Is NCT07128355 recruiting in Boston, MA?

Yes, NCT07128355 is currently recruiting participants at its Boston, MA location. This non-msi-h or pmmr colorectal cancer with liver metastasis clinical trial is actively enrolling qualified participants.

Is participation in this Boston clinical trial free?

Yes, all study-related care is provided at no cost to qualified participants. Many studies also offer compensation for time and travel expenses.

Non-MSI-H or pMMR Colorectal Cancer With Liver Metastasis Clinical Trial in Boston, MA

Q: How do I join the non-msi-h or pmmr colorectal cancer with liver metastasis clinical trial in Boston?

To join this clinical trial in Boston, complete the eligibility form on this page. A study coordinator will contact you to discuss next steps and determine if you qualify.

About This Non-MSI-H or pMMR Colorectal Cancer With Liver Metastasis Study in Boston

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.

Sponsor: Massachusetts General Hospital

Who Can Participate

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.

Not sure if you qualify? Submit your interest and a study coordinator will help determine your eligibility.

Frequently Asked Questions

Q:Is this study available in Boston?

Yes, this clinical trial (NCT07128355) has an active research site in Boston, MA that is currently enrolling participants.

Q:Is it safe to participate?

Clinical trials follow strict safety guidelines and ethical standards. This study has been reviewed and approved, and participants are closely monitored by medical professionals. You can withdraw at any time.

Q:Will I be compensated?

Many clinical trials offer compensation for your time and travel expenses. Specific compensation details will be discussed during the screening process. All study-related medical care is provided at no cost.

Q:Can I leave the trial if I change my mind?

Absolutely. Participation is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty.

Still have questions? Our study coordinators are here to help.

Non-MSI-H or pMMR Colorectal Cancer With Liver Metastasis Treatment Options in Boston, MA

If you're searching for non-msi-h or pmmr colorectal cancer with liver metastasis treatment options in Boston, MA, this clinical trial (NCT07128355) may be an excellent opportunity. Clinical trials provide access to cutting-edge treatments that aren't yet available to the general public, often at no cost to participants.

Our Boston research site is actively enrolling participants for this clinical trial. You'll receive care from experienced non-msi-h or pmmr colorectal cancer with liver metastasis specialists who are at the forefront of medical research. All study-related care, including examinations, treatments, and monitoring, is provided at no cost to qualified participants.

Looking for more options? Browse all non-msi-h or pmmr colorectal cancer with liver metastasis clinical trials near you to find additional studies recruiting in your area.

Non-MSI-H or pMMR Colorectal Cancer With Liver Metastasis Clinical Trial in Boston, MA

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