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PD-L1 Inhibitor

MEDI4736 + Olaparib for Advanced Cancers (MEDIOLA Trial)

Phase 1 & 2

Waitlist Available

Led By Susan Domcheck, MD

Research Sponsored by AstraZeneca

Eligibility Criteria Checklist

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

Must have

Patients must have histologically or cytologically confirmed progressive advanced or metastatic solid tumor of specific types as outlined in the protocol

Female patients must either be of non-reproductive potential or have a negative serum pregnancy test within 28 days of study treatment and confirmed prior to treatment on Day 1, and agree to use contraception if they or their partner are of reproductive potential

Must not have

Current dependency on total parenteral nutrition or IV fluid hydration

Concomitant use of known strong cytochrome P450 (CYP) 3A inhibitors or moderate CYP3A inhibitors

Timeline

Screening 3 weeks

Treatment Varies

Follow Up from baseline (day 1) until confirmed pd/death. assessed until dco 14 jun 2019 and 17 sep 2021 for initial and second stage cohorts, respectively

Awards & highlights

All Individual Drugs Already Approved

Approved for 10 Other Conditions

No Placebo-Only Group

Summary

This trial is testing a new cancer drug combination to see if it is effective, safe, and has anti-tumor activity. The study will also look at how the drugs are metabolized and how well the combination is tolerated.

Who is the study for?

This trial is for adults with certain advanced solid tumors, including specific breast and ovarian cancers, stomach cancer, or small cell lung cancer. Participants must have a life expectancy of at least 12 weeks, measurable lesions for assessment, and be able to swallow pills without altering them. They should not have had recent chemotherapy or other treatments that might interfere with the study drugs.

What is being tested?

The trial is testing the combination of MEDI4736 with olaparib (and in one module also bevacizumab) to evaluate their effectiveness and safety in treating these cancers. It will also assess how these drugs interact within the body and determine how well patients tolerate this drug regimen.

What are the potential side effects?

Potential side effects may include typical reactions from immunotherapy such as fatigue, digestive issues, skin reactions; from PARP inhibitors like olaparib such as nausea, anemia; and from anti-angiogenic agents like bevacizumab which can cause high blood pressure and increased bleeding risk.

Eligibility Criteria

Inclusion Criteria

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

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My cancer is advanced or has spread, and this was confirmed by lab tests.

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I am not pregnant and agree to use birth control during the study if I can have children.

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I am fully active or can carry out light work.

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My organs and bone marrow are working well.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I rely on IVs for nutrition or hydration.

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I am not taking strong or moderate drugs that affect liver enzymes.

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I am not on any other cancer treatments or long-term steroids.

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I have brain metastases that are causing symptoms or are not under control.

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I have had a bone marrow or double cord blood transplant.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ at screening

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~at screening

This trial's timeline: 3 weeks for screening, Varies for treatment, and at screening for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Initial Stage Cohorts: Disease Control Rate (DCR) at Week 12

Second Stage Cohort: Objective Response Rate (ORR)

Second Stage Cohorts: DCR at Week 24

Secondary study objectives

Initial Stage Cohorts: DCR at Week 28

Initial Stage Cohorts: Percentage Change From Baseline in Target Tumor Size at Weeks 12 and 28

Initial and Second Stage Cohorts: Best Percentage Change From Baseline in Target Tumor Size

+12 more

Other study objectives

Angiogenic predictive biomarkers: may include but is not limited to tumor gene expression profiling, tumor vascular morphology/microvessel density and peripheral soluble markers of angiogenesis eg, VEGF, Ang-1

Characterize the pharmacodynamics profile of bevacizumab: Efficacy of bevacizumab in combination with olaparib and MEDI4736 compared to olaparib and MEDI4736 alone

Pharmacodynamics: Paired tumor biopsies

+6 more

Side effects data

From 2023 Phase 3 trial • 713 Patients • NCT02125461

36%

Cough

24%

Fatigue

22%

Dyspnoea

18%

Diarrhoea

17%

Arthralgia

17%

Radiation pneumonitis

15%

Pyrexia

15%

Decreased appetite

14%

Nausea

13%

Pruritus

13%

Rash

12%

Upper respiratory tract infection

12%

Constipation

11%

Asthenia

11%

Hypothyroidism

11%

Headache

11%

Back pain

10%

Productive cough

10%

Pneumonia

Pneumonitis

Nasopharyngitis

Insomnia

Musculoskeletal pain

Vomiting

Oedema peripheral

Myalgia

Dry skin

Hyperthyroidism

Anaemia

Bronchitis

Dizziness

Non-cardiac chest pain

Pain in extremity

Urinary tract infection

Hypertension

Hypokalaemia

Paraesthesia

Musculoskeletal chest pain

Lung infection

Atrial fibrillation

Myocardial infarction

Cardiac failure congestive

Sepsis

Herpes zoster

Chronic obstructive pulmonary disease

Acute kidney injury

100%

80%

60%

40%

20%

Study treatment Arm

Durvalumab (MEDI4736)

Placebo

Awards & Highlights

All Individual Drugs Already Approved

Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.

Approved for 10 Other Conditions

This treatment demonstrated efficacy for 10 other conditions.

No Placebo-Only Group

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

Trial Design

3Treatment groups

Experimental Treatment

Group I: Arm 3Experimental Treatment3 Interventions

Includes 2nd stage cohort (module 6): Olaparib twice daily starting on week 1 day 1 / MEDI4736 every 4 weeks starting on week 1 day 1 / Bevacizumab every 2 weeks starting on week 1 day 1

Group II: Arm 2Experimental Treatment2 Interventions

Includes 2nd stage cohorts (modules 5 \& 7): Olaparib twice daily starting on week 1 day 1 and MEDI4736 every 4 weeks starting on week 1 day 1

Group III: Arm 1Experimental Treatment2 Interventions

Includes initial stage cohorts (modules 1 to 4): Olaparib twice daily starting on week 1 day 1 and MEDI4736 every 4 weeks starting on week 5 day 1

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Olaparib

FDA approved

Durvalumab

FDA approved