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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.

Register:	ClinicalTrials.gov
Last refreshed on:	12 December 2020
Main ID:	NCT02674061
Date of registration:	02/02/2016
Prospective Registration:	Yes
Primary sponsor:	Merck Sharp & Dohme Corp.
Public title:	Efficacy and Safety Study of Pembrolizumab (MK-3475) in Participants With Advanced Recurrent Ovarian Cancer (MK-3475-100/KEYNOTE-100)
Scientific 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)
Date of first enrolment:	February 25, 2016
Target sample size:	376
Recruitment status:	Active, not recruiting
URL:	https://clinicaltrials.gov/show/NCT02674061
Study type:	Interventional
Study design:	Allocation: Non-Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: None (Open Label).
Phase:	Phase 2

Countries of recruitment
Australia	Belgium	Canada	Finland	France	Germany	Israel	Italy
Jamaica	Japan	Lithuania	Netherlands	Norway	Poland	Russian Federation	South Africa
Spain	Sweden	United Kingdom	United States

Contacts

Name:	Medical Director
Address:
Telephone:
Email:
Affiliation:	Merck Sharp & Dohme Corp.

Key inclusion & exclusion 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 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 in 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 AEs 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-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

Age minimum: 18 Years
Age maximum: N/A
Gender: Female

Health Condition(s) or Problem(s) studied

Ovarian Neoplasms

Intervention(s)

Biological: Pembrolizumab

Primary Outcome(s)

ORR Per RECIST 1.1 by BICR in Subgroup of Cohort A and Cohort B Participants With PD-L1 CPS =1 [Time Frame: Up to ~43 months (through database cut-off date of 18-September-2019)]

Objective Response Rate (ORR) Per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) by Blinded Independent Central Review (BICR) in All Cohort A and Cohort B Participants [Time Frame: Up to ~43 months (through database cut-off date of 18-September-2019)]

ORR Per RECIST 1.1 by BICR in Subgroup of Cohort A and Cohort B Participants With Programmed Cell Death Ligand -1 (PD-L1) Combined Positive Score (CPS) =10 [Time Frame: Up to ~43 months (through database cut-off date of 18-September-2019)]

Secondary Outcome(s)

DCR Per RECIST 1.1 by BICR in Subgroup of Cohort A and Cohort B Participants With PD-L1 CPS =10 [Time Frame: Up to ~43 months (through database cut-off date of 18-September-2019)]

DCR Per RECIST 1.1 by BICR in Subgroup of Cohort A Participants With PFI/TFI =3-6 Months [Time Frame: Up to ~43 months (through database cut-off date of 18-September-2019)]

OS in Subgroup of Cohort A and Cohort B Participants With PD-L1 CPS =10 [Time Frame: Up to ~43 months (through database cut-off date of 18-September-2019)]

Percentage of Participants With OS (OS Rate) at Month 18 in Subgroup of Cohort A and Cohort B Participants With PD-L1 CPS =1 [Time Frame: Month 18]

Percentage of Participants With OS (OS Rate) at Month 18 in Subgroup of Cohort A Participants With PFI/TFI =3-6 Months [Time Frame: Month 18]

Percentage of Participants With OS (OS Rate) at Month 18 in Subgroup of Cohort A Participants With PFI/TFI >6-12 Months [Time Frame: Month 18]

DCR Per RECIST 1.1 by BICR in Subgroup of Cohort A Participants With PFI/TFI >6-12 Months [Time Frame: Up to ~43 months (through database cut-off date of 18-September-2019)]

Percentage of Participants With PFS (PFS Rate) at Month 12 Per RECIST 1.1 by Investigator in Subgroup of Cohort A Participants With PFI/TFI >6-12 Months [Time Frame: Month 12]

DCR Per RECIST 1.1 by Investigator in Subgroup of Cohort A Participants With PFI/TFI =3-6 Months [Time Frame: Up to ~43 months (through database cut-off date of 18-September-2019)]

