Active not recruitingPHASE2INTERVENTIONAL

Study Evaluating the Efficacy of a Double Immunotherapy Combined With Olaparib in Patients With Solid Cancers and Carriers of Homologous Recombination Repair Genes After Olaparib Treatment

This research is investigating a new way to treat advanced solid cancers, including breast, lung, head and neck, endometrial, kidney, pancreatic, ovarian, bladder, and prostate cancers. It focuses on people whose cancer has specific changes in their 'homologous recombination repair' genes and who have already been treated with olaparib and other therapies. The study combines olaparib with two immunotherapy drugs, durvalumab and tremelimumab. The idea is that olaparib might make the cancer cells more visible to the immune system, and the immunotherapy drugs can then help the body's own immune system fight the cancer more effectively. This is a Phase 2 study, meaning it's still an early stage and aims to see if the treatment is safe and shows promise.

At a glance

Status

Active not recruiting

Phase

PHASE2

Sponsor

Centre Georges Francois Leclerc

Enrolment target

270

Start

10 Feb 2020

Estimated completion

10 Aug 2027

Immunotherapy

What is this study about?

This study is a bit like fitting together different pieces of a puzzle to find a better way to treat certain advanced cancers. We know that some cancers have specific changes in their genetic code, particularly in genes involved in repairing damaged DNA. These are often called 'homologous recombination repair' genes. When these genes aren't working properly, cancer cells can become more sensitive to certain treatments, like a drug called olaparib.

Olaparib works by blocking a protein called PARP, which helps repair DNA. By blocking PARP, olaparib makes it harder for cancer cells with these specific genetic changes to fix themselves, leading to their death. The exciting part is that when cancer cells are damaged in this way, they might also become more visible to our body's own immune system. This study aims to combine olaparib with two other drugs, durvalumab and tremelimumab, which are types of immunotherapy. These immunotherapy drugs help to 'unleash' the immune system, allowing it to recognise and attack cancer cells more effectively.

The main goal is to see if combining these treatments can offer a stronger attack against cancer in people who have these specific genetic changes and whose cancer has already been treated with other medicines. By understanding more about how different drugs work together, especially in people with particular genetic make-ups, doctors hope to offer more targeted and effective treatments in the future.

Key takeaways

This study combines two immunotherapy drugs with olaparib.
It's for people with advanced solid cancers and specific gene changes.
The aim is to boost the immune system's fight against cancer.
It's a Phase 2 trial, checking if the treatment is effective and safe.
Participation requires previous genetic testing for DNA repair gene changes.

Who may be eligible?

To join this study, you would generally need to be an adult (18 years or older) with certain types of advanced solid cancer, such as breast, lung, head and neck, endometrial, kidney, pancreatic, ovarian, bladder, or prostate cancer. Your cancer must have already been treated and progressed after previous therapies.

A key requirement is that your cancer cells must have specific changes in their DNA repair genes, which would have been identified through previous genetic testing (exome sequencing). The type of cancer and previous treatments you've had also matter. For example, some cancers need to have progressed after specific types of chemotherapy or other targeted treatments.

This study looks for people whose cancer has these particular genetic changes, as the treatment investigated is designed to work best in this group. It's important to discuss your medical history and test results with your doctor to see if you might be a good fit.

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.

Are you 18 years old or older?
Do you have a solid cancer (like breast, lung, or prostate) that has spread?
Has your cancer been treated before and progressed?
Have you had genetic testing that showed changes in your DNA repair genes (like BRCA1 or BRCA2)?
Have you discussed your previous treatments with your doctor to see if they match the study's requirements?

Answer every question to see your result.

What does participation involve?

The detailed steps for participating aren't fully provided in this summary, but generally, taking part in a clinical trial involves regular visits to the hospital or clinic. During these visits, you would likely have physical exams, blood tests, and scans to monitor your health and how the treatment is working. You would receive the study medications (olaparib, durvalumab, and tremelimumab) according to a specific schedule, which your study doctor and nurses would explain in detail. There will also be follow-up appointments after you finish the treatment to track your progress. The total duration of the study, including treatment and follow-up, would be made clear at the beginning.

Potential risks and benefits

Participating in a clinical trial means you might be among the first to receive a new combination of treatments that could potentially be more effective than standard options, especially since this treatment is tailored to specific genetic changes in your cancer. However, as with all medical treatments, there are potential risks, including side effects from the drugs. These side effects can vary in severity and might be unexpected, as the combination is still being studied. You will be closely monitored for any reactions, and you have the right to withdraw from the study at any time, for any reason, without affecting your future medical care.

Locations (8)

CHU Amiens
Verified postcode
Amiens, France
CHRU Jean Minjoz
Verified postcode
Besançon, France
Institut Bergonié
Verified postcode
Bordeaux, France
Centre Georges François Leclerc
Verified postcode
Dijon, France
CHU François Mitterrand
Verified postcode
Dijon, France
Institut Hospitalier Franco-Britannique
Verified postcode
Levallois-Perret, France
Centre Oscar Lambret
Verified postcode
Lille, France
Centre Leon Berard
Verified postcode
Lyon, France

Common questions

What are 'solid cancers'?

Solid cancers are those that form a lump or tumour, like breast, lung, or prostate cancer, as opposed to blood cancers like leukaemia.

What does 'immunotherapy' mean?

Immunotherapy is a type of treatment that helps your body's own immune system fight cancer more effectively.

What are 'homologous recombination repair genes'?

These are specific genes in your body that are important for fixing damaged DNA. If they have changes, cancer cells might be more sensitive to certain treatments.

What does 'Phase 2' mean for a clinical trial?

Phase 2 means the treatment has already been shown to be safe in a small group of people, and now researchers want to see if it works and check for side effects in a larger group.

Will I get all three drugs?

Yes, if you join this study, the plan is for you to receive all three drugs: olaparib, durvalumab, and tremelimumab, as part of the combined treatment.