Enrolled patients will receive upfront (week 1) short-course radiotherapy to gross pelvic disease (25Gy in 5fx) in combination with AB928 (150 mg orally, once daily as part of a continuous dose regimen). This will be followed by consolidation chemotherapy (weeks 3-20) with mFOLFOX x9 cycles in combination with AB928 and AB122.
Enrolled patients will receive upfront (week 1) short-course radiotherapy to gross pelvic disease (25Gy in 5fx) in combination with AB928 (150 mg orally, once daily as part of a continuous dose regimen). This will be followed by consolidation chemotherapy (weeks 3-20) with mFOLFOX x9 cycles in combination with AB928 and AB122. Patients will thereafter be assessed for therapeutic responses (week 22-24) with a digital rectal examination, pelvic MRI, and endoscopy. Each case will be reviewed by the Weill Cornell Medicine Colorectal Multidisciplinary Tumor Board for consensus agreement regarding clinical treatment response. The patients thereafter will proceed with total mesorectal excision (TME, week 24) by transabdominal resection for pathologic evaluation (primary tumor and pelvic lymph nodes will be examined).
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
43
Patients will receive a radiation therapy dose of 25Gy in 5 fractions in combination with etrumadenant 150 mg orally, once daily as part of a continuous dose regimen.
Patients will receive a radiation therapy dose of 25Gy in 5fx
After completing the radiation therapy, patients will receive FOLFOX regimen for 9 cycles in combination with etrumadenant and zimberelimab. All patients will be offered adjuvant zimberelimab for up to one year.
After completing the radiation therapy, patients will receive FOLFOX regimen for 9 cycles in combination with etrumadenant and zimberelimab. All patients will be offered adjuvant zimberelimab for up to one year.
Weill Cornell Medical College
New York, New York, United States
RECRUITINGBrooklyn Methodist Hospital - NewYork Presbyterian
New York, New York, United States
RECRUITINGNew York Presbyterian Hospital - Queens
New York, New York, United States
RECRUITINGNumber of treated patients who achieve complete pathologic response
The primary endpoint is the proportion of treated rectal cancer patients who achieve a complete pathologic response. All patients will be offered surgical resection however those who achieve a clinical CR at the time of clinical response assessment may choose a non-operative management approach. Due to practicality the latter will be included as complete responders at the time of analysis for this trial.
Time frame: Week 24
Number of patients who experience treatment-related adverse events
Number of patients with treatment-related early and late adverse events as assessed by the CTCAE version 5.0
Time frame: Day 5 of radiation therapy
Number of patients who experience treatment-related adverse events
Number of patients with treatment-related early and late adverse events as assessed by the CTCAE version 5.0
Time frame: 3 months
Number of patients who experience treatment-related adverse events
Number of patients with treatment-related early and late adverse events as assessed by the CTCAE version 5.0
Time frame: 6 months
Number of patients who experience treatment-related adverse events
Number of patients with treatment-related early and late adverse events as assessed by the CTCAE version 5.0
Time frame: 12 months
Number of patients who experience treatment-related adverse events
Number of patients with treatment-related early and late adverse events as assessed by the CTCAE version 5.0
Time frame: 60 months
Progression free survival
PFS is defined as the duration of time from start of treatment to time of progression.
Time frame: 36 months
Overall survival
Overall Survival is defined as the duration of time from start of treatment until death.
Time frame: 60 months
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