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PD-L1 Inhibitor

Durvalumab + Olaparib with Radiation for Pancreatic Cancer

Q: What is the aggregate figure of participants participating in this medical trial?

Indeed, data posted on clinicaltrials.gov confirms that this research endeavor is currently searching for patients. The trial was initially made available to the public on November 7th 2022 and has seen its most recent update in late November of the same year. 18 participants are being sought from one medical site.

Q: Has the FDA issued authorization for olaparib, durvalumab, and radiation therapy as treatment methods?

Our staff at Power have rated the safety of this trifecta treatment (olaparib, durvalumab, radiation therapy) as a 1 due to its status as a Phase 1 study. This means available evidence for both efficacy and safety is minimal.

Q: Is it still possible to participate in this research trial?

Affirmative. Clinicaltrials.gov displays that recruitment for this trial is active; it was initially posted on November 7th 2022 and most recently updated on the thirtieth of November in the same year. This research seeks 18 subjects from a single medical facility.

Phase 1

Waitlist Available

Led By Michael D Green

Research Sponsored by National Cancer Institute (NCI)

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Patients must have unresectable locally advanced pancreatic cancer as determined by a multidisciplinary tumor board applying National Comprehensive Cancer Network (NCCN) version (v)2.2021 criteria or as surgically determined during failed resection attempt

Eastern Cooperative Oncology Group (ECOG) performance status =< 1 (Karnofsky >= 70%)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 4 years

Awards & highlights

Study Summary

This trialtests a combination of targeted therapy, immunotherapy, and radiation to treat pancreatic cancer that can't be removed by surgery.

Who is the study for?

Adults with locally advanced, unresectable pancreatic cancer who've had at least 16 weeks of first-line chemotherapy without progression. They must be in good physical condition (ECOG <=1), have adequate organ function, and not be pregnant. HIV or hepatitis patients may join if they meet specific criteria. Participants need to agree to use contraception and provide tissue from a previous biopsy if available.Check my eligibility

What is being tested?

The trial is testing the combination of olaparib (a PARP inhibitor that prevents cancer cells from repairing DNA damage) with durvalumab (an immunotherapy drug) alongside radiation therapy. The goal is to see if this trio can better control tumor growth by stimulating an immune response against the cancer.See study design

What are the potential side effects?

Potential side effects include typical reactions related to immunotherapy such as inflammation in various organs, infusion-related reactions, fatigue, blood disorders which could affect infection risk and healing capacity. Radiation therapy might cause localized skin irritation or damage to nearby tissues.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My pancreatic cancer cannot be removed by surgery as determined by experts.

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I am mostly active and can care for myself.

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I am post-menopausal or have a negative pregnancy test if pre-menopausal.

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I've completed at least 16 weeks of first-line chemotherapy for my cancer without it getting worse.

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My hemoglobin level is at least 9.0 g/dL without recent blood transfusions.

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I weigh more than 30 kilograms.

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I am 18 years old or older.

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I have been diagnosed with a specific type of pancreatic cancer.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 4 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 4 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 4 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Dose-limiting toxicities (DLTs) for olaparib in combination with durvalumab and radiation

Secondary outcome measures

Adverse events (AEs)

Number and diversity of T cells

Overall response rate (ORR)

+3 more

Other outcome measures

Correlation of efficacy endpoints with clinicopathologic variables

Trial Design

1Treatment groups

Experimental Treatment

Group I: Treatment (olaparib, durvalumab, radiation therapy)Experimental Treatment6 Interventions

Patients receive olaparib PO BID on days 1-28 and durvalumab IV over 55-65 minutes on day 1 of each cycle. Beginning cycle 2, patients also undergo radiation therapy daily on weekdays for 3 weeks. Cycles repeat every 28 days for up to 2 years in the absence of disease progression or unacceptable toxicity. Patients undergo tumor biopsy, diagnostic imaging and blood sample collection throughout the study.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Durvalumab

2017

Completed Phase 2

~3870

Biopsy

2014

Completed Phase 4

~850

Biospecimen Collection

2004

Completed Phase 2

~1730

Radiation Therapy

2017

Completed Phase 3

~7250

Olaparib

2007

Completed Phase 4

~2140

0 / 8Eligibility criteria met

Find a Location

Who is running the clinical trial?

National Cancer Institute (NCI)Lead Sponsor

13,654 Previous Clinical Trials

40,933,107 Total Patients Enrolled

Michael D GreenPrincipal InvestigatorUniversity of Michigan Comprehensive Cancer Center EDDOP

1 Previous Clinical Trials

25 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is the aggregate figure of participants participating in this medical trial?

"Indeed, data posted on clinicaltrials.gov confirms that this research endeavor is currently searching for patients. The trial was initially made available to the public on November 7th 2022 and has seen its most recent update in late November of the same year. 18 participants are being sought from one medical site."

Answered by AI

Has the FDA issued authorization for olaparib, durvalumab, and radiation therapy as treatment methods?

"Our staff at Power have rated the safety of this trifecta treatment (olaparib, durvalumab, radiation therapy) as a 1 due to its status as a Phase 1 study. This means available evidence for both efficacy and safety is minimal."

Answered by AI

Is it still possible to participate in this research trial?

"Affirmative. Clinicaltrials.gov displays that recruitment for this trial is active; it was initially posted on November 7th 2022 and most recently updated on the thirtieth of November in the same year. This research seeks 18 subjects from a single medical facility."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Testing the Safety of the Anti-Cancer Drugs Durvalumab and Olaparib During Radiation Therapy for Locally Advanced Unresectable Pancreatic Cancer

2023. "Testing the Safety of the Anti-Cancer Drugs Durvalumab and Olaparib During Radiation Therapy for Locally Advanced Unresectable Pancreatic Cancer". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05411094.