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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT02628067




Registration number
NCT02628067
Ethics application status
Date submitted
9/12/2015
Date registered
11/12/2015
Date last updated
23/05/2019

Titles & IDs
Public title
Study of Pembrolizumab (MK-3475) in Participants With Advanced Solid Tumors (MK-3475-158/KEYNOTE-158)
Scientific title
A Clinical Trial of Pembrolizumab (MK-3475) Evaluating Predictive Biomarkers in Subjects With Advanced Solid Tumors (KEYNOTE 158)
Secondary ID [1] 0 0
2015-002067-41
Secondary ID [2] 0 0
3475-158
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Advanced Cancer 0 0
Condition category
Condition code

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Other interventions - pembrolizumab

Experimental: Pembrolizumab - Participants receive pembrolizumab 200 mg intravenously every 3 weeks (Q3W) for up to 35 administrations (approximately 2 years of treatment)


Other interventions: pembrolizumab
intravenous infusion

Intervention code [1] 0 0
Other interventions
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Objective Response Rate (ORR)
Timepoint [1] 0 0
Up to 7.5 years

Eligibility
Key inclusion criteria
- Histologically or cytologically-documented, advanced solid tumor of one of the
following types:

- Anal Squamous Cell Carcinoma

- Biliary Adenocarcinoma (gallbladder or biliary tree (intrahepatic or extrahepatic
cholangiocarcinoma) except Ampulla of Vater cancers)

- Neuroendocrine Tumors (well- and moderately-differentiated) of the lung,
appendix, small intestine, colon, rectum, or pancreas

- Endometrial Carcinoma (sarcomas and mesenchymal tumors are excluded)

- Cervical Squamous Cell Carcinoma

- Vulvar Squamous Cell Carcinoma

- Small Cell Lung Carcinoma

- Mesothelioma

- Thyroid Carcinoma

- Salivary Gland Carcinoma (sarcomas and mesenchymal tumors are excluded)

- OR

- Any advanced solid tumor, with the exception of colorectal carcinoma (CRC), which
is Microsatellite Instability (MSI)-High (MSI-H)

- Progression of tumor or intolerance to therapies known to provide clinical benefit.
There is no limit to the number of prior treatment regimens

- Can supply tumor tissue for study analyses (dependent on tumor type)

- Radiologically-measurable disease

- Performance status of 0 or 1 on the Eastern Cooperative Oncology Group (ECOG)
Performance Scale within 3 days prior to first dose of pembrolizumab

- Life expectancy of at least 3 months

- Adequate organ function

- Female participants of childbearing potential must be willing to use adequate
contraception for the course of the study through 120 days after the last dose of
study medication

- Male participants with partners of must childbearing potential must be willing to use
adequate contraception for the course of the study through 120 days after the last
dose of study medication
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- Currently participating and receiving study therapy or has participated in a study of
an investigational agent and received study therapy or used an investigational device
within 4 weeks of the first dose of study medication

- Diagnosis of immunodeficiency or receiving systemic steroid therapy or any other form
of immunosuppressive therapy within 7 days prior to the first dose of study medication

- Active autoimmune disease that has required systemic treatment in the past 2 years

- Prior anti-cancer monoclonal antibody (mAb) within 4 weeks prior to study Day 1 or not
recovered from an adverse event caused by mAbs administered more than 4 weeks earlier

- Prior chemotherapy, targeted small molecule therapy, or radiation therapy within 2
weeks of study Day 1 or not recovered from adverse events caused by a previously
administered agent

- Known additional malignancy within 2 years prior to enrollment with the exception of
curatively treated basal cell carcinoma of the skin, squamous cell carcinoma of the
skin and/or curatively resected in situ cancers

- Known active central nervous system (CNS) metastases and/or carcinomatous meningitis

- Has known glioblastoma multiforme of the brainstem

- History of non-infectious pneumonitis that required steroids or current pneumonitis

- Active infection requiring systemic therapy

- Known psychiatric or substance abuse disorders that would interfere with cooperation
with the requirements of the study

- Pregnant, breastfeeding, or expecting to conceive or father children within the
projected duration of the study, starting with the screening visit through 120 days
after the last dose of study medication

- Previously participated in any other pembrolizumab (MK-3475) study, or received prior
therapy with an anti-programmed cell death (PD)-1, anti-PD-Ligand 1 (anti-PD-L1),
anti-PD-L2, or any other immunomodulating mAb or drug specifically targeting T-cell
co-stimulation or checkpoint pathways

- Known history of Human Immunodeficiency Virus (HIV)

- Known active Hepatitis B or C

- Received live vaccine within 30 days of planned start of study medication

- Has severe hypersensitivity (=Grade 3) to pembrolizumab and/or any of its excipients

- Known history of active tuberculosis (TB, Bacillus tuberculosis)

Study design
Purpose of the study
Treatment
Allocation to intervention
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Phase 2
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
Merck Sharp & Dohme - North Ryde
Recruitment postcode(s) [1] 0 0
- North Ryde
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
California
Country [2] 0 0
United States of America
State/province [2] 0 0
Colorado
Country [3] 0 0
United States of America
State/province [3] 0 0
Florida
Country [4] 0 0
United States of America
State/province [4] 0 0
Maryland
Country [5] 0 0
United States of America
State/province [5] 0 0
Massachusetts
Country [6] 0 0
United States of America
State/province [6] 0 0
New Jersey
Country [7] 0 0
United States of America
State/province [7] 0 0
New Mexico
Country [8] 0 0
United States of America
State/province [8] 0 0
Texas
Country [9] 0 0
Brazil
State/province [9] 0 0
Sao Paulo
Country [10] 0 0
Canada
State/province [10] 0 0
Quebec
Country [11] 0 0
Colombia
State/province [11] 0 0
Bogota
Country [12] 0 0
Denmark
State/province [12] 0 0
Glostrup
Country [13] 0 0
France
State/province [13] 0 0
Paris
Country [14] 0 0
Germany
State/province [14] 0 0
Haar
Country [15] 0 0
Israel
State/province [15] 0 0
Hod Hasharon
Country [16] 0 0
Italy
State/province [16] 0 0
Rome
Country [17] 0 0
Japan
State/province [17] 0 0
Chiyoda-Ku, Tokyo
Country [18] 0 0
Korea, Republic of
State/province [18] 0 0
Seoul
Country [19] 0 0
Mexico
State/province [19] 0 0
Mexico City
Country [20] 0 0
Netherlands
State/province [20] 0 0
Haarlem
Country [21] 0 0
Norway
State/province [21] 0 0
Drammen
Country [22] 0 0
Philippines
State/province [22] 0 0
Makati
Country [23] 0 0
Russian Federation
State/province [23] 0 0
Moscow
Country [24] 0 0
South Africa
State/province [24] 0 0
Midrand
Country [25] 0 0
Spain
State/province [25] 0 0
Madrid
Country [26] 0 0
Taiwan
State/province [26] 0 0
Taipei
Country [27] 0 0
United Kingdom
State/province [27] 0 0
Hoddesdon

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Merck Sharp & Dohme Corp.
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
In this study, participants with multiple types of advanced (unresectable and/or metastatic)
solid tumors that have progressed on standard of care therapy will be treated with
pembrolizumab.
Trial website
https://clinicaltrials.gov/show/NCT02628067
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Medical Director
Address 0 0
Merck Sharp & Dohme Corp.
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Toll Free Number
Address 0 0
Country 0 0
Phone 0 0
1-888-577-8839
Fax 0 0
Email 0 0
Contact person for scientific queries

Summary results
For IPD and results data, please see https://clinicaltrials.gov/show/NCT02628067