Percentage of Participants With PFS (PFS Rate) at Month 6 Per RECIST 1.1 by BICR in Subgroup of Cohort A Participants With PFI/TFI =3-6 Months [Time Frame: Month 6]

Disease Control Rate (DCR) Per RECIST 1.1 by BICR in All Cohort A and Cohort B Participants [Time Frame: Up to ~43 months (through database cut-off date of 18-September-2019)]

DCR Per RECIST 1.1 by Investigator in Subgroup of Cohort A and Cohort B Participants With PD-L1 CPS =10 [Time Frame: Up to ~43 months (through database cut-off date of 18-September-2019)]

DOR Per RECIST 1.1 by Investigator in All Cohort A and Cohort B Participants [Time Frame: Up to ~43 months (through database cut-off date of 18-September-2019)]

DOR Per RECIST 1.1 by BICR in Subgroup of Cohort A and Cohort B Participants With PD-L1 CPS =1 [Time Frame: Up to ~43 months (through database cut-off date of 18-September-2019)]

DOR Per RECIST 1.1 by BICR in Subgroup of Cohort A Participants With PFI/TFI =3-6 Months [Time Frame: Up to ~43 months (through database cut-off date of 18-September-2019)]

DCR Per RECIST 1.1 by BICR in Subgroup of Cohort A and Cohort B Participants With PD-L1 CPS =1 [Time Frame: Up to ~43 months (through database cut-off date of 18-September-2019)]

DOR Per RECIST 1.1 by BICR in Subgroup of Cohort A Participants With PFI/TFI >6-12 Months [Time Frame: Up to ~43 months (through database cut-off date of 18-September-2019)]

DCR Per RECIST 1.1 by Investigator in Subgroup of Cohort A and Cohort B Participants With PD-L1 CPS =1 [Time Frame: Up to ~43 months (through database cut-off date of 18-September-2019)]

DOR Per RECIST 1.1 by Investigator in Subgroup of Cohort A and Cohort B Participants With PD-L1 CPS =10 [Time Frame: Up to ~43 months (through database cut-off date of 18-September-2019)]

DOR Per RECIST 1.1 by BICR in Subgroup of Cohort A and Cohort B Participants With PD-L1 CPS =10 [Time Frame: Up to ~43 months (through database cut-off date of 18-September-2019)]

Number of Participants Who Discontinued Study Treatment Due to an AE [Time Frame: Up to ~43 months (through database cut-off date of 18-September-2019)]

DOR Per RECIST 1.1 by Investigator in Subgroup of Cohort A Participants With PFI/TFI >6-12 Months [Time Frame: Up to ~43 months (through database cut-off date of 18-September-2019)]

ORR Per RECIST 1.1 by Investigator in Subgroup of Cohort A and Cohort B Participants With PD-L1 CPS =10 [Time Frame: Up to ~43 months (through database cut-off date of 18-September-2019)]

DOR Per RECIST 1.1 by Investigator in Subgroup of Cohort A and Cohort B Participants With PD-L1 CPS =1 [Time Frame: Up to ~43 months (through database cut-off date of 18-September-2019)]

Duration of Response (DOR) Per RECIST 1.1 by BICR in All Cohort A and Cohort B Participants [Time Frame: Up to ~43 months (through database cut-off date of 18-September-2019)]

Percentage of Participants With PFS (PFS Rate) at Month 6 Per RECIST 1.1 by BICR in Subgroup of Cohort A Participants With PFI/TFI >6-12 Months [Time Frame: Month 6]

ORR Per RECIST 1.1 by BICR in Subgroup of Cohort A Participants With PFI/ TFI >6-12 Months [Time Frame: Up to ~43 months (through database cut-off date of 18-September-2019)]

OS in Subgroup of Cohort A Participants With PFI/TFI =3-6 Months [Time Frame: Up to ~43 months (through database cut-off date of 18-September-2019)]

ORR Per RECIST 1.1 by Investigator in Subgroup of Cohort A and Cohort B Participants With PD-L1 CPS =1 [Time Frame: Up to ~43 months (through database cut-off date of 18-September-2019)]

