Triple Negative Breast CancerPhase 1/2ModiFYNCT05329532
Modi-1 Moditope in Breast, Head and Neck, Ovarian, or Renal Cancer
A Phase 1/2 study testing Modi-1 Moditope, Pembrolizumab and MicronJet600™ microneedle device (NanoPass) in people with Triple Negative Breast Cancer and Renal Cell Cancer, run by Scancell Ltd at 16 sites in United Kingdom.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Triple Negative Breast Cancer, Renal Cell Cancer, High Grade Ovarian Serous Adenocarcinoma
- What is being tested?
- Modi-1 Moditope, Pembrolizumab and MicronJet600™ microneedle device (NanoPass)
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 168 participants
- Where
- 16 sitesUnited Kingdom
- Study dates
- 7 Apr 2022to 1 Jul 2027
- Phase
- Phase 1/2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patient either has one of the following histologically or cytologically confirmed advanced cancers not amenable to curative intent surgical resection:
- TNBC
- SCCHN (oral cavity, oropharynx, hypopharynx, or larynx)
- HGSOC including fallopian tube and primary peritoneal cancers
- RCC Or the patient has histologically or cytologically confirmed SCCHN scheduled to have curative intent surgical resection.
- Patient must meet one of the following specific criteria for prior treatment of the relevant tumour type:
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- TNBC:
- patient has received available standard therapy for advanced disease (Modi-1ev/Modi-1eKv monotherapy cohort only).
- patient stopped immunotherapy due to toxicity and with residual disease as measurable by RECIST 1.1 (Modi-1ev/Modi-1eKv monotherapy cohort only).
- patient completing a systemic treatment regimen with immunotherapy, for whom a subsequent SOC therapy is not yet indicated or appropriate and with measurable disease in accordance with RECIST 1.1 (Modi-1ev/Modi-1eKv monotherapy cohort only).
- patient has refused SOC therapy (Modi-1ev/Modi-1eKv monotherapy cohort only).
- SCCHN:
- patient has received first-line platinum-containing chemotherapy (with or without radiotherapy) as treatment for advanced disease (Modi-1ev/Modi-1eKv monotherapy and Modi-1ev/Modi-1eKv + CPI cohorts).
- patient with locally advanced or metastatic disease measurable by RECIST 1.1 for whom all forms of platinum-based chemoradiotherapy treatment are contraindicated (Modi-1ev/Modi-1eKv monotherapy and Modi-1ev/Modi-1eKv + CPI cohorts).
- patient completing immunotherapy for whom a subsequent SOC therapy is not yet indicated or appropriate and with measurable disease in accordance with RECIST 1.1 (Modi-1ev/Modi-1eKv monotherapy cohort only).
- patient stopped immunotherapy due to toxicity or completion of immunotherapy but with measurable disease in accordance with RECIST 1.1 (Modi-1ev/Modi-1eKv monotherapy cohort only).
- patient with untreated metastatic or unresectable recurrent SCCHN whose tumours express PD-L1 with a combined positive score (CPS) of one or more and are eligible for SOC immunotherapy (Modi-1ev/Modi-1eKv + CPI cohort only). Patients who received their first dose of CPI therapy within 28 days of the first dose of Modi-1ev/Modi-1eKv are eligible.
- patient has refused SOC therapy (Modi-1ev/Modi-1eKv monotherapy cohort only).
- SCCHN:
- o neoadjuvant expansion cohort only; patients who are treatment-naïve and are scheduled to have tumour resection surgery, in whom minimum of 3 weeks of Modi-1ev/Modi-1eKv and a single 400 mg intravenous (i.v.) total dose of pembrolizumab immunotherapy can be administered. Patients will only be enrolled once the Modi-1 Moditope® expansion doses and a lack of increased anti-CCP antibodies (with, and without, concomitant pembrolizumab) have been established.
- HGSOC including fallopian tube and primary peritoneal cancers:
- patient must be considered unsuitable for platinum chemotherapy, defined as recurrence/progression within 6 months of prior platinum-containing chemotherapy or patients in whom platinum therapy is no longer thought appropriate. Patient must have received no more than two non-platinum regimens, from the time the patient is considered unsuitable for platinum chemotherapy (Modi-1ev/Modi-1eKv monotherapy cohort only).
