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Modi-1 in Breast, Head and Neck, Ovarian, or Renal Cancer (ModiFY)

Primary Purpose

Triple Negative Breast Cancer, Renal Cell Cancer, High Grade Ovarian Serous Adenocarcinoma

Status
Recruiting
Phase
Phase 1
Locations
United Kingdom
Study Type
Interventional
Intervention
Modi-1/Modi-1v
Pembrolizumab
MicronJet600™ microneedle device (NanoPass)
Sponsored by
Scancell Ltd
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Triple Negative Breast Cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. Patient either has one of the following histologically or cytologically confirmed advanced cancers not amenable to curative intent surgical resection:

    • Advanced 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.
  2. Specific criteria for prior treatment of individual tumour types are as follows:

    • TNBC:

      • The patient has received available standard therapy for advanced disease (Modi-1/Modi-1v monotherapy cohorts only), or
      • Patients who stopped immunotherapy due to toxicity and with residual disease as measurable by RECIST 1.1 (Modi-1/Modi-1v monotherapy cohorts only), or
      • Patients completing a systemic treatment regimen with immunotherapy, for whom a subsequent standard of care therapy is not yet indicated or appropriate and with measurable disease in accordance with RECIST 1.1 (Modi-1/Modi-1v monotherapy cohorts only), or
      • Patients with residual disease as measurable by RECIST 1.1 on an ongoing standard of care immunotherapy regimen (Modi-1 + CPI combination cohorts only).
    • HPV (-) SCCHN:

      • The patient should have received first-line platinum containing chemotherapy (with or without radiotherapy) as treatment for advanced disease (Modi-1/Modi-1v monotherapy cohorts and Modi 1 + CPI cohorts), or
      • Patients with locally advanced or metastatic disease as measurable by RECIST 1.1 for whom all forms of platinum-based chemoradiotherapy treatment are contraindicated (Modi-1/Modi-1v monotherapy cohorts and Modi 1 + CPI cohorts), or
      • Patients completing immunotherapy therapy for whom a subsequent standard of care therapy is not yet indicated or appropriate and with measurable disease in accordance with RECIST 1.1 (Modi-1/Modi-1v monotherapy cohorts only), or
      • Patients who stopped immunotherapy due to toxicity or completion of immunotherapy but with measurable disease in accordance with RECIST 1.1 (Modi-1/Modi-1v monotherapy cohorts only), or
      • For untreated metastatic or unresectable recurrent SCCHN in adults whose tumours express PD-L1 with a combined positive score (CPS) of one or more (Modi-1 + CPI cohorts only), or
      • Patients with residual disease as measurable by RECIST 1.1 on ongoing standard of care CPI monotherapy (Modi-1 + CPI combination cohorts only).
    • SCCHN:

      o Neoadjuvant expansion cohort only; patients who are treatment-naïve and are scheduled to have tumour resection surgery, in whom a period of 6 weeks of neoadjuvant immunotherapy can be administered. Patients will only be enrolled once the Modi-1 expansion doses and a lack of increased anti-CCP antibodies (with, and without, concomitant pembrolizumab) has been established.

    • HGSOC including fallopian tube and primary peritoneal cancers:

      • The 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. Patients must have received no more than two non-platinum regimens (Modi-1/Modi-1v monotherapy cohorts), or
      • Patients completing a course of systemic therapy for whom a subsequent standard of care therapy is not yet indicated or appropriate and with measurable disease in accordance with RECIST 1.1 (Modi-1/Modi-1v monotherapy cohorts only).
    • RCC:

    The patient must have received first-line treatment consisting of anti-angiogenic therapy. The patient must also have favourable or intermediate International Metastatic Renal-Cell Carcinoma Database Consortium (IMDC) risk score (Heng et al, 2013) (Modi1/Modi-1v monotherapy cohorts and Modi-1 + CPI cohorts), or

