALT) ≤2.5 x ULN or ≤5.0 x ULN if liver metastases present
adequate organ function as determined by the following laboratory values: absolute neutrophil count ≥1.5 x 10^9/L, platelets ≥100 x 10^9/L, haemoglobin >90 g/L (>5.6 mmol/L), lymphocytes ≥ 1 x 10^9/L, serum creatinine ≤1.5 x upper limit of the normal range (ULN), serum total bilirubin ≤1.5 x ULN, serum transaminases (AST/ALT) ≤2.5 x ULN or ≤5.0 x ULN if liver metastases present
Structured fields extracted by AI. May contain errors — verify against the official protocol.
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