NCT05446870|CompletedPhase 2ResultsFDA Drug

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

Merck Sharp & Dohme LLC ClinicalTrials.gov

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5 other identifiers

4830-002MK-4830-0022023-505005-16-00U1111-1290-66342021-005458-27

Study Type

interventional

Target

160

Locations

11 countries

Sites

Timeline

RegisteredJul 2022

StartedJul 2022

CompletionOct 2024

Brief 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.

Trial Health

On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment

160

participants targeted

Target at P75+ for phase_2

Timeline

Completed

Started Jul 2022

Geographic Reach

11 countries

45 active sites

Status

completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

2.2 years study duration

First Submitted

Initial submission to the registry

July 1, 2022

Completed

6 days until next milestone

First Posted

Study publicly available on registry

July 7, 2022

Completed

18 days until next milestone

Study Start

First participant enrolled

July 25, 2022

Completed

1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 20, 2023

Completed

10 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 16, 2024

Completed

2 months until next milestone

Results Posted

Study results publicly available

December 17, 2024

Completed

Last Updated

October 1, 2025

Status Verified

September 1, 2025

Enrollment Period

1.4 years

First QC Date

July 1, 2022

Results QC Date

November 27, 2024

Last Update Submit

September 11, 2025

Conditions

High-grade Serous Ovarian Carcinoma Ovarian Carcinoma

Outcome Measures

Primary Outcomes (1)

Change From Baseline in Circulating Tumor Deoxyribonucleic Acid (ctDNA)
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.
Baseline and Week 7

Secondary Outcomes (8)

Participants With Surgery and Pathological Complete Response (pCR): Change From Baseline in ctDNA
Baseline and Week 12
Association of Change From Baseline in ctDNA With pCR
Baseline and Week 12
Participants With Surgery and Chemotherapy Response Score (CRS): Change From Baseline in ctDNA
Baseline and Week 12
Association of Change From Baseline in ctDNA With CRS3
Baseline and Week 12
pCR Rate
Up to approximately 12 weeks
+3 more secondary outcomes

Study Arms (2)

Pembrolizumab + Standard of Care (SOC) + MK-4830

EXPERIMENTAL

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.

Biological: PembrolizumabDrug: PaclitaxelDrug: CarboplatinBiological: AvastinBiological: MK-4830Drug: Docetaxel

Pembrolizumab + SOC

ACTIVE COMPARATOR

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.

Biological: PembrolizumabDrug: PaclitaxelDrug: CarboplatinBiological: AvastinDrug: Docetaxel