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

NCT05329532 · Status: RECRUITING · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 168

Last updated 2025-09-17

No results posted yet for this study

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.

Conditions

Interventions

BIOLOGICAL

Modi-1 Moditope

Modi-1 Moditope administered intradermally (i.d.) using the MicronJet600™ microneedle device (NanoPass).

BIOLOGICAL

Pembrolizumab

Pembrolizumab (exploratory cohorts) will be administered by intravenous infusion on Day 8, prior to tumour resection surgery at 6 weeks.

DEVICE

MicronJet600™ microneedle device (NanoPass)

Intradermal injection device

Sponsors & Collaborators

  • Scancell Ltd

    lead INDUSTRY

Principal Investigators

  • Christian Ottensmeier, MD · The Clatterbridge Cancer Centre NHS Foundation Trust, United Kingdom

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-04-07
Primary Completion
2026-07-01
Completion
2027-07-01
FDA Drug
Yes
FDA Device
Yes

Countries

  • United Kingdom

Study Locations

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Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05329532 on ClinicalTrials.gov