OncoMatch/Clinical Trials/NCT05329532
Modi-1 Moditope in Breast, Head and Neck, Ovarian, or Renal Cancer
Is NCT05329532 recruiting? Yes, currently enrolling (Jun 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
Treatments studied
Immunotherapy
Other
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.
Frequently asked questions
Is NCT05329532 currently recruiting?
Yes, this trial is currently recruiting patients.
Could you qualify for this trial?
Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.
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