Toripalimab for Colon Cancer

Recruiting at 4 trial locations

Overseen By Olatunji B. Alese, MD, FASCO

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Emory University

Must not be taking: Steroids, Immunosuppressants, Live vaccines, others

Disqualifiers: Metastatic cancer, Autoimmune disease, others

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

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 8

Duration: 6 months

40 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests toripalimab, an immunotherapy, to determine if it can reduce the risk of colon cancer recurrence after surgery. It targets patients with specific types of colon cancer (stage IIB, IIC, or III) that have a deficiency in mismatch repair, a mechanism the body uses to fix DNA errors. Participants will receive the treatment via IV every three weeks for six months and will be monitored for five years. Suitable candidates have had their cancer surgically removed and a clear check-up showing no active disease. As a Phase 2 trial, this research aims to measure the treatment's effectiveness in an initial, smaller group of people.

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

The trial does not specify if you need to stop taking your current medications, but you cannot be on systemic steroid therapy or any other form of immunosuppressive therapy within 7 days before starting the study treatment. It's best to discuss your specific medications with the trial team.

Is there any evidence suggesting that toripalimab is likely to be safe for humans?

Research has shown that toripalimab is generally well-tolerated, though side effects can occur. In one study, 60% of patients experienced at least one treatment-related side effect. Some side effects were serious, with 20% of patients experiencing a more severe reaction. However, another study reported no treatment-related deaths. Additionally, only 12.5% of patients discontinued treatment due to side effects.

These findings suggest that while toripalimab can cause side effects, it has been used safely in other studies. It is important to weigh both the benefits and risks and to discuss any concerns with the research team. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for colon cancer?

Unlike the standard treatments for colon cancer, which often include chemotherapy and targeted therapies, toripalimab is a type of immunotherapy known as a checkpoint inhibitor. This drug works differently by blocking the PD-1 pathway, a mechanism cancer cells use to hide from the immune system. By targeting this pathway, toripalimab helps the body's immune system recognize and attack cancer cells more effectively. Researchers are excited about toripalimab because it represents a novel approach that could potentially enhance the body's natural defenses against colon cancer, offering a new avenue for patients who may not respond well to traditional treatments.

What evidence suggests that toripalimab might be an effective treatment for colon cancer?

Research shows that toripalimab, the treatment under study in this trial, holds promise for treating colon cancer, particularly in patients with a genetic feature called deficient mismatch repair (dMMR). Previous studies found toripalimab effective in reducing the chance of cancer recurrence after surgery. Some trials reported high survival rates, such as 94% for patients using toripalimab alone. The treatment also controlled cancer effectively in many patients. These findings suggest toripalimab could be a strong option for reducing the risk of colon cancer returning after surgery. ^{1 2 3 4 6}

Who Is on the Research Team?

Oluwadunni E. Emiloju, MBBS, MS

Principal Investigator

Emory University Hospital/Winship Cancer Institute

Are You a Good Fit for This Trial?

This trial is for individuals who've had surgery for stage IIB, IIC, or III colon cancer that's mismatch repair deficient. It's not specified who can't join the trial, but typically there are criteria based on overall health and other medical conditions.

Inclusion Criteria

ANC ≥ 1,500 /mcL

Hemoglobin ≥ 9 g/dL or ≥ 5.0 mmol/L

Total bilirubin ≤ 1.5 x ULN or direct bilirubin ≤ ULN for patients with total bilirubin levels > 1.5 x ULN

Exclusion Criteria

Autoimmune disease requiring systemic treatment in past 2 years

I have not received any live vaccines in the last 30 days.

Current pregnancy or breastfeeding

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive toripalimab intravenously every 3 weeks for 6 months (8 doses) in the absence of disease recurrence or unacceptable toxicity

6 months

8 visits (in-person)

Follow-up

Participants undergo surveillance follow-up with blood tests, CT scans, and colonoscopy at specified intervals until 5 years post-resection

5 years

What Are the Treatments Tested in This Trial?

Interventions

• Toripalimab

Trial Overview The study is testing if toripalimab, an immunotherapy drug, can prevent colon cancer from coming back after surgery. Participants will also undergo biospecimen collection, biopsies, colonoscopies, CT scans and fill out questionnaires.

How Is the Trial Designed?

Group I: Treatment (toripalimab) Experimental Treatment 6 Interventions

Eligible consenting participants receive toripalimab intravenously every 3 weeks for 6 months (8 doses) in the absence of disease recurrence or unacceptable toxicity. Following this, patients undergo surveillance follow up with blood tests, computed tomography (CT) scans, colonoscopy at specified intervals until 5 years post-resection. For patients who have a recurrence, a biopsy will be performed at the time of recurrence.

Who Is Running the Clinical Trial?

Emory University

Lead Sponsor

Trials

1,735

Recruited

2,605,000+

National Cancer Institute (NCI)

Collaborator

Trials

14,080

Recruited

41,180,000+

Coherus Biosciences, Inc.

Industry Sponsor

Trials

19

Recruited

3,700+

Coherus Oncology, Inc.

Industry Sponsor

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT07140679

NCT07140679 | Immunotherapy (Toripalimab) for ... This phase II trial tests how well immunotherapy (toripalimab) works for reducing the risk of cancer recurrence after surgery in patients with ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12490223/

Toripalimab, bevacizumab, and irinotecan in dMMR/MSI ... Toripalimab with or without irinotecan and bevacizumab shows promising efficacy and manageable toxicity in dMMR/MSI T4NanyM0 colon cancer and ...

3. thelancet.com thelancet.com/journals/eclinm/article/PIIS2589-5370(25)00432-8/fulltext

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 the monotherapy ...

4. nature.com nature.com/articles/s41392-024-01939-5

A phase II clinical trial of toripalimab in advanced solid ... Despite the high disease control rate of 54.5% in patients with POL-non-EDMs, the overall response rate was only 9.1%. These results indicated ...

5. facingourrisk.org facingourrisk.org/research-clinical-trials/study/358/post-surgery-immunotherapy-toripalimab-for-mmr-d-msi-h-stage-iib-iii-colon-cancer

Post-surgery Immunotherapy (Toripalimab) for MMR-D / ... This phase II trial evaluates how well immunotherapy (toripalimab) works for reducing the risk of cancer recurrence after surgery in ...

6. ascopubs.org ascopubs.org/doi/10.1200/JCO.2022.40.16_suppl.e15573

Toripalimab with Fruquintinib as the third-line treatment for ... No treatment-related death was reported. TRAEs leading to either Fruquintinib or Toripalimab discontinuation occurred in 3 (12.5%) pts each.