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AZD0171 + Durvalumab + Chemotherapy for Pancreatic Cancer

Phase 2
Waitlist Available
Research Sponsored by AstraZeneca
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Eastern Cooperative Oncology Group performance status of 0 or 1 at screening/enrollment
Presence of tumoral CD8+ T cells based on a predetermined benchmarked PDAC external sample
Must not have
Symptomatic central nervous system metastasis or any history of leptomeningeal disease or cord compression
Any unresolved toxicities ≥ Grade 2 per Common Terminology Criteria for Adverse Events v5.0 from prior therapy (excluding vitiligo, alopecia, controlled diabetes)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 24 months
Awards & highlights

Summary

This trial will test a new combination of drugs to treat pancreatic cancer.

Who is the study for?
This trial is for adults with metastatic pancreatic cancer who are in good physical condition (ECOG 0 or 1) and have a specific immune score. They must have at least one measurable tumor lesion, weigh over 35 kg, and provide tissue samples. Excluded are those with active infections, recent serious heart issues, other cancers, immunosuppressive treatments within the last two weeks, certain autoimmune diseases or prior cancer therapies.Check my eligibility
What is being tested?
The study tests AZD0171 combined with Durvalumab and standard chemotherapy drugs Gemcitabine and Nab-paclitaxel in patients with advanced pancreatic cancer. It aims to assess safety, how the body processes these drugs (pharmacokinetics), and their effectiveness against tumors.See study design
What are the potential side effects?
Potential side effects may include reactions related to the immune system affecting various organs due to Durvalumab; typical chemotherapy-related effects like nausea, fatigue from Gemcitabine; hair loss and nerve damage from Nab-paclitaxel; plus any new side effects from AZD0171.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am fully active or restricted in physically strenuous activity but can do light work.
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My cancer shows a specific immune response.
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My body weight is at least 35 kg.
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I have been diagnosed with a type of pancreatic cancer that has spread.
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My organ and bone marrow functions are normal.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have brain metastases or spinal cord issues related to my cancer.
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I don't have any major side effects from previous treatments, except for possible skin or hair issues, or controlled diabetes.
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I have or had an autoimmune or inflammatory disorder.
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I have had a heart attack, stroke, or similar event in the last 3 months.
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I do not have any unmanaged ongoing illnesses.
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I have previously received immunotherapy.
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I have not taken any cancer treatment before starting this study.
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I do not have an active infection and tested negative for COVID-19 recently.
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I have had another type of cancer.
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I haven't taken immunosuppressive drugs in the last 14 days.
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I have had a solid organ transplant.
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My pancreatic cancer has a specific mutation that responds well to standard treatments.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 24 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 24 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Number of participants with adverse events (AEs), immune mediated AEs (imAEs) and serious AEs (SAEs)
Overall survival at 12 months (OS-12)
Secondary outcome measures
Change from baseline in leukaemia inhibitory factor (LIF) bound to AZD0171 (total LIF)
Disease control rate (DCR)
Duration of response (DoR)
+11 more

Trial Design

1Treatment groups
Experimental Treatment
Group I: AZD0171 + Durvalumab + chemotherapyExperimental Treatment4 Interventions
Participants will receive AZD0171 (intravenous [IV]) along with durvalumab (IV) in combination with standard-of-care chemotherapy IV (gemcitabine and nab-paclitaxel).
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Durvalumab
2017
Completed Phase 2
~3840
Gemcitabine
2017
Completed Phase 3
~2070
Nab-paclitaxel
2014
Completed Phase 3
~2030

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.
Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
The most common treatments for solid tumors, particularly those similar to AZD0171 and Durvalumab, involve immunotherapy. Durvalumab is a PD-L1 inhibitor that works by blocking the interaction between PD-L1 on tumor cells and PD-1 on T-cells, thereby enhancing the immune system's ability to attack cancer cells. AZD0171, while investigational, is likely designed to complement this mechanism by further modulating the immune response. These treatments are significant for solid tumor patients because they offer a targeted approach to boost the body's natural defenses against cancer, potentially leading to better outcomes and fewer side effects compared to traditional chemotherapy.
Applications of Model-Based Meta-Analysis in Drug Development.Immunotherapy for the treatment of metastatic small cell lung cancer: Focus on pembrolizumab.Characteristics of Real-World Metastatic Non-Small Cell Lung Cancer Patients Treated with Nivolumab and Pembrolizumab During the Year Following Approval.

Find a Location

Who is running the clinical trial?

AstraZenecaLead Sponsor
4,302 Previous Clinical Trials
288,624,473 Total Patients Enrolled

Media Library

AZD0171 (Other) Clinical Trial Eligibility Overview. Trial Name: NCT04999969 — Phase 2
Solid Tumors Research Study Groups: AZD0171 + Durvalumab + chemotherapy
Solid Tumors Clinical Trial 2023: AZD0171 Highlights & Side Effects. Trial Name: NCT04999969 — Phase 2
AZD0171 (Other) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04999969 — Phase 2
~8 spots leftby Oct 2024