Non-MSI-H or pMMR Colorectal Cancer With Liver Metastasis study: Botensilimab vs Balstilimab
Official title Botensilimab, Balstilimab, and SBRT in Colorectal Cancer
ClinicalTrials.gov ID: NCT07128355
What this study is testing
What is Botensilimab?
Botensilimab is an investigational drug being studied for non-MSI-H or pMMR colorectal cancer with liver metastasis.
Plain-language explanation of the investigational treatment. It is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- To see if giving Botensilimab, Balstilimab, and radiation together is doable and safe in this patient group.
- Who it's for
- Adults with colorectal cancer that is not MSI‑H or pMMR, has liver metastases, and has not responded to chemotherapy.
- What's involved
- Participants will receive the two drugs and a special form of radiation therapy (SBRT) to the liver lesions.
- Phase 1: an early, usually small safety study
- Time commitment: about 24 weeks
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Participants must have histologically or cytologically confirmed adenocarcinoma of colorectal origin.
- MSS or pMMR status confirmed by IHC or PCR.
- Must have at least 1 measurable (≥ 1 cm) previously unirradiated hepatic lesion amenable to ablative RT and meeting dose constraints.
- Must have received or confirmed intolerance to 5-FU, Oxaliplatin, and Irinotecan (in any combination).
- Age ≥18 years
You likely can't join if
- Participants who have had chemotherapy, targeted small molecule therapy or study therapy within 14 days prior to starting protocol treatment, or...
- EXCEPTION: Participants with ≤ Grade 2 neuropathy are permitted.
- If participant received major surgery, they must have recovered adequately from the toxicity and/or complications from the intervention prior to...
- Known or suspected, active, autoimmune disease
- Condition requiring systemic treatment with either corticosteroids (\> 10 mg daily prednisone equivalents) or other immunosuppressive medications...
- Positive TB (Bacillus Tuberculosis) at screening. NOTE: skin test is not allowed.
See the full eligibility criteria
- Participants must have histologically or cytologically confirmed adenocarcinoma of colorectal origin.
- MSS or pMMR status confirmed by IHC or PCR.
- Must have at least 1 measurable (≥ 1 cm) previously unirradiated hepatic lesion amenable to ablative RT and meeting dose constraints.
- Must have received or confirmed intolerance to 5-FU, Oxaliplatin, and Irinotecan (in any combination).
- Age ≥18 years
- ECOG performance status ≤ 1
- Life expectancy of greater than 3 months.
- Absolute Neutrophil Count (ANC) ≥ 1500 /mcL
- White Blood Cells (WBC) ≥ 2000 /mcL
- Platelets (PLT) ≥ 100,000 /mcL
- Hemoglobin (HGB) ≥ 8 g/dL without transfusion within 2 weeks of measurement
- AST and ALT ≤ 2.5 x ULN
- Total Bilirubin ≤ 1.5 x ULN OR \< 3 mg/dL for participants with Gilbert Syndrome
- Creatinine Clearance ≥ 40 mL/min if calculated using Cockcroft-Gault formula
- The effects of radiation on the developing human fetus are known to be teratogenic and the safety of Botensilimab and Balstilimab in pregnant women and their fetuses has not been established.
- WOCBP must have a negative serum or urine pregnancy test (minimum sensitivity 25 IU/L or equivalent units of HCG).
- Participants with a prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or how well it works assessment of the investigational regimen are eligible...
- Ability to understand and the willingness to sign a written informed consent document.
- Participants who have had chemotherapy, targeted small molecule therapy or study therapy within 14 days prior to starting protocol treatment, or those who have not recovered (i.e., ≤ Grade 1 or at baseline) from adverse...
- EXCEPTION: Participants with ≤ Grade 2 neuropathy are permitted.
- If participant received major surgery, they must have recovered adequately from the toxicity and/or complications from the intervention prior to starting protocol treatment.
- Known or suspected, active, autoimmune disease
- Condition requiring systemic treatment with either corticosteroids (\> 10 mg daily prednisone equivalents) or other immunosuppressive medications within 14 days prior to study drug administration.
- Positive TB (Bacillus Tuberculosis) at screening. NOTE: skin test is not allowed. Interferon-Gamma Release Assay (IGRA)-based tests such as QuantiFERON TB Gold and T-Spot TB tests are acceptable.
- Partial or complete bowel obstruction within the last 3 months, signs/ symptoms of bowel obstruction, or known radiologic evidence of impeding obstruction.
- Refractory ascites defined as requiring 2 or more therapeutic paracenteses within the last 4 weeks, or ≥ times within the last 90 days, or ≥ time within the last 2 weeks prior to study entry, or requiring diuretics...
- Known history of active or chronic HBV or HCV infection
- Known history of testing positive for human immunodeficiency virus (HIV) or known acquired immunodeficiency syndrome (AIDS).
- Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations...
- Known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial.
- Participant is pregnant, breastfeeding, expecting to conceive, or father children within the projected duration of the trial, starting with the consent visit through 120 days for woman and 120 days for men, after the...
- Known history of, or any evidence of active, non-infectious pneumonitis.
- Active infection requiring systemic therapy.
- Has received a live vaccine within 30 days of planned start of study therapy. Intranasal influenza vaccines (e.g., Flu-Mist®) are live attenuated vaccines, and are not allowed.
- History of allergic reactions attributed to compounds of similar chemical or biologic composition to any study agents.
- History of severe hypersensitivity reaction to any monoclonal antibody.
- Uncontrolled brain metastases. Participants treated with radiation \> 4 weeks prior to registration, with follow up imaging showing control are eligible.
- Participants who present with significant active diarrhea.
The study team makes the final eligibility decision.
Where it is enrolling
- Boston, Massachusetts, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part, but confirm specifics with the study team.
How long does this study last?
The study runs about 24 weeks per participant, based on its public description. The team confirms the exact schedule and number of visits before you enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
This study is enrolling now at Boston, Massachusetts, United States. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.