Long-term Safety and Efficacy Extension Study for Participants With Advanced Tumors Who Are Currently on Treatment or in Follow-up in a Pembrolizumab (MK-3475) Study (MK-3475-587/KEYNOTE-587)
Launched by MERCK SHARP & DOHME LLC · Mar 29, 2018
Trial Information
Current as of June 27, 2025
Recruiting
Keywords
ClinConnect Summary
This clinical trial, called MK-3475-587, is looking into the long-term safety and effectiveness of a treatment called pembrolizumab (also known as MK-3475) for patients with advanced tumors. If you have previously participated in studies involving pembrolizumab and are currently receiving treatment or are in follow-up, you may be eligible to join this trial. Participants will be grouped based on their previous treatment phase and could receive pembrolizumab alone or in combination with another medication. Depending on which phase you enter, you may receive treatment every three weeks or every six weeks for up to two years.
To be eligible, you should have been treated with pembrolizumab before and must not have received any other anticancer treatments since your last dose. You should also be in good overall health and able to perform daily activities. Throughout the study, participants will be closely monitored for any side effects and to see how well the treatment is working. It's important to know that there are specific health criteria that must be met to participate, ensuring everyone's safety during the trial. If you're interested in learning more or think you might qualify, talk to your doctor for more information.
Gender
ALL
Eligibility criteria
- Inclusion Criteria:
- • Treated on the parent pembrolizumab studies established by the Sponsor as MK-3475-587 ready.
- • Currently receiving pembrolizumab, pembrolizumab based combinations or lenvatinib from parent studies or in a follow-up phase.
- Additional eligibility criteria for participants who enter Second Course Phase once they are enrolled on MK-3475-587:
- • Has not received any anticancer systemic treatment since the last dose of pembrolizumab or a pembrolizumab-based combination in First Course Phase.
- • Has an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
- • Demonstrates adequate organ function.
- • Have resolution of any toxic effect(s) of First Course Phase trial treatment with pembrolizumab or a pembrolizumab-based combination to Grade 1 or less (except alopecia) before trial treatment in Second Course Phase is started. If participant received major surgery or radiation therapy of \>30 Gray (Gy), they must have recovered from the toxicity and/or complications of the intervention.
- • A female participant is eligible to enroll if she is not pregnant, not breastfeeding, and ≥1 of the following conditions applies: A woman of childbearing potential (WOCBP) who agrees to use contraception during the study treatment period and for ≥120 days (corresponding to time needed to eliminate any study combination treatment(s) plus 30 days (a menstruation cycle) for study treatments with risk of genotoxicity.
- Additional eligibility criteria for participants who enter dosing with Lenvatinib:
- • Adequately controlled blood pressure (BP) to \<150/90 mmHg, with or without antihypertensive medications.
- • For male agrees to be abstinent from penile-vaginal intercourse OR agrees to use a highly effective contraceptive method while receiving study drug and for 7 days after the last dose of lenvatinib.
- • Is female and not pregnant/breastfeeding and at least one of the following applies during the study and for ≥4 days after: is not a woman of childbearing potential (WOCBP), is a WOCBP and uses highly effective contraception (low user dependency method OR a user dependent hormonal method in combination with a barrier method) or is a WOCBP who is abstinent from heterosexual intercourse.
- Exclusion Criteria:
- • -There are no exclusion criteria to participate in MK-3475-587.
- Participants are excluded from entering Second Course trial treatment once they are enrolled on MK-3475-587 if any of the following criteria applies:
- • Has severe hypersensitivity (≥ Grade 3) to pembrolizumab and/or any of its excipients.
- • Has received a live vaccine within 30 days prior to the first dose of Second Course Phase trial treatment.
- • 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 to the Cycle 1 Day 1 of Second Course Phase.
- • Has a known additional malignancy that is progressing or requires active treatment. Exceptions include early stage cancers (carcinoma in situ or Stage 1) treated with curative intent, melanoma (non-ulcerated, thin primary), basal cell carcinoma of the skin, squamous cell carcinoma of the skin, in situ cervical cancer, or in situ breast cancer that has undergone potentially curative therapy.
- • Has known active central nervous system metastases and/or carcinomatous meningitis.
- • 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) is not considered a form of systemic treatment and is allowed.
- • Has a history of (non-infectious) pneumonitis that required steroids or has current pneumonitis. Note: Participants that experienced pneumonitis during First Course that did not meet the criteria for permanent discontinuation are eligible.
- • Non-small cell lung cancer (NSCLC) participants only: Has interstitial lung disease.
- • Has an active infection requiring systemic therapy.
