What side effects are associated with this type of intervention?

Common side effects of treatments for solid tumors, particularly those involving PD-L1 inhibitors like Durvalumab and investigational drugs similar to AZD0171, include fatigue, rash, diarrhea, and pneumonitis. These treatments may also cause hypertension, nausea, and immune-related adverse events. When combined with chemotherapy, additional side effects such as myelosuppression, nausea, and neuropathy may occur.

What prior FDA approvals exist?

The FDA has approved several immunotherapies for the treatment of solid tumors, particularly those targeting the PD-1/PD-L1 pathway. Notable approvals include Nivolumab (Opdivo) and Pembrolizumab (Keytruda), both PD-1 inhibitors, which have been approved for various cancers including non-small cell lung cancer (NSCLC) and melanoma. Durvalumab (Imfinzi), a PD-L1 inhibitor, has been approved for the treatment of NSCLC and bladder cancer. Additionally, combination therapies such as Nivolumab with Ipilimumab (a CTLA-4 inhibitor) have shown efficacy in treating melanoma and renal cell carcinoma. These approvals highlight the growing role of immunotherapy in managing solid tumors.

What other types of research exist?

Promising alternatives to AZD0171 and Durvalumab for solid tumors include Pembrolizumab (PD-1 inhibitor), Nivolumab (PD-1 inhibitor), and Atezolizumab (PD-L1 inhibitor). Combination therapies such as Pembrolizumab with Lenvatinib or Nivolumab with Ipilimumab are also showing significant promise in clinical trials.

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Other

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 is testing a new drug (AZD0171) and an existing drug (durvalumab) along with standard chemotherapy in patients with advanced pancreatic cancer. The goal is to see if this combination can help the immune system fight the cancer while also killing cancer cells directly.

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.

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.

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 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 24 months

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Number of participants with adverse events (AEs), immune mediated AEs (imAEs) and serious AEs (SAEs)

Overall survival at 12 months (OS-12)

Secondary study objectives

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

~1920

Nab-paclitaxel

2014

Completed Phase 3

~1950

0 / 17Eligibility criteria met

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.