- patient completing a course of systemic therapy for whom a subsequent SOC therapy is not yet indicated or appropriate and with measurable disease in accordance with RECIST 1.1 (Modi-1ev/Modi-1eKv monotherapy cohort only).
- patient has refused SOC therapy (Modi-1ev/Modi-1eKv monotherapy cohort only).
- RCC:
- patient is untreated for advanced RCC (Modi-1ev/Modi-1eKv + CPI doublet cohort only).
- patient has received first-line treatment consisting of anti-angiogenic therapy (Modi-1ev/Modi-1eKv monotherapy cohort).
- patient has favourable or intermediate International Metastatic Renal-Cell Carcinoma Database Consortium (IMDC) risk score (Heng et al. 2013) (Modi-1ev/Modi-1eKv monotherapy cohort).
- patient has intermediate or poor International Metastatic Renal-Cell Carcinoma Database Consortium (IMDC) risk score (Heng et al. 2013) and is eligible for SOC nivolumab with ipilimumab immunotherapy (Modi-1ev/Modi-1eKv + CPI doublet cohort only).
- patient has stopped immunotherapy due to toxicity and with residual disease as measurable by RECIST 1.1 (Modi-1ev/Modi-1eKv monotherapy cohort only).
- patient completing immunotherapy, for whom a subsequent SOC therapy is not yet indicated or appropriate and with measurable disease in accordance with RECIST 1.1 (Modi-1ev/Modi-1eKv monotherapy cohort only).
- patient on active surveillance (Modi-1ev/Modi-1eKv monotherapy cohort only).
- patient is eligible for SOC nivolumab with ipilimumab immunotherapy (Modi-1ev/Modi-1eKv + CPI doublet cohort only).
- patient has refused SOC therapy (Modi-1ev/Modi-1eKv monotherapy cohort only).
- Where applicable, patient has completed last dose of prior cancer therapy at least 4 weeks before the first dose of study treatment.
- Patient has been fully vaccinated against COVID-19, the last vaccination being at least 14 days prior to the patient's first dose of IMP, except for those who have declined or are not eligible for COVID-19 vaccination.
- Patient has recovered to Grade ≤1 (CTCAE v5.0) from the effects (excluding alopecia) of any prior therapy for their malignancies.
- Patient has at least one measurable lesion per RECIST 1.1 criteria by computed tomography (CT) scan or magnetic resonance imaging (MRI) (non-neoadjuvant cohorts).
- Wherever possible, patients not scheduled for curative intent resection surgery should have a fresh tumour biopsy (or have an archival biopsy [obtained within the past 5 years] if obtaining a fresh biopsy is not feasible) at baseline for molecular studies, and agree to a post-treatment biopsy (at Week 25 or one of the EOT visits), if feasible. Patients in the SCCHN neoadjuvant cohort must have both a fresh pre-treatment biopsy and agree to have their resected tumour analysed.
- Patient is male or female and at least 18 years of age.
- Patient has a life expectancy of more than 6 months.
- Patient has an ECOG performance status of 0 or 1.
- Patient has adequate organ function as determined by the following laboratory values: absolute neutrophil count ≥1.5 x 109/L, platelets ≥100 x 109/L, haemoglobin >90 g/L (>5.6 mmol/L), lymphocytes ≥ 1 x 109/L, serum creatinine ≤1.5 x upper limit of the normal range (ULN), serum total bilirubin ≤1.5 x ULN, serum transaminases (aspartate aminotransferase [AST]/alanine aminotransferase [ALT]) ≤2.5 x ULN or ≤5.0 x ULN if liver metastases present.
- Patient must be able and willing to provide written informed consent prior to any study related procedure. (In the event that the patient is re-screened for study participation or if a protocol amendment alters the care of an ongoing patient, a new informed consent form must be signed).
- Women of child-bearing potential must have a negative serum pregnancy test during Screening (and a urine test within the 7 days prior to Day 1) and be neither breastfeeding nor intending to become pregnant during study participation. Women of child-bearing potential must agree to use highly effective contraceptive methods prior to study entry, for the duration of study participation, and for 120 days after discontinuation of vaccine monotherapy or 5 months after use with a CPI (or longer if the Summary of Product Characteristics [SmPC] of the CPI requires it).
- Men who are potentially fertile with partners of child-bearing potential must agree to use highly effective contraceptive methods for the duration of study participation, and for 120 days after discontinuation of vaccine monotherapy or 5 months after use with a CPI (or longer if the SmPC of the CPI requires it).
