Pembrolizumab + Olaparib for Cervical Cancer

No longer recruiting at 1 trial location

Overseen By John P. Diaz, MD

Age: 18+

Sex: Female

Trial Phase: Phase 2

Sponsor: John Diaz

Must not be taking: CYP3A inhibitors, CYP3A inducers

Disqualifiers: Pregnancy, HIV, Hepatitis B/C, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

Duration: 3 years

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new combination of two drugs, pembrolizumab and olaparib, to determine their effectiveness in treating cervical cancer that has returned or spread after standard chemotherapy. Pembrolizumab aids the immune system in attacking cancer cells, while olaparib targets cancer cell repair mechanisms. Women with cervical cancer that cannot be cured with surgery or radiation, and who have already undergone chemotherapy, might be suitable for this study. Participants should have measurable cancer that can be tracked throughout the trial. As a Phase 2 trial, this research measures the treatment's effectiveness in an initial, smaller group, offering early access to potentially effective therapies.

Will I have to stop taking my current medications?

The trial requires a washout period for certain medications. If you are taking strong or moderate CYP3A inhibitors or inducers, you will need to stop them 2 to 5 weeks before starting the trial, depending on the specific medication. It's best to discuss your current medications with the trial team to see if any adjustments are needed.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research shows that using pembrolizumab and olaparib together can cause some side effects. In earlier studies, some patients experienced serious side effects. About 61% of patients faced significant negative effects, with anemia (a lower than normal number of red blood cells) being the most common, affecting 29% of them. Some patients also experienced a decrease in white blood cells.

In another study, 37.5% of patients experienced anemia, and 12.5% had thrombocytopenia (a low number of blood platelets). These are the types of side effects to be aware of with this treatment. However, pembrolizumab alone has proven safe and effective for advanced cervical cancer in real-world settings.

This information helps those considering joining a trial understand the treatment's safety profile. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about the combination of pembrolizumab and olaparib for cervical cancer because it offers a unique approach to treatment. Most current treatments for cervical cancer involve chemotherapy and radiation, which can be effective but often come with significant side effects. Pembrolizumab is an immune checkpoint inhibitor that helps the immune system recognize and attack cancer cells, while olaparib is a PARP inhibitor that targets cancer cell DNA repair mechanisms. This combination not only enhances the immune response against cancer cells but also disrupts their ability to repair themselves, potentially leading to more effective outcomes. This dual action approach is what makes this treatment particularly promising compared to traditional methods.

What evidence suggests that this treatment might be an effective treatment for cervical cancer?

Research shows that combining pembrolizumab and olaparib may help treat recurrent cervical cancer. Studies have found that patients tolerate this treatment well, and it offers health benefits. For those previously treated for cervical cancer, this combination is considered safe. Although more research is needed, these results suggest that this treatment could be a promising option for individuals with advanced cervical cancer. ^{1 2 3 5 6}

Who Is on the Research Team?

John Diaz, MD

Principal Investigator

Miami Cancer Institute at Baptist Health Inc.

Are You a Good Fit for This Trial?

This trial is for women aged 18+ with advanced or recurrent cervical cancer who've had ≤2 chemo treatments. They must not be pregnant, breastfeeding, and if of childbearing potential, agree to contraception. Participants need a life expectancy ≥16 weeks and adequate organ function as per specific criteria.

Inclusion Criteria

I have had up to 2 chemotherapy treatments before.

My cancer can be measured by scans and has grown in previously treated areas.

I am fully active or restricted in physically strenuous activity but can do light work.

Exclusion Criteria

Currently participating in or participated in a study of an investigational agent within 4 weeks prior to the first dose of study intervention

You have a mental health condition or substance abuse problem that affects your ability to follow the trial requirements.

I have been treated with specific immune therapy drugs before.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive pembrolizumab and olaparib for advanced cervical cancer

3 years

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Olaparib
• Pembrolizumab

Trial Overview The study tests the combination of pembrolizumab (an immunotherapy drug) and olaparib (a targeted therapy drug) in patients with cervical cancer that has returned or spread after standard chemotherapy. It's an open-label phase II trial where all participants receive the drugs.

How Is the Trial Designed?

Group I: Treatment Experimental Treatment 2 Interventions

PD-1 inhibitor pembrolizumab, in combination with the PARP inhibitor olaparib

Olaparib is already approved in European Union, United States for the following indications:

Approved in European Union as Lynparza for:

• Breast cancer
• Ovarian cancer
• Fallopian tube cancer
• Peritoneal cancer
• Pancreatic cancer
• Prostate cancer
• Endometrial cancer

Approved in United States as Lynparza for:

• Ovarian, fallopian tube, and primary peritoneal cancer
• Breast cancer
• Prostate cancer
• Pancreatic cancer

Who Is Running the Clinical Trial?

John Diaz

Lead Sponsor

Trials

1

Recruited

8+

Baptist Health South Florida

Lead Sponsor

Trials

54

Recruited

8,100+

Merck Sharp & Dohme LLC

Industry Sponsor

Trials

4,096

Recruited

5,232,000+

Chirfi Guindo

Merck Sharp & Dohme LLC

Chief Marketing Officer since 2022

Degree in Engineering from Ecole Centrale de Paris, MBA from New York University Stern School of Business

Robert M. Davis

Merck Sharp & Dohme LLC

Chief Executive Officer since 2021

JD from Northwestern University Pritzker School of Law, MBA from Northwestern University Kellogg Graduate School of Management, Bachelor's in Finance from Miami University

Florida Department of Health

Collaborator

Trials

30

Recruited

13,000+

Citations

1. annalsofoncology.org annalsofoncology.org/article/S0923-7534(24)02307-X/fulltext

Results from the phase II trial of GOTIC-025 This trial investigates Pem plus Ola combination therapy in platinum-experienced recurrent cervical cancer, revealing manageable safety.

2. gynecologiconcology-online.net gynecologiconcology-online.net/article/S0090-8258(25)00572-4/fulltext

Efficacy and safety of pembrolizumab in combination with ... The combination of pembrolizumab and olaparib was well tolerated and demonstrated a clinical benefit in women with previously treated recurrent cervical cancer.

3. merck.com merck.com/news/merck-announces-phase-3-keylynk-001-trial-met-primary-endpoint-of-progression-free-survival-pfs-in-patients-with-advanced-epithelial-ovarian-cancer/

Merck Announces Phase 3 KEYLYNK-001 Trial Met ... The study did not reach its secondary endpoint of overall survival (OS). The role of KEYTRUDA in the intention-to-treat population remains ...

4. clinicaltrials.gov clinicaltrials.gov/study/NCT04483544

Pembrolizumab and Olaparib in Cervical Cancer Patients The study is a non-randomized, open-label phase II clinical trial to test the investigational combination of the drug pembrolizumab with the drug olaparib ...

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12359185/

Real-world outcomes after pembrolizumab treatment for ... The median OS was 47.5 months and median PFS was 9.1 months. Complete response was reached in ten patients, and there were seven patients with ...

6. merck.com merck.com/news/keytruda-pembrolizumab-plus-chemotherapy-with-or-without-bevacizumab-reduced-risk-of-disease-progression-or-death-versus-chemotherapy-with-or-without-bevacizumab-in-certain-patients-with-plati/

KEYTRUDA® (pembrolizumab) Plus Chemotherapy With ... “These results build upon the success of KEYTRUDA in gynecologic cancers ... cervical cancer. Serious adverse reactions occurred in 39% of ...