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A Randomized, Phase 2 Study of Pembrolizumab And Chemotherapy With or Without MK-4830 as Neoadjuvant Treatment for High-Grade Serous Ovarian Cancer
EU CTIS ID: 2023-505005-16-00
What this study is testing
Among patients with detectable ctDNA at baseline, to evaluate whether the reduction from baseline in circulating tumor DNA at Cycle 3 (ΔctDNA) is larger in participants receiving MK-4830 + pembrolizumab in combination with standard of care (SOC) therapy than in those receiving pembrolizumab + SOC therapy.
- Therapeutic exploratory (Phase II)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Has histologically-confirmed International Federation of Gynecology and Obstetrics (FIGO) Stage III or Stage IV HGSOC, primary peritoneal cancer, or fallopian tube cancer.
- Is a candidate for carboplatin and paclitaxel chemotherapy, to be administered in the neoadjuvant and adjuvant setting.
- Is a candidate for interval debulking surgery.
- Is able to provide archival tissue or newly obtained core, incisional, or excisional biopsy of a tumor lesion.
- Has adequate organ functions.
You likely can't join if
- Has a non-HGSOC histology.
- Has known active Central Nervous System (CNS) metastases and/or carcinomatous meningitis.
- Has severe hypersensitivity to pembrolizumab, carboplatin, paclitaxel (or docetaxel, if applicable),Avastin or biosimilar (if using) and/or any of their excipients.
- Has an active autoimmune disease that has required systemic treatment in past 2 years.
- Has an active infection requiring systemic therapy.
- Has a known history of human immunodeficiency virus (HIV) infection.
See the full eligibility criteria
- Has histologically-confirmed International Federation of Gynecology and Obstetrics (FIGO) Stage III or Stage IV HGSOC, primary peritoneal cancer, or fallopian tube cancer.
- Is a candidate for carboplatin and paclitaxel chemotherapy, to be administered in the neoadjuvant and adjuvant setting.
- Is a candidate for interval debulking surgery.
- Is able to provide archival tissue or newly obtained core, incisional, or excisional biopsy of a tumor lesion.
- Has adequate organ functions.
- Has a non-HGSOC histology.
- Has known active Central Nervous System (CNS) metastases and/or carcinomatous meningitis.
- Has severe hypersensitivity to pembrolizumab, carboplatin, paclitaxel (or docetaxel, if applicable),Avastin or biosimilar (if using) and/or any of their excipients.
- Has an active autoimmune disease that has required systemic treatment in past 2 years.
- Has an active infection requiring systemic therapy.
- Has a known history of human immunodeficiency virus (HIV) infection.
- Has a known history of hepatitis B or known active hepatitis C virus infection.
- Has received colony-stimulating factors within 4 weeks prior to receiving study intervention on Day 1of Cycle 1.
- Has had surgery <6 months prior to Screening to treat borderline ovarian tumors, early-stage OC, or early-stage fallopian tube cancer.
- Has a known psychiatric or substance abuse disorder that would interfere with the participant's ability to cooperate with the requirements of the study.
- Has current, clinically relevant bowel obstruction.
- Has a history of (noninfectious) pneumonitis/interstitial lung disease that required steroids or has current pneumonitis/interstitial lung disease.
- Has a history of hemorrhage, hemoptysis, or active gastrointestinal (GI) bleeding within 6 months prior to randomization.
- Has uncontrolled hypertension.
- Has had an allogenic tissue/solid organ transplant.
- Has either had major surgery within 3 weeks of randomization or has not recovered from any effects of any major surgery.
- Has a known additional malignancy that is progressing or has required active treatment within the past 3 years.
- Has received prior treatment for any stage of OC, including radiation or systemic anticancer therapy.
- Planned or has been administered intraperitoneal chemotherapy as first-line therapy.
- Has received prior therapy with an anti-programmed cell death 1 protein (PD-1), anti-programmed cell death 1 ligand 1 (PD-L1), anti-programmed cell death 1 ligand 2 (PD-L2), anti-immunoglobulin-like transcript 4 (ILT4), or anti-human leukocyte antigen (HLA)-G agent or with an agent directed to another stimulatory or coinhibitory T-cell receptor.
- Has received a live or live-attenuated vaccine within 30 days before the first dose of study intervention.
- Is currently participating in or has participated in a study of an investigational agent or has used an investigational device within 4 weeks before the first dose of study intervention.
- Has a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy (in dosing exceeding 10 mg daily of prednisone equivalent) or any other form of immunosuppressive therapy within 7 days prior the first dose of study medication.
The study team makes the final eligibility decision.
Where it's taking place
- Canada
- Taiwan
- Chile
- Singapore
- Israel
- Korea, Republic of
- United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling female, 18-64 years, 65+ years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Canada; Taiwan; Chile; Singapore; Israel; Korea, Republic of and 1 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.