- Patient must be willing and able to comply with scheduled visits, treatment plan, laboratory tests and other study procedures.
- Patient scheduled to receive a CPI (e.g., pembrolizumab alone or nivolumab alone or where applicable with ipilimumab) together with Modi-1ev/Modi-1eKv must have been clinically evaluated, have not received prior CPI therapy, and the CPI must be deemed an appropriate treatment for their disease according to the CPI's SmPC (this does not apply to the neoadjuvant SCCHN cohort).
Who cannot join
- Patient has symptomatic central nervous system metastases or carcinomatous meningitis.
- Patient is taking any systemic steroid therapy (exceeding 10 mg/day of prednisolone or equivalent) or is on any other form of immune suppressant medication within 2 weeks prior to the first dose of IMP. Physiological doses of systemic steroids such as those for the management of adrenal insufficiency, topical and inhaled steroids, such as those for the management of asthma, and patients with hypothyroidism stable on hormone replacement, are permitted.
- Patient has a history of malignancy other than the disease under study within 2 years prior to Screening, with the exception of malignancies with a negligible risk of metastasis or death (e.g., 2-year overall survival rate >90%), such as adequately treated carcinoma-in-situ of the breast or the cervix, melanoma-in-situ, non-melanoma skin carcinoma, superficial bladder cancer, prostate cancer with Gleason grade ≤6 and prostate specific antigen within normal range or stage I endometrial cancer.
- Patient is pregnant, lactating, or is expecting to conceive/father children within the duration of the study.
- Patient has a concurrent illness which would preclude study conduct and assessment, including, but not limited to, uncontrolled medical conditions, uncontrolled and active infection (considered opportunistic, life threatening, or clinically significant), uncontrolled risk of bleeding, uncontrolled diabetes mellitus, pulmonary disease (including obstructive pulmonary disease and pulmonary fibrosis), alcoholic liver disease, or primary biliary cirrhosis.
- Patient has New York Heart Association (NYHA) class III or IV heart disease, myocardial infarction or stroke within previous 6 months, a history of significant cardiac abnormality and/or significant abnormal baseline ECG readout, active ischaemia, or any other uncontrolled cardiac condition such as angina pectoris, clinically significant arrhythmia requiring therapy, uncontrolled hypertension, significant cerebrovascular disease, or congestive heart failure.
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- Patient has anti-CCP antibody levels classified as equivocal or positive according to NHS guidelines, i.e., ≥ the ULN, or has an active autoimmune disease that may impact on the study treatment in the opinion of the Investigator.
- Patient has received a live vaccine within 28 days, or an influenza vaccine within 14 days prior to the first dose of IMP. The timing of any other vaccines should be assessed on a case-by-case basis by the Investigator prior to study enrolment.
- Patient has a known history of human immunodeficiency virus (HIV), hepatitis B virus (HBV; surface antigen reactive) or hepatitis C (HCV; RNA detected).
- COVID-19 vaccination within 14 days prior to the first dose of IMP.
- Patient has a known current or recent history (within the last year) of substance abuse including illicit drugs or alcohol.
- History of any of the following: drug-induced severe cutaneous adverse reaction (SCAR; including, but not limited to Stevens-Johnson syndrome/toxic epidermal necrolysis [SJS/TEN], or drug reaction with eosinophilia and systemic symptoms [DRESS]), or dose-limiting immune-mediated reactions (Modi-1ev/Modi-1eKv + CPI RCC cohort only).
- Patient has a known hypersensitivity to the IMP under study or their excipients. Where SOC CPIs are planned to be given with the IMP, the patient must not have a known hypersensitivity to the CPIs or their excipients.
Trial locations and contacts
16 sites in 1 country. Contact the study team or a site near you to ask about taking part.
