drugset / Trial / NCT03851614

Study of DNA Damage, Angiogenesis, and PD-L1 Inhibitors in Advanced Solid Tumors

NCT03851614

Phase 2 Active not recruiting 90 enrolled University Health Network, Toronto AstraZeneca · collab
RandomizedParallel-groupOpen-labelTreatment

Summary

This is a phase 2, single-centre, randomized, multi-cohort trial of subjects with advanced Mismatch Repair Proficient Colorectal Cancer (MMRp-CRC), Pancreatic Adenocarcinoma (PA), and Leiomyosarcoma (LMS). Subjects will be stratified based on their primary malignancy and enrolled into one of the following cohorts: * Cohort A: olaparib and durvalumab. * Cohort B: cediranib and durvalumab. Subjects will receive durvalumab through an intravenous line every 4 weeks. If subjects are assigned to the olaparib group, then they will take this pill twice a day continuously. If subjects are assigned to the cediranib group, then they will take this pill once a day for 5 consecutive days, and then have 2 consecutive days off, every week. Subjects will be enrolled in this trial to evaluate the changes in genomic and immune biomarkers in tumor, peripheral blood and stool samples, in addition to changes in radiomic profiles. About 90 people (45 subjects in each cohort) will be enrolled into this study at the Princess Margaret Cancer Centre.

Timeline

Start
2019-04-08
Primary completion
2027-01-01
Completion
2027-01-01

Drugs

EvaluationDrugModalityDoseRoute
Subject Cediranib Small molecule 20 mg Oral
Subject Durvalumab Monoclonal antibody 1500 mg Intravenous
Subject Olaparib Small molecule 300 mg Oral