Immunotherapy (Toripalimab) for Reducing Recurrence Risk After Surgery for Mismatch Repair Deficient Stage IIB, IIC, or III Colon Cancer

Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorEmory University

About this trial

This phase II trial tests how well immunotherapy (toripalimab) works for reducing the risk of cancer recurrence after surgery in patients with mismatch repair deficient stage IIB, IIC, or III colon cancer.

Eligibility criteria

Qualifiers

Patients with resected pathologic stage IIB, IIC and III dMMR colon cancer (American Joint Committee on Cancer [AJCC] 8)

Deficient mismatch repair (MMR) by immunohistochemistry or microsatellite instability (MSI-H) by polymerase chain reaction (PCR) or next generation sequencing (NGS)

Complete (R0) resection of pathologic stage IIB, IIC and III dMMR colon cancer 4 to 12 weeks prior to first dose of study drug

Available tissue sample from surgical specimen

Disqualifiers

Neoadjuvant treatment for dMMR colon cancer

Presence of metastatic dMMR colon cancer

Underlying medical conditions that, in the investigator's opinion, will make the administration of the study drug hazardous or obscure the interpretation of adverse events

Uncontrolled psychiatric illness or psychological condition potentially hampering compliance with the study protocol and follow-up schedule

Trial design

Treatments tested in this trial

  • Biopsy Procedure
  • Biospecimen Collection
  • Colonoscopy
  • Computed Tomography
  • Questionnaire Administration
  • Toripalimab

Treatment groups

40 Participants
are divided into 1 treatment group

Sponsors and collaborators

Emory University

Lead sponsor

National Cancer Institute (NCI)

Collaborator

Coherus Oncology, Inc.

Collaborator