Modi-1 Moditope in Breast, Head and Neck, Ovarian, or Renal Cancer

Recruiting now · Phase 1/Phase 2

Conditions studied: Triple Negative Breast Cancer, Renal Cell Cancer, High Grade Ovarian Serous Adenocarcinoma, Squamous Cell Carcinoma of the Head and Neck

In brief

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.

Key facts

Study ID

NCT05329532

Run by

Scancell Ltd

People needed

168

Starts

2022-04-07

Expected to finish

2027-07-01

Last updated by the study team

2025-09-17

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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:
• 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:

You may not qualify if…

• 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.
• 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.

Where it is running

• Torbay and South Devon NHS Foundation Trust — Torquay, United Kingdom (enrolling)
• Velindre Cancer Centre — Cardiff, Default, United Kingdom (enrolling)
• Edinburgh Cancer Centre (NHS Lothian) — Edinburgh, Default, United Kingdom (enrolling)
• Royal Surrey NHS Foundation — Guildford, Default, United Kingdom (enrolling)
• Belfast City Hospital — Belfast, United Kingdom (enrolling)
• Addenbrooke's Hospital, Cambridge University Hospitals — Cambridge, United Kingdom (enrolling)
• The Clatterbridge Cancer Centre NHS Foundation Trust — Liverpool, United Kingdom (enrolling)
• Mount Vernon — London, Default, United Kingdom (enrolling)
• University College London Hospital NHS Foundation Trust — London, Default, United Kingdom (enrolling)
• Christie NHS Foundation Trust — Manchester, Default, United Kingdom (enrolling)
• Nottingham University Hospitals Cancer Centre — Nottingham, Default, United Kingdom (enrolling)
• Lancashire Teaching Hospitals NHS Foundation Trust — Preston, Default, United Kingdom (enrolling)
• Sheffield Teaching Hospital NHS Foundation Trust — Sheffield, Default, United Kingdom (enrolling)
• Imperial College Healthcare NHS Trust — London, Default, United Kingdom
• The Royal Marsden NHS Foundation Trust — Sutton, Default, United Kingdom
• Brighton and Sussex University Hospital — Brighton, Default, United Kingdom

Full record on ClinicalTrials.gov

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