Neoplasms

Digestive System Diseases

All Conditions

Rectal Neoplasms

Colorectal Neoplasms

Intestinal Neoplasms

Gastrointestinal Neoplasms

Digestive System Neoplasms

Gastrointestinal Diseases

Intestinal Diseases

Rectal Diseases

Anti-Arrhythmia Agents

Vasodilator Agents

Analgesics

All Drugs and Chemicals

Adenosine

Enrolled patients will receive Radiation therapy of 25 Gy in 5 fractions along with etrumadenant 150mg oral drug taken once daily. this will then be followed by 9 cycles of FOLFOX in combination of etrumadenant and zimberelimab investigational drugs.

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.

Etrumadenant (AB928)

Patients will receive a radiation therapy dose of 25Gy in 5fx

Radiation therapy

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.

FOLFOX regimen

Zimberelimab (AB122)

Sharanya Chandrasekhar, M.S.

Pragya Yadav, Ph.D.

Encouse Golden, M.D.,Ph.D.

Encouse Golden, M.D., Ph.D.

Pashtoon Kasi, M.D.

Mary Palmer, M.S.

Hani Ashamalla, M.D.

Hina Ali, M.D.

Pragya Yadav, Ph.D

Andrew Brandmaier, M.D.

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).

A Phase I-II Study to Test the Safety and Efficacy of PD1 (AB122) and Adenosine Receptor (AB928) Antagonists With Chemotherapy After Short-Course Radiation for Rectal Cancer.

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.

Number of patients with treatment-related early and late adverse events as assessed by the CTCAE version 5.0

PFS is defined as the duration of time from start of treatment to time of progression.

Overall Survival is defined as the duration of time from start of treatment until death.

Spots Global Cancer Trial Database for etrumadenant (ab928)