Active not recruitingPHASE3INTERVENTIONAL

Pembrolizumab/Placebo Plus Paclitaxel With or Without Bevacizumab for Platinum-resistant Recurrent Ovarian Cancer (MK-3475-B96/KEYNOTE-B96/ENGOT-ov65).

This study is for women with ovarian cancer that has returned and is no longer responding well to platinum-based chemotherapy. Researchers are testing a new treatment combination involving pembrolizumab, along with paclitaxel and possibly bevacizumab. The main goal is to see if this new combination can keep the cancer from growing for a longer time compared to current treatments. They are especially interested in whether pembrolizumab works better for certain types of tumours. This is a Phase 3 trial, meaning it's a key step in testing how effective and safe this new treatment is for a larger group of patients before it can become widely available. Doctors refer to this as a study for "platinum-resistant recurrent ovarian cancer".

At a glance

Status

Active not recruiting

Phase

PHASE3

Sponsor

Merck Sharp & Dohme LLC

Enrolment target

643

Start

13 Dec 2021

Estimated completion

16 Jul 2027

Ovarian Cancer Carcinoma, Ovarian Epithelial Fallopian Tube Neoplasms

Results

Results from this study

Posted March 2026

Results have been published for this study.

Primary outcome

Progression-Free Survival (PFS) Per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) as Assessed by the Investigator in Participants With Programmed Cell Death-Ligand 1 (PD-L1) Positive Tumors (Combined Positive Score [CPS] ≥1)

PFS was defined as the time from randomization to the first documented progressive disease (PD) per RECIST 1.1 based on Investigator assessment or death due to any cause, whichever occurs first. Per RECIST 1.1, PD was defined as ≥20% increase in the sum of diameters of target lesions. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of ≥5 mm. Per protocol, RECIST 1.1 was modified to allow up to 10 target lesions total (up to 5 per organ). The appearance of one or more lesions and the unequivocal progression of non-target lesions was also considered PD. Per protocol, PFS per RECIST 1.1 as assessed by the Investigator in participants with PD-L1 CPS ≥1 is reported here. PFS was calculated using the product-limit (Kaplan-Meier) method for censored data.

Full results on the registry

What is this study about?

This research study is looking for better ways to treat ovarian cancer that has come back after earlier treatment and isn't responding well to platinum-based chemotherapy anymore. It's called "platinum-resistant recurrent ovarian cancer". The study is comparing a new treatment plan to current standard care.

The new treatment plan includes a drug called pembrolizumab, which helps your own immune system fight cancer. This is given alongside paclitaxel, a common chemotherapy drug, and sometimes bevacizumab, another drug that can slow down cancer growth. The main aim is to see if adding pembrolizumab can stop the cancer from getting worse for a longer period of time. Researchers will compare patients who receive pembrolizumab with those who receive a placebo (a dummy drug with no active ingredients).

This kind of study is really important because it helps doctors understand if new combinations of medicines are more effective, and safer, than what's currently available. It’s a Phase 3 study, which means it’s one of the final steps before a new treatment might be approved for wider use. By taking part, you could contribute to finding new and improved treatments for ovarian cancer.

Key takeaways

This study is for advanced ovarian cancer that has returned.
It tests a new drug, pembrolizumab, alongside existing treatments.
The main goal is to find out if the new combination stops cancer growth for longer.
This is a Phase 3 study, a key step before potential wider use.
Participation involves regular hospital visits for treatment and monitoring.

Who may be eligible?

This study is for women with ovarian, fallopian tube, or a type of abdominal cancer called primary peritoneal carcinoma. You must have been treated for ovarian cancer once or twice before, and at least one of those treatments must have been with a platinum-based chemotherapy.

Crucially, your cancer must have started growing again within six months of your last platinum-based chemotherapy. You need to be well enough to receive paclitaxel chemotherapy (and bevacizumab, if used in your treatment group), and your general health and organ function must be good. Importantly, you cannot be pregnant or breastfeeding.

There are also reasons you might not be able to join. For example, if you have certain rare types of ovarian cancer, if your cancer didn't respond to platinum-based treatment in the very first place, or if your cancer has already spread to your brain and is causing symptoms.

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.

Have I been diagnosed with ovarian, fallopian tube, or primary peritoneal cancer?
Has my cancer returned despite previous platinum-based chemotherapy?
Am I well enough to receive chemotherapy (like paclitaxel)?
Am I not pregnant or breastfeeding?
Do I have a tumor sample available or am I able to provide one?

Answer every question to see your result.

What does participation involve?

If you decide to take part, you'll be randomly assigned to one of several treatment groups. This is like flipping a coin to ensure a fair comparison. You might receive the new drug combination with pembrolizumab or the standard treatment which includes paclitaxel, with or without bevacizumab, and a placebo instead of pembrolizumab.

Your treatment will be given on a regular schedule, typically through an IV (a drip into your arm), and you'll have regular hospital visits for these treatments, check-ups, blood tests, and scans. These tests will help doctors monitor how well the treatment is working and check for any side effects. The total length of your participation can vary, but it will involve ongoing treatment and follow-up appointments. You'll be given a detailed schedule by the study team.

Potential risks and benefits

Potential benefits of joining this trial include receiving a new, potentially more effective treatment for your cancer and contributing to medical research that could help others in the future. However, there's no guarantee the treatment will work for you, and like all medicines, the study drugs can have side effects. These could range from mild to serious, and the study team will explain all known risks to you. You are free to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (187)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

HonorHealth ( Site 0041)
Verified postcode
Phoenix, United States
Marin Cancer Care ( Site 0055)
Verified postcode
Greenbrae, United States
Pacific Cancer Care ( Site 0028)
Verified postcode
Monterey, United States
Eisenhower Medical Center ( Site 0067)
Verified postcode
Rancho Mirage, United States
Yale-New Haven Hospital-Smilow Cancer Hospital at Yale-New Haven ( Site 0004)
Verified postcode
New Haven, United States
University of Florida College of Medicine-UF Health Cancer Center/Clinical Trials Office ( Site 0054
Verified postcode
Gainesville, United States
Sarasota Memorial Hospital ( Site 0018)
Verified postcode
Sarasota, United States
Moffitt Cancer Center ( Site 0033)
Verified postcode
Tampa, United States
Northwest Georgia Oncology Centers, a Service of Wellstar Cobb Hospital-Research ( Site 0005)
Verified postcode
Marietta, United States
Advocate Medical Group-Oncology ( Site 0049)
Verified postcode
Park Ridge, United States
Parkview Research Center at Parkview Regional Medical Center ( Site 0027)
Verified postcode
Fort Wayne, United States
St. Vincent Hospital and Health Care Center, Inc ( Site 0032)
Verified postcode
Indianapolis, United States

Common questions

What is a 'placebo'?

A placebo is a dummy medicine that looks like the real drug but contains no active ingredients. It helps researchers fairly compare the new treatment against a non-active substitute.

What does 'platinum-resistant' mean?

It means your ovarian cancer has started growing again fairly soon after you finished a chemotherapy that included a 'platinum' drug, like carboplatin, showing it's no longer responding well to that type of treatment.

Will I know if I'm getting the new drug?

No, in this type of study, patients usually don't know whether they are receiving the investigational drug or the placebo. This helps ensure the study results are unbiased.

How long will I be in the study?

The duration of your participation will depend on how you respond to treatment and other factors. It typically involves regular treatment cycles and follow-up visits over an extended period, which the study team will explain.

Can I stop participating in the study?

Yes, you can choose to leave the study at any time without giving a reason, and it will not affect your future medical care.