← Back to Search

PD-L1 Inhibitor

MEDI4736 + Olaparib for Advanced Cancers (MEDIOLA Trial)

Phase 1 & 2

Waitlist Available

Led By Susan Domchek, 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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline (day 1) and weeks 12 and 28. assessed until dco 14 jun 2019

Awards & highlights

MEDIOLA Trial 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.Check my eligibility

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.See study design

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.

MEDIOLA Trial Eligibility Criteria

Inclusion Criteria

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

Select...

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

Select...

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

Select...

I am fully active or can carry out light work.

Select...

My organs and bone marrow are working well.

MEDIOLA Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ from baseline (day 1) until death from any cause. assessed until dco 14 jun 2019 for initial stage cohorts except for ovarian cancer cohort and dco 17 sep 2021 for initial stage ovarian cancer cohort and second stage cohorts

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~from baseline (day 1) until death from any cause. assessed until dco 14 jun 2019 for initial stage cohorts except for ovarian cancer cohort and dco 17 sep 2021 for initial stage ovarian cancer cohort and second stage cohorts

This trial's timeline: 3 weeks for screening, Varies for treatment, and from baseline (day 1) until death from any cause. assessed until dco 14 jun 2019 for initial stage cohorts except for ovarian cancer cohort and dco 17 sep 2021 for initial stage ovarian cancer cohort and second stage cohorts for reporting.

Treatment Details

Study Objectives

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

Primary outcome measures

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 outcome measures

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 outcome measures

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

MEDIOLA 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

Bevacizumab

FDA approved

0 / 4Eligibility criteria met

Find a Location

Who is running the clinical trial?

AstraZenecaLead Sponsor

4,257 Previous Clinical Trials

288,593,522 Total Patients Enrolled

1 Trials studying Breast

298 Patients Enrolled for Breast

Iqvia Pty LtdIndustry Sponsor

106 Previous Clinical Trials

169,744 Total Patients Enrolled

Susan Domchek, MDPrincipal InvestigatorAbramson Cancer Center, University of Pennsylvania

5 Previous Clinical Trials

1,800 Total Patients Enrolled

Frequently Asked Questions

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

Is the age threshold of this experiment higher than twenty years old?

"According to the clinical trial's requirements, enrolment is open for those aged 18 or above and below 130 years old."

Answered by AI

Are there any other exploratory investigations into the efficacy of MEDI4736?

"MEDI4736 was first investigated 16 years ago at a research site in Basking Ridge. Since then, 1172 clinical trials related to this drug have been concluded and 821 are still currently active; many of these sites lie within the city limits of Philadelphia, Pennsylvania."

Answered by AI

How many medical centers are participating in the clinical trial?

"Currently, 7 different medical centres are hosting this trial. These include sites based in Philadelphia, Hilliard and Saint Louis with a few more locations available. To minimize journey times if you enroll in the study it is recommendable to select your closest site."

Answered by AI

Are there vacancies available for volunteers in this clinical investigation?

"The clinicaltrials.gov portal reveals that this particular medical study has stopped accepting participants, as the last update was on July 25th 2022 - following its initial posting in March of 2016. Despite this setback, there are still 1547 other trials actively recruiting candidates at present."

Answered by AI

What types of illnesses has MEDI4736 been indicated to help?

"MEDI4736 is a viable treatment for recurrent and platinum-resistant epithelial ovarian cancer, malignant neoplasms, or recurrent platinum sensitive primary peritoneal cancers."

Answered by AI

Which patient demographics are eligible to participate in this trial?

"To be eligible for the trial, 264 participants must have stomach cancer and fall between 18 - 130 years old."

Answered by AI

What is the upper limit of participants involved in this clinical research?

"At this time, the trial is not recruiting participants. It initially went live on March 17th 2016 and was last updated July 25th 2022. Should you be looking for other trials to join, there are 726 studies actively enrolling patients with stomach cancer and 821 studies involving MEDI4736 that are admitting new members."

Answered by AI

What are the objectives of this trial?

"The primary outcome being measured over a 90-day span of the trial is to evaluate MEDI4736's safety and tolerability in combination with olaparib (and potentially bevacizumab) by monitoring vital signs. Other evaluations include tracking olaparib pharmacokinetics, measuring serum PD-L1 levels, and recording overall survival rates."

Answered by AI

Recent research and studies

The Lancet OncologyJournal

Olaparib and Durvalumab in Patients with Germline Brca-mutated Metastatic Breast Cancer (MEDIOLA): An Open-label, Multicentre, Phase 1/2, Basket Study

Domchek, Susan M, Sophie Postel-Vinay, Seock-Ah Im, Yeon Hee Park, Jean-Pierre Delord, Antoine Italiano, Jerome Alexandre, et al.. 2020. “Olaparib and Durvalumab in Patients with Germline Brca-mutated Metastatic Breast Cancer (MEDIOLA): An Open-label, Multicentre, Phase 1/2, Basket Study”. The Lancet Oncology. Elsevier BV. doi:10.1016/s1470-2045(20)30324-7.

OncoImmunologyJournal

PARP Inhibition Is a Modulator of Anti-tumor Immune Response in Brca-deficient Tumors

Staniszewska, Anna D., Joshua Armenia, Matthew King, Chrysiis Michaloglou, Avinash Reddy, Maneesh Singh, Maryann San Martin, et al.. 2022. “PARP Inhibition Is a Modulator of Anti-tumor Immune Response in Brca-deficient Tumors”. Oncoimmunology. Informa UK Limited. doi:10.1080/2162402x.2022.2083755.

clinicaltrials.govStudy

A Phase I/II Study of MEDI4736 in Combination With Olaparib in Patients With Advanced Solid Tumors.

2016. "A Phase I/II Study of MEDI4736 in Combination With Olaparib in Patients With Advanced Solid Tumors.". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT02734004.

All > No Stomach For Cancer > Lynparza