16 sites in 1 country
United Kingdom16 sites, 14 recruiting
- Recruiting
Belfast City Hospital
Belfast
Joe Thornton, +44 1865 582066, info@scancell.co.uk
- Active, not recruiting
Brighton and Sussex University Hospital
Brighton, Default
- Recruiting
Addenbrooke's Hospital, Cambridge University Hospitals
Cambridge
Joe Thornton, +44 1865 582066, info@scancell.co.uk
441865582066
- Recruiting
Velindre Cancer Centre
Cardiff, Default
Joe Thornton, info@scancell.co.uk
- Recruiting
Edinburgh Cancer Centre (NHS Lothian)
Edinburgh, Default
Joe Thornton, info@scancell.co.uk
- Recruiting
Royal Surrey NHS Foundation
Guildford, Default
Joe Thornton, info@scancell.co.uk
- Recruiting
The Clatterbridge Cancer Centre NHS Foundation Trust
Liverpool, CH63 4JY
Christian Ottensmeier, MD, info@scancell.co.uk
- Active, not recruiting
Imperial College Healthcare NHS Trust
London, Default
- Recruiting
Mount Vernon
London, Default
Joe Thornton, info@scancell.co.uk
- Recruiting
University College London Hospital NHS Foundation Trust
London, Default
Joe Thornton, info@scancell.co.uk
- Recruiting
Christie NHS Foundation Trust
Manchester, Default
Joe Thornton, info@scancell.co.uk
- Recruiting
Nottingham University Hospitals Cancer Centre
Nottingham, Default
Joe Thornton, info@scancell.co.uk
- Recruiting
Lancashire Teaching Hospitals NHS Foundation Trust
Preston, Default
Joe Thornton, info@scancell.co.uk
- Recruiting
Sheffield Teaching Hospital NHS Foundation Trust
Sheffield, Default
Joe Thornton, info@scancell.co.uk
- Not yet recruiting
The Royal Marsden NHS Foundation Trust
Sutton, Default
Joe Thornton, info@scancell.co.uk
- Recruiting
Torbay and South Devon NHS Foundation Trust
Torquay
Joe Thornton, +44 1865 582066, info@scancell.co.uk
About this study
Official title: A Phase 1/2, Multicentre, Open-Label Study of Modi-1 Moditope in Patients With Breast, Head and Neck, Ovarian, or Renal Cancer
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.
Read the detailed description
This is an open-label, parallel arm, Phase 1/2 study to assess the safety, tolerability, immunological activity, and preliminary efficacy of the Modi-1 Moditope vaccine in patients with advanced TNBC, advanced/unresectable SCCHN, HGSOC, or RCC.
Modi-1 Moditope vaccines, consist of a combination of specific peptides conjugated to a toll-like receptor ligand 1/2 adjuvant, designed to enhance immune responses against peptides commonly expressed or upregulated by cancer cells. Thus, improving immune recognition of these cancers and potentially increasing response rates in patients with advanced solid tumours.
The aim of this study is to investigate preliminary efficacy of Modi-1 Moditope, in an open labelled clinical trial, in participants with TNBC, SCCHN, RCC and HGSOC, powered to demonstrate that Modi-1 Moditope have potent anti-tumour activity.
In this trial, Modi-1 Moditope will be administered, either as monotherapy or in combination with a CPI (as standard of care).
In addition, an exploratory, randomised cohort will be included to assess the impact of Modi-1 Moditope (with or without pembrolizumab) in participants with SCCHN scheduled for resection surgery with curative intent.
Modi-1 Moditope will be administered intradermally using the MicronJet600™ microneedle device referred to as NanoPass.
The study aims to enrol 168 (138 in non-neoadjuvant cohorts and 30 in the exploratory neoadjuvant SCCHN cohort) individuals across multiple UK collaborating clinical centres.
- Conditions
- Triple Negative Breast Cancer, Renal Cell Cancer, High Grade Ovarian Serous Adenocarcinoma, Squamous Cell Carcinoma of the Head and Neck
- Being tested
- Modi-1 Moditope, Pembrolizumab, MicronJet600™ microneedle device (NanoPass)
- Keywords
- vaccine, peptide, Phase II
- Medical subject headings
- Triple Negative Breast Neoplasms, Carcinoma, Renal Cell, Squamous Cell Carcinoma of Head and Neck
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Modi-1 ModitopeBiological
Modi-1 Moditope administered intradermally (i.d.) using the MicronJet600™ microneedle device (NanoPass).
PembrolizumabBiological
Pembrolizumab (exploratory cohorts) will be administered by intravenous infusion on Day 8, prior to tumour resection surgery at 6 weeks.
