Phase 2/3 study of (Neo)adjuvant V940 and pembrolizumab in cSCC

• Research type

  Research Study

• Full title

  A Phase 2/3, adaptive, randomized, open-label, clinical study to evaluate neoadjuvant and adjuvant V940 (mRNA-4157) in combination with pembrolizumab (MK- 3475) versus standard of care, and pembrolizumab monotherapy in participants with resectable locally advanced cutaneous squamous cell carcinoma (LA cSCC) (INTerpath-007)

• IRAS ID

  1009279

• Contact name

  - -

• Contact email

  N/A

• Sponsor organisation

  Merck Sharp & Dohme LLC

• Clinicaltrials.gov Identifier

  NCT06295809

• Research summary

  Locally advanced cutaneous squamous cell carcinoma (LA cSCC) is skin cancer that has spread deeper into tissues, muscles, or nearby lymph glands below the skin, but has not spread to other body parts. Participants with LA cSCC usually have surgery to remove the cancer and sometimes also radiation therapy.
  Researchers want to learn if pembrolizumab and V940 can help treat resectable LA cSCC. Resectable means the cancer can be removed by surgery. Pembrolizumab is an immunotherapy, which is a treatment that helps the immune system fight cancer. V940 is designed to help a person’s immune system attack their specific cancer.

  Up to 1012 participants with resectable LA cSCC will be in the study. They will be 18 years old and older and:
  • Be able to have surgery to remove LA cSCC
  • Not have had previous treatment for the LA cSCC (unless it was previous surgery or radiation to another cSCC tumour in a different area of the body)

  There will be 3 treatment groups:
  • Group A (250 participants) will receive 2 doses of V940 and pembrolizumab, then surgery (and radiation if needed). After surgery (and radiation if needed), participants will receive V940 for about 5 months and pembrolizumab for about 1 year.
  • Group B (250 participants) will receive surgery (and radiation if needed)-standard treatment.
  • Group C (100 participants) will receive 2 doses of pembrolizumab, then surgery (and radiation if needed). After surgery (and radiation if needed), participants will receive pembrolizumab for about 1 year.
  Then researchers will look at the safety and benefit data before deciding whether to add more participants in the study. New participants will have an equal chance of receiving either Group A or Group B treatment.
  During the study, participants will give blood, urine, and tumour samples. They will also have imaging tests, physical examinations, photos taken of skin tumours, and answer questions about their health. Participants may be in this study for up to 7 years.

• REC name

  South Central - Oxford A Research Ethics Committee

• REC reference

  24/SC/0091

• Date of REC Opinion

  15 May 2024

• REC opinion

  Further Information Favourable Opinion