Dupilumab + Toripalimab for Colorectal Cancer

Overseen By Rashmi Unawane

Age: 18+

Sex: Any

Trial Phase: Phase 1 & 2

Sponsor: Dan Feng

Must not be taking: Immunomodulatory drugs, Dupilumab

Disqualifiers: Autoimmune disorders, Active infections, HIV, others

Stay on Your Current Meds You can continue your current medications while participating

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Breakthrough Therapy This drug has been fast-tracked for approval by the FDA given its high promise

Compensation: Varies

Number of Visits: 6

Duration: 3 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new combination of medications, Dupilumab and Toripalimab, to determine their safety and effectiveness for individuals with a specific type of colorectal cancer that has spread to the liver. Researchers focus on cases where the cancer is microsatellite stable (MSS), lacking certain genetic traits that make it easier to treat. Participants should have colorectal cancer with liver metastases that can be surgically removed and should not have received certain prior treatments. This trial is particularly suited for those who can undergo surgery to remove their liver metastases. As a Phase 1, Phase 2 trial, the study aims to understand how the treatment works in people and measure its effectiveness in an initial, smaller group, offering participants a chance to contribute to groundbreaking research.

Do I need to stop my current medications to join the trial?

The trial does not specify if you need to stop your current medications, but you cannot have taken immunomodulatory drugs or dupilumab within 8 weeks before joining. It's best to discuss your specific medications with the trial team.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that patients generally tolerate the combination of Dupilumab and Toripalimab well. One study found that 62.1% of patients experienced better disease control with this treatment. Although specific side effects were not mentioned, these findings suggest the treatment might be safe for many. It is important to remember that this treatment remains under study, and further information will help clarify its safety. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about the combination of Dupilumab and Toripalimab for colorectal cancer because it introduces a novel approach to treatment. Unlike traditional chemotherapy and radiation, this combination leverages the immune system to fight cancer. Dupilumab is an antibody that targets and blocks the signaling of certain proteins involved in inflammation, potentially reducing tumor-promoting inflammation. Toripalimab, on the other hand, is an immune checkpoint inhibitor that helps activate the body's immune response against cancer cells. This dual mechanism offers a fresh strategy that might provide better outcomes for patients with colorectal cancer.

What evidence suggests that this trial's treatments could be effective for colorectal cancer?

Research has shown that using Dupilumab and Toripalimab together may effectively treat a type of colorectal cancer that has spread to the liver. Participants in this trial will receive the combination of Dupilumab and Toripalimab. In earlier studies, some patients who received this treatment achieved excellent results, with certain groups experiencing a 100% survival rate over five years. Another study found that 53.3% of patients had a complete response, meaning no cancer was found in their tissue after treatment. These results suggest that this treatment could work well for this type of cancer. ^{1 3 4 5 6}

Who Is on the Research Team?

Dan Feng, MD, PhD

Principal Investigator

Icahn School of Medicine at Mount Sinai

Thomas Marron, MD, PhD

Principal Investigator

Icahn School of Medicine at Mount Sinai

Are You a Good Fit for This Trial?

This trial is for individuals with a type of colorectal cancer that's stable at the microsatellite level (MSS CRC) and who have liver metastases that can be surgically removed. Specific inclusion and exclusion criteria details are not provided, but typically include factors like age, health status, previous treatments, and specific medical conditions.

Inclusion Criteria

Ability to understand and sign a written informed consent

My colorectal cancer is not MSI-H or has proficient MMR.

I am 18 years old or older.

Exclusion Criteria

History of autoimmune disorder with exceptions

Use of investigational agents for cancer treatment

Active autoimmune disease requiring systemic treatment in the past year

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive neoadjuvant immunotherapy with dupilumab and toripalimab before planned surgery

3 weeks

2 visits (in-person)

Surgery

Participants undergo surgery to resect liver metastases

1 week

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

12 weeks

3 visits (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• Dupilumab
• Toripalimab

Trial Overview

The study is testing the safety and effectiveness of two drugs—Toripalimab and Dupilumab—given before surgery to patients with MSS CRC who have liver metastases. It's an early-stage trial to see how well these drugs work in this specific situation.

How Is the Trial Designed?

Group I: Dupilumab and toripalimab Experimental Treatment 2 Interventions

Participants will receive the combination of Dupilumab and Toripalimab

Who Is Running the Clinical Trial?

Dan Feng

Lead Sponsor

Coherus Oncology, Inc.

Industry Sponsor

Citations

1.

clinicaltrials.gov

clinicaltrials.gov/study/NCT07277322

Neoadjuvant Dupilumab and Toripalimab in MSS CRC ...

This is a Phase 1b/2 study of neoadjuvant dupilumab and toripalimab in MSS CRC subjects with resectable liver metastases.

2.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC12572784/

Neoadjuvant PD-1 blockade with toripalimab with or ...

At the 5-year landmark analysis, the 5-year overall survival rates were 100% (95% CI 100-100) in the combination group and 94% (95% CI 84–99) in ...

3.

trial.medpath.com

trial.medpath.com/clinical-trial/fefeca7f3f512c27/nct07277322-neoadjuvant-immunotherapy-mss-colorectal-cancer-liver-metastases

Neoadjuvant Dupilumab and Toripalimab in MSS CRC ...

This Phase 1b/2 trial will evaluate the safety and efficacy of neoadjuvant immunotherapy in microsatellite stable (MSS) colorectal cancer (CRC) subjects with ...

4.

ctv.veeva.com

ctv.veeva.com/study/neoadjuvant-dupilumab-and-toripalimab-in-mss-crc-subjects-with-resectable-liver-metastases

Neoadjuvant Dupilumab and Toripalimab in MSS CRC ...

This is a Phase 1b/2 study of neoadjuvant dupilumab and toripalimab in MSS CRC subjects with resectable liver metastases.

5.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC12399360/

Short-term surgical outcomes following neoadjuvant ...

Histopathological examination revealed a major pathological response in 11 cases (73.3%), with complete pathological response in 8 (53.3%), near ...

6.

pubmed.ncbi.nlm.nih.gov

pubmed.ncbi.nlm.nih.gov/40318829/

Patient outcomes and safety of combination biologic ...

Clinical outcomes were generally favorable, with improved disease control observed in 62.1% of cases. Combination biologic therapy with ...