The study is for patients with advanced melanoma who are eligible for standard therapy with Pembrolizumab.
A Study to Compare Pharmacokinetics, Efficacy, Safety, and Immunogenicity of MB12 (Proposed Pembrolizumab Biosimilar) to Keytruda® in Non-small Cell Lung Cancer (BENITO Study)
This is not medical advice. AI-assisted translation — inaccuracies may occur. Always verify the original and consult your oncologist before taking any steps.
This trial is no longer recruiting — here are similar active trials
Matched by cancer type/biomarker, currently recruiting.
This study, known as LUNAR-2, aims to investigate the effectiveness and safety of using TTFields, delivered by the NovoTTF-200T device, concomitantly administered with pembrolizumab and platinum-based chemotherapy for patients with advanced non-small cell lung cancer that has spread to other parts of the body. The primary goals of the study are to assess overall survival and progression-free survival. Secondary objectives include analyzing outcomes based on the specific histology (subtype) of the lung cancer.
The goal of this randomized, double-blind, multi-regional phase 3 study of cadonilimab combined with chemotherapy versus chemotherapy in combination with or without nivolumab for the first-line treatment of participants with HER2-negative, previously untreated, unresectable or metastatic gastric or gastroesophageal junction adenocarcinoma trial is to compare OS between cadonilimab combined with chemotherapy and chemotherapy in combination with or without nivolumab in the ITT population.
Metastatic colorectal cancer or mCRC is a cancer that starts in the parts of the large intestine (the colon or rectum) and has already spread to other parts of the body. This cancer can be hard to treat because it can behave differently from one person to another. Over time, treatments may stop working, and side effects can build up. In later treatment stages, there are only a few standard medicine options available. Because of this, studies often look at both how long people live and how treatment affects quality of life. The main aim of this study is to see how long adults in Poland with mCRC live without their cancer getting worse (progression-free survival or PFS) when they receive fruquintinib after at least two previous treatments. Fruquintinib (TAK 113) is a medicine taken by mouth that is designed to slow tumor growth. Other aim is to find out how long adults in Poland with mCRC live while being treated with fruquintinib (overall survival or OS). The study also wants to record how fruquintinib is used in routine care in adults with mCRC in Poland (for example when treatment starts, changes in doses, and how long treatment continues). Another aim is to learn about people with mCRC, such as their medical history and past treatment as well as their quality of life while they are in the study. The study will look at data already existing in the participants' medical charts.
About the trial
This is a randomized, multicenter, multinational, double-blind, integrated pharmacokinetics (PK) and efficacy similarity study to compare the PK, efficacy, safety, and immunogenicity of MB12 versus Keytruda® in combination with pemetrexed-platinum chemotherapy as first-line treatment in patients with metastatic non-squamous NSCLC.
Original English text from ClinicalTrials.gov
Who can (and can't) join
✓ Qualifies
- •Wiek minimum 18 lat
- •Potwierdzony zaawansowany rak płuca, etap IV (bez mutacji EGFR i translokacji ALK)
- •Brak wcześniejszego leczenia systemowego tego raka
- •Co najmniej jeden widoczny guz do pomiaru na badaniach obrazowych
- •Znany status markera PD-L1
- •Dobra ogólna kondycja zdrowotna (ECOG ≤1)
- •Prawidłowe wyniki badań wątroby, nerek i krwi
✗ Disqualifies
- •Rak płuca typu płaskonabłonkowego
- •Przerzuty do mózgu lub błon mózgowo-rdzeniowych
- •Wcześniejsze leczenie immunologiczne (anti-PD-1, anti-PD-L1 lub podobne)
- •Poważna operacja w ciągu 3 tygodni przed rozpoczęciem leczenia
- •Aktywna choroba autoimmunologiczna wymagająca leczenia w ostatnich 2 latach
- •Uczulenie na pembrolizumab lub jego składniki
- •Uczulenie na chemioterapię (cisplatyna, karboplatyna, pemetreksed)
Simplified criteria — AI translation
Trial details
- Minimum age
- 18 Years
- Last updated (source)
- September 10, 2026
- Sex
- No restrictions
Therapies / drugs in trial
Locations (173)
Site 101001
Yerevan, Armenia