    • Patients who stopped immunotherapy due to toxicity and with residual disease as measurable by RECIST 1.1 (Modi-1/Modi-1v monotherapy cohorts only), or
    • Patients completing immunotherapy, for whom a subsequent standard of care therapy is not yet indicated or appropriate and with measurable disease in accordance with RECIST 1.1 (Modi-1/Modi-1v monotherapy cohorts only), or
    • Patients on active surveillance (Modi-1/Modi-1v monotherapy cohorts only), or
    • Patients eligible for standard of care nivolumab immunotherapy (Modi-1 + CPI combination cohorts only), or
    • Patients with residual disease as measurable by RECIST 1.1 on ongoing standard of care monotherapy CPI (Modi-1 + CPI combination cohorts only)
  3. Patient has completed their last dose of prior cancer therapy at least 4 weeks before the first dose of study treatment.
  4. Patient has been fully vaccinated against COVID-19, the last vaccination being at least 28 days prior to enrolment, except for those who have declined or are not eligible for COVID-19 vaccination.
  5. Patient has recovered to Grade ≤1 (CTCAE v5.0) from the effects (excluding alopecia) of any prior therapy for their malignancies.
  6. Patient has at least one measurable lesion per RECIST 1.1 criteria by computed tomography scan or magnetic resonance imaging (non-neoadjuvant cohorts).
  7. 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 the end of treatment 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.
  8. Patient is male or female and at least 18 years of age.
  9. Patient has a life expectancy of more than 6 months.
  10. Patient has an ECOG performance status of 0 or 1.
  11. Patient has adequate organ function as determined by the following laboratory values:

    • Absolute neutrophil count ≥1.5 x 10^9/L
    • Platelet count ≥100 x 10^9/L
    • Haemoglobin >90 g/L (>5.6 mmol/L)
    • Lymphocytes ≥1 x 10^9/L
    • Serum creatinine ≤1.5 x the upper limit of normal (ULN)
    • Serum total bilirubin ≤1.5 x ULN (an exception for patients with Gilbert's syndrome may be granted after discussion with the Sponsor)
    • Serum transaminases (aspartate transaminase/alanine transaminase) ≤2.5 x ULN or ≤5.0 x ULN if liver metastases are present.
  12. 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.
  13. Women of child-bearing potential must have a negative serum pregnancy test during Screening (and 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).
  14. 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)
  15. Patient must be willing and able to comply with scheduled visits, treatment plan, laboratory tests and other study procedures.
  16. Patients scheduled to receive a CPI (e.g., pembrolizumab or nivolumab) together with Modi 1 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.

Exclusion Criteria:

  1. Patient has symptomatic central nervous system metastases or carcinomatous meningitis.
  2. 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 investigational study treatment. 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.
  3. Patient has a history of malignancy other than the disease under study within the 2 years prior to Screening, with the exception of malignancies with a negligible risk of metastasis or death (e.g., with a 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.
  4. Patient is pregnant, lactating, or is expecting to conceive/father children within the duration of the study.
  5. 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.
  6. Patient has New York Heart Association class III or IV heart disease, has had a myocardial infarction or stroke within the previous 6 months prior to the Screening, has 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.
  7. Patient has anti-citrullinated peptide antibody levels of ≥7 U/mL (classified as equivocal or positive according to NHS guidelines) or an active autoimmune disease that may impact on the study treatment in the opinion of the Investigator.
  8. Patient has received a live vaccine or influenza vaccine within 28 days prior to the first dose of study treatment. The timing of any other vaccines should be assessed on a case-by-case basis by the Investigator prior to study enrolment.
  9. Patient has a known history of human immunodeficiency virus (HIV) or has any positive test for hepatitis B virus (surface antigen reactive) or hepatitis C virus (RNA detected) indicating active acute or chronic infection.
  10. COVID-19 vaccination within 28 days prior to the first dose of study treatment.
  11. Patient has a known current or recent history (within the last year) of substance abuse including illicit drugs or alcohol.