- • Has a known history of human immunodeficiency virus (HIV) infection.
- • Has a known history of or is positive for hepatitis B or hepatitis C. For parent studies where inclusion of participants with hepatitis was permitted, MK-3475-587 will follow the parent study eligibility criteria for hepatitis.
- • Is pregnant or breastfeeding or expecting to conceive or father children within the projected duration of the study, starting with the Second Course Phase eligibility Visit through 120 days after the last dose of study treatment.
- • Has severe cardiovascular disease, i.e., arrhythmias, requiring chronic treatment, congestive heart failure (New York Heart Association Class III or IV) or symptomatic ischemic heart disease.
- • Has hepatic decompensation (Child-Pugh score \>6 \[class B and C\]).
- • Has uncontrolled thyroid dysfunction.
- • Has uncontrolled diabetes mellitus.
- • Has had an allogeneic tissue/solid organ transplant.
- • Has a known history of active tuberculosis (TB; Bacillus tuberculosis).
- Additional exclusion criteria for participants who enter dosing with Lenvatinib:
- • Has had major surgery within 3 weeks prior to first dose of study intervention(s).
- • Has preexisting ≥Grade 3 gastrointestinal or non-gastrointestinal fistula.
- • Has urine protein ≥1 g/24 hours.
- • Has LVEF below the institutional (or local laboratory) normal range, as determined by multigated acquisition scan (MUGA) or echocardiogram (ECHO).
- • Has radiographic evidence of encasement or invasion of a major blood vessel, or of intratumoral cavitation.
- • Prolongation of QT intervals corrected for heart rate using Fridericia's (cube root) correction (QTcF) interval to \>480 ms.
- • Has clinically significant cardiovascular disease within 12 months from first dose of study intervention, including New York Heart Association Class III or IV congestive heart failure, unstable angina, myocardial infarction, cerebral vascular accident, or cardiac arrhythmia associated with hemodynamic instability.
- • Gastrointestinal malabsorption or any other condition that might affect the absorption of lenvatinib.
- • Active hemoptysis (bright red blood of at least 0.5 teaspoon) within 3 weeks prior to the first dose of study drug.
- • Has a history of any contraindication or has a severe hypersensitivity to any components of lenvatinib.
About Merck Sharp & Dohme Llc
Merck Sharp & Dohme LLC, a subsidiary of Merck & Co., Inc., is a leading global biopharmaceutical company dedicated to discovering, developing, and delivering innovative medicines and vaccines that address unmet medical needs. With a strong focus on research and development, Merck Sharp & Dohme leverages advanced science and technology to enhance patient outcomes across various therapeutic areas, including oncology, infectious diseases, and cardiovascular health. Committed to ethical practices and regulatory compliance, the company actively engages in clinical trials to advance medical knowledge and improve health care for patients worldwide.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
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Cary, North Carolina, United States
Cordoba, , Argentina
Koshigaya, Saitama, Japan
Daegu, Taegu Kwangyokshi, Korea, Republic Of
Basel, Basel Stadt, Switzerland
Wuhan, Hubei, China
Clermont Ferrand, Puy De Dome, France
Gothenburg, Vastra Gotalands Lan, Sweden
Fortaleza, Ceara, Brazil
Changsha, Hunan, China
Villejuif, Val De Marne, France
Nishihara, Okinawa, Japan
Kuala Lumpur, , Malaysia
Aberdeen, Aberdeen City, United Kingdom
Sapporo, Hokkaido, Japan
Opole, Opolskie, Poland
La Rioja, , Argentina