Number of Participants Who Experienced an Adverse Event (AE) [Time Frame: Up to ~43 months (through database cut-off date of 18-September-2019)]

ORR Per RECIST 1.1 by Investigator in All Cohort A and Cohort B Participants [Time Frame: Up to ~43 months (through database cut-off date of 18-September-2019)]

Percentage of Participants With PFS (PFS Rate) at Month 6 Per RECIST 1.1 by Investigator in Subgroup of Cohort A Participants With PFI/TFI =3-6 Months [Time Frame: Month 6]

Percentage of Participants With OS (OS Rate) at Month 12 in All Cohort A and Cohort B Participants [Time Frame: Month 12]

Percentage of Participants With OS (OS Rate) at Month 6 in Subgroup of Cohort A Participants With PFI/TFI =3-6 Months [Time Frame: Month 6]

OS in Subgroup of Cohort A Participants With PFI/TFI >6-12 Months [Time Frame: Up to ~43 months (through database cut-off date of 18-September-2019)]

Percentage of Participants With PFS (PFS Rate) at Month 18 Per RECIST 1.1 by BICR in Subgroup of Cohort A Participants With PFI/TFI =3-6 Months [Time Frame: Month 18]

PFS Per RECIST 1.1 by BICR in Subgroup of Cohort A and Cohort B Participants With PD-L1 CPS =10 [Time Frame: Up to ~43 months (through database cut-off date of 18-September-2019)]

Percentage of Participants With PFS (PFS Rate) at Month 18 Per RECIST 1.1 by Investigator in Subgroup of Cohort A and Cohort B Participants With PD-L1 CPS =10 [Time Frame: Month 18]

Percentage of Participants With PFS (PFS Rate) at Month 12 Per RECIST 1.1 by BICR in Subgroup of Cohort A Participants With PFI/TFI >6-12 Months [Time Frame: Month 12]

PFS Per RECIST 1.1 by Investigator in Subgroup of Cohort A Participants With PFI/TFI >6-12 Months [Time Frame: Up to ~43 months (through database cut-off date of 18-September-2019)]

ORR Per RECIST 1.1 by Investigator in Subgroup of Cohort A Participants With PFI/ TFI =3-6 Months [Time Frame: Up to ~43 months (through database cut-off date of 18-September-2019)]

Percentage of Participants With PFS (PFS Rate) at Month 12 Per RECIST 1.1 by Investigator in Subgroup of Cohort A Participants With PFI/TFI =3-6 Months [Time Frame: Month 12]

ORR Per RECIST 1.1 by Investigator in Subgroup of Cohort A Participants With PFI/ TFI >6-12 Months [Time Frame: Up to ~43 months (through database cut-off date of 18-September-2019)]

OS in Subgroup of Cohort A and Cohort B Participants With PD-L1 CPS =1 [Time Frame: Up to ~43 months (through database cut-off date of 18-September-2019)]

Percentage of Participants With PFS (PFS Rate) at Month 18 Per RECIST 1.1 by Investigator in Subgroup of Cohort A Participants With PFI/TFI >6-12 Months [Time Frame: Month 18]

Overall Survival (OS) in All Cohort A and Cohort B Participants [Time Frame: Up to ~43 months (through database cut-off date of 18-September-2019)]

Percentage of Participants With PFS (PFS Rate) at Month 18 Per RECIST 1.1 by Investigator in Subgroup of Cohort A Participants With PFI/TFI =3-6 Months [Time Frame: Month 18]

Percentage of Participants With OS (OS Rate) at Month 12 in Subgroup of Cohort A and Cohort B Participants With PD-L1 CPS =1 [Time Frame: Month 12]

Percentage of Participants With PFS (PFS Rate) at Month 12 Per RECIST 1.1 by BICR in Subgroup of Cohort A Participants With PFI/TFI =3-6 Months [Time Frame: Month 12]

Percentage of Participants With OS (OS Rate) at Month 12 in Subgroup of Cohort A and Cohort B Participants With PD-L1 CPS =10 [Time Frame: Month 12]

