What side effects are associated with this type of intervention?

Common side effects of immune checkpoint inhibitors, such as PD-L1 inhibitors like Durvalumab, include fatigue, rash, diarrhea, and nausea. More severe immune-related adverse events can affect various organs, leading to conditions such as colitis, hepatitis, pneumonitis, and endocrinopathies (e.g., thyroid dysfunction, adrenal insufficiency). These side effects result from the immune system's heightened activity against both cancer cells and normal tissues.

What prior FDA approvals exist?

The FDA has approved several immune checkpoint inhibitors for the treatment of solid tumors. Durvalumab, a PD-L1 inhibitor, is approved for use in non-small cell lung cancer (NSCLC) and urothelial carcinoma. Other similar drugs include Pembrolizumab and Nivolumab, both PD-1 inhibitors, which are approved for a variety of solid tumors such as melanoma, NSCLC, head and neck squamous cell carcinoma, and more. Atezolizumab, another PD-L1 inhibitor, is approved for use in NSCLC and urothelial carcinoma. These approvals highlight the role of immune checkpoint inhibitors in the treatment of various solid tumors.

What other types of research exist?

Promising alternatives for solid tumor treatment in 2024 include: 1) Nivolumab (PD-1 inhibitor) combined with Ipilimumab (CTLA-4 inhibitor), which has shown efficacy in various solid tumors. 2) Pembrolizumab (PD-1 inhibitor) alone or in combination with other agents like chemotherapy or targeted therapies. 3) Relatlimab (LAG-3 inhibitor) combined with Nivolumab, which has demonstrated improved progression-free survival in melanoma. These alternatives offer different mechanisms and combination strategies that may provide effective treatment options for solid tumor patients.

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AZD8701 + Durvalumab for Solid Cancers

Phase 1

Waitlist Available

Research Sponsored by AstraZeneca

Eligibility Criteria Checklist

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

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up every 8 weeks (first 48 weeks) and then every 12 weeks from start of treatment until the earlier of progression, death or end of study (for max 42 months)

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing a new drug, AZD8701, alone and with an existing drug, Durvalumab, in adults with advanced cancers. The goal is to see if these treatments can stop cancer growth or help the immune system fight the cancer. The study focuses on patients whose cancers are hard to treat or have responded to similar treatments before. Durvalumab is a drug that helps the immune system fight cancer and has been used with other treatments to help patients live longer.

Who is the study for?

Adults with advanced solid tumors, including various cancers like lung, breast, and melanoma. They must have a tumor sample available, weigh over 35 kg, and have tried standard treatments without success or no options exist. Participants should be in relatively good health (ECOG 0-1), not pregnant or breastfeeding, willing to use contraception if of childbearing potential, and free from significant heart disease or active COVID-19.

What is being tested?

The trial is testing AZD8701 alone and combined with Durvalumab for safety and effectiveness against certain advanced solid tumors. It will look at how the body processes these drugs (pharmacokinetics/dynamics) as well as their ability to provoke an immune response (immunogenicity) and fight cancer cells.

What are the potential side effects?

Potential side effects may include typical reactions associated with immunotherapy such as fatigue, skin reactions, inflammation of organs like the lungs or intestines (colitis), hormonal gland problems (like thyroid dysfunction), liver issues; however specific side effects for AZD8701 are being studied.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ every 8 weeks (first 48 weeks) and then every 12 weeks from start of treatment until the earlier of progression, death or end of study (for max 42 months)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~every 8 weeks (first 48 weeks) and then every 12 weeks from start of treatment until the earlier of progression, death or end of study (for max 42 months)

This trial's timeline: 3 weeks for screening, Varies for treatment, and every 8 weeks (first 48 weeks) and then every 12 weeks from start of treatment until the earlier of progression, death or end of study (for max 42 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

Incidence of AEs and SAEs related to AZD8701 as monotherapy and in combination with Durvalumab in disease specific expansions treated at the MTD/OBD/MFD

Maximum Tolerated dose (or optimal dose or maximum feasible dose) and RP2D of AZD8701 as monotherapy and in combination with Durvalumab assessed through evaluation of AEs and SAEs

Maximum Tolerated dose (or optimal dose or maximum feasible dose) and RP2D of AZD8701 as monotherapy and in combination with Durvalumab assessed through evaluation of Dose Limiting Toxicities (DLTs)

+2 more

Secondary study objectives

Best percentage change in tumour size according to RECIST 1.1 by investigator assessment

Change in FOXP3 mRNA expression

Disease Control Rate at 16 weeks according to RECIST 1.1 by investigator assessment

+13 more

Side effects data

From 2022 Phase 3 trial • 867 Patients • NCT03084471

26%

Asthenia

20%

Anaemia

20%

Constipation

17%

Decreased appetite

16%

Diarrhoea

15%

Nausea

13%

Pruritus

10%

Urinary tract infection

10%

Cough

10%

Fatigue

Vomiting

Dyspnoea

Back pain

Oedema peripheral

Pyrexia

Arthralgia

Hypothyroidism

Haematuria

Abdominal pain

Blood creatinine increased

Weight decreased

Sepsis

Tumour hyperprogression

General physical health deterioration

Pneumonia

Death

Acute kidney injury

Pyelonephritis

Device related infection

Urosepsis

Pulmonary embolism

100%

80%

60%

40%

20%

Study treatment Arm

Durvalumab

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Group I: MonotherapyExperimental Treatment1 Intervention

Participants will receive AZD8701 intravenously, on Day 1, 3, 5 and 8 and then weekly for a maximum of 2 years.

Group II: Combination TherapyExperimental Treatment2 Interventions

Participants will receive AZD8701 (intravenously, on Day 1, 3, 5 and 8 and then weekly) and durvalumab (MEDI4736) intravenously monthly for a maximum of 2 years.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

AZD8701

2020

Completed Phase 1

~60

Durvalumab

2017

Completed Phase 2

~3750

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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

Immune checkpoint inhibitors, such as PD-1 inhibitors (e.g., pembrolizumab, nivolumab) and PD-L1 inhibitors (e.g., durvalumab), work by blocking the proteins that prevent T-cells from attacking cancer cells. This blockade enhances the immune system's ability to recognize and destroy cancer cells. Understanding these mechanisms is crucial for solid tumor patients because it highlights the potential of these therapies to improve survival and quality of life by leveraging the body's own immune system to fight cancer.

Immune Escape in Prostate Cancer: Known and Predicted Mechanisms and Targets.Recurrent glioma clinical trial, CheckMate-143: the game is not over yet.Cancer immunology and melanoma immunotherapy.