MicronJet600™ microneedle device (NanoPass)Device
Intradermal injection device
| Study group | Role | What they receive |
|---|---|---|
| Patients with TNBC, advanced/unresectable SCCHN, high grade serous ovarian carcinoma, or RCC | Experimental | Modi-1 Moditope Monotherapy Receives: Biological: Modi-1 Moditope; Device: MicronJet600™ microneedle device (NanoPass) |
| Patients with advanced/unresectable SCCHN or RCC eligible for standard of care checkpoint inhibitors | Experimental | Modi-1 Moditope + Standard of Care Checkpoint Inhibitors Receives: Biological: Modi-1 Moditope; Device: MicronJet600™ microneedle device (NanoPass) |
| Patients with SCCHN eligible for curative intent resection surgery (neoadjuvant cohort) | Experimental | Modi-1 Monotherapy vs Modi-1 Moditope + Pembrolizumab Receives: Biological: Modi-1 Moditope; Biological: Pembrolizumab; Device: MicronJet600™ microneedle device (NanoPass) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of clinical and laboratory adverse events (AEs)
To measure the incidence of AEs of Modi-1 Moditope (as monotherapy and in combination with a CPI (e.g., pembrolizumab or nivolumab provided as standard of care) when administered intradermally
Measured: For the duration of the study (12 weeks after the final dose of study treatment)
Cellular immune response to Modi-1 Moditope on IFNγ ELISpot assay
(i) the mean peptide-specific ELISpot response minus two standard deviations is greater than the mean pre-treatment peptide-specific response plus one standard deviation (of this mean); and (ii) the ELISpot response is more than 50 spots per million peripheral blood mononuclear cells.
Measured: For the duration of the study (12 weeks after the final dose of study treatment)
Secondary outcomes (5)
Imaging Response using RECIST 1.1 and iRECIST to Modi-1 Moditope in the non-neoadjuvant setting
To measure imaging response of Modi-1 Moditope in non-neoadjuvant cohorts, as monotherapy in patients with TNBC, advanced/unresectable HPV-negative SCCHN, HGSOC, or RCC and in combination with CPI therapy (e.g., pembrolizumab, nivolumab, Ipilimumab)
Measured: For the duration of the study (12 weeks after the final dose of study treatment)
Overall survival
The overall survival will measured in patients vaccinated with Modi-1 Moditope either as monotherapy or in combination with checkpoint inhibitors in the target population.
Measured: For the duration of the study (12 weeks after the final dose of study treatment)
Progression-free survival in patients vaccinated with Modi-1 Moditope
The progression-free survival will measured in patients vaccinated with Modi-1 Moditope either as monotherapy or in combination with checkpoint inhibitors in the target population.
Measured: For the duration of the study (12 weeks after the final dose of study treatment)
Pathological response in the neoadjuvant setting in patients vaccinated with Modi-1 Moditope or Modi-1 Moditope + Pembrolizumab
Pathological response will be measured in tumour tissue of patients vaccinated with Modi-1 Moditope monotherapy or Modi-1 Moditope + Pembrolizumab in patients with SCCHN undergoing planned resection
Measured: For the duration of the study (6 weeks after resection surgery)
Celluar immune response in the neoadjuvant setting in patients vaccinated with Modi-1 Moditope or Modi-1 Moditope + Pembrolizumab
Immune cells will be profiled and measured in tumour tissue of patients vaccinated with Modi-1 Moditope monotherapy or Modi-1 Moditope + Pembrolizumab in patients with SCCHN undergoing planned resection
Measured: For the duration of the study (6 weeks after resection surgery)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Apr 2022
- Study start7 Apr 2022
- Primary completion1 Jul 2026 (estimated)
- Study completion1 Jul 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Triple Negative Breast CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- Open label, uncontrolled study.
- Masking
- None (open label)
- Enrolment
- 168 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Scancell Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Christian Ottensmeier, MD, Principal investigator, The Clatterbridge Cancer Centre NHS Foundation Trust, United Kingdom
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05329532
- Sponsor's protocol ID
- Modi-1-001
- Acronym
- ModiFY
- Status last verified
- Sep 2025
- First submitted
- 31 Jan 2022
- Last updated
- 17 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- Yes
- Individual data sharing
- No: There is not a plan to make individual patient data available
Study at a glance
From the registry record, last updated by the sponsor on 17 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1/2, Multicentre, Open-Label Study of Modi-1 Moditope in Patients With Breast, Head and Neck, Ovarian, or Renal Cancer
- ClinicalTrials.gov ID
- NCT05329532
- Acronym / sponsor ID
- ModiFY / Modi-1-001
- Conditions
- Triple Negative Breast Cancer, Renal Cell Cancer, High Grade Ovarian Serous Adenocarcinoma, Squamous Cell Carcinoma of the Head and Neck
- Keywords
- vaccine, peptide, Phase II
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 168 participants (estimated)
- Lead sponsor
- Scancell LtdIndustry (pharma, biotech, devices)
- Study start
- 7 Apr 2022 (actual)
- Primary completion
- 1 Jul 2026 (estimated)
- Study completion
- 1 Jul 2027 (estimated)
- First posted
- 15 Apr 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
This is an open-label, parallel arm, Phase 1/2 study to assess the safety, tolerability, immunological activity, and preliminary efficacy of the Modi-1 Moditope vaccine in patients with advanced TNBC, advanced/unresectable SCCHN, HGSOC, or RCC.
