FOLFOX, Botensilimab, and Balstilimab for the Treatment of Localized Rectal Cancer Before Surgery
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorCity of Hope Medical Center
About this trial
This phase II trial tests how well fluorouracil, oxaliplatin and leucovorin calcium (folinic acid) (FOLFOX) with botensilimab and balstilimab given before surgery (neoadjuvant) works in treating patients with rectal adenocarcinoma that has not spread to other parts of the body (localized). Currently, neoadjuvant therapy for rectal cancer includes chemotherapy and chemoradiation. Despite these aggressive treatments, only about half of patients achieve a complete clinical response. In fact, over half of rectal cancer patients go on to have surgery and often suffer post-surgery complications involving urine and bowel problems. Thus, there has been an increased focus on non-surgical treatments. Chemotherapy drugs, such as fluorouracil, oxaliplatin and leucovorin calcium, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Immunotherapy with monoclonal antibodies, such as botensilimab and balstilimab, may help the body's immune system attack the tumor, and may interfere with the ability of tumor cells to grow and spread. Giving neoadjuvant FOLFOX with botensilimab and balstilimab may improve the rate of complete response and decrease the need for surgery and radiation therapy in patients with localized rectal adenocarcinoma.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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
Trial design
Design model
Single group
Treatments tested in this trial
Balstilimab
Biological/VaccineGiven IV
Biospecimen Collection
Procedure/SurgeryUndergo blood sample collection
Botensilimab
Biological/VaccineGiven IV
Capecitabine
DrugGiven PO
Computed Tomography
Procedure/SurgeryUndergo CT
Digital Rectal Examination
Procedure/SurgeryUndergo digital rectal exam
Endoscopic Biopsy
Procedure/SurgeryUndergo biopsy with endoscopic exam
Fluorouracil
DrugGiven IV
Leucovorin Calcium
DrugGiven IV
Magnetic Resonance Imaging
Procedure/SurgeryUndergo MRI
Oxaliplatin
DrugGiven IV
Radiation Therapy
RadiationUndergo radiation therapy
Sigmoidoscopy
Procedure/SurgeryUndergo sigmoidoscopy
Treatment groups
26 Participants
are divided into 1 treatment groupGroup A: Treatment (FOLFOX, botensilimab, balstilimab)Experimental treatment 13 interventions
Trial outcomes
Primary outcomes
1
Complete clinical response (cCR) rate
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
Time frame
At 3 months after treatmentSecondary outcomes
1
Overall response rate (ORR)
ORR is calculated as the number of patients with complete response (per Response Evaluation Criteria in Solid Tumors version \[v\] 1.1) divided by the total number of treated/evaluable subjects. 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 OR and 90% CI. Cox proportional hazards models were used to estimate hazard ratios (HR) with 95% CI.
Time frame
Up to 5 years2
Incidence of adverse events (AE) and serious adverse events (SAE)
AE and SAE will be described and graded at all dose levels using Common Terminology Criteria in Adverse Events v 5.0. Data will be summarized using descriptive statistics for continuous variables and frequencies and percentages will be used for categorical variables.
Time frame
Up to 90 days post-treatment3
Disease free survival (DFS)
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 OR and 90% CI. Cox proportional hazards models were used to estimate HR with 95% CI. DFS distributions will be estimated using the Kaplan-Meier method.
Time frame
From the date of study enrollment until the recurrence of disease or death, whichever occurs first, assessed at 3 years post-treatment4
Progression-free survival (PFS)
Data will be summarized using descriptive statistics for continuous variables and frequencies and percentages will be used for categorical variables. PFS distributions will be estimated using the Kaplan-Meier method. Kaplan-Meier method was used to plot PFS curves, and the log-rank test was applied to compare the distribution between groups. Cox proportional hazards models were used to estimate HR with 95% CI.
Time frame
From the date of study enrollment until objective tumor progression or death, assessed up to 5 yearsSponsors and contacts
Click on the lead sponsor to view all of their trials.
City of Hope Medical Center
Lead sponsor
National Cancer Institute (NCI)
Collaborator
Source ClinicalTrials.gov