Pembrolizumab + Olaparib for Cervical Cancer

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

8 Participants Needed

Trial Summary

What is the purpose of this trial?

This trial is testing a combination of two drugs, pembrolizumab and olaparib, in patients with advanced or recurrent cervical cancer who have already had chemotherapy. Pembrolizumab helps the immune system fight the cancer, while olaparib stops cancer cells from repairing themselves. Olaparib has been approved for use in various cancers, including ovarian and breast cancer. The goal is to find a more effective treatment for these patients.

Research Team

John Diaz, MD

Principal Investigator

Miami Cancer Institute at Baptist Health Inc.

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+