Percentage of Participants With OS (OS Rate) at Month 18 in All Cohort A and Cohort B Participants [Time Frame: Month 18]

Percentage of Participants With OS (OS Rate) at Month 12 in Subgroup of Cohort A Participants With PFI/TFI =3-6 Months [Time Frame: Month 12]

PFS Per RECIST 1.1 by Investigator in Subgroup of Cohort A and Cohort B Participants With PD-L1 CPS =1 [Time Frame: Up to ~43 months (through database cut-off date of 18-September-2019)]

Percentage of Participants With PFS (PFS Rate) at Month 18 Per RECIST 1.1 by BICR in Subgroup of Cohort A and Cohort B Participants With PD-L1 CPS =1 [Time Frame: Month 18]

Percentage of Participants With PFS (PFS Rate) at Month 6 Per RECIST 1.1 by BICR in Subgroup of Cohort A and Cohort B Participants With PD-L1 CPS =10 [Time Frame: Month 6]

Percentage of Participants With PFS (PFS Rate) at Month 6 Per RECIST 1.1 by Investigator in All Cohort A and Cohort B Participants [Time Frame: Month 6]

Percentage of Participants With OS (OS Rate) at Month 6 in Subgroup of Cohort A Participants With PFI/TFI >6-12 Months [Time Frame: Month 6]

Percentage of Participants With PFS (PFS Rate) at Month 6 Per RECIST 1.1 by Investigator in Subgroup of Cohort A and Cohort B Participants With PD-L1 CPS =10 [Time Frame: Month 6]

Percentage of Participants With OS (OS Rate) at Month 12 in Subgroup of Cohort A Participants With PFI/TFI >6-12 Months [Time Frame: Month 12]

Percentage of Participants With PFS (PFS Rate) at Month 12 Per RECIST 1.1 by Investigator in All Cohort A and Cohort B Participants [Time Frame: Month 12]

Percentage of Participants With OS (OS Rate) at Month 18 in Subgroup of Cohort A and Cohort B Participants With PD-L1 CPS =10 [Time Frame: Month 18]

PFS Per RECIST 1.1 by Investigator in Subgroup of Cohort A and Cohort B Participants With PD-L1 CPS =10 [Time Frame: Up to ~43 months (through database cut-off date of 18-September-2019)]

Percentage of Participants With PFS (PFS Rate) at Month 18 Per RECIST 1.1 by Investigator in All Cohort A and Cohort B Participants [Time Frame: Month 18]

Percentage of Participants With OS (OS Rate) at Month 6 in Subgroup of Cohort A and Cohort B Participants With PD-L1 CPS =10 [Time Frame: Month 6]

Percentage of Participants With PFS (PFS Rate) at Month 12 Per RECIST 1.1 by BICR in All Cohort A and Cohort B Participants [Time Frame: Month 12]

Percentage of Participants With PFS (PFS Rate) at Month 12 Per RECIST 1.1 by BICR in Subgroup of Cohort A and Cohort B Participants With PD-L1 CPS =1 [Time Frame: Month 12]

Percentage of Participants With PFS (PFS Rate) at Month 18 Per RECIST 1.1 by BICR in Subgroup of Cohort A and Cohort B Participants With PD-L1 CPS =10 [Time Frame: Month 18]

Progression Free Survival (PFS) Per RECIST 1.1 by BICR in All Cohort A and Cohort B Participants [Time Frame: Up to ~43 months (through database cut-off date of 18-September-2019)]

Percentage of Participants With PFS (PFS Rate) at Month 18 Per RECIST 1.1 by Investigator in Subgroup of Cohort A and Cohort B Participants With PD-L1 CPS =1 [Time Frame: Month 18]

Percentage of Participants With PFS (PFS Rate) at Month 18 Per RECIST 1.1 by BICR in Subgroup of Cohort A Participants With PFI/TFI >6-12 Months [Time Frame: Month 18]

Percentage of Participants With PFS (PFS Rate) at Month 6 Per RECIST 1.1 by BICR in All Cohort A and Cohort B Participants [Time Frame: Month 6]