Sites / Locations

  • Brighton and Sussex University HospitalRecruiting
  • University Hospitals Bristol and Weston NHS Foundation Trust
  • Velindre Cancer Centre
  • Edinburgh Cancer Centre (NHS Lothian)Recruiting
  • Guy's and St Thomas' NHS Foundation Trust
  • Imperial College Healthcare NHS TrustRecruiting
  • University College London Hospital NHS Foundation TrustRecruiting
  • Christie NHS Foundation TrustRecruiting
  • Newcastle Hospitals NHS Foundation Trust
  • Nottingham University Hospitals Cancer CentreRecruiting
  • Lancashire Teaching Hospitals NHS Foundation TrustRecruiting
  • Sheffield Teaching Hospital NHS Foundation TrustRecruiting
  • The Royal Marsden NHS Foundation Trust
  • The Clatterbridge Cancer Centre NHS Foundation TrustRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Experimental

Arm Label

Patients with TNBC, advanced/unresectable SCCHN, high grade serous ovarian carcinoma, or RCC

Patients with SCCHN eligible for curative intent resection surgery (neoadjuvant cohort; monotherapy)

Patients with SCCHN eligible for curative intent resection surgery (neoadjuvant cohort; combination)

Arm Description

Outcomes

Primary Outcome Measures

Incidence of clinical and laboratory adverse events (AEs)
To measure the incidence of AEs of Modi-1 and Modi-1v (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-1on 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.

Secondary Outcome Measures

Imaging Response using RECIST 1.1 and iRECIST to Modi-1 and Modi-1v in the non-neoadjuvant setting
To measure imaging response of Modi-1 and Modi1v 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, atezolizumab and avelumab)
Overall survival
The overall survival will measured in patients vaccinated with Modi-1 and Modi-1v either as monotherapy or in combination with checkpoint inhibitors in the target population.
Progression-free survival in patients vaccinated with Modi-1 and Modi-1v.
The progression-free survival will measured in patients vaccinated with Modi-1 and Modi-1v either as monotherapy or in combination with checkpoint inhibitors in the target population.
Pathological response in the neoadjuvant setting in patients vaccinated with Modi-1 or Modi-1 + Pembrolizumab
Pathological response will be measured in tumour tissue of patients vaccinated with Modi-1 monotherapy or Modi-1 + Pembrolizumab in patients with SCCHN undergoing planned resection
Celluar immune response in the neoadjuvant setting in patients vaccinated with Modi-1 or Modi-1 + Pembrolizumab
Immune cells will be profiled and measured in tumour tissue of patients vaccinated with Modi-1 monotherapy or Modi-1 + Pembrolizumab in patients with SCCHN undergoing planned resection

Full Information

First Posted
January 31, 2022
Last Updated
November 18, 2022
Sponsor
Scancell Ltd
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1. Study Identification

Unique Protocol Identification Number
NCT05329532
Brief Title
Modi-1 in Breast, Head and Neck, Ovarian, or Renal Cancer
Acronym
ModiFY
Official Title
A Phase 1/2, Multicentre, Open-Label Study of Modi-1 in Patients With Breast, Head and Neck, Ovarian, or Renal Cancer
Study Type
Interventional

2. Study Status

Record Verification Date
May 2022
Overall Recruitment Status
Recruiting
Study Start Date
April 7, 2022 (Actual)
Primary Completion Date
April 4, 2026 (Anticipated)
Study Completion Date
June 30, 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Scancell Ltd

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
Yes
Product Manufactured in and Exported from the U.S.
Yes
Data Monitoring Committee
No

5. Study Description

Brief Summary
The main objectives of this study are to assess the safety, tolerability, immunological activity, and preliminary efficacy of the Modi-1/Modi-1v vaccine, both as monotherapy and in combination with a checkpoint inhibitor (CPI) such as pembrolizumab or nivolumab (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 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/Modi-1v vaccine in patients with advanced TNBC, advanced/unresectable SCCHN, HGSOC, or RCC. The study proposes a trial of novel Modi-1/Modi-1v 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 vaccine(s), in an open labelled clinical trial, in participants with TNBC, SCCHN, RCC and HGSOC, powered to demonstrate that Modi-1 vaccines have potent anti-tumour activity. In this trial, Modi-1/Modi-1v 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 (with or without pembrolizumab) in participants with SCCHN scheduled for resection surgery with curative intent. Modi-1/Modi-1v will be administered intradermally using the MicronJet600™ microneedle device referred to as NanoPass. The study aims to enrol 144 (114 in non-neoadjuvant cohorts and 30 in the exploratory neoadjuvant SCCHN cohort) individuals across multiple UK collaborating clinical centres.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Triple Negative Breast Cancer, Renal Cell Cancer, High Grade Ovarian Serous Adenocarcinoma, Squamous Cell Carcinoma of the Head and Neck

