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

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ClinicalTrials.gov Identifier: NCT05446870
Recruitment Status : Recruiting
First Posted : July 7, 2022
Last Update Posted : March 6, 2023
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme LLC

Study Description
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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 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.

Condition or disease Intervention/treatment Phase
High-grade Serous Ovarian Carcinoma Ovarian Carcinoma Biological: Pembrolizumab Drug: Paclitaxel Drug: Carboplatin Biological: Avastin Biological: MK-4830 Drug: Docetaxel Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 160 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Randomized, Phase 2 Study of Pembrolizumab And Chemotherapy With or Without MK-4830 as Neoadjuvant Treatment for High-Grade Serous Ovarian Cancer
Actual Study Start Date : July 25, 2022
Estimated Primary Completion Date : October 14, 2024
Estimated Study Completion Date : June 13, 2025

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Ovarian Cancer

Arms and Interventions
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Arm Intervention/treatment
Experimental: Pembrolizumab + Standard of Care (SOC) + MK-4830
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.
 Biological: Pembrolizumab
200 mg by IV infusion on Day 1 of each 21-day cycle
Other Names:
  • MK-3475
  • KEYTRUDA®

Drug: Paclitaxel
175 mg/m^2 by IV infusion on Day 1 of each 21-day cycle
Other Name: TAXOL®

Drug: Carboplatin
AUC 5 to 6 by IV infusion on Day 1 of each 21-day cycle
Other Name: PARAPLATIN®

Biological: Avastin
According to local practice and at the choice of the investigator.
Other Names:
  • Bevacizumab
  • Zirabev
  • MVASI
  • AYBINTIO
  • Versavo
  • Onbevezy
  • OYAVAS
  • ALYMSYS
  • Avegra

Biological: MK-4830
800 mg by IV infusion on Day 1 of each 21-day cycle

Drug: Docetaxel
75 mg/m^2 by IV infusion on Day 1 of each 21-day cycle
Active Comparator: Pembrolizumab + SOC
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.
 Biological: Pembrolizumab
200 mg by IV infusion on Day 1 of each 21-day cycle
Other Names:
  • MK-3475
  • KEYTRUDA®

Drug: Paclitaxel
175 mg/m^2 by IV infusion on Day 1 of each 21-day cycle
Other Name: TAXOL®

Drug: Carboplatin
AUC 5 to 6 by IV infusion on Day 1 of each 21-day cycle
Other Name: PARAPLATIN®

Biological: Avastin
According to local practice and at the choice of the investigator.
Other Names:
  • Bevacizumab
  • Zirabev
  • MVASI
  • AYBINTIO
  • Versavo
  • Onbevezy
  • OYAVAS
  • ALYMSYS
  • Avegra

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


Outcome Measures
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Primary Outcome Measures :
  1. Change from Baseline in Circulating Tumor Deoxyribonucleic Acid (ctDNA) [ Time Frame: Baseline and Week 7 ]
    Change from baseline in circulating tumor deoxyribonucleic acid (ctDNA).


Secondary Outcome Measures :
  1. Change from Baseline in Neoadjuvant ctDNA [ Time Frame: Baseline and Week 7 ]
    Change from baseline in neoadjuvant ctDNA.

  2. Pathological Complete Response (pCR) Rate [ Time Frame: Up to approximately 12 weeks ]
    Percentage of participants with all surgical specimens collected during the interval debulking surgery that are microscopically negative for residual tumor by logistic regression modeling of pathological Complete Response (pCR).

  3. Chemotherapy Response Score (CRS) [ Time Frame: Up to approximately 12 Weeks ]
    Percentage of participants with residual disease assessed by logistic regression modeling of chemotherapy response score (CRS). CRS is a 3-tiered scoring system (CRS 1-3) based on the pathological analysis of surgically removed omental masses, with 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. A binary response of CRS3 (no residual disease) vs. non-CRS3 (residual disease) will be assessed.

  4. Number of Participants Who Experienced an Adverse Event (AE) [ Time Frame: Up to approximately 40 Weeks ]
    An AE was any untoward medical occurrence in a participant administered study drug, which does not necessarily have to have a causal relationship with the study drug.

  5. Number of Participants Who Discontinued Study Treatment Due to an AE [ Time Frame: Up to approximately 28 Weeks ]
    An AE was any untoward medical occurrence in a participant administered study drug which does not necessarily have to have a causal relationship with the study drug.


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Gender Eligibility Description:   Females with advanced HGSOC, fallopian tube cancer, or primary peritoneal cancer.
Accepts Healthy Volunteers:   No
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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05446870


Contacts
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Contact: Toll Free Number 1-888-577-8839 Trialsites@merck.com

Locations
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Sponsors and Collaborators
Merck Sharp & Dohme LLC
Investigators
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Study Director: Medical Director Merck Sharp & Dohme LLC
More Information
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Additional Information:

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Responsible Party: Merck Sharp & Dohme LLC
ClinicalTrials.gov Identifier: NCT05446870    
Other Study ID Numbers: 4830-002
MK-4830-002 ( Other Identifier: Merck )
2021-005458-27 ( EudraCT Number )
First Posted: July 7, 2022    Key Record Dates
Last Update Posted: March 6, 2023
Last Verified: March 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: http://engagezone.msd.com/doc/ProcedureAccessClinicalTrialData.pdf
URL: http://engagezone.msd.com/ds_documentation.php

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Carcinoma
Ovarian Neoplasms
Carcinoma, Ovarian Epithelial
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Endocrine Gland Neoplasms
Neoplasms by Site
Ovarian Diseases
Adnexal Diseases
Genital Neoplasms, Female
Urogenital Neoplasms
Endocrine System Diseases
Gonadal Disorders
Paclitaxel
 Docetaxel
Bevacizumab
Carboplatin
Pembrolizumab
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents, Immunological
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Physiological Effects of Drugs