Clinical trial · Interventional
Pembrolizumab With Chemotherapy and MK-4830 for Treating Participants With Ovarian Cancer (MK-4830-002)
A Randomized, Phase 2 Study of Pembrolizumab And Chemotherapy With or Without MK-4830 as Neoadjuvant Treatment for High-Grade Serous Ovarian Cancer
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The primary objective is to evaluate in participants with high-grade serous ovarian cancer (HGSOC), whether the reduction from baseline in circulating tumor deoxyribonucleic acid (ctDNA) 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.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| High-grade Serous Ovarian Carcinoma | Ovarian Neoplasm | PROBABILISTIC | 0.70 |
| Ovarian Carcinoma | Ovarian Carcinoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (6)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Avastin | Biological | Bevacizumab | ALIAS |
| Carboplatin | Drug | Carboplatin | ALIAS |
| Docetaxel | Drug | Docetaxel | ALIAS |
| MK-4830 | Biological | — | UNRESOLVED |
| Paclitaxel | Drug | Paclitaxel | ALIAS |
| Pembrolizumab | Biological | Pembrolizumab | ALIAS |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Pembrolizumab + Standard of Care (SOC) + MK-4830
- description
- Before surgery participants will receive pembrolizumab 200 mg, paclitaxel 175 mg/m\^2 (or docetaxel 75 mg/m\^2), carboplatin Area Under the Curve (AUC) 5 to 6, and MK-4830 800 mg by intravenous (IV) infusion on Day 1 of each 21-day cycle (every 3 weeks \[Q3W\]) for 3 cycles. After surgery participants will receive pembrolizumab 200 mg, paclitaxel 175 mg/m\^2 (or docetaxel 75 mg/m\^2), carboplatin AUC 5 to 6, and MK-4830 800 mg (with avastin \[or biosimilar\] at the investigator's discretion and per insitutional guidelines) by IV infusion on Day 1 of each 21-day cycle (Q3W) for 3 cycles.
- interventionNames
- Biological: Pembrolizumab
- Drug: Paclitaxel
- Drug: Carboplatin
- Biological: Avastin
- Biological: MK-4830
- Drug: Docetaxel
- type
- ACTIVE_COMPARATOR
- label
- Pembrolizumab + SOC
- description
- Before surgery participants will receive pembrolizumab 200 mg, paclitaxel 175 mg/m\^2 (or docetaxel 75 mg/m\^2), and carboplatin AUC 5 to 6 by IV infusion on Day 1 of each 21-day cycle (Q3W) for 3 cycles. After surgery participants will receive pembrolizumab 200 mg, paclitaxel 175 mg/m\^2 (or docetaxel 75 mg/m\^2), and carboplatin AUC 5 to 6 (with avastin \[or biosimilar\] at the investigator's discretion and per insitutional guidelines) by IV infusion on Day 1 of each 21-day cycle (Q3W) for 3 cycles.
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
The main inclusion and exclusion criteria include but are not limited to the following: Inclusion 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. Exclusion Criteria: * Has a non-HGSOC histology. * Has a history of (noninfectious) pneumonitis/interstitial lung disease that required steroids or has current pneumonitis/interstitial lung disease. * 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 ovarian cancer (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. * 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 1 of 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 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.
References
Publications (0)
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