Phase 2
N=160
Pembrolizumab With Chemotherapy and MK-4830 for Treating Participants With Ovarian Cancer (MK-4830-002)
High-grade Serous Ovarian Carcinoma · Ovarian Carcinoma
Bottom Line
View on ClinicalTrials.gov: NCT05446870 ↗Enrolled (actual)
160
Serious AEs
38.4%
Results posted
Dec 2024
Primary outcome: Primary: Change From Baseline in Circulating Tumor Deoxyribonucleic Acid (ctDNA) — 0.08; 0.04 Fold change
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Pembrolizumab (Biological); Paclitaxel (Drug); Carboplatin (Drug); Avastin (Biological); MK-4830 (Biological); Docetaxel (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- Female
- Sponsor
- Merck Sharp & Dohme LLC
- Primary completion
- Dec 2023
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline in Circulating Tumor Deoxyribonucleic Acid (ctDNA) |
0.08; 0.04 | — |
| SECONDARY Participants With Surgery and Pathological Complete Response (pCR): Change From Baseline in ctDNA |
0.05; 0.04 | — |
| SECONDARY Association of Change From Baseline in ctDNA With pCR |
12.8; 11.3 | — |
| SECONDARY Participants With Surgery and Chemotherapy Response Score (CRS): Change From Baseline in ctDNA |
0.09; 0.04 | — |
| SECONDARY Association of Change From Baseline in ctDNA With CRS3 |
45.7; 23.1 | — |
| SECONDARY pCR Rate |
10.3; 9.2 | — |
| SECONDARY CRS3 Rate |
43.6; 23.0 | — |
| SECONDARY Number of Participants Who Experienced an Adverse Event (AE) |
77; 80 | — |
| SECONDARY Number of Participants Who Discontinued Study Intervention Due to an AE |
13; 15 | — |
Summary
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.
Eligibility Criteria
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.
Data sourced from ClinicalTrials.gov (NCT05446870). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.