Actively Recruiting
Modi-1 Moditope in Breast, Head and Neck, Ovarian, or Renal Cancer
Led by Scancell Ltd · Updated on 2025-09-17
168
Participants Needed
16
Research Sites
273 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Modi-1 Moditope in Breast, Head and Neck, Ovarian, or Renal Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patient has confirmed advanced triple negative breast cancer, squamous cell carcinoma of the head and neck, high grade serous ovarian carcinoma (including fallopian tube and primary peritoneal cancers), or renal cell carcinoma not suitable for curative surgery, or has head and neck cancer scheduled for surgery with curative intent
- Patient meets specified prior treatment criteria based on tumor type, including prior therapies or treatment-naive status for neoadjuvant head and neck cancer cohort
- Last dose of prior cancer therapy completed at least 4 weeks before study treatment
- Fully vaccinated against COVID-19 at least 14 days before first study dose, or declined/not eligible for vaccination
- Recovered to Grade 1 or less from side effects of prior cancer therapy (excluding hair loss)
- Has at least one measurable lesion by CT or MRI (for non-neoadjuvant cohorts)
- Agrees to provide fresh or archival tumor biopsies at baseline and post-treatment if feasible
- Male or female aged 18 years or older
- Life expectancy greater than 6 months
- ECOG performance status of 0 or 1
- Adequate organ function based on specified laboratory values
- Able and willing to provide written informed consent
- Women of child-bearing potential with negative pregnancy test, not breastfeeding, and agree to use effective contraception during and after study participation
- Men with partners of child-bearing potential agree to use effective contraception during and after study participation
- Willing and able to comply with study visits, treatments, and procedures
- For patients receiving checkpoint inhibitors with Modi-1, must be clinically evaluated, no prior checkpoint inhibitor therapy, and treatment appropriate per medication guidelines (except neoadjuvant head and neck cohort)
You will not qualify if you...
- Symptomatic central nervous system metastases or carcinomatous meningitis
- Use of systemic steroids over 10 mg/day prednisolone or equivalent, or other immunosuppressive medications within 2 weeks before first study dose (except certain permitted steroid uses)
- History of other malignancies within 2 years prior to screening, except certain low-risk cancers
- Pregnant, breastfeeding, or planning to conceive or father children during the study
- Concurrent uncontrolled illnesses including active infections, bleeding risks, diabetes, lung disease, liver disease, or autoimmune conditions impacting treatment
- Severe heart disease or recent heart attack or stroke within 6 months, or significant uncontrolled cardiac conditions
- Positive anti-CCP antibodies or active autoimmune disease affecting study treatment
- Received live vaccine within 28 days or influenza vaccine within 14 days before first study dose
- Known HIV, hepatitis B, or hepatitis C infection
- COVID-19 vaccination within 14 days prior to first study dose
- History of substance abuse including drugs or alcohol within the past year
- History of severe drug-induced skin reactions or dose-limiting immune reactions (specific to certain cohorts)
- Known allergy to study vaccine, checkpoint inhibitors, or their components
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
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
CONTACT
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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