Clinicaltrials.gov identifier:
NCT02628067
Treatment
Treatment study for people with advanced cancers
Study Contact Information:
Study Director: Medical Director, Merck Sharp & Dohme LLC
Toll-free number: 1-888-577-8839
Testing an Immunotherapy, Pembrolizumab, in Patients With Advanced Solid Tumors
About the Study
This study is looking at the effectiveness of an , pembrolizumab, in treating people who have been diagnosed with advanced that have progressed on standard-of-care therapy, by radiology and through tumor biopsies. While participants may receive up to two years of treatment, the response will be measured for up to 10.5 years.
What the Study Involves
There will be two groups in this study. All participants will receive the study drug pembrolizumab, although the dose will be different.
Group 1:
- Participants will receive 200 mg of pembrolizumab intravenously on the first day of each 3-week cycle for up to 35 administrations (about 2 years of treatment).
Group 2:
- Participants with any advanced solid tumor that grown or come back after one or more lines of therapy and has a high [excluding participants with mismatch repair deficient tumors] will receive 400 mg of pembrolizumab intravenously on the first day of each 6-week cycle for up to 18 administrations (about 2 years of treatment).
After completion of study treatment, participants are followed for up to 10 years.
New Jersey
City: New Brunswick RECRUITING
Facility: Call for Information (Investigational Site 0008)
Contact Info:
No contact info provided
Other Countries
Country: Australia
City: North Ryde RECRUITING
Facility: MSD Australia
Contact Info:
61 2 8988 8428
Country: Brazil
City: Sao Paulo RECRUITING
Facility: MSD Brasil
Contact Info:
0800 012 22 32
Country: Chile
City: Santiago RECRUITING
Facility: Merck Sharp & Dohme (I.A.) Corp.
Contact Info:
56 2 6558958
Country: Colombia
City: Bogota RECRUITING
Facility: MDS Colombia SAS
Contact Info:
57 1219109011090
Country: Denmark
City: Glostrup RECRUITING
Facility: MSD Denmark
Contact Info:
45 21387145
Country: France
City: Paris RECRUITING
Facility: MSD France
Contact Info:
33 147548990
Country: Germany
City: Haar RECRUITING
Facility: MSD Sharp & Dohme GmbH
Contact Info:
49 800 673 673 673
Country: Israel
City: Hod Hasharon RECRUITING
Facility: Merck Sharp & Dohme Co. Ltd.
Contact Info:
972-9-9533310
Country: Italy
City: Rome RECRUITING
Facility: MSD Italia S.r.l.
Contact Info:
39 06361911
Country: Korea, Republic of
City: Seoul RECRUITING
Facility: MSD Korea LTD
Contact Info:
82-2-331-2000 2015
Country: Mexico
City: Mexico City RECRUITING
Facility: MSD
Contact Info:
52 55254819608
Country: Netherlands
City: Haarlem RECRUITING
Facility: Merck Sharp & Dohme BV
Contact Info:
31 23 515 3362
Country: Norway
City: Drammen RECRUITING
Facility: MSD Norge A/S
Contact Info:
47 32 20 75 20
Country: Peru
City: Lima RECRUITING
Facility: Merck Sharp & Dohme, Peru S.R.L.
Contact Info:
(51-1) 411-5100
Country: Poland
City: Warsaw RECRUITING
Facility: MSD Polska Sp. Z o.o.
Contact Info:
48 22 478 43 24
Country: Portugal
City: Paco D'arcos RECRUITING
Facility: Merck Sharp & Dohme Lda.
Contact Info:
00351-214465803
Country: Russian Federation
City: Moscow RECRUITING
Facility: Merck Sharp & Dohme IDEA, Inc.
Contact Info:
74959167100, EXT.366
Country: South Africa
City: Midrand RECRUITING
Facility: MSD (Pty) LTD South Africa
Contact Info:
27 11 655 3140
Country: Spain
City: Madrid RECRUITING
Facility: Merck Sharp and Dohme de Espana S.A.
Contact Info:
(0034) 913210654
Country: Taiwan
City: Taipei RECRUITING
Facility: Merck Sharp & Dohme (I.A.) Corp.
Contact Info:
886-2-66316000
People, 18 years and older, who meet the following criteria:
Advanced solid tumor of one of the following types:
- Biliary Cancer
- Neuroendocrine Tumors of the lung, appendix, small intestine, colon, rectum, or pancreas
- Endometrial Cancer (sarcomas and mesenchymal tumors are excluded)
- Cervical Squamous Cell Cancer
- Vulvar Squamous Cell Cancer
- Thyroid Cancer
- Any advanced solid tumor which is (MSI)-High (MSI-H) with the exception of colorectal cancer OR
- Any advanced solid tumor that didn't respond or got worse after at least one line of therapy and has a high (TMB-High)
- Participants whose cancer did not improve or got worse after at least one line of standard of care therapy
- There is no limit to the number of prior treatments
- Colorectal carcinoma participants must have received at least 2 lines of standard of care treatment
- Participants must not have melanoma or non-small-cell lung cancer
- Can supply tumor tissue for study analyses (dependent on tumor type)
- Can be measured by radiology (through imaging technologies)
- Life expectancy > 3 months with adequate organ function
- Under the age of 18
- Receiving another study therapy within 4 weeks of the first dose of study treatment
- Diagnosis of immunodeficiency or receiving systemic steroid therapy or any other immunosuppressive therapy within 7 days prior to the first dose of study treatment
- Active autoimmune disease that has required systemic treatment in the past 2 years
- Prior anti-cancer monoclonal antibody within 4 weeks prior to study Day 1 or not recovered from side effects from this treatment
- Prior chemotherapy, targeted small molecule therapy, or radiation therapy within 2 weeks of study Day 1 or not recovered from side effects caused by these therapies
- Known additional cancer within 2 years prior to enrollment with the exception of some skin cancers
- Known active central nervous system cancers
- Has a history of or currently has lung disease with progressive scarring of the lungs that required steroids
- Active infection requiring , including hepatitis b, hepatitis c, and HIV, or known history of active tuberculosis
- Known psychiatric or substance abuse disorders that would interfere with ability to cooperate with the study requirements
- 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 treatment
- Previously participated in any other pembrolizumab study, or received prior therapy with other types of immunotherapies
- Has had a stem cell tissue/solid organ transplant