Percentage of Participants With PFS (PFS Rate) at Month 6 Per RECIST 1.1 by Investigator in Subgroup of Cohort A Participants With PFI/TFI >6-12 Months [Time Frame: Month 6]

Percentage of Participants With PFS (PFS Rate) at Month 6 Per RECIST 1.1 by BICR in Subgroup of Cohort A and Cohort B Participants With PD-L1 CPS =1 [Time Frame: Month 6]

PFS Per RECIST 1.1 by BICR in Subgroup of Cohort A Participants With PFI/TFI =3-6 Months [Time Frame: Up to ~43 months (through database cut-off date of 18-September-2019)]

PFS Per RECIST 1.1 by BICR in Subgroup of Cohort A and Cohort B Participants With PD-L1 CPS =1 [Time Frame: Up to ~43 months (through database cut-off date of 18-September-2019)]

PFS Per RECIST 1.1 by Investigator in All Cohort A and Cohort B Participants [Time Frame: Up to ~43 months (through database cut-off date of 18-September-2019)]

PFS Per RECIST 1.1 by BICR in Subgroup of Cohort A Participants With PFI/TFI >6-12 Months [Time Frame: Up to ~43 months (through database cut-off date of 18-September-2019)]

DCR Per RECIST 1.1 by Investigator in All Cohort A and Cohort B Participants [Time Frame: Up to ~43 months (through database cut-off date of 18-September-2019)]

DCR Per RECIST 1.1 by Investigator in Subgroup of Cohort A Participants With PFI/TFI >6-12 Months [Time Frame: Up to ~43 months (through database cut-off date of 18-September-2019)]

DOR Per RECIST 1.1 by Investigator in Subgroup of Cohort A Participants With PFI/TFI =3-6 Months [Time Frame: Up to ~43 months (through database cut-off date of 18-September-2019)]

ORR Per RECIST 1.1 by BICR in Subgroup of Cohort A Participants With Platinum-Free Interval (PFI)/Treatment-Free Interval (TFI) =3-6 Months [Time Frame: Up to ~43 months (through database cut-off date of 18-September-2019)]

Percentage of Participants With OS (OS Rate) at Month 6 in All Cohort A and Cohort B Participants [Time Frame: Month 6]

Percentage of Participants With OS (OS Rate) at Month 6 in Subgroup of Cohort A and Cohort B Participants With PD-L1 CPS =1 [Time Frame: Month 6]

Percentage of Participants With PFS (PFS Rate) at Month 12 Per RECIST 1.1 by BICR in Subgroup of Cohort A and Cohort B Participants With PD-L1 CPS =10 [Time Frame: Month 12]

Percentage of Participants With PFS (PFS Rate) at Month 12 Per RECIST 1.1 by Investigator in Subgroup of Cohort A and Cohort B Participants With PD-L1 CPS =1 [Time Frame: Month 12]

Percentage of Participants With PFS (PFS Rate) at Month 12 Per RECIST 1.1 by Investigator in Subgroup of Cohort A and Cohort B Participants With PD-L1 CPS =10 [Time Frame: Month 12]

Percentage of Participants With PFS (PFS Rate) at Month 18 Per RECIST 1.1 by BICR in All Cohort A and Cohort B Participants [Time Frame: Month 18]

Percentage of Participants With PFS (PFS Rate) at Month 6 Per RECIST 1.1 by Investigator in Subgroup of Cohort A and Cohort B Participants With PD-L1 CPS =1 [Time Frame: Month 6]

PFS Per RECIST 1.1 by Investigator in Subgroup of Cohort A Participants With PFI/TFI =3-6 Months [Time Frame: Up to ~43 months (through database cut-off date of 18-September-2019)]

Secondary ID(s)

KEYNOTE-100

163237

MK-3475-100

2015-003338-29

3475-100

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Ethics review

Results

Results available:	Yes
Date Posted:	22/09/2020
Date Completed:
URL:	https://clinicaltrials.gov/ct2/show/results/NCT02674061

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