Pembrolizumab for Recurrent Ovarian Cancer

Recruiting at 2 trial locations

Age: 18+

Sex: Female

Trial Phase: Phase 2

Sponsor: Jonsson Comprehensive Cancer Center

Must not be taking: Immunosuppressants, Steroids

Disqualifiers: Immunodeficiency, Active TB, Autoimmune, 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

Breakthrough Therapy This drug has been fast-tracked for approval by the FDA given its high promise

Approved in 3 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 36

Duration: 2 years

5 Participants Needed

Trial Summary

What is the purpose of this trial?

This phase II trial studies how well pembrolizumab works in treating participants with ovarian cancer that has come back after previous treatment. Monoclonal antibodies, such as pembrolizumab, may interfere with the ability of tumor cells to grow and spread.

Research Team

Gottfried Konecny, MD

Principal Investigator

UCLA / Jonsson Comprehensive Cancer Center

Eligibility Criteria

This trial is for individuals with recurrent ovarian cancer, including peritoneal and fallopian tube cancers. Participants must have had 1-5 previous treatments, a gap of at least 3 months since the last treatment, be in good physical condition (ECOG 0 or 1), and have adequate organ function. Women of childbearing age must agree to use contraception during the study and for four months after.

Inclusion Criteria

Female subject of childbearing potential should have a negative urine or serum pregnancy within 72 hours prior to receiving the first dose of study medication. If the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required

My white blood cell count is high enough for treatment.

Have measurable disease based on Response Evaluation Criteria in Solid Tumors (RECIST) 1.1

Exclusion Criteria

I have recovered from any major surgery before starting treatment.

Has known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial

I have or had lung inflammation not caused by an infection.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive pembrolizumab intravenously on day 1, with courses repeating every 3 weeks for up to 35 courses (2 years) in the absence of disease progression or unacceptable toxicity

2 years

35 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

Up to 2 years

1 visit at 30 days, then every 9 and 12 weeks

Treatment Details

Interventions

• Pembrolizumab

Trial Overview The trial is testing Pembrolizumab, a monoclonal antibody designed to block cancer growth by interfering with tumor cells' ability to evade immune detection. It's given to participants whose ovarian cancer has returned despite prior treatments.

Participant Groups

Group I: Treatment (pembrolizumab) Experimental Treatment 1 Intervention

Participants receive pembrolizumab intravenously IV on day 1. Courses repeat every 3 weeks for up to 35 courses (2 years) in the absence of disease progression or unacceptable toxicity.

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

Approved in United States as KEYTRUDA for:

• Head and neck squamous cell carcinoma (HNSCC) with PD-L1 CPS ≥1
• Melanoma
• Non-small cell lung cancer (NSCLC)
• Urothelial carcinoma
• Colorectal cancer
• Gastric cancer
• Hepatocellular carcinoma
• Renal cell carcinoma
• Cervical cancer
• Endometrial carcinoma

Approved in European Union as KEYTRUDA for:

• Head and neck squamous cell carcinoma (HNSCC) with PD-L1 CPS ≥1
• Melanoma
• Non-small cell lung cancer (NSCLC)
• Urothelial carcinoma
• Colorectal cancer
• Gastric cancer
• Hepatocellular carcinoma
• Renal cell carcinoma
• Cervical cancer
• Endometrial carcinoma

Approved in United Kingdom as KEYTRUDA for:

• Untreated metastatic or unresectable recurrent head and neck squamous cell carcinoma (HNSCC) with PD-L1 CPS ≥1

Who Is Running the Clinical Trial?

Jonsson Comprehensive Cancer Center

Lead Sponsor

Trials

373

Recruited

35,200+

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