Neoadjuvant Dupilumab and Toripalimab in MSS CRC Subjects With Resectable Liver Metastases
Trial statusNot yet recruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorDan Feng
About this trial
This Phase 1b/2 trial will evaluate the safety and efficacy of neoadjuvant immunotherapy in microsatellite stable (MSS) colorectal cancer (CRC) subjects with resectable liver metastases.
Eligibility criteria
Qualifiers
synchronous liver metastases (present at the time of diagnosis of MSS CRC) and treatment-naïve
metachronous liver metastasis (developed after resection of the primary tumor) without prior adjuvant chemotherapy
metachronous liver metastasis (developed after resection of the primary tumor) with adjuvant chemotherapy completed greater than 3 months from the time of consent.
Has not undergone a hysterectomy or bilateral oophorectomy; or
Disqualifiers
Vitiligo, alopecia, psoriasis or any chronic skin condition that does not require systemic therapy
Hypothyroidism (e.g. following autoimmune thyroiditis) stable on thyroid replacement
Celiac disease controlled by diet alone
Trial design
Treatments tested in this trial
- Dupilumab
- Toripalimab
Treatment groups
24 Participants
are divided into 1 treatment groupSponsors and collaborators
Dan Feng
Lead sponsor
Icahn School of Medicine at Mount Sinai
Sponsor institution
Coherus Oncology, Inc.
Collaborator
Source ClinicalTrials.gov