Modi-1 Moditope vaccines, consist of a combination of specific peptides conjugated to a toll-like receptor ligand 1/2 adjuvant, designed to enhance immune responses against peptides commonly expressed or upregulated by cancer cells. Thus, improving immune recognition of these cancers and potentially increasing response rates in patients with advanced solid tumours.
The aim of this study is to investigate preliminary efficacy of Modi-1 Moditope, in an open labelled clinical trial, in participants with TNBC, SCCHN, RCC and HGSOC, powered to demonstrate that Modi-1 Moditope have potent anti-tumour activity.
In this trial, Modi-1 Moditope will be administered, either as monotherapy or in combination with a CPI (as standard of care).
In addition, an exploratory, randomised cohort will be included to assess the impact of Modi-1 Moditope (with or without pembrolizumab) in participants with SCCHN scheduled for resection surgery with curative intent.
Modi-1 Moditope will be administered intradermally using the MicronJet600™ microneedle device referred to as NanoPass.
The study aims to enrol 168 (138 in non-neoadjuvant cohorts and 30 in the exploratory neoadjuvant SCCHN cohort) individuals across multiple UK collaborating clinical centres.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- Open label, uncontrolled study.
| Arm | Type | Receives |
|---|---|---|
| Patients with TNBC, advanced/unresectable SCCHN, high grade serous ovarian carcinoma, or RCC | Experimental | Biological: Modi-1 Moditope, Device: MicronJet600™ microneedle device (NanoPass)Modi-1 Moditope Monotherapy |
| Patients with advanced/unresectable SCCHN or RCC eligible for standard of care checkpoint inhibitors | Experimental | Biological: Modi-1 Moditope, Device: MicronJet600™ microneedle device (NanoPass)Modi-1 Moditope + Standard of Care Checkpoint Inhibitors |
| Patients with SCCHN eligible for curative intent resection surgery (neoadjuvant cohort) | Experimental | Biological: Modi-1 Moditope, Biological: Pembrolizumab, Device: MicronJet600™ microneedle device (NanoPass)Modi-1 Monotherapy vs Modi-1 Moditope + Pembrolizumab |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (48 listed)
- Patient either has one of the following histologically or cytologically confirmed advanced cancers not amenable to curative intent surgical resection:
- Patient must meet one of the following specific criteria for prior treatment of the relevant tumour type:
- o neoadjuvant expansion cohort only; patients who are treatment-naïve and are scheduled to have tumour resection surgery, in whom minimum of 3 weeks of Modi-1ev/Modi-1eKv and a single 400 mg intravenous (i.v.) total dose of pembrolizumab immunotherapy can be administered. Patients will only be enrolled once the Modi-1 Moditope® expansion doses and a lack of increased anti-CCP antibodies (with, and without, concomitant pembrolizumab) have been established.
- Where applicable, patient has completed last dose of prior cancer therapy at least 4 weeks before the first dose of study treatment.
- Patient has been fully vaccinated against COVID-19, the last vaccination being at least 14 days prior to the patient's first dose of IMP, except for those who have declined or are not eligible for COVID-19 vaccination.
Key exclusion criteria (13 listed)
- Patient has symptomatic central nervous system metastases or carcinomatous meningitis.
- Patient is taking any systemic steroid therapy (exceeding 10 mg/day of prednisolone or equivalent) or is on any other form of immune suppressant medication within 2 weeks prior to the first dose of IMP. Physiological doses of systemic steroids such as those for the management of adrenal insufficiency, topical and inhaled steroids, such as those for the management of asthma, and patients with hypothyroidism stable on hormone replacement, are permitted.
