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

Merck Sharp & Dohme (MSD) logo

Merck Sharp & Dohme (MSD)

Status and phase

Active, not recruiting
Phase 2

Conditions

High-grade Serous Ovarian Carcinoma
Ovarian Carcinoma

Treatments

Biological: Pembrolizumab
Drug: Carboplatin
Biological: MK-4830
Drug: Paclitaxel
Drug: Docetaxel
Biological: Avastin

Study type

Interventional

Funder types

Industry

Identifiers

NCT05446870
2021-005458-27 (EudraCT Number)
2023-505005-16 (Registry Identifier)
4830-002
MK-4830-002 (Other Identifier)

Details and patient eligibility

About

The primary objective is to evaluate in participants with high-grade serous ovarian cancer (HGSOC), whether the reduction from baseline in circulating tumor DNA (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.

Enrollment

160 patients

Sex

Female

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion 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 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.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

160 participants in 2 patient groups

Pembrolizumab + Standard of Care (SOC) + MK-4830
Experimental group
Description:
Before surgery participants will receive pembrolizumab 200 mg, paclitaxel 175 mg/m^2, carboplatin Area Under the Curve (AUC) 5 to 6, (or docetaxel 75 mg/m^2), and MK-4830 800 mg by intravenous (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, carboplatin AUC 5 to 6, (or docetaxel 75 mg/m^2), MK-4830 800 mg, and avastin (or biosimilar) by IV infusion on Day 1 of each 21-day cycle (Q3W) for 3 cycles.
Treatment:
Biological: Avastin
Drug: Docetaxel
Drug: Paclitaxel
Biological: MK-4830
Drug: Carboplatin
Biological: Pembrolizumab
Pembrolizumab + SOC
Active Comparator group
Description:
Before surgery participants will receive pembrolizumab 200 mg, paclitaxel 175 mg/m^2, carboplatin AUC 5 to 6 and (or docetaxel 75 mg/m^2) 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, carboplatin AUC 5 to 6, (or docetaxel 75 mg/m^2) and avastin (or biosimilar) by IV infusion on Day 1 of each 21-day cycle (Q3W) for 3 cycles.
Treatment:
Biological: Avastin
Drug: Docetaxel
Drug: Paclitaxel
Drug: Carboplatin
Biological: Pembrolizumab

Trial contacts and locations

45

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Central trial contact

Toll Free Number

Data sourced from clinicaltrials.gov

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