NCT03503630

Short-course Radiation Followed by mFOLFOX-6 Plus COMPOUND 2055269 for Locally-advanced Rectal Adenocarcinoma

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 44 (actual)
• Sponsor: Ali Shamseddine · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Locally Advanced Rectal Cancer

Interventions

Type	Name	Description
DRUG	COMPOUND 2055269	COMPOUND 2055269 to be given every 2 weeks with chemotherapy for 6 cycles
RADIATION	Radiation Therapy	Radiotherapy 25 Gy to be given on Days 1-5
DRUG	mFOLFOX	Given every 2 weeks for 6 cycles
PROCEDURE	Total Mesorectal Excision	Surgery to be done 2-3 weeks after last cycle of chemotherapy and COMPOUND 2055269

Timeline

• Start date: 2018-07-20
• Primary completion: 2021-03-15
• Completion: 2024-07-02
• First posted: 2018-04-20
• Last updated: 2024-01-31

Locations

3 sites across 2 countries: Jordan, Lebanon