- Patient has a history of malignancy other than the disease under study within 2 years prior to Screening, with the exception of malignancies with a negligible risk of metastasis or death (e.g., 2-year overall survival rate >90%), such as adequately treated carcinoma-in-situ of the breast or the cervix, melanoma-in-situ, non-melanoma skin carcinoma, superficial bladder cancer, prostate cancer with Gleason grade ≤6 and prostate specific antigen within normal range or stage I endometrial cancer.
- Patient is pregnant, lactating, or is expecting to conceive/father children within the duration of the study.
- Patient has a concurrent illness which would preclude study conduct and assessment, including, but not limited to, uncontrolled medical conditions, uncontrolled and active infection (considered opportunistic, life threatening, or clinically significant), uncontrolled risk of bleeding, uncontrolled diabetes mellitus, pulmonary disease (including obstructive pulmonary disease and pulmonary fibrosis), alcoholic liver disease, or primary biliary cirrhosis.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Modi-1 ModitopeModi-1 Moditope administered intradermally (i.d.) using the MicronJet600™ microneedle device (NanoPass). | Biological | Patients with SCCHN eligible for curative intent resection surgery (neoadjuvant cohort), Patients with TNBC, advanced/unresectable SCCHN, high grade serous ovarian carcinoma, or RCC, Patients with advanced/unresectable SCCHN or RCC eligible for standard of care checkpoint inhibitors |
| PembrolizumabPembrolizumab (exploratory cohorts) will be administered by intravenous infusion on Day 8, prior to tumour resection surgery at 6 weeks. | Biological | Patients with SCCHN eligible for curative intent resection surgery (neoadjuvant cohort) |
| MicronJet600™ microneedle device (NanoPass)Intradermal injection device | Device | Patients with SCCHN eligible for curative intent resection surgery (neoadjuvant cohort), Patients with TNBC, advanced/unresectable SCCHN, high grade serous ovarian carcinoma, or RCC, Patients with advanced/unresectable SCCHN or RCC eligible for standard of care checkpoint inhibitors |
Primary outcome
Incidence of clinical and laboratory adverse events (AEs)
Time frame: For the duration of the study (12 weeks after the final dose of study treatment)
To measure the incidence of AEs of Modi-1 Moditope (as monotherapy and in combination with a CPI (e.g., pembrolizumab or nivolumab provided as standard of care) when administered intradermally
Cellular immune response to Modi-1 Moditope on IFNγ ELISpot assay
Time frame: For the duration of the study (12 weeks after the final dose of study treatment)
(i) the mean peptide-specific ELISpot response minus two standard deviations is greater than the mean pre-treatment peptide-specific response plus one standard deviation (of this mean); and (ii) the ELISpot response is more than 50 spots per million peripheral blood mononuclear cells.
5 secondary outcomes
Imaging Response using RECIST 1.1 and iRECIST to Modi-1 Moditope in the non-neoadjuvant setting
Time frame: For the duration of the study (12 weeks after the final dose of study treatment)
Overall survival
Time frame: For the duration of the study (12 weeks after the final dose of study treatment)
Progression-free survival in patients vaccinated with Modi-1 Moditope
Time frame: For the duration of the study (12 weeks after the final dose of study treatment)
Pathological response in the neoadjuvant setting in patients vaccinated with Modi-1 Moditope or Modi-1 Moditope + Pembrolizumab
Time frame: For the duration of the study (6 weeks after resection surgery)
Celluar immune response in the neoadjuvant setting in patients vaccinated with Modi-1 Moditope or Modi-1 Moditope + Pembrolizumab
Time frame: For the duration of the study (6 weeks after resection surgery)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Sep 2025.
- Individual participant dataSharing planned: No. There is not a plan to make individual patient data available
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Christian Ottensmeier, MD principal investigator
The Clatterbridge Cancer Centre NHS Foundation Trust, United Kingdom
16 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Modi-1 Moditope, Pembrolizumab and MicronJet600™ microneedle device (NanoPass) in people with Triple Negative Breast Cancer and Renal Cell Cancer, run by Scancell Ltd at 16 sites in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 48 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 17 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 16 sites in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Robert Miller (+441865582690, info@scancell.co.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of clinical and laboratory adverse events (AEs) (time frame: For the duration of the study (12 weeks after the final dose of study treatment)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Sep 2025.