Clinical trial for Advanced Colon Adenocarcinoma
Official title Neoadjuvant Botensilimab and Balstilimab for the Treatment of Advanced Resectable Colorectal Cancer NEST3
ClinicalTrials.gov ID: NCT07595874
What this study is testing
What is Balstilimab?
Balstilimab is an investigational intravenous biological drug being studied as a potential treatment for advanced resectable colon adenocarcinoma. Balstilimab is designed to block the PD‑1 protein on immune cells, helping the immune system recognize and attack cancer cells.
Also referred to as AGEN 2034, AGEN-2034, AGEN2034.
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
- The study aims to see if giving botensilimab and balstilimab before surgery can shrink tumors and be safe for patients with advanced resectable colorectal cancer.
- Who it's for
- Adults who have stage IIB‑IIIC colon or rectal cancer that is advanced but can still be removed by surgery.
- What's involved
- Participants will receive intravenous infusions of botensilimab and balstilimab before surgery, along with routine check‑ups and tests to monitor safety and tumor response.
- Time commitment
- The trial involves several weeks of drug infusions before surgery and a few follow‑up visits, lasting overall about a few months.
- Phase 2: a mid-size study of how well it works
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
- Documented informed consent of the participant and Legally Authorized Representative (when applicable)
- Assent, when appropriate, will be obtained and documented for adults lacking capacity per institutional guidelines
- Agreement to allow the use of tissue from past and future surgery and standard of care biopsies
- Age: ≥ 18 years
- Eastern Cooperative Oncology Group (ECOG) ≤ 2
You likely can't join if
- Any treatment for colorectal cancer prior to enrollment that includes (but not limited to) chemotherapy, surgery, radiation, immunotherapy and/or...
- Note: Surgical intervention e.g. a diverting ostomy to relieve an obstruction from colorectal cancer, those patients will be allowed to enter the...
- Patients with a condition requiring systemic treatment with either corticosteroids (\> 10 mg daily prednisone equivalent) within 14 days or another...
- Prior allogeneic organ transplantation
- Herbal medications that require a prescription or are anti-cancer
- Other active malignancy. Patients with a prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere...
See the full eligibility criteria
- Documented informed consent of the participant and Legally Authorized Representative (when applicable)
- Assent, when appropriate, will be obtained and documented for adults lacking capacity per institutional guidelines
- Agreement to allow the use of tissue from past and future surgery and standard of care biopsies
- Age: ≥ 18 years
- Eastern Cooperative Oncology Group (ECOG) ≤ 2
- Upper rectum or rectosigmoid considered as non-rectal and not undergoing neoadjuvant treatment
- The tumor component should not extend to less 12 cm from the anal verge.
- Any patient with rectal cancer for whom radiotherapy is not advised is included in this protocol (i.e., excluding rectal adenocarcinomas warranting treatment with chemoradiation)
- Microsatellite stability by mismatch repair by immunohistochemistry, polymerase chain reaction and/or other Clinical Laboratory Improvement Amendments (CLIA) certified next generation sequencing.
- Candidate for and planning a curative resection. Must have surgeon identified
- T4, N+ (American Joint Committee on Cancer [AJCC] TNM staging criteria), or both by central radiographic assessment.
- Note: Patients with T3N0 stage IIA are excluded. Stage IIB, IIC, IIIA, IIIB, and IIIC are included. Patients with stage IV disease are excluded
- Absolute neutrophil count (ANC) ≥ 1,500/mm\^3
- Platelets ≥ 75,000/mm\^3
- NOTE: Platelet transfusions are not permitted within 14 days of platelet assessment
- Hemoglobin ≥ 8 g/dL
- NOTE: Red blood cell transfusions are permitted. Patients should not have active clinically significant bleeding requiring regular transfusions. Iron infusions are also allowed
- Total bilirubin ≤ 1.5 X upper limit of normal (ULN) (unless has Gilbert's disease, in which case the liver function tests must meet the other eligibility in the protocol)
- Aspartate aminotransferase (AST) ≤ 3.0 x ULN
- Alanine aminotransferase (ALT) ≤ 3.0 x ULN
- Creatinine clearance of ≥ 40 mL/min per the Cockcroft-Gault formula
- Women of childbearing potential (WOCBP): negative urine or serum pregnancy test. If the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required
- Agreement by females and males of childbearing potential\ to use an effective method of birth control or abstain from heterosexual activity for the course of the study through at least 9 months for women, and at least 6...
- Childbearing potential defined as not being surgically sterilized (men and women) or have not been free from menses for \> 1 year (women only).
- The following are acceptable birth control methods for this study: Surgical sterilization (tubal ligation or hysterectomy for women, or vasectomy for men), double-barrier methods (i.e.
- Any treatment for colorectal cancer prior to enrollment that includes (but not limited to) chemotherapy, surgery, radiation, immunotherapy and/or biological therapy.
- Note: Surgical intervention e.g. a diverting ostomy to relieve an obstruction from colorectal cancer, those patients will be allowed to enter the study as long as no distant metastatic disease
- Patients with a condition requiring systemic treatment with either corticosteroids (\> 10 mg daily prednisone equivalent) within 14 days or another immunosuppressive medication within 30 days of the first dose of study...
- Prior allogeneic organ transplantation
- Herbal medications that require a prescription or are anti-cancer
- Other active malignancy. Patients 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...
- Active acute colonic obstruction. Patients whose obstruction is relieved by a successful defunctioning stoma are allowed once recovered to a fitness level consistent with the other eligibility criteria
- Clinically significant uncontrolled illness
- Females only: Pregnant or breastfeeding
- Prior allergic reaction or hypersensitivity to any of the study drug components
- Active autoimmune disease or history of autoimmune disease that required systemic treatment within 2 years before starting treatment, i.e., with use of disease-modifying agents or immunosuppressive drugs (excluding...
- History or current evidence of any condition, co-morbidity, therapy, that might confound the results of the study, interfere with the patient's participation for the full duration of the study, or is not in the best...
- Uncontrolled infection with human Immunodeficiency virus (HIV). Patients on stable highly active antiretroviral therapy (HAART) are eligible. Serological testing for HIV at screening is not required
- Uncontrolled infection with hepatitis B virus. Patients who are receiving or who have received anti-HBV therapy are eligible. Serological testing for HBV at screening is not required
- Known active hepatitis C virus (HCV) as determined by positive serology and confirmed by polymerase chain reaction (PCR). Patients on or who have received antiretroviral therapy are eligible.
- Any other condition that would, in the Investigator's judgment, contraindicate the patient's participation in the clinical study due to safety concerns with clinical study procedures
- Prospective participants who, in the opinion of the investigator, may not be able to comply with all study procedures (including compliance issues related to feasibility/logistics)
The study team makes the final eligibility decision.
Where it is enrolling
- Goodyear, Arizona, United States
- Corona, California, United States
- Duarte, California, United States
- Huntington Beach, California, United States
- Irvine, California, United States
- Long Beach, California, United States
- South Pasadena, California, United States
- Upland, California, United States
- Newnan, Georgia, United States
- Chicago, Illinois, United States
- Zion, Illinois, 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 listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to 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 Goodyear, Arizona, United States; Corona, California, United States; Duarte, California, United States; Huntington Beach, California, United States; Irvine, California, United States; Long Beach, California, United States and 5 more locations. 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.