Midlothian, Virginia, United States
Brisbane, Queensland, Australia
Tokyo, , Japan
Groningen, , Netherlands
Tomsk, Tomskaya Oblast, Russian Federation
Málaga, Malaga, Spain
Mitaka Shi, Tokyo, Japan
Tulsa, Oklahoma, United States
Sendai, Miyagi, Japan
Kazan, Tatarstan, Respublika, Russian Federation
Berazategui, Buenos Aires, Argentina
Viña Del Mar, Valparaiso, Chile
Lima, , Peru
Moscow, Moskva, Russian Federation
Taipei, , Taiwan
Ottawa, Ontario, Canada
Toon, Ehime, Japan
Daegu, Taegu Kwangyokshi, Korea, Republic Of
Ciudad De Buenos Aires, Buenos Aires, Argentina
Mexico City, Distrito Federal, Mexico
Berazategui, Buenos Aires, Argentina
Santiago, Region M. De Santiago, Chile
Saint Petersburg, Sankt Peterburg, Russian Federation
Antalya, , Turkey
Augusta, Georgia, United States
Mar Del Plata, Buenos Aires, Argentina
Buenos Aires, , Argentina
Fortaleza, Ceara, Brazil
Temuco, Araucania, Chile
Suresnes, Hauts De Seine, France
Saint Herblain, Loire Atlantique, France
Napoli, , Italy
Cheongju Si, Chungbuk, Korea, Republic Of
Mexico City, , Mexico
Lima, , Peru
Saint Petersburg, Sankt Peterburg, Russian Federation
St Petersburg, Sankt Peterburg, Russian Federation
Kazan, Tatarstan, Respublika, Russian Federation
Taoyuan, , Taiwan
Jacksonville, Florida, United States
Belo Horizonte, Minas Gerais, Brazil
Fuzhou, Fujian, China
Osaka, , Japan
Ciudad De Mexico, Distrito Federal, Mexico
Barnaul, Altayskiy Kray, Russian Federation
Leeds, , United Kingdom
Namur, , Belgium
Orange, California, United States
Guanghzou, Guangdong, China
Marseille, Bouches Du Rhone, France
Padova, Veneto, Italy
Torino, , Italy
Osaka, , Japan
Seoul, , Korea, Republic Of
Lisboa, , Portugal
Badalona, Cataluna, Spain
Paducah, Kentucky, United States
Ciudad Autónoma De Buenos Aires, Buenos Aires, Argentina
Rosario, Santa Fe, Argentina
Guangzhou, Guangdong, China
Xian, Shanxi, China
Urumqi, Xinjiang, China
Amiens, Somme, France
Poitiers, Vienne, France
Milan, Lombardia, Italy
Sendai Shi, Miyagi, Japan
Niigata, , Japan
Groningen, , Netherlands
Gliwice, Slaskie, Poland
Sherbrooke, Quebec, Canada
Seattle, Washington, United States
Wuhan, Hubei, China
Barranquilla, Atlantico, Colombia
Valledupar, Cesar, Colombia
Cali, Valle Del Cauca, Colombia
Brest, Finistere, France
Boulogne, Hauts De Seine, France
Hong Kong, , Hong Kong
Catania, Sicilia, Italy
Milano, , Italy
Tsukuba, Ibaraki, Japan
Guangzhou, Guangdong, China
Medellín, Antioquia, Colombia
Bogota, Cundinamarca, Colombia
Roma, Lazio, Italy
Monza, Lombardia, Italy
Bunkyō, Tokyo, Japan
İstanbul, , Turkey
Fullerton, California, United States
Jaú, Sao Paulo, Brazil
Calgary, Alberta, Canada
Winnipeg, Manitoba, Canada
Zhengzhou, Henan, China
Toulouse, Haute Garonne, France
Rouen, Seine Maritime, France
Paris, , France
Szolnok, Jasz Nagykun Szolnok, Hungary
Orbassano, Torino, Italy
Kawasaki, Kanagawa, Japan
Tokorozawa, Saitama, Japan
Kraków, Malopolskie, Poland
Johannesburg, Gauteng, South Africa
Istanbul, , Turkey
Tucson, Arizona, United States
Covington, Louisiana, United States
Santiago, Region M. De Santiago, Chile
Guatemala, , Guatemala
Ramat Gan, , Israel
Clermont Ferrand, Puy De Dome, France
Passo Fundo, Rio Grande Do Sul, Brazil
Santiago, Region M. De Santiago, Chile
Guiyang, Guizhou, China
Clermont Ferrand, Puy De Dome, France
Safed, , Israel
Bologna, Emilia Romagna, Italy
İzmir, , Turkey
Pelotas, Rio Grande Do Sul, Brazil
Montreal, Quebec, Canada
Beijing, Beijing, China
Beijing, Beijing, China
Yangzhou, Jiangsu, China
Xian, Shaanxi, China
Shanghai, Shanghai, China
Tianjin, Tianjin, China
Hangzhou, Zhejiang, China
Ramat Gan, , Israel
Pavia, , Italy
Kumamoto, , Japan
Poznan, Wielkopolskie, Poland
