Active not recruitingPHASE2INTERVENTIONAL

Study of Olaparib (MK-7339) in Combination With Pembrolizumab (MK-3475) in the Treatment of Homologous Recombination Repair Mutation (HRRm) and/or Homologous Recombination Deficiency (HRD)-Positive Advanced Cancer (MK-7339-007/KEYLYNK-007)

This study is investigating a new combination of two medicines, olaparib and pembrolizumab, for adults with advanced solid tumours. "Advanced" means the cancer has spread or cannot be removed by surgery. This research focuses on cancers that have certain genetic changes or problems with how their cells repair themselves, known as Homologous Recombination Repair Mutation (HRRm) or Homologous Recombination Deficiency (HRD). The aim is to see if this combination treatment is effective and safe for people whose cancer has not responded well to previous standard treatments. It's a Phase 2 study, meaning it's still in the earlier stages of testing new treatments.

At a glance

Status

Active not recruiting

Phase

PHASE2

Sponsor

Merck Sharp & Dohme LLC

Enrolment target

300

Start

18 Nov 2019

Estimated completion

29 Jun 2026

Solid Tumors

What is this study about?

This study, called MK-7339-007 or KEYLYNK-007, is a type of research where doctors test new treatments. In this case, they are looking at how safe and effective a combination of two drugs, olaparib and pembrolizumab, might be. It's designed for adults who have advanced solid tumours. "Advanced" means the cancer has either spread to other parts of the body (metastatic) or cannot be removed through surgery.

What makes this study specific is that it's focusing on cancers that have particular features related to how their cells repair themselves. These features are called Homologous Recombination Repair Mutation (HRRm) or Homologous Recombination Deficiency (HRD). These are scientific terms, but in simple language, it means there are certain genetic changes or weaknesses in the cancer cells' ability to fix damaged DNA. Researchers believe that certain drugs might work better in cancers with these specific characteristics.

The main goal is to find out if this combination of olaparib and pembrolizumab can help people whose cancer hasn't responded well to other standard treatments they've already tried. It's a Phase 2 study, which means it’s an important step in researching new medicines, but it’s not yet a widely available treatment. The information gathered will help doctors understand if this treatment option could be beneficial for certain patients in the future.

Key takeaways

This study is for adults with advanced solid tumours.
It tests a new combination of two drugs: olaparib and pembrolizumab.
The focus is on cancers with specific genetic repair weaknesses (HRRm/HRD).
Participants must have tried other standard treatments already.
Safety and effectiveness of the drug combination are being assessed.
Regular monitoring and follow-up will be part of the study.

Who may be eligible?

To join this study, you must be an adult with advanced solid tumour cancer that has either spread or can't be removed by surgery. Crucially, your cancer must have specific genetic changes or weaknesses in cell repair (HRRm or HRD), which will be checked by the study team. You must have already tried standard treatments for your cancer, and they either didn't work well or you couldn't tolerate them.

Your cancer needs to be measurable, meaning doctors can see and track it with scans. You also need to be well enough to take part, as assessed by a doctor (a score of 0 or 1 on the ECOG scale). You should have a life expectancy of at least three months. Importantly, if you've had certain platinum-based chemotherapy drugs before (like cisplatin or carboplatin), your cancer must have responded positively to them (either shrunk or gone away completely).

There are also some requirements regarding pregnancy and contraception for both men and women taking part, to ensure safety. For example, women must not be pregnant or breastfeeding, and if they could become pregnant, they must agree to use effective contraception during and for a period after treatment. Men must also use contraception and refrain from donating sperm for a certain period.

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 an adult with an advanced solid tumour (cancer that has spread or can't be surgically removed)?
Has your cancer been checked for specific genetic changes (HRRm or HRD)?
Have standard treatments for your cancer not worked well or caused severe side effects?
Is your cancer currently measurable by scans?
Are you generally well enough for daily activities and light work?
If you've had platinum-based chemotherapy (like cisplatin or carboplatin), did your cancer respond positively to it?

Answer every question to see your result.

What does participation involve?

Taking part in this study means you would receive the two study drugs, olaparib and pembrolizumab, as a combination treatment. The specific details of how and when you take these drugs would be explained by the study team.

You would have regular visits to the clinic for medical check-ups, blood tests, and scans to monitor your health and how the treatment is affecting your cancer. These visits are important for the research team to understand the safety and effectiveness of the drugs.

After you finish the treatment part of the study, there will be follow-up appointments to continue monitoring your health and the long-term effects. The total duration of your participation, including treatment and follow-up, would be fully explained to you before you agree to join.

Potential risks and benefits

Participating in this study might offer a potential benefit if the combination of olaparib and pembrolizumab proves to be an effective treatment for your specific type of advanced cancer, especially if other standard treatments haven't worked. However, like all medicines, these drugs can have side effects, which could range from mild to serious. The study team will monitor you closely for any side effects and will explain all known risks before you make a decision. Remember, you have the right to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (135)

The Kirklin Clinic ( Site 0086)
Verified postcode
Birmingham, United States
Banner MD Anderson Cancer Center ( Site 0049)
Verified postcode
Gilbert, United States
UC Davis Comprehensive Cancer Center ( Site 0039)
Verified postcode
Sacramento, United States
San Francisco Oncology Associates ( Site 0085)
Verified postcode
San Francisco, United States
University of California San Francisco ( Site 0015)
Verified postcode
San Francisco, United States
Banner MD Anderson Cancer Center ( Site 0092)
Verified postcode
Greeley, United States
University of Florida ( Site 0078)
Verified postcode
Gainesville, United States
Winship Cancer Institute of Emory University ( Site 0057)
Verified postcode
Atlanta, United States
Northeast Georgia Medical Center ( Site 0026)
Verified postcode
Gainesville, United States
Northwest Georgia Oncology Centers PC ( Site 0047)
Verified postcode
Marietta, United States
Norton Cancer Institute - St. Matthews ( Site 0024)
Verified postcode
Louisville, United States
Atlantic Health System ( Site 0046)
Verified postcode
Summit, United States

Common questions

What does 'advanced solid tumour' mean?

It means the cancer has spread to other parts of the body (metastatic) or cannot be removed through surgery.

What are HRRm and HRD?

These are genetic changes or weaknesses in a cancer cell's ability to repair its own DNA. The study focuses on cancers with these specific features.

What kind of treatments have I needed before?

You must have already tried standard treatments for your cancer that either didn't work well enough or you couldn't tolerate them.

What are olaparib and pembrolizumab?

They are the two medicines being tested together in this study. They're both used to treat certain cancers, but this study is looking at them as a combination.

Will I have to have regular appointments?

Yes, you would have regular clinic visits for check-ups, blood tests, and scans to monitor your health and how the treatment is working.