Pembrolizumab for Recurrent Ovarian Cancer

Not currently 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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests the effectiveness of pembrolizumab, a monoclonal antibody, in treating ovarian cancer that has recurred after previous treatment. Pembrolizumab may help prevent cancer cells from growing and spreading. This trial may suit individuals whose ovarian cancer has returned after at least one treatment and who have had a treatment break of at least three months. Participants will receive pembrolizumab every three weeks for up to two years, provided the treatment remains effective and does not cause severe side effects. As a Phase 2 trial, the research focuses on assessing the treatment's effectiveness in an initial, smaller group of people.

Do I have to stop taking my current medications for the trial?

The trial does not specify if you need to stop taking your current medications. However, you cannot be on systemic steroid therapy or any form of immunosuppressive therapy within 7 days before starting the trial treatment. It's best to discuss your specific medications with the trial team.

Is there any evidence suggesting that pembrolizumab is likely to be safe for humans?

Research shows that pembrolizumab is generally well-tolerated by patients. Studies have found that while it can cause some side effects, these are often manageable. For instance, in patients with various solid tumors, pembrolizumab has been linked to a high overall survival rate, suggesting it is relatively safe for humans.

In a study on recurrent ovarian cancer, about 8% of patients experienced a reduction in their cancer with pembrolizumab. Although side effects can occur, they are usually mild, such as tiredness and nausea. Notably, patients with higher levels of a protein called PD-L1 tended to respond better, which might mean fewer side effects for some.

Overall, pembrolizumab has been safely used in many cancer treatments, and its safety in ovarian cancer appears similar to its use in other cancers. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Pembrolizumab is unique because it harnesses the power of the immune system to fight recurrent ovarian cancer. Unlike traditional chemotherapy, which directly attacks cancer cells, pembrolizumab is an immunotherapy that works by blocking the PD-1 pathway. This allows the body's immune system to recognize and destroy cancer cells more effectively. Researchers are excited about pembrolizumab because it offers a new way to treat ovarian cancer, potentially leading to longer-lasting responses and fewer side effects compared to conventional treatments.

What evidence suggests that pembrolizumab might be an effective treatment for recurrent ovarian cancer?

Research has shown that pembrolizumab may help treat various solid tumors, including ovarian cancer. In earlier studies, it effectively shrank or eliminated cancer and helped patients live longer. One study found that when combined with other treatments, pembrolizumab led to tumor shrinkage in about 21% of patients. For those with advanced cancer, using pembrolizumab alone resulted in a 25% response rate, with a quarter of patients experiencing tumor shrinkage and living nearly 15 months on average. This trial will evaluate pembrolizumab alone for recurrent ovarian cancer. These findings suggest that pembrolizumab can slow the growth of recurring ovarian cancer and may help extend patients' lives. ^{1 2 3 5 6}

Who Is on the Research Team?

Gottfried Konecny, MD

Principal Investigator

UCLA / Jonsson Comprehensive Cancer Center

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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

Citations

1. 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 ... The 12-month OS rate for patients receiving the KEYTRUDA regimen was 69.1% versus 59.3% for patients receiving the placebo regimen. Eighteen- ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12521426/

Efficacy and safety of pembrolizumab for the treatment of ... Pembrolizumab has demonstrated high objective remission and overall survival rates in a variety of solid tumors, and clinical trials are now ...

3. clinicaltrials.gov clinicaltrials.gov/study/NCT02674061

Efficacy and Safety Study of Pembrolizumab (MK-3475) in ... This study will assess the efficacy and safety of pembrolizumab (MK-3475) monotherapy in female participants with recurrent ovarian cancer (ROC)

4. sciencedirect.com sciencedirect.com/science/article/pii/S2352578925001183

Efficacy of pembrolizumab in combination with ... The combination of pembrolizumab, bevacizumab, and oral metronomic cyclophosphamide was well tolerated and demonstrated a 21.1 percent response rate.

5. jamanetwork.com jamanetwork.com/journals/jamaoncology/fullarticle/2829929

Pembrolizumab in Patients With Advanced Clear Cell ... The overall response rate was 25%, the median duration of response 13.1 months, the median overall survival was 14.8 months, and the safety ...

6. annalsofoncology.org annalsofoncology.org/article/S0923-7534(19)31241-4/fulltext

Antitumor activity and safety of pembrolizumab in patients ... The objective response rate of single-agent pembrolizumab was ∼8% in patients with recurrent ovarian cancer. Higher PD-L1 expression was correlated with higher ...