Modi-1 Moditope in Breast, Head and Neck, Ovarian, or Renal Cancer (NCT05329532) | Clinical Trial Compass
RecruitingPhase 1/2
Modi-1 Moditope in Breast, Head and Neck, Ovarian, or Renal Cancer
United Kingdom168 participantsStarted 2022-04-07
Plain-language 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 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.
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. 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:
✓. 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.
What they're measuring
1
Incidence of clinical and laboratory adverse events (AEs)
Timeframe: For the duration of the study (12 weeks after the final dose of study treatment)
2
Cellular immune response to Modi-1 Moditope on IFNγ ELISpot assay
Timeframe: For the duration of the study (12 weeks after the final dose of study treatment)
✓. Patient is male or female and at least 18 years of age.
Exclusion criteria
✕. 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.