• 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:

• 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).