Spots Global Cancer Trial Database for INNATE: Immunotherapy During Neoadjuvant Therapy for Rectal Cancer

The following info and data is provided "as is" to help patients around the globe.
We do not endorse or review these studies in any way.

Trial Identification

Brief Title: INNATE: Immunotherapy During Neoadjuvant Therapy for Rectal Cancer

Official Title: INNATE: Immunotherapy During Neoadjuvant Therapy for Rectal Cancer, a Phase II Randomized Multi-center Trial With and Without APX005M, an Anti-CD40 Agonist

Study ID: NCT04130854

Conditions

Locally Advanced Rectal Adenocarcinoma

Interventions

APX005M, mFOLFOX, and Radiation Therapy 5Gy x 5 days

mFOLFOX and Radiation Therapy 5Gy x 5 days

Study Description

Brief Summary: Determine the complete pathologic complete response (pCR) rate in patients with locally advanced rectal adenocarcinoma.

Detailed Description: A phase II randomized trial 3:2 with short course radiotherapy followed by mFOLFOX chemotherapy prior to trans abdominal resection with or without an antiCD40 agonist antibody (APX005M). There will be continuous safety assessment for at least 6 patients. Planned accrual of 58 patients. An interim analysis after 30 patients have completed treatment and there will be early stopping criteria for futility or efficacy. Short course radiotherapy will consist of 5Gy x 5 to the pelvis and patients on APX005M arm will receive one infusion during radiotherapy course, have a two week break, then start FOLFOX with APX005M in conjunction with five out of six cycles of chemotherapy. Patients will be restaged and then undergo definitive surgery.