The purpose of this study is to show that the addition of COMPOUND 2055269, an immunotherapeutic drug, to Folfox chemotherapy will improve the pathologic complete response rate in patients with locally advanced rectal cancer.
The purpose of this study is to show that the addition of COMPOUND 2055269, an immunotherapeutic drug, to Folfox chemotherapy will improve the pathologic complete response rate in patients with locally advanced rectal cancer. COMPOUND 2055269 has demonstrated meaningful clinical activity across various tumor types and treatment settings. No clinical trial is conducted over COMPOUND 2055269 in locally-advanced rectal adenocarcinoma.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
44
COMPOUND 2055269 to be given every 2 weeks with chemotherapy for 6 cycles
Radiotherapy 25 Gy to be given on Days 1-5
Given every 2 weeks for 6 cycles
King Hussein Cancer Center
Amman, Jordan
American University of Beirut Medical Center
Beirut, Lebanon
Hôtel Dieu de France
Beirut, Lebanon
The primary objective of the study is to evaluate the pathologic complete response (pCR) rate following short-course radiation then mFOLFOX-6/COMPOUND 2055269
Will be done via pathologic assessment on the surgical specimen
Time frame: After 17 weeks (once surgery is done)
The proportion of patients who remain progression free at 3 years.
1\) Progression free survival is measured by imaging and serial tumor markers during follow up visits
Time frame: 3 years
PD-L1 expression and T-cell infiltration changes after treatment
2\) PD-L1 \& T cell infiltration is measured by a pathology assessment on day 10 and after surgery
Time frame: At day 10 biopsy and after 17 weeks (once surgery is done)
Number of participants with treatment- related adverse events as assessed by NCI-CTCAE v4.0
Treatment- related adverse events are assessed by NCI-CTCAE v4.0 in each visit
Time frame: 3 years
Quality of life of the patients in a neoadjuvant setting with COMPOUND 2055269 as assessed by FACT-C questionnaire
Quality of life is measured via FACT-C questionnaire in each visit.
Time frame: 3 years
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Surgery to be done 2-3 weeks after last cycle of chemotherapy and COMPOUND 2055269