FOLFOX, Botensilimab, and Balstilimab for Localized Rectal Cancer
This study is looking at a new way to treat localized rectal cancer (cancer that hasn't spread) before surgery. It combines a standard chemotherapy called FOLFOX (fluorouracil, oxaliplatin, and leucovorin calcium) with two immunotherapy drugs, botensilimab and balstilimab. The goal is to see if this combination can lead to a complete clinical response (meaning the cancer is no longer detectable) more often than current treatments, potentially helping patients avoid surgery and its complications. This trial is for adults aged 18 and older with Stage IIA or III rectal cancer. Researchers will measure the complete clinical response rate three months after treatment. The study is currently recruiting 26 participants, but its overall status is unclear.
- Study design
- This is an interventional study, meaning participants will receive a specific treatment. It aims to enroll 26 participants.
- What's involved
- You would provide informed consent, allow the use of archival tumor tissue, and undergo blood sample collection, CT scans, and receive intravenous (IV) infusions of balstilimab, botensilimab, leucovorin calcium, oxaliplatin, and fluorouracil, and oral capecitabine.
- Compensation
- Not stated in the trial record.
- Follow-up
- Researchers will measure your complete clinical response rate three months after treatment and estimate survival and recurrence rates for up to five years.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
NCT06780787
FOLFOX, Botensilimab, and Balstilimab for the Treatment of Localized Rectal Cancer Before Surgery
Recruiting
PHASE2Ages 18+InterventionalTreatmentCity of Hope Medical CenterInvestigator-initiated
~26 participants
Updated 2026-06-29 on ClinicalTrials.gov
What's tested:BalstilimabBiospecimen CollectionBotensilimabCapecitabineComputed TomographyDigital Rectal Examination
At a glance
Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Complete clinical response (cCR) rate
Measured over At 3 months after treatment
Conditions
NCT06780787
Where you'd take part
This study runs at 1 site. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.
City of Hope Medical Center
Duarte, Californiastudy coordinator listed
Recruiting
Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.
Study leadership
- Marwan Fakih · PRINCIPAL_INVESTIGATOR · City of Hope Medical Center
Who to contact
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Eligibility criteria
Inclusion
Documented informed consent of the participant and/or legally authorized representative
Assent, when appropriate, will be obtained per institutional guidelines
Agreement to allow the use of archival tissue from diagnostic tumor biopsies
If unavailable, exceptions may be granted with study principal investigator (PI) approval
Age: ≥ 18 years
Eastern Cooperative Oncology Group (ECOG) ≤ 1
Histologically confirmed adenocarcinoma of the rectum
Rectal involvement defined as involvement of the rectum within 12 cm proximal from anal verge
Radial margin of at least 3mm from the mesorectal fascia, with no threatened circumferential tumor margin based on MRI. No more than 4 lymph nodes (LN) with short axis \> 1 cm
T3N0, or TxN1 or TxN2 clinical stage based on MRI staging
No evidence of distant metastatic disease based on imaging studies including CT chest and CT or MRI of abdomen and pelvis
Absolute neutrophil count (ANC) ≥ 1,500/mm\^3
Without bone marrow involvement: Platelets ≥ 100,000/mm\^3
Hemoglobin ≥ 9g/dL
NOTE: Red blood cell transfusions are not permitted within 14 days of hemoglobin assessment
Total bilirubin ≤ 1.5 x upper limit of normal (ULN) (unless has Gilbert's disease)
Aspartate aminotransferase (AST) ≤ 3.0 x ULN
Alanine aminotransferase (ALT) ≤ 3.0 x ULN
Creatinine \< 1.5 x ULN or clearance of ≥ 40 mL/min per 24 hour urine test or 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 months for men, after the last dose of oxaliplatin therapy. If patients discontinue oxaliplatin more than 9 months (females) or 6 months (males) before discontinuation of balstilimab and/or botensilimab, females and males of childbearing potential must use an effective method of birth control or abstain from sexual activity for the course of the study through at least 120 days after the last dose of balstilimab and/or botensilimab
Childbearing potential defined as not being surgically sterilized (men and women) or have not been free from menses for \> 1 year (women only)
Exclusion
Any treatment for rectal cancer prior to enrollment that includes (but not limited to) chemotherapy, radiation, and/or biological therapy
Any prior immunotherapy
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 treatment. Inhaled or topical steroids, and adrenal replacement steroid doses \> 10 mg daily prednisone equivalent, are permitted in the absence of active autoimmune disease
Prior allogeneic organ transplantation
Surgical intervention within 4 weeks prior to study treatment, except for minor procedures such as port placement or biopsies
Concurrent malignancy other than the diagnosis of rectal cancer, with the exception of curatively resected non-melanoma skin cancer, cervical cancer in situ, prostate cancer Gleason 6 or below that is localized to the prostate, or any other curatively resected cancer from which the patient remains in remission for at least 2 years without treatment
Unstable cardiac disease as defined by one of the following:
Cardiac events such as myocardial infarction (MI) within the past 6 months
NYHA (New York Heart Association) heart failure class III-IV
Uncontrolled atrial fibrillation
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 hypothyroidism, vitiligo, and psoriasis that is controlled with topical management)
History of acute thrombotic venous events in the last 30 days before enrollment. If within 30 days, the patient should be on anticoagulants and without symptoms
Any evidence of current interstitial lung disease (ILD) or pneumonitis or a prior history of ILD or non-infectious pneumonitis requiring high-dose glucocorticoids
Psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the study
History or current evidence of any condition, co-morbidity, therapy, any active infections (requiring antibiotics), or laboratory abnormality 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 interest of the patient to participate, in the opinion of the treating investigator
Known previous severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection within 10 days for mild or asymptomatic infections or 20 days for severe/critical illness prior to cycle 1 day 1 (C1D1)
Uncontrolled infection with human immunodeficiency virus (HIV). Patients on stable highly active antiretroviral therapy (HAART) with undetectable viral load and normal CD4 counts for at least 6 months prior to study entry are eligible. Serological testing for HIV at screening is not required
Known to be positive for hepatitis B virus (HBV) surface antigen, or any other positive test for HBV indicating acute or chronic infection. Patients who are receiving or who have received anti-HBV therapy and have undetectable HBV deoxyribonucleic acid (DNA) for at least 6 months prior to study entry 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 provided they are virus-free by PCR for at least 6 months prior to study entry. Serological testing for HCV at screening is not required
Grade 2 or above neuropathy at the time of enrollment
Dependence on total parenteral nutrition or intravenous hydration
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)
What this trial measures
- Complete clinical response (cCR) rateAt 3 months after treatment
Data will be summarized using descriptive statistics for continuous variables and frequencies and percentages will be used for categorical variables. Univariate logistic regression was used to estimate odds ratios (OR) and 90% confidence interval (CI) for cCR