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Neoadjuvant Dupilumab and Toripalimab in MSS CRC Subjects With Resectable Liver Metastases

ConditionsMetastatic Colorectal CancerLiver Metastases
Trial statusRecruiting
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

This trial does not accept healthy volunteers

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

Design model

Sequential

Treatments tested in this trial

  • Dupilumab

    Drug

    Dupilumab is commercially sourced, and provided as 300mg pre-filled syringes, though packaging may vary. Dupilumab 600mg SC on Day 1 and 300mg SC on Day 15 (+/-2 days).

  • Toripalimab

    Drug

    Toripalimab will be supplied as a liquid in sterile, single-use vials that will display the product lot number on the label. Each vial contains 240 mg/6 mL (40 mg/mL) solution. Toripalimab 240mg IV over 60 minutes or longer on Day 1 before planned surgery.

Treatment groups

24 Participants
are divided into 1 treatment group
Group A: Dupilumab and toripalimabExperimental treatment 2 interventions

Trial outcomes

Primary outcomes

1

Number of dose limiting toxicities (DLTs)

Phase 2: Safety of treatment, defined as the frequency and percentage of DLTs, from start of treatment up to 30 days post the last administration of study drug (dupilumab).

Time frame
up to 30 days post last administration of study drug dupilumab

Secondary outcomes

1

Major pathological response (MPR)

Major pathological response (MPR), defined as the presence of viable tumor cells in less than 10% of the target lesion.

Time frame
Day of Surgery (day 16-22)
2

Time to surgery

Time from the initial dose of dupilumab to the time of surgery, measured in days.

Time frame
up to 22 days
3

Percentage of participants with adverse event

Safety and tolerability defined by the percentage of individuals who experience adverse events (according to NCI CTCAE v5.0) at any point during the neoadjuvant period, or within 90 days following the final dose of dupilumab received, that are attributable to dupilumab and/or toripalimab,

Time frame
within 90 days following the final dose of dupilumab
4

Event free survival (EFS)

Time from initial treatment of dupilumab and toripalimab to progression of disease, recurrence of tumor following surgery, or death from any cause regardless of etiology.

Time frame
Initial treatment to progression of disease, recurrence of tumor following surgery, up to 8 weeks, whichever comes first after first dose of dupilumab,

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Dan Feng

Lead sponsor

Icahn School of Medicine at Mount Sinai

Sponsor institution

Coherus Oncology, Inc.

Collaborator

Source ClinicalTrials.gov
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