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Efficacy and Safety Study of Pembrolizumab (MK-3475) in Women With Advanced Recurrent Ovarian Cancer (MK-3475-100/KEYNOTE-100)

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ClinicalTrials.gov Identifier: NCT02674061
Recruitment Status : Active, not recruiting
First Posted : February 4, 2016
Last Update Posted : November 20, 2017
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.

Brief Summary:
This study will assess the efficacy and safety of pembrolizumab (MK-3475) in women with advanced ovarian cancer who have demonstrated recurrent disease following the front line platinum-based treatment and debulking surgery and received up to 5 lines of treatment for recurrent ovarian cancer (ROC) per local standard of care. Participants will receive pembrolizumab every 3 weeks (Q3W) for up to 2 years.

Condition or disease Intervention/treatment Phase
Ovarian Neoplasms Biological: pembrolizumab Phase 2

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 325 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase II, Open-label, Single-arm, Multicenter Study to Evaluate Efficacy and Safety of Pembrolizumab Monotherapy in Subjects With Advanced Recurrent Ovarian Cancer (KEYNOTE-100)
Actual Study Start Date : February 25, 2016
Estimated Primary Completion Date : September 18, 2019
Estimated Study Completion Date : September 18, 2019


Arm Intervention/treatment
Experimental: Cohort A: Pembrolizumab
Participants who have received 0 to 2 prior lines for treating ROC (or 1-3 total prior lines counting the front line) will receive pembrolizumab 200 mg intravenously (IV) on Day 1 of each 3-week cycle for up to approximately 2 years.
Biological: pembrolizumab
IV infusion
Other Names:
  • MK-3475
  • KEYTRUDA®

Experimental: Cohort B: Pembrolizumab
Participants who have received 3 to 5 prior lines for treating ROC (or 4-6 total prior lines counting the front line) will receive pembrolizumab 200 mg IV on Day 1 of each 3-week cycle for up to approximately 2 years.
Biological: pembrolizumab
IV infusion
Other Names:
  • MK-3475
  • KEYTRUDA®




Primary Outcome Measures :
  1. Overall Response Rate [ Time Frame: Up to 2 years ]

Secondary Outcome Measures :
  1. Disease Control Rate [ Time Frame: Up to 2 years ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Has histologically confirmed epithelial ovarian cancer, fallopian tube cancer or primary peritoneal cancer
  • Has received a front line platinum-based regimen (administered via either intravenous or intraperitoneal route) per local standard of care or treatment guideline following the primary or interval debulking surgery with documented disease recurrence (note: Maintenance treatment following the front line treatment is permitted and counted together as part of the front line treatment)
  • Has fulfilled the following additional requirements regarding prior treatments for recurrent ovarian cancer (ROC) depending on the cohort participant is to be enrolled. Each participant must have documented evidence of clinical response or disease stabilization to the last regimen received.

    • Cohort A: Has received 0 to 2 additional prior lines for treating ROC (or 1-3 total prior lines counting the front line) and must have a platinum-free interval (PFI) of ≥ 3 to 12 months if the last regimen received is a platinum-based, or a treatment-free interval (TFI) of ≥ 3 to 12 months if the last regimen received is a non-platinum-based
    • Cohort B: Has received 3 to 5 additional prior lines for treating ROC (or 4-6 total prior lines counting the front line) and must have a PFI of ≥ 3 months if the last regimen received is a platinum-based, or a TFI of ≥ 3 months if the last regimen received is a non-platinum-based
  • Has measurable disease at baseline based on Response Evaluation Criteria is Solid Tumors (RECIST) 1.1 as determined by the central imaging vendor
  • Has an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
  • Has a life expectancy of ≥16 weeks
  • Has provided a tumor tissue sample either collected from prior cytoreductive surgery or fresh newly obtained tumor tissue at screening
  • Has adequate organ function
  • Female participants of childbearing potential must be willing to use an adequate method of contraception for the course of the study through 120 days after the last dose of study drug

Exclusion Criteria:

  • Is currently participating in or has participated in a clinical study and received an investigational agent or used an investigational device within 4 weeks prior to the first dose of study treatment
  • Has an active autoimmune disease that has required systemic treatment in the past 2 years (i.e., use of disease modifying agents, corticosteroids or immunosuppressive drugs). Replacement therapy (e.g., thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency, etc.) is not considered a form of systemic treatment
  • Has a diagnosis of immunodeficiency or is receiving systemic steroid therapy or any other form of immunosuppressive therapy within 7 days prior to the planned first dose of the study
  • Has had prior anti-cancer monoclonal antibody (mAb), chemotherapy, targeted small molecule therapy, or radiation therapy within 4 weeks prior to the planned first dose of the study
  • Has not recovered from adverse events to ≤ Grade 1 or prior treatment level due to a previously administered agent
  • Has epithelial ovarian cancer (EOC) with mucinous histology subtype
  • Has a known additional malignancy that progressed or required active treatment within the last 5 years. Exceptions include basal cell carcinoma of the skin, squamous cell carcinoma of the skin that has undergone potentially curative therapy or in situ cervical cancer.
  • Has known active central nervous system (CNS) metastases and/or carcinomatous meningitis. Participants with previously treated brain metastases may participate provided they have stable brain metastases
  • Has known history of, or any evidence of active, non-infectious pneumonitis
  • Has an active infection requiring systemic therapy
  • Has symptoms of bowel obstruction in the past 3 months
  • Has known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the study
  • Is pregnant or breastfeeding, or expecting to conceive children within the projected duration of the study, starting with the screening visit through 120 days after the last dose of study drug
  • Has received prior therapy with an anti-programmed cell death (PD)-1, anti-PD-ligand-1 (anti-PD-L1), anti-PD-L2 agent or with an agent directed to another co-inhibitory T-cell receptor (e.g. cytotoxic T-lymphocyte-associated antigen-4 [CTLA-4], tumor necrosis factor receptors OX-40 or CD137) or has participated in prior pembrolizumab (MK-3475) studies
  • Has a known history of Human Immunodeficiency Virus (HIV)
  • Has known active Hepatitis B or Hepatitis C
  • Has received a live vaccine within 30 days of the planned first dose of the study

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): NCT02674061


Sponsors and Collaborators
Merck Sharp & Dohme Corp.
Investigators
Study Director: Medical Director Merck Sharp & Dohme Corp.

Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT02674061     History of Changes
Other Study ID Numbers: 3475-100
2015-003338-29 ( EudraCT Number )
163237 ( Registry Identifier: JAPIC-CTI )
First Posted: February 4, 2016    Key Record Dates
Last Update Posted: November 20, 2017
Last Verified: November 2017

Keywords provided by Merck Sharp & Dohme Corp.:
PD1
PD-1
PDL1
PD-L1

Additional relevant MeSH terms:
Ovarian Neoplasms
Endocrine Gland Neoplasms
Neoplasms by Site
Neoplasms
Ovarian Diseases
Adnexal Diseases
Genital Diseases, Female
Genital Neoplasms, Female
Urogenital Neoplasms
Endocrine System Diseases
Gonadal Disorders
Pembrolizumab
Antineoplastic Agents