Platform Study of Immunotherapy Combinations in Colorectal Cancer Liver Metastases
New trial tests immunotherapy combinations for colorectal cancer spread to liver
Plain English Summary
Platform Study of Immunotherapy Combinations in Colorectal Cancer Liver Metastases is a Phase 2 clinical trial sponsored by Weill Medical College of Cornell University studying Colorectal Cancer Metastatic, Liver Metastases, Colorectal Cancer. This trial tests different combinations of immunotherapy drugs, with or without radiation, to see if they can help shrink liver tumors before surgery. It is for patients with colorectal cancer that has spread to the liver and who are planning to have surgery to remove these tumors. Participants will receive infusions of study drugs and possibly radiation before and after surgery, and will be monitored for up to 2 years. Standard treatment for this condition may involve surgery, chemotherapy, or targeted therapies, depending on the individual case. The trial aims to enroll 24 participants.
Official Summary
The goal of this clinical trial is to to learn about different combinations of immunotherapy in patients with colorectal cancer whose cancer has spread to their liver and are planning to have surgery to remove tumor metastases from their liver. The main questions it aims to answer are: * whether these combinations of immunotherapy change the tumor microenvironment in the liver * whether these combinations of immunotherapy are safe and effective when used in colorectal cancer with liver metastases Participants will be randomly assigned to one of the following: * Botensilimab and balstilimab * Botensilimab, balstilimab, and AGEN1423 * Botensilimab, balstilimab, and radiation Participants will be asked to come in to receive drug infusions (and radiation, if applicable) before and after their surgical resection. Participants will be followed for up to 2 years.
Who Can Participate
Here is what you need to know about eligibility for this trial. Patients with colorectal cancer that has spread to the liver and who are scheduled for surgery to remove liver tumors can join. Patients must have tumors that are not MSI-H/dMMR and have measurable disease. Patients cannot have had previous treatment with certain types of immunotherapy (PD-1, PD-L1, CTLA-4) and must not have active autoimmune disease requiring recent treatment. Patients must agree to use effective contraception if of childbearing potential and not be pregnant or breastfeeding. This trial is studying Colorectal Cancer Metastatic, Liver Metastases, Colorectal Cancer, so participants generally need a confirmed diagnosis. The trial is currently accepting new participants.
What They're Measuring
The primary outcome measures how immunotherapy combinations affect the immune cells within the liver tumors, which could indicate how well the treatment is working to fight the cancer. The specific primary outcome measures are: Mean CD8:Treg ratio, as determined by flow cytometry of tumor tissue, at time of surgical resection in each treatment arm (At surgical resection). These endpoints are how researchers determine whether the treatment is effective and will form the basis of any future regulatory submissions.
About This Phase
This trial is in Phase 2, which tests whether the treatment actually works against the target condition. Phase 2 trials involve 100-300 patients and continue to monitor safety while evaluating effectiveness. This phase often tests different dosages to find the optimal amount. About 33% of Phase 2 drugs advance to Phase 3. If successful, the treatment will move to large-scale Phase 3 trials needed for FDA approval.
Why This Trial Matters
This trial addresses a critical need for new treatments for colorectal cancer that has spread to the liver, aiming to improve outcomes for patients undergoing surgery. Phase 2 success would typically lead to larger Phase 3 trials needed for regulatory approval. This research targets Colorectal Cancer Metastatic, Liver Metastases, Colorectal Cancer, where improved treatment options are needed.
Investor Insight
This trial explores novel immunotherapy combinations in a difficult-to-treat cancer subset, potentially opening new avenues for treatment and representing an investment in advanced cancer therapies. Phase 2 trials have approximately a 15-20% chance of eventually gaining FDA approval.
Is This Trial Right for Me?
Ask your doctor if this trial is a good fit for you, considering your specific cancer and overall health. Be prepared for regular clinic visits for infusions and potential radiation, as well as follow-up appointments for up to 2 years. You will need to provide tumor samples from your surgery for research analysis. This trial is currently recruiting participants. The trial is being conducted at 1 site. Always discuss clinical trial participation with your healthcare provider before making any decisions. This information is for educational purposes only and is not medical advice.
AI-generated analysis for educational purposes only. This is not medical advice. Discuss clinical trial participation with your doctor. Data sourced from ClinicalTrials.gov.