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Parallel Assignment
Model Description
Open label, uncontrolled study.
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
144 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Patients with TNBC, advanced/unresectable SCCHN, high grade serous ovarian carcinoma, or RCC
Arm Type
Experimental
Arm Title
Patients with SCCHN eligible for curative intent resection surgery (neoadjuvant cohort; monotherapy)
Arm Type
Experimental
Arm Title
Patients with SCCHN eligible for curative intent resection surgery (neoadjuvant cohort; combination)
Arm Type
Experimental
Intervention Type
Biological
Intervention Name(s)
Modi-1/Modi-1v
Intervention Description
Modi-1/Modi-1v administered intradermally (i.d.) using the MicronJet600™ microneedle device (NanoPass).
Intervention Type
Biological
Intervention Name(s)
Pembrolizumab
Intervention Description
Pembrolizumab (exploratory cohorts) will be administered by intravenous infusion on Day 8, prior to tumour resection surgery at 6 weeks.
Intervention Type
Device
Intervention Name(s)
MicronJet600™ microneedle device (NanoPass)
Intervention Description
Intradermal injection device
Primary Outcome Measure Information:
Title
Incidence of clinical and laboratory adverse events (AEs)
Description
To measure the incidence of AEs of Modi-1 and Modi-1v (as monotherapy and in combination with a CPI (e.g., pembrolizumab or nivolumab provided as standard of care) when administered intradermally
Time Frame
For the duration of the study (12 weeks after the final dose of study treatment)
Title
Cellular immune response to Modi-1on IFNγ ELISpot assay
Description
(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.
Time Frame
For the duration of the study (12 weeks after the final dose of study treatment)
Secondary Outcome Measure Information:
Title
Imaging Response using RECIST 1.1 and iRECIST to Modi-1 and Modi-1v in the non-neoadjuvant setting
Description
To measure imaging response of Modi-1 and Modi1v 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, atezolizumab and avelumab)
Time Frame
For the duration of the study (12 weeks after the final dose of study treatment)
Title
Overall survival
Description
The overall survival will measured in patients vaccinated with Modi-1 and Modi-1v either as monotherapy or in combination with checkpoint inhibitors in the target population.
Time Frame
For the duration of the study (12 weeks after the final dose of study treatment)
Title
Progression-free survival in patients vaccinated with Modi-1 and Modi-1v.
Description
The progression-free survival will measured in patients vaccinated with Modi-1 and Modi-1v either as monotherapy or in combination with checkpoint inhibitors in the target population.
Time Frame
For the duration of the study (12 weeks after the final dose of study treatment)
Title
Pathological response in the neoadjuvant setting in patients vaccinated with Modi-1 or Modi-1 + Pembrolizumab
Description
Pathological response will be measured in tumour tissue of patients vaccinated with Modi-1 monotherapy or Modi-1 + Pembrolizumab in patients with SCCHN undergoing planned resection
Time Frame
For the duration of the study (6 weeks after resection surgery)
Title
Celluar immune response in the neoadjuvant setting in patients vaccinated with Modi-1 or Modi-1 + Pembrolizumab
Description
Immune cells will be profiled and measured in tumour tissue of patients vaccinated with Modi-1 monotherapy or Modi-1 + Pembrolizumab in patients with SCCHN undergoing planned resection
Time Frame
For the duration of the study (6 weeks after resection surgery)
Other Pre-specified Outcome Measures:
Title
Immune cell profiling in tumour samples
Description
Immune cells will be profiled from available biopsy tissue
Time Frame
For the duration of the study (12 weeks after the final dose of study treatment)
Title
Measurement of circulating tumour deoxyribonucleic acid (ctDNA)
Description
ctDNA will be measured in blood in patients vaccinated with Modi-1 and Modi-1v either as monotherapy or in combination with checkpoint inhibitors in the target population.
Time Frame