Moscow, Moskva, Russian Federation
St. Petersburg, Sankt Peterburg, Russian Federation
Cordoba, Andalucia, Spain
Palma De Mallorca, Baleares, Spain
Stanford, California, United States
Khodosivka, Kyivska Oblast, Ukraine
Columbia, Maryland, United States
New Brunswick, New Jersey, United States
Austin, Texas, United States
San Juan, , Argentina
Sao Paulo, , Brazil
Beijing, Beijing, China
Changsha, Hunan, China
Besançon, Doubs, France
Lille, Nord Pas De Calais, France
Haifa, , Israel
Roma, , Italy
Toon,, Ehime, Japan
Kasama, Ibaraki, Japan
Yokosuka, Kanagawa, Japan
Ginowan, Okinawa, Japan
Chuo Ku, Osaka, Japan
Osakasayama, Osaka, Japan
Sayama, Osaka, Japan
Kitaadachi Gun, Saitama, Japan
Koshigaya, Saitama, Japan
Koto, Tokyo, Japan
Koto, Tokyo, Japan
Tokyo, , Japan
Deagu, Taegu Kwangyokshi, Korea, Republic Of
St. Petersburg, Sankt Peterburg, Russian Federation
Durban, Kwazulu Natal, South Africa
Kharlkiv, Kharkivska Oblast, Ukraine
Rosario, Santa Fe, Argentina
Brussels, Bruxelles Capitale, Region De, Belgium
Fortaleza, Ceara, Brazil
Fortaleza, Ceara, Brazil
Beijing, Beijing, China
Hangzhou, Zhejiang, China
San Jose, , Costa Rica
Villejuif, Ile De France, France
Ramat Gan, , Israel
Milano, , Italy
Niigata Shi, Niigata, Japan
Seoul, , Korea, Republic Of
La Paz, Baja California Sur, Mexico
Monterrey, Nuevo Leon, Mexico
Oslo, , Norway
Cordoba, , Spain
Adana, , Turkey
Zaporizhia, Zaporizka Oblast, Ukraine
Richmond, Virginia, United States
Yancheng, Jiangsu, China
Warszawa, Mazowieckie, Poland
Urumqi, Xinjiang, China
Hangzhou, Zhejiang, China
Izmir, , Turkey
Zerifin, , Israel
Shiwa Gun, Iwate, Japan
Koto, Tokyo, Japan
Koto, Tokyo, Japan
Tokyo, , Japan
Inceon, , Korea, Republic Of
Changsha, Hunan, China
Suita, Osaka, Japan
Fukuoka, , Japan
Osaka, , Japan
Gangnam Gu, Seoul, Korea, Republic Of
Monterrey, Nuevo Leon, Mexico
Caba, Buenos Aires, Argentina
Harbin, Heilongjiang, China
Montería, Cordoba, Colombia
Kawasaki, Kanagawa, Japan
Ankara, , Turkey
Herston, Queensland, Australia
Shanghai, Shanghai, China
Santiago, Region M. De Santiago, Chile
Kyoto, , Japan
San Pedro Garza García, Nuevo Leon, Mexico
Nagoya, Aichi, Japan
Namur, , Belgium
São José Do Rio Preto, Sao Paulo, Brazil
Laval, Quebec, Canada
Sherbrooke, Quebec, Canada
Trois Rivières, Quebec, Canada
Quebec, , Canada
Guangzhou, Guangdong, China
Paris, Ile De France, France
Homburg, Saarland, Germany
Toyama, , Japan
Riga, , Latvia
Warszawa, Mazowieckie, Poland
Opole, Opolskie, Poland
Poznan, Wielkopolskie, Poland
Ivanovo, Ivanovskaya Oblast, Russian Federation
Saint Petersburg, Sankt Peterburg, Russian Federation
Kazan, Tatarstan, Respublika, Russian Federation
Madrid, , Spain
Muang, Khon Kaen, Thailand
Ivano Frankivsk, Ivano Frankivska Oblast, Ukraine
Kyiv, Kyivska Oblast, Ukraine
Kyiv, Kyivska Oblast, Ukraine
Vinnytsia, Vinnytska Oblast, Ukraine
Zaporizhia, Zaporizka Oblast, Ukraine
Zaporizhzhia, Zaporizka Oblast, Ukraine
Anderlecht, , Belgium
Brussels, , Belgium
Brussels, , Belgium
Bruxelles, , Belgium
Prague, , Czechia
Praha, , Czechia
Inceon, Incheon, Korea, Republic Of
Ufa, , Russian Federation
Ufa, , Russian Federation
Saransk, , Russian Federation
Kazan, , Russian Federation
Kazan, , Russian Federation
Madrid, , Spain
Valencia, , Spain
Valencia, , Spain
Valencia, , Spain
Valencia, , Spain
Edinburgh, , United Kingdom
London, , United Kingdom
London, , United Kingdom
London, , United Kingdom
London, , United Kingdom
London, , United Kingdom
Patients applied
Trial Officials
Medical Director
Study Director
Merck Sharp & Dohme LLC
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported
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