Botensilimab, Balstilimab, and SBRT in Colorectal Cancer
A Pilot Study of Botensilimab and Balstilimab and SBRT in Non-MSI-H or pMMR Colorectal Cancer With Liver Metastasis
Who can join
As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.
- Age
- 18 Years and older
- Sex
- All sexes
- Healthy volunteers
- Not accepted
- Compensation
- Not stated
Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.
What to expect
No one can promise a trial will help you personally — that is what the research is trying to find out.
What participation involves
- Time periods mentioned: 24 weeks, 108 weeks, 1 year
Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.
Show the study's own words
- "After screening, participants will receive SOC SBRT for 2-3 weeks, and botensilimab + balstilimab for up to 24 weeks followed by balstilimab alone for 14 additional 6-week cycles, for a total treatment time of up to 108 weeks."
- "Participants will be followed for 1 year."
- Compensation
- Not stated
- Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
- Participants are monitored closely by the research team throughout the study.
- Some participants may receive access to an investigational treatment, which is still being studied.
- Your participation helps researchers learn whether this approach could help future patients.
About this study
In plain language
This small study tests whether botensilimab and balstilimab can be given with radiation for colon or rectal cancer that has spread to the liver and no longer responds to chemotherapy. It is for adults whose cancer has test results called MSS or pMMR, which describe how cancer cells repair DNA.
This is a single-arm pilot feasibility study evaluating the combination of Botensilimab and Balstilimab with Radiation Therapy (RT) in Non-Microsatellite Instability High (MSI-H) or Proficient Mismatch Repair (pMMR) chemorefractory colorectal cancer (CRC) with liver metastasis.
Compensation is read from the study's own description and may be missing — always confirm with the study team.
Eligibility
Who can join
- Be age 18 or older, with colon or rectal adenocarcinoma confirmed by tissue or cell testing. This is cancer that starts in gland cells.
- Have cancer confirmed as MSS or pMMR by lab testing.
- Have 1 to 5 liver tumors that can all safely receive radiation, with at least one measuring 1 cm or more. Also have a tumor at least 1 cm outside the liver and planned radiation area. These required tumors must not have had radiation before.
- Have received 5-FU, oxaliplatin, and irinotecan, or have been unable to tolerate them.
- Be fully active or able to do light work, and be expected to live more than 3 months.
- Meet the study's blood count, liver, and kidney test limits.
- If able to become pregnant, have a negative pregnancy test. People who can become pregnant and men with partners who can become pregnant must use highly effective birth control during and after treatment for the required time.
- Be able to understand the study and agree to sign a consent form.
Who can't join
- Have had chemotherapy, certain targeted drugs, or study treatment within 14 days, or have not recovered enough from past treatment or major surgery. Some lasting nerve damage is allowed.
- Have an active or suspected disease in which the immune system attacks the body, or recently need medicines that weaken the immune system. Some steroid uses are allowed.
- Test positive for TB; have active or chronic hepatitis B or C; or have an infection needing whole-body treatment. HIV or AIDS may exclude you, but people with CD4 counts above 200 and/or an undetectable virus level may qualify.
- Have a recent bowel blockage, signs of a blockage, hard-to-control fluid buildup in the belly, or significant ongoing diarrhea.
- Have an uncontrolled illness, such as certain heart problems, or mental health, substance use, or social problems that prevent following study rules. A history of lung inflammation not caused by infection also excludes you.
- Be pregnant, breastfeeding, or planning to become pregnant or father a child during the study or within 120 days after the last treatment.
- Have received a live vaccine within 30 days before treatment, have an allergy to drugs like the study drugs, or have had a severe allergic reaction to a monoclonal antibody drug.
- Have brain tumors from cancer spread that are not controlled. You may qualify if radiation ended more than 4 weeks before enrollment and follow-up scans show control.
Simplified for readability. The official criteria below are what the study team uses.
Official eligibility criteria
Inclusion 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. A maximum of 5 hepatic lesions are allowed provided all are amenable to ablative RT and meet dose constraints. Must have at least 1 other unirradiated measurable (≥ 1cm) extrahepatic lesion, outside of RT field. Patients should ideally have a second unirradiated lesion, outside of RT field, that would be amenable for paired biopsies. * 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. * Participants must meet the following organ and marrow function as defined below: * 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. --Woman of childbearing potential (WOCBP) and men with WOCBP partners must agree to use highly effective contraceptive measures starting at screening through 5 months (180 days) after the last dose of balstilimab and/or botensilimab. * 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 efficacy assessment of the investigational regimen are eligible for this trial. * Ability to understand and the willingness to sign a written informed consent document. Exclusion Criteria: * 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 events due to agents administered more than 2 weeks earlier. * 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. --EXCEPTIONS: Inhaled or topical steroids and adrenal replacement doses \> 10 mg daily prednisone equivalents are permitted in the absence of active autoimmune disease. Subjects are permitted to use topical, ocular, intra-articular, intranasal, and inhalational corticosteroids (with minimal systemic absorption). Physiologic replacement doses of systemic corticosteroids are permitted, even if \>10 mg/day prednisone equivalents. A brief course of corticosteroids for prophylaxis (e.g., contrast dye allergy) or for treatment of non-autoimmune conditions (e.g., delayed-type hypersensitivity reaction caused by contact allergen) is permitted. * 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 within 2 weeks of study entry. * 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). These participants are at increased risk of lethal infections when treated with marrow-suppressive therapy. \-- EXCEPTIONS: Patients with CD4 \>200 cells/mm3 and/or undetectable viral load are eligible. * 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 that would limit compliance with study requirements. * 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 last dose of study treatment. There is an unknown but potential risk for adverse events in nursing infants secondary to treatment of the mother with radiation, breastfeeding should be discontinued if the mother is treated with radiation. * 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. --EXCEPTION: Seasonal influenza vaccines for injection are generally inactivated flu vaccines and are 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.
Study sites (1)
MA
- Massachusetts General Hospital · Boston, MA 02114Aparna R. Parikh, MD · Study contact · 617-724-4000 · aparna.parikh@mgh.harvard.eduAparna R. Parikh, MD · Principal investigatorMore trials in Boston