Actively Recruiting
Phase II Clinical Trial of FOLFOX, Botensilimab, Plus Balstilimab in Patients With Localized Rectal Cancer
Led by City of Hope Medical Center · Updated on 2025-06-26
26
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
Sponsors
C
City of Hope Medical Center
Lead Sponsor
N
National Cancer Institute (NCI)
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating a combination treatment of chemotherapy drugs fluorouracil, oxaliplatin, and leucovorin calcium (FOLFOX) alongside immunotherapy drugs botensilimab and balstilimab given before surgery (neoadjuvant) for patients with localized rectal adenocarcinoma. This phase II trial aims to improve the rate of complete clinical response and reduce the need for surgery and radiation, as current treatments only achieve complete response in about half of patients and surgery often causes complications. Participants receive cycles of FOLFOX chemotherapy with intravenous botensilimab and balstilimab every 14 days for up to 8 cycles, unless disease progression or toxicity occurs. Patients who achieve a complete clinical response may continue balstilimab alone for 12 additional cycles. Those without complete response may receive radiation therapy and oral capecitabine as standard treatment. Throughout the study, patients undergo blood tests, biopsies, endoscopic exams, sigmoidoscopies, digital rectal exams, CT scans, and MRI scans. After completing study treatment, participants are followed up at 30 and 90 days, then every 3 months for the first year and every 6 months for up to two years. Researchers assess the rate of complete clinical response at 3 months post-treatment and monitor safety, disease-free survival, pelvic recurrence, duration of response, and overall survival for up to five years. Blood biomarkers and tumor microenvironment changes are also studied to understand treatment effects.
CONDITIONS
Brief Title
FOLFOX, Botensilimab, and Balstilimab for the Treatment of Localized Rectal Cancer Before Surgery
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Documented informed consent from participant or legal representative
- Agreement to allow use of archival tissue from diagnostic tumor biopsies (exceptions possible with approval)
- Age 18 years or older
- Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1
- Histologically confirmed adenocarcinoma of the rectum
- Rectal tumor located within 12 cm from the anal verge
- Radial margin of at least 3 mm from mesorectal fascia with no threatened circumferential tumor margin based on MRI
- Clinical stage T3N0, or TxN1 or TxN2 based on MRI
- No distant metastases on imaging including CT chest and CT or MRI abdomen and pelvis
- Absolute neutrophil count ≥ 1,500/mm³
- Platelets ≥ 100,000/mm³ if no bone marrow involvement
- Hemoglobin ≥ 9 g/dL (no red blood cell transfusions within 14 days prior)
- Total bilirubin ≤ 1.5 times upper limit of normal (ULN) unless Gilbert's disease
- AST and ALT ≤ 3.0 times ULN
- Creatinine < 1.5 times ULN or creatinine clearance ≥ 40 mL/min
- Negative pregnancy test for women of childbearing potential
- Agreement to use effective birth control or abstain from heterosexual activity during and after study as specified
You will not qualify if you...
- Prior treatment for rectal cancer including chemotherapy, radiation, or immunotherapy
- Prior immunotherapy
- Systemic corticosteroid use >10 mg prednisone equivalent within 14 days or other immunosuppressive medications within 30 days before study treatment
- Prior allogeneic organ transplant
- Surgery within 4 weeks before study treatment except minor procedures
- Concurrent malignancy except certain curatively treated cancers in remission for at least 2 years
- Unstable cardiac disease or recent myocardial infarction within 6 months
- Clinically significant uncontrolled illness
- Pregnant or breastfeeding women
- Prior allergic reaction to study drugs
- Active autoimmune disease requiring systemic treatment in past 2 years (except controlled hypothyroidism, vitiligo, psoriasis with topical management)
- Recent acute thrombotic events within 30 days unless on anticoagulants without symptoms
- Current or history of interstitial lung disease or pneumonitis requiring high-dose steroids
- Psychiatric or substance abuse conditions interfering with study participation
- Other conditions or abnormalities that may interfere with study or safety
- Recent severe COVID-19 infection within specified timeframes
- Uncontrolled HIV infection
- Positive hepatitis B or active hepatitis C infection
- Grade 2 or higher neuropathy
- Dependence on total parenteral nutrition or intravenous hydration
- Any other conditions contraindicating participation as judged by investigator
- Inability to comply with study procedures or feasibility issues
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to approximately 8 cycles of 14 days each, plus up to 12 additional cycles of balstilimab if complete clinical response
Participants receive FOLFOX chemotherapy and immunotherapy with botensilimab and balstilimab in cycles every 14 days for up to 8 cycles unless disease progresses or toxicity occurs. Participants with complete clinical response may continue balstilimab alone for up to 12 additional cycles. Those without complete response may receive radiation therapy on weekdays along with oral capecitabine concurrently as standard care. Blood samples and various exams including biopsy, sigmoidoscopy, digital rectal exams, CT, and MRI are performed throughout treatment.
Visits every 14 days for up to 8 cycles; additional visits as needed for continued balstilimab or radiation therapy
Duration - Up to 2 years after treatment completion
After completing study treatment, participants are followed for safety and disease outcomes with visits at 30 and 90 days post-treatment, then every 3 months within the first year, followed by every 6 months for up to 2 years.
Visits at 30 and 90 days post-treatment, then every 3 months for 1 year, then every 6 months for up to 2 years
Trial Site Locations
Total: 1 location
1
City of Hope Medical Center
Duarte, California, United States, 91010
Actively Recruiting
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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