Cemiplimab + Combinations for Colorectal Cancer
(EMPIRE Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests the effectiveness of immunotherapies, such as cemiplimab, alone or combined with other drugs, in preventing the recurrence of colorectal cancer. The focus is on patients with a specific marker, called ctDNA, after surgical removal and treatment of their cancer. Eligible participants include those with colorectal cancer who have completed surgery and chemotherapy and tested positive for ctDNA. As a Phase 2 trial, the research measures the treatment's effectiveness in an initial, smaller group of people.
Is there any evidence suggesting that this trial's treatments are likely to be safe?
A previous study found cemiplimab to be generally safe for cancer treatment, though 91% of patients experienced side effects, with only some being serious.
When combined with REGN7075, research showed cemiplimab was mostly well-tolerated, and most patients managed the side effects. However, the study did not focus on severe side effects.
Combining cemiplimab with fianlimab was also generally well-tolerated. Common side effects included skin reactions on the hands and feet and liver issues, but these were not severe for most people. Only about 9% experienced more serious side effects.
Overall, while these treatments were generally well-tolerated, some patients experienced significant side effects, and individual reactions can vary.12345Why are researchers excited about this trial's treatments?
Researchers are excited about these treatments because they offer new ways to tackle colorectal cancer. Unlike the standard options like chemotherapy and targeted therapies, cemiplimab is an immunotherapy that harnesses the body's immune system to fight cancer cells. In the study, cemiplimab is combined with other novel agents like REGN7075 and fianlimab, which may enhance its cancer-fighting power. By potentially boosting the immune response more effectively, these combinations could provide a new lifeline for patients who haven't had success with traditional treatments.
What evidence suggests that this trial's treatments could be effective for colorectal cancer?
Research has shown that cemiplimab can help the immune system recognize and attack cancer cells. In this trial, participants may receive cemiplimab alone or with other treatments. Studies have found that cemiplimab, especially when combined with fianlimab, can shrink tumors in about 61% of patients with various cancer types. Participants in this trial may receive this combination. Another group will receive cemiplimab with REGN7075. Early results suggest this combination can boost the immune response even in hard-to-treat cancers, such as some colorectal cancers. REGN7075 has shown promise in making these "cold" tumors more responsive to treatment. In summary, these combinations have shown encouraging results in fighting tumors, with cemiplimab playing a key role in enhancing the body's immune response to cancer.36789
Are You a Good Fit for This Trial?
This trial is for adults (18+) with stage II/III colon or rectal cancer, or limited stage IV colorectal cancer, who have had surgery and at least 3 months of chemotherapy. Participants must show no signs of spread on scans and test positive for ctDNA after treatment. Only those with certain tumor types (MSS/pMMR) can join.Inclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive cemiplimab monotherapy or cemiplimab plus fianlimab or other novel combinations
Follow-up
Participants are monitored for safety and effectiveness after treatment
Extension/Long-term follow-up
Participants are monitored for recurrence-free survival and ctDNA clearance sustainability
What Are the Treatments Tested in This Trial?
Interventions
- Cemiplimab
Trial Overview
The study tests whether immunotherapy drugs—cemiplimab alone, cemiplimab plus fianlimab, or cemiplimab plus REGN7075—can help prevent colorectal cancer from returning in people who are ctDNA-positive after standard treatment. Patients are assigned to different groups to compare these treatments.
How Is the Trial Designed?
3
Treatment groups
Experimental Treatment
Active Control
cemiplimab plus REGN7075
cemiplimab
cemiplimab plus fianlimab
Find a Clinic Near You
Who Is Running the Clinical Trial?
NSABP Foundation Inc
Lead Sponsor
Regeneron Pharmaceuticals
Industry Sponsor
Leonard Schleifer
Regeneron Pharmaceuticals
Chief Executive Officer since 1988
MD and PhD in Medicine
George Yancopoulos
Regeneron Pharmaceuticals
Chief Medical Officer since 1997
MD from Harvard Medical School
Citations
Study Details | NCT07224022 | Cemiplimab With Fianlimab ...
This is a research study to test whether two immunotherapy drugs-cemiplimab and fianlimab-can safely and effectively shrink colon tumors before surgery in ...
2.
onclive.com
onclive.com/view/dr-mckean-on-the-efficacy-of-fianlimab-plus-cemiplimab-in-advanced-melanomaDr McKean on the Efficacy of Fianlimab Plus Cemiplimab ...
The results revealed an ORR of 57% (95% CI 47%-67%), with deep and durable responses observed across the cohorts. Notably, the complete response ...
Fianlimab, a human lymphocyte activation gene‐3 ... - PMC
Although outcomes for many cancers have been greatly improved for patients with advanced solid tumors with the advent of anti–PD‐1 therapies, , ...
Phase I Study of Fianlimab, a Human Lymphocyte ...
Our data show a high ORR (61.5%) and prolonged median PFS (12 months) with fianlimab plus cemiplimab in patients who received anti–PD-1 adjuvant ...
5.
ajmc.com
ajmc.com/view/fianlimab-plus-cemiplimab-shows-deep-durable-responses-in-melanoma-dr-meredith-mckeanFianlimab Plus Cemiplimab Shows Deep, Durable ...
We had an objective response rate of 57% at that median follow-up of 23 months, and we continue to need additional follow up because we've not ...
Safety, efficacy, and quality of life with cemiplimab treatment ...
Immune checkpoint inhibitors have shown promise in treating advanced non-small cell lung cancer and have a solid safety profile. Cemiplimab ...
A phase 1/2 study of REGN7075 in combination with ...
A phase 1/2 study of REGN7075 in combination with cemiplimab (cemi) in patients (pts) with advanced solid tumors: Efficacy and safety results.
Dr Rischin on the Safety of Adjuvant Cemiplimab in High- ...
Findings showed that treatment-emergent adverse effects (TEAEs) of any grade occurred in 91% of patients who received cemiplimab (n = 205) and ...
9.
newsroom.regeneron.com
newsroom.regeneron.com/news-releases/news-release-details/libtayor-cemiplimab-plus-chemotherapy-results-five-yearsLibtayo® (cemiplimab) Plus Chemotherapy Results at Five ...
The safety profile at five years remained consistent with previously reported data. The median duration of exposure was 39 weeks to Libtayo plus ...
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