Active not recruitingPHASE1, PHASE2INTERVENTIONAL

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

This research study is investigating new ways to treat advanced cancers, including specific types of ovarian, breast, small cell lung, and stomach cancers. Scientists are testing combinations of investigational drugs called MEDI4736, olaparib, and sometimes bevacizumab. The main goals are to understand if these combinations are safe for patients, how well they work against the cancer, and how the body handles these medications. This study is split into different stages, looking at various cancer types and drug combinations, to gather important information that could help in developing future treatments.

At a glance

Status

Active not recruiting

Phase

PHASE1, PHASE2

Sponsor

AstraZeneca

Enrolment target

264

Start

17 Mar 2016

Estimated completion

17 Sep 2026

Ovarian Breast SCLC Gastric Cancers

Results

Results from this study

Posted October 2023

Results have been published for this study.

Primary outcome

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

The DCR at 12 weeks was defined as the percentage of participants who had complete response (CR) + partial response (PR) + stable disease (SD) at 12 weeks. Participants demonstrated SD for a minimum interval of 11 weeks (minus 1 week to allow for an early assessment within the assessment window, i.e. 77 days) following the start of treatment. The DCR was determined using Investigator assessments according to Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1).

Full results on the registry

What is this study about?

This study is specifically designed for people living with advanced forms of certain cancers, such as ovarian, breast, a type of lung cancer called small cell lung cancer (SCLC), and stomach cancer. When we say 'advanced,' it means the cancer may have spread or returned after previous treatments.

The main aim of this research is to see how well different combinations of new drugs work. These drugs are called MEDI4736, olaparib, and sometimes another drug called bevacizumab. The study wants to find out if these combinations are safe for patients, how they affect the cancer, and how the body processes them. This is an early-stage study, meaning it's one of the first times these combinations are being tested in people. The information gathered will help doctors and researchers understand if these treatments could be helpful in the future.

The study is divided into several parts, or 'modules,' each focusing on different cancer types or slightly different drug combinations. For instance, some parts are looking at specific genetic changes in ovarian or breast cancer. The researchers will carefully monitor patients throughout the study to learn as much as possible about these new treatment approaches.

Key takeaways

Targets advanced ovarian, breast, SCLC, and stomach cancers.
Tests new combinations of MEDI4736, olaparib, and bevacizumab.
Focuses on safety, effectiveness, and how the drugs work in the body.
Patients should not have received certain prior cancer treatments.
Regular hospital visits and health monitoring are part of participation.
This is an early-stage study to gather important information.

Who may be eligible?

To join this study, you generally need to have an advanced solid cancer that has been confirmed by a doctor, specifically certain types of ovarian, breast, small cell lung (SCLC), or stomach cancer. Your cancer should show signs of progression, meaning it's either growing or has spread. You must be at least 18 years old (or 19 in South Korea) and generally be fit enough to participate, with a good overall health status.

Several important conditions must also be met. For example, you shouldn't have had certain types of anti-cancer treatments, including PARP inhibitors or immunotherapy, in the past. You also need to have at least one measurable area of cancer that doctors can track with scans like CT or MRI. You must be able to swallow medications in pill form, and if you are a woman who could become pregnant, you'll need to use effective birth control.

You would not be able to join if you've recently had chemotherapy or other systemic cancer treatments within a few weeks before the study starts. The study team will review your full medical history to make sure the study is a safe and suitable option for you.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Do I have advanced ovarian, breast, SCLC, or stomach cancer?
Am I at least 18 years old?
Have I avoided certain cancer treatments (like PARP inhibitors or immunotherapy) in the past?
Am I generally healthy enough for a clinical study?
Can I swallow pills without chewing or crushing them?
Are there any measurable areas of cancer that can be tracked?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you'll be given study medications in pill form (olaparib) and others that might be given as an infusion (MEDI4736 and bevacizumab). You'll have regular hospital or clinic visits for check-ups, blood tests, and scans (like CT or MRI) to see how the treatment is working and to monitor your health. These visits will help the doctors understand how your body is reacting to the medicines. The exact number of visits and tests will vary depending on your specific treatment plan within the study. The study will continue for a certain period, and you will have follow-up appointments even after you stop taking the study drugs, to keep track of your health. Your total time in the study will be discussed with you by the research team.

Potential risks and benefits

Participating in a clinical trial like this may offer potential benefits, such as access to new treatments before they are widely available, and close monitoring of your health by experienced medical professionals. However, there are also potential risks; the study drugs might cause side effects, some of which could be serious or unexpected, as these are new combinations. It's important to remember that these treatments may not work for everyone, and your cancer might not respond to the study drugs. You will be fully informed about all known risks and benefits before deciding to join, and you have the right to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (47)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

Research Site
Verified postcode
Newnan, United States
Research Site
Verified postcode
Towson, United States
Research Site
Verified postcode
Boston, United States
Research Site
Verified postcode
Detroit, United States
Research Site
Verified postcode
St Louis, United States
Research Site
Verified postcode
Hilliard, United States
Research Site
Verified postcode
Philadelphia, United States
Research Site
Verified postcode
Bordeaux, France
Research Site
Verified postcode
Caen, France
Research Site
Verified postcode
Clermont-Ferrand, France
Research Site
Verified postcode
Dijon, France
Research Site
Verified postcode
Marseille, France

Common questions

What types of cancer are being studied?

This study is for people with advanced ovarian cancer, breast cancer, small cell lung cancer, and stomach cancer.

What drugs are being tested?

The study is testing combinations of MEDI4736, olaparib, and sometimes bevacizumab.

What is the main goal of the study?

The main goals are to see how safe the drug combinations are, how well they work against cancer, and how the body handles them.

Do I need to have a specific type of cancer gene change?

For some parts of the study, you might need to have a specific genetic change, like in the BRCA gene, or a specific type of HER2-negative breast cancer.

Will I get all three drugs?

Depending on which part of the study you might be in, you could receive a combination of two or three of the drugs mentioned.