Combination Therapy with Cediranib, Olaparib, and Durvalumab for Advanced Solid Tumors (DAPPER Trial)

Recruiting in Palo Alto (17 mi)

Overseen ByLillian Siu, MD

Age: 18+

Sex: Any

Travel: May be covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Waitlist Available

Sponsor: University Health Network, Toronto

No Placebo Group

Prior Safety Data

Breakthrough Therapy

Trial Summary

What is the purpose of this trial?This trial tests a combination of medicines to help the immune system fight advanced colorectal, pancreatic, and soft tissue cancers. It aims to see if these new treatments can be more effective for patients whose cancers are hard to treat with standard therapies.

Eligibility Criteria

Adults with advanced colorectal cancer, pancreatic adenocarcinoma, or leiomyosarcoma that's not curable and has failed standard therapy can join. They must be willing to use effective contraception, provide tumor tissue samples, have normal organ function, and no recent major surgeries. Excluded are those with certain heart conditions, uncontrolled hypertension or seizures, recent bleeding events or blood transfusions.

Participant Groups

The trial tests combinations of Olaparib (a pill for DNA repair inhibition), Cediranib (a pill for blocking blood vessel growth in tumors), and Durvalumab (an IV drug boosting immune response against cancer). Participants will receive treatments based on their assigned cohort to see how these drugs affect tumor biomarkers.

2Treatment groups

Experimental Treatment

Group I: Cohort BExperimental Treatment2 Interventions

Cediranib (given orally at a dose of 20 mg daily, 5 days on 2 days off) in combination with Durvalumab (given intravenously at a dose of 1500 mg every 4 weeks)

Group II: Cohort AExperimental Treatment2 Interventions

Olaparib (given orally at a dose of 300 mg twice a day) in combination with Durvalumab (given intravenously at a dose of 1500 mg every 4 weeks)

Cediranib is already approved in United States, European Union for the following indications:

🇺🇸 Approved in United States as Cediranib for: