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Completed

NCT Number: NCT05446870

Pembrolizumab With Chemotherapy and MK-4830 for Treating Participants With Ovarian Cancer (MK-4830-002)

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.

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Key information

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Phase 2

Primary location

Antwerp University Hospital-Oncology ( Site 1301), Edegem, Antwerpen, Belgium

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Pembrolizumab

Biological

200 mg by IV infusion on Day 1 of each 21-day cycle

Other names: MK-3475, KEYTRUDA®

paclitaxel

Drug

175 mg/m^2 by IV infusion on Day 1 of each 21-day cycle

Other names: TAXOL®

carboplatin

Drug

AUC 5 to 6 by IV infusion on Day 1 of each 21-day cycle

Other names: PARAPLATIN®

Avastin

Biological

According to local practice and at the choice of the investigator.

Other names: Bevacizumab, Zirabev, MVASI, AYBINTIO, Versavo, Onbevezy, OYAVAS, ALYMSYS, Avegra

MK-4830

Biological

800 mg by IV infusion on Day 1 of each 21-day cycle

docetaxel

Drug

75 mg/m^2 by IV infusion on Day 1 of each 21-day cycle

Primary outcomes

  1. Change From Baseline in Circulating Tumor Deoxyribonucleic Acid (ctDNA)

    Time frame: Baseline and Week 7

    Blood samples were collected to determine levels of ctDNA. The fold change in the mean mutant/tumor molecules per mL (MTM/mL) at Cycle 3 from baseline is presented.

Secondary outcomes

  1. Participants With Surgery and Pathological Complete Response (pCR): Change From Baseline in ctDNA

    Time frame: Baseline and Week 12

    Blood samples were collected to determine levels of ctDNA. pCR was defined as all surgical specimens collected during the interval debulking surgery microscopically negative for residual tumor. Per protocol, change from baseline in ctDNA in participants with surgery and pCR was reported.

  2. Association of Change From Baseline in ctDNA With pCR

    Time frame: Baseline and Week 12

    Blood samples were collected to determine levels of ctDNA. pCR was defined as all surgical specimens collected during the interval debulking surgery microscopically negative for residual tumor. pCR rate was defined as percentage of participants with pCR. Per protocol, the association of change from baseline in ctDNA with pCR in participants with surgery and pCR was reported.

  3. Participants With Surgery and Chemotherapy Response Score (CRS): Change From Baseline in ctDNA

    Time frame: Baseline and Week 12

    Blood samples were collected to determine levels of ctDNA. CRS is a 3-tiered scoring system (CRS1-3) based on the pathological analysis of surgically removed omental masses. CRS was defined as CRS1 (minimal or no tumor response, mainly viable tumor), CRS2 (appreciable tumor response amidst viable tumor that is readily identifiable and regularly distributed), and CRS3 (complete or near-complete response, characterized by the lack of residual tumor cells in the omentum or presence of tumor foci up to 2 mm maximum size); higher values indicate greater response. Per protocol, change from baseline in ctDNA in participants with surgery and CRS was reported.

  4. Association of Change From Baseline in ctDNA With CRS3

    Time frame: Baseline and Week 12

    Blood samples were collected to determine levels of ctDNA. CRS is a 3-tiered scoring system (CRS1-3) based on the pathological analysis of surgically removed omental masses. CRS was defined as CRS1 (minimal or no tumor response, mainly viable tumor), CRS2 (appreciable tumor response amidst viable tumor that is readily identifiable and regularly distributed), and CRS3 (complete or near-complete response, characterized by the lack of residual tumor cells in the omentum or presence of tumor foci up to 2 mm maximum size); higher values indicate greater response. CRS3 rate was defined as percentage of participants with CRS3. Per protocol, the association of change from baseline in ctDNA with CRS3 in participants with surgery and CRS was reported.

  5. pCR Rate

    Time frame: Up to approximately 12 weeks

    pCR rate was defined as the percentage of participants with all surgical specimens collected during the interval debulking surgery that were microscopically negative for residual tumor. The pCR rate as assessed by local pathologist was reported.

  6. CRS3 Rate

    Time frame: Up to approximately 12 weeks

    CRS is a 3-tiered scoring system (CRS1-3) based on the pathological analysis of surgically removed omental masses. CRS was defined as CRS1 (minimal or no tumor response, mainly viable tumor), CRS2 (appreciable tumor response amidst viable tumor that is readily identifiable and regularly distributed), and CRS3 (complete or near-complete response, characterized by the lack of residual tumor cells in the omentum or presence of tumor foci up to 2 mm maximum size); higher values indicate greater response. CRS3 rate was defined as percentage of participants with CRS3. Per protocol, CRS3 rate as assessed by local pathologist was reported.

  7. Number of Participants Who Experienced an Adverse Event (AE)

    Time frame: Up to approximately 26 months

    An AE was any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. An AE could have been any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated). The number of participants who experienced one or more AEs was reported.

  8. Number of Participants Who Discontinued Study Intervention Due to an AE

    Time frame: Up to approximately 28 weeks

    An AE was any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. An AE could have been any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated). The number of participants who discontinued study intervention due to an AE was reported.

Sponsors and collaborators

Lead sponsor

Merck Sharp & Dohme LLC

Industry

Registry information

Official study title

A Randomized, Phase 2 Study of Pembrolizumab And Chemotherapy With or Without MK-4830 as Neoadjuvant Treatment for High-Grade Serous Ovarian Cancer

Important dates

Study start
2022
Primary completion
2023
Study completion
2024
First posted
Jul 7, 2022
Registry last updated
Oct 1, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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