For the duration of the study (12 weeks after the final dose of study treatment)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patient either has one of the following histologically or cytologically confirmed advanced cancers not amenable to curative intent surgical resection: Advanced 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. Specific criteria for prior treatment of individual tumour types are as follows: TNBC: The patient has received available standard therapy for advanced disease (Modi-1/Modi-1v monotherapy cohorts only), or Patients who stopped immunotherapy due to toxicity and with residual disease as measurable by RECIST 1.1 (Modi-1/Modi-1v monotherapy cohorts only), or Patients completing a systemic treatment regimen with immunotherapy, for whom a subsequent standard of care therapy is not yet indicated or appropriate and with measurable disease in accordance with RECIST 1.1 (Modi-1/Modi-1v monotherapy cohorts only), or Patients with residual disease as measurable by RECIST 1.1 on an ongoing standard of care immunotherapy regimen (Modi-1 + CPI combination cohorts only). HPV (-) SCCHN: The patient should have received first-line platinum containing chemotherapy (with or without radiotherapy) as treatment for advanced disease (Modi-1/Modi-1v monotherapy cohorts and Modi 1 + CPI cohorts), or Patients with locally advanced or metastatic disease as measurable by RECIST 1.1 for whom all forms of platinum-based chemoradiotherapy treatment are contraindicated (Modi-1/Modi-1v monotherapy cohorts and Modi 1 + CPI cohorts), or Patients completing immunotherapy therapy for whom a subsequent standard of care therapy is not yet indicated or appropriate and with measurable disease in accordance with RECIST 1.1 (Modi-1/Modi-1v monotherapy cohorts only), or Patients who stopped immunotherapy due to toxicity or completion of immunotherapy but with measurable disease in accordance with RECIST 1.1 (Modi-1/Modi-1v monotherapy cohorts only), or For untreated metastatic or unresectable recurrent SCCHN in adults whose tumours express PD-L1 with a combined positive score (CPS) of one or more (Modi-1 + CPI cohorts only), or Patients with residual disease as measurable by RECIST 1.1 on ongoing standard of care CPI monotherapy (Modi-1 + CPI combination cohorts only). SCCHN: o Neoadjuvant expansion cohort only; patients who are treatment-naïve and are scheduled to have tumour resection surgery, in whom a period of 6 weeks of neoadjuvant immunotherapy can be administered. Patients will only be enrolled once the Modi-1 expansion doses and a lack of increased anti-CCP antibodies (with, and without, concomitant pembrolizumab) has been established. HGSOC including fallopian tube and primary peritoneal cancers: The 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. Patients must have received no more than two non-platinum regimens (Modi-1/Modi-1v monotherapy cohorts), or Patients completing a course of systemic therapy for whom a subsequent standard of care therapy is not yet indicated or appropriate and with measurable disease in accordance with RECIST 1.1 (Modi-1/Modi-1v monotherapy cohorts only). RCC: The patient must have received first-line treatment consisting of anti-angiogenic therapy. The patient must also have favourable or intermediate International Metastatic Renal-Cell Carcinoma Database Consortium (IMDC) risk score (Heng et al, 2013) (Modi1/Modi-1v monotherapy cohorts and Modi-1 + CPI cohorts), or Patients who stopped immunotherapy due to toxicity and with residual disease as measurable by RECIST 1.1 (Modi-1/Modi-1v monotherapy cohorts only), or Patients completing immunotherapy, for whom a subsequent standard of care therapy is not yet indicated or appropriate and with measurable disease in accordance with RECIST 1.1 (Modi-1/Modi-1v monotherapy cohorts only), or Patients on active surveillance (Modi-1/Modi-1v monotherapy cohorts only), or Patients eligible for standard of care nivolumab immunotherapy (Modi-1 + CPI combination cohorts only), or Patients with residual disease as measurable by RECIST 1.1 on ongoing standard of care monotherapy CPI (Modi-1 + CPI combination cohorts only) Patient has completed their 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 28 days prior to enrolment, 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 scan or magnetic resonance imaging (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 the end of treatment 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 10^9/L Platelet count ≥100 x 10^9/L Haemoglobin >90 g/L (>5.6 mmol/L) Lymphocytes ≥1 x 10^9/L Serum creatinine ≤1.5 x the upper limit of normal (ULN) Serum total bilirubin ≤1.5 x ULN (an exception for patients with Gilbert's syndrome may be granted after discussion with the Sponsor) Serum transaminases (aspartate transaminase/alanine transaminase) ≤2.5 x ULN or ≤5.0 x ULN if liver metastases are 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 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. Patients scheduled to receive a CPI (e.g., pembrolizumab or nivolumab) together with Modi 1 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. 