Study Design
- Study Type: INTERVENTIONAL
- Allocation: RANDOMIZED
- Model: PARALLEL
- Masking: NONE
- Enrollment: 24 participants
Interventions
- DRUG: Botensilimab — 75 mg IV Q6W
- DRUG: Balstilimab — 450 mg IV Q3W
- DRUG: AGEN1423 — 30 mg/kg IV Q3W
- RADIATION: Radiation — 8Gy x 3 between Day 0 - 18; Allowed techniques for radiation are 3D conformal, intensity modulated radiotherapy (IMRT), or SBRT
Primary Outcomes
- Mean CD8:Treg ratio, as determined by flow cytometry of tumor tissue, at time of surgical resection in each treatment arm (At surgical resection)
Secondary Outcomes
- Number of Treatment-Related Adverse Events (TRAEs) as assessed by CTCAE v5.0 per treatment arm (90 days following the last dose of study drug)
- Pathological Response Rate Per Arm (At surgical resection)
- Radiographic Response Rate Per Arm (90 days following the last dose of study drug)
- Number of Participants Per Arm with ctDNA Clearance (90 days following the last dose of study drug)
Full Eligibility Criteria
Inclusion Criteria: * Diagnosis of metastatic colorectal adenocarcinoma with liver metastases * Participant must be planning to undergo a surgical resection of their liver metastases. * Tumor is non-MSI-H/dMMR * Presence of measurable disease * Participants must be willing to consent to additional molecular analyses of tumor samples removed during surgery for research purposes * Women of childbearing potential (WOCBP), or anyone with a uterus, must not be pregnant or breastfeeding. All participants of childbearing potential must agree to use highly effective contraception during this study * Participants may not receive chemotherapy, growth factor support, transfusions, or albumin administration within 14 days of start of study treatment. Exclusion Criteria: * Not eligible for surgery * Any medical condition such as uncontrolled infection, uncontrolled diabetes mellitus or cardiac disease which, in the opinion of the treating physician, would make this protocol unreasonably hazardous for the patient. * Previous allogeneic tissue/organ transplant * Previously received PD-1, PD-L1, or CTLA-4 therapy including experimental immunologic agents * Participants must not have any contraindications to immune checkpoint inhibitors * Participants must not have active autoimmune disease that has required systemic treatment within 2 years prior to registration. Some exceptions are allowed
Trial Locations
- Weill Cornell Medicine/NewYork-Presbyterian Hospital, New York, New York, United States
Frequently Asked Questions
What is clinical trial NCT06300463?
NCT06300463 is a Phase 2 INTERVENTIONAL study titled "Platform Study of Immunotherapy Combinations in Colorectal Cancer Liver Metastases." It is currently recruiting and is sponsored by Weill Medical College of Cornell University. The trial targets enrollment of 24 participants.
What conditions does NCT06300463 study?
This trial investigates treatments for Colorectal Cancer Metastatic, Liver Metastases, Colorectal Cancer. The primary condition under study is Colorectal Cancer Metastatic.
What treatments are being tested in NCT06300463?
The interventions being studied include: Botensilimab (DRUG), Balstilimab (DRUG), AGEN1423 (DRUG), Radiation (RADIATION). 75 mg IV Q6W
What does Phase 2 mean for NCT06300463?
Phase 2 trials test whether the treatment works for the intended condition. They involve 100-300 patients and continue to evaluate safety while measuring effectiveness.
What is the current status of NCT06300463?
This trial is currently "Recruiting." It started on 2024-03-26. The estimated completion date is 2027-12.
Who is sponsoring NCT06300463?
NCT06300463 is sponsored by Weill Medical College of Cornell University. The sponsor is responsible for funding, designing, and overseeing the clinical trial.
How many people can participate in NCT06300463?
The trial aims to enroll 24 participants. The trial is currently recruiting and accepting new participants.
How is NCT06300463 designed?
This is a interventional study, uses randomized allocation, follows a parallel design, employs none masking.
What are the primary outcomes being measured in NCT06300463?
The primary outcome measures are: Mean CD8:Treg ratio, as determined by flow cytometry of tumor tissue, at time of surgical resection in each treatment arm (At surgical resection). These are the main endpoints researchers use to determine whether the treatment is effective.
Where is NCT06300463 being conducted?
This trial is being conducted at 1 site, including New York, New York (United States).
Where can I find official information about NCT06300463?
The official record for NCT06300463 is available on ClinicalTrials.gov at https://clinicaltrials.gov/study/NCT06300463. This government database provides the most up-to-date and detailed information about the trial.
What is NCT06300463 testing in simple terms?
This trial tests different combinations of immunotherapy drugs, with or without radiation, to see if they can help shrink liver tumors before surgery. It is for patients with colorectal cancer that has spread to the liver and who are planning to have surgery to remove these tumors.
Why is this trial significant?
This trial addresses a critical need for new treatments for colorectal cancer that has spread to the liver, aiming to improve outcomes for patients undergoing surgery.
What are the potential risks of participating in NCT06300463?
Common side effects of immunotherapy can include fatigue, rash, and flu-like symptoms. More serious side effects can involve immune system reactions affecting various organs, such as the lungs, intestines, or liver. Radiation therapy can cause localized side effects depending on the area treated. As with any clinical trial, participants are closely monitored and can withdraw at any time.
Should I consider participating in NCT06300463?
Ask your doctor if this trial is a good fit for you, considering your specific cancer and overall health. Be prepared for regular clinic visits for infusions and potential radiation, as well as follow-up appointments for up to 2 years. You will need to provide tumor samples from your surgery for research analysis. Always discuss clinical trial participation with your healthcare provider to determine if it is appropriate for your specific situation.
What does NCT06300463 signal from an investment perspective?
This trial explores novel immunotherapy combinations in a difficult-to-treat cancer subset, potentially opening new avenues for treatment and representing an investment in advanced cancer therapies. This is a Phase 2 trial, which is focused on confirming efficacy before larger pivotal studies.
What happens if the treatment in this trial doesn't work?
Participants will receive infusions of study drugs and possibly radiation before and after surgery, and will be monitored for up to 2 years. Participants in clinical trials always have the right to withdraw and pursue alternative treatments. The study team will help transition patients to other available options.
Related Conditions
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This analysis is AI-generated and does not constitute medical advice. Always consult your healthcare provider before making decisions about clinical trial participation.