Actively Recruiting
A Phase 1/2 Open-Label Study of Modi-1 Moditope Vaccine Alone or With Checkpoint Inhibitors in Patients With Breast, Head and Neck, Ovarian, or Renal Cancer
Led by Scancell Ltd · Updated on 2025-09-17
168
Participants Needed
16
Research Sites
52 weeks
Total Duration
On this page
AI-Summary
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 1/2 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.
CONDITIONS
Brief Title
Modi-1 Moditope in Breast, Head and Neck, Ovarian, or Renal Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Histologically or cytologically confirmed advanced triple negative breast cancer, squamous cell carcinoma of the head and neck, high grade serous ovarian carcinoma, or renal cell carcinoma not suitable for curative surgery, or SCCHN scheduled for curative surgery
- Meet specific prior treatment criteria for each cancer type as detailed in the protocol
- Completed last dose of prior cancer therapy at least 4 weeks before the first study dose
- Fully vaccinated against COVID-19 at least 14 days before first study dose, unless declined or ineligible
- Recovered to Grade 1 or lower from effects of prior cancer therapy (excluding hair loss)
- Have at least one measurable lesion by CT or MRI (non-neoadjuvant cohorts)
- Agree to provide fresh or archival tumor biopsy samples as applicable
- Male or female at least 18 years old
- Life expectancy greater than 6 months
- ECOG performance status of 0 or 1
- Adequate organ and blood function per specified laboratory values
- Able and willing to provide written informed consent
- Women of child-bearing potential must have negative pregnancy tests and agree to use effective contraception
- Men with partners of child-bearing potential must agree to use effective contraception
- Willing and able to comply with scheduled visits, treatments, and procedures
- Patients receiving checkpoint inhibitors must be clinically evaluated and eligible for such treatment as standard of care
You will not qualify if you...
- Symptomatic central nervous system metastases or carcinomatous meningitis
- Use of systemic steroids over 10 mg/day or other immune suppressants within 2 weeks prior to study treatment, except for specific allowed cases
- History of other malignancies within 2 years except certain low-risk cancers
- Pregnancy, lactation, or intent to conceive/father children during the study
- Uncontrolled medical conditions including infections, bleeding risks, diabetes, pulmonary disease, liver disease, or primary biliary cirrhosis
- Severe cardiac conditions such as recent heart attack, stroke, significant arrhythmia, or uncontrolled hypertension
- Positive anti-CCP antibodies or active autoimmune disease impacting treatment
- Recent live or influenza vaccinations within specified timeframes
- Known HIV, hepatitis B or C infection
- COVID-19 vaccination within 14 days before study treatment
- History of substance abuse within the past year
- History of severe drug-induced skin reactions or immune-mediated reactions where applicable
- Known hypersensitivity to study treatments or their components
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 6 weeks or until resection surgery (neoadjuvant cohort)
Participants receive the Modi-1 Moditope vaccine, either alone or in combination with checkpoint inhibitors, to assess safety and preliminary efficacy in treating advanced cancers. In the neoadjuvant cohort, treatment is given prior to surgery.
Multiple visits for vaccine administration; 1 infusion visit for pembrolizumab (exploratory cohort)
Duration - Up to 12 weeks after final treatment or surgery
Participants are monitored for safety, immune responses, and clinical outcomes for up to 12 weeks after completing treatment or surgery.
Multiple follow-up visits over 12 weeks
Trial Site Locations
Total: 16 locations
1
Brighton and Sussex University Hospital
Brighton, Default, United Kingdom
Active, Not Recruiting
2
Velindre Cancer Centre
Cardiff, Default, United Kingdom
Actively Recruiting
3
Edinburgh Cancer Centre (NHS Lothian)
Edinburgh, Default, United Kingdom
Actively Recruiting
4
Royal Surrey NHS Foundation
Guildford, Default, United Kingdom
Actively Recruiting
5
Imperial College Healthcare NHS Trust
London, Default, United Kingdom
Active, Not Recruiting
6
Mount Vernon
London, Default, United Kingdom
Actively Recruiting
7
University College London Hospital NHS Foundation Trust
London, Default, United Kingdom
Actively Recruiting
8
Christie NHS Foundation Trust
Manchester, Default, United Kingdom
Actively Recruiting
9
Nottingham University Hospitals Cancer Centre
Nottingham, Default, United Kingdom
Actively Recruiting
10
Lancashire Teaching Hospitals NHS Foundation Trust
Preston, Default, United Kingdom
Actively Recruiting
11
Sheffield Teaching Hospital NHS Foundation Trust
Sheffield, Default, United Kingdom
Actively Recruiting
12
The Royal Marsden NHS Foundation Trust
Sutton, Default, United Kingdom
Not Yet Recruiting
13
Belfast City Hospital
Belfast, United Kingdom
Actively Recruiting
14
Addenbrooke's Hospital, Cambridge University Hospitals
Cambridge, United Kingdom
Actively Recruiting
15
The Clatterbridge Cancer Centre NHS Foundation Trust
Liverpool, United Kingdom, CH63 4JY
Actively Recruiting
16
Torbay and South Devon NHS Foundation Trust
Torquay, United Kingdom
Actively Recruiting
Research Team
R
Robert Miller
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
3
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