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 investigational study treatment. 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 the 2 years prior to Screening, with the exception of malignancies with a negligible risk of metastasis or death (e.g., with a 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 class III or IV heart disease, has had a myocardial infarction or stroke within the previous 6 months prior to the Screening, has 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-citrullinated peptide antibody levels of ≥7 U/mL (classified as equivocal or positive according to NHS guidelines) or an active autoimmune disease that may impact on the study treatment in the opinion of the Investigator. Patient has received a live vaccine or influenza vaccine within 28 days prior to the first dose of study treatment. 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) or has any positive test for hepatitis B virus (surface antigen reactive) or hepatitis C virus (RNA detected) indicating active acute or chronic infection. COVID-19 vaccination within 28 days prior to the first dose of study treatment. Patient has a known current or recent history (within the last year) of substance abuse including illicit drugs or alcohol.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Robert Miller
Phone
+441865582690
Email
info@scancell.co.uk
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Christian Ottensmeier, MD
Organizational Affiliation
The Clatterbridge Cancer Centre NHS Foundation Trust, United Kingdom
Official's Role
Principal Investigator
Facility Information:
Facility Name
Brighton and Sussex University Hospital
City
Brighton
State/Province
Default
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Fayaz Master
Email
info@scancell.co.uk
Facility Name
University Hospitals Bristol and Weston NHS Foundation Trust
City
Bristol
State/Province
Default
Country
United Kingdom
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Fayaz Master
Email
info@scancell.co.uk
Facility Name
Velindre Cancer Centre
City
Cardiff
State/Province
Default
Country
United Kingdom
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Fayaz Master
Email
info@scancell.co.uk
Facility Name
Edinburgh Cancer Centre (NHS Lothian)
City
Edinburgh
State/Province
Default
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Fayaz Master
Email
info@scancell.co.uk
Facility Name
Guy's and St Thomas' NHS Foundation Trust
City
London
State/Province
Default
Country
United Kingdom
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Fayaz Master
Email
info@scancell.co.uk
Facility Name
Imperial College Healthcare NHS Trust
City
London
State/Province
Default
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Fayaz Master
Email
info@scancell.co.uk
Facility Name
University College London Hospital NHS Foundation Trust
City
London
State/Province
Default
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Fayaz Master
Email
info@scancell.co.uk
Facility Name
Christie NHS Foundation Trust
City
Manchester
State/Province
Default
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Fayaz Master
Email
info@scancell.co.uk
Facility Name
Newcastle Hospitals NHS Foundation Trust
City
Newcastle
State/Province
Default
Country
United Kingdom
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Fayaz Master
Email
info@scancell.co.uk
Facility Name
Nottingham University Hospitals Cancer Centre
City
Nottingham
State/Province
Default
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Fayaz Master
Email
info@scancell.co.uk
Facility Name
Lancashire Teaching Hospitals NHS Foundation Trust
City
Preston
State/Province
Default
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Fayaz Master
Email
info@scancell.co.uk
Facility Name
Sheffield Teaching Hospital NHS Foundation Trust
City
Sheffield
State/Province
Default
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Fayaz Master
Email
info@scancell.co.uk
Facility Name
The Royal Marsden NHS Foundation Trust
City
Sutton
State/Province
Default
Country
United Kingdom
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Fayaz Master
Email
info@scancell.co.uk
Facility Name
The Clatterbridge Cancer Centre NHS Foundation Trust
City
Liverpool
ZIP/Postal Code
CH63 4JY
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Christian Ottensmeier, MD
Email
info@scancell.co.uk

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
There is not a plan to make individual patient data available

Learn more about this trial

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

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