Site 101002
Yerevan, Armenia
Site 101003
Yerevan, Armenia
Site 101004
Yerevan, Armenia
Site 103001
Sarajevo, Bosnia and Herzegovina
Site 103002
Tuzla, Bosnia and Herzegovina
Site 103003
Zenica, Bosnia and Herzegovina
Site 301014
Barretos, Brazil
Site 301026
Belém, Brazil
Site 301002
Belo Horizonte, Brazil
Site 301023
Bento Gonçalves, Brazil
Site 301006
Blumenau, Brazil
Site 301019
Caxias do Sul, Brazil
Site 301015
Curitiba, Brazil
Site 301028
Curitiba, Brazil
Site 301024
Florianópolis, Brazil
Site 301010
Fortaleza, Brazil
Site 301011
Ijuí, Brazil
Site 301008
Itajaí, Brazil
Site 301012
Jaú, Brazil
Site 301018
Natal, Brazil
Site 301003
Porto Alegre, Brazil
Site 301005
Porto Alegre, Brazil
Site 301007
Porto Alegre, Brazil
Site 301016
Porto Alegre, Brazil
Site 301022
Recife, Brazil
Site 301009
Rio de Janeiro, Brazil
Site 301020
Santo André, Brazil
Site 301001
São José do Rio Preto, Brazil
Site 108004
Batumi, Georgia
Site 108005
Kutaisi, Georgia
Site 108011
Marneuli, Georgia
Site 108001
Tbilisi, Georgia
Site 108002
Tbilisi, Georgia
Site 108003
Tbilisi, Georgia
Site 108006
Tbilisi, Georgia
Site 108007
Tbilisi, Georgia
Site 108008
Tbilisi, Georgia
Site 108009
Tbilisi, Georgia
Site 108010
Tbilisi, Georgia
Site 108012
Tbilisi, Georgia
Site 110006
Athens, Greece
Site 110003
Kifissia, Greece
Site 110004
Larissa, Greece
Site 110009
Pátrai, Greece
Site 110001
Thessaloniki, Greece
Site 110002
Thessaloniki, Greece
Site 110005
Thessaloniki, Greece
Site 110008
Thessaloniki, Greece
Site 110010
Volos, Greece
Site 113012
Brescia, Italy
Site 113010
Cremona, Italy
Site 113007
Genova, Italy
Site 113011
Lecce, Italy
Site 113009
Meldola, Italy
Site 113001
Pavia, Italy
Site 113003
Roma, Italy
Site 113006
Roma, Italy
Site 113005
Siena, Italy
Site 113008
Torino, Italy
Site 207002
Hakodate-shi, Japan
Site 207012
Okayama, Japan
Site 207010
Shinagawa-Ku, Japan
Site 207001
Shizuoka, Japan
Site 114001
Amman, Jordan
Site 114002
Amman, Jordan
Site 114003
Amman, Jordan
Site 114004
Amman, Jordan
Site 114005
Amman, Jordan
Site 114007
Amman, Jordan
Site 114006
Irbid, Jordan
Site 202001
Cheras, Malaysia
Site 202002
Kota Bharu, Malaysia
Site 202003
Kuala Selangor, Malaysia
Research site 116001
Chisinau, Moldova
Site 304001
Panama City, Panama
Site 304002
Panama City, Panama
Site 304003
Panama City, Panama
Site 203006
Bacolod City, Philippines
Site 203003
Baguio City, Philippines
Site 203004
Iloilo City, Philippines
Site 203009
Iloilo City, Philippines
Site 203005
Makati City, Philippines
Site 203007
Manila, Philippines
Site 203002
Quezon City, Philippines
Site 118004
Katowice, Poland
Site 118001
Lodz, Poland
Site 118005
Lublin, Poland
Site 118002
Prabuty, Poland
Site 118003
Słupsk, Poland
Site 119001
Lisbon, Portugal
Site 119002
Matosinhos Municipality, Portugal
Site 119003
Porto, Portugal
Site 120001
Cluj-Napoca, Romania
Site 120003
Craiova, Romania
Site 120004
Craiova, Romania
Site 120006
Floreşti, Romania
Site 120005
Timișoara, Romania
Site 121001
Belgrade, Serbia
Site 121002
Belgrade, Serbia
Site 121004
Kamenitz, Serbia
Site 121003
Kragujevac, Serbia
Site 121005
Užice, Serbia
Site 122003
Bardejov, Slovakia
Site 122001
Bratislava, Slovakia
Site 122002
Partizánske, Slovakia
Site 123005
Johannesburg, South Africa
Site 123006
Johannesburg, South Africa
Site 123007
Kraaifontein, South Africa
Site 123004
KwaZulu, South Africa
Site 123002
Port Elizabeth, South Africa
Site 123001
Pretoria, South Africa
Site 123003
Pretoria, South Africa
Site 204005
Busan, South Korea
Site 204004
Gyeonggi-do, South Korea
Site 204006
Gyeonggi-do, South Korea
Site 204001
Incheon, South Korea
Site 204002
Seoul, South Korea
Site 204007
Seoul, South Korea
Site 124006
A Coruña, Spain
Site 124002
Barcelona, Spain
Site 124013
Barcelona, Spain
Site 124007
Madrid, Spain
Site 124009
Madrid, Spain
Site 124011
Madrid, Spain
Site 124012
Madrid, Spain
Site 124008
Málaga, Spain
Site 124016
Murcia, Spain
Site 124003
Oviedo, Spain
Site 124001
Palma de Mallorca, Spain
Site 124014
Pontevedra, Spain
Site 124005
Sant Joan Despí, Spain
Site 124010
Santiago de Compostela, Spain
Site 124004
Seville, Spain
Site 124015
Valencia, Spain
Site 205003
Kaohsiung City, Taiwan
Site 205009
Kaohsiung City, Taiwan
Site 205004
Liuying, Taiwan
Site 205002
Taichung, Taiwan
Site 205008
Taichung, Taiwan
Site 205005
Tainan, Taiwan
Site 205006
Taipei, Taiwan
Site 205007
Taipei, Taiwan
Site 206004
Bangkok, Thailand
Site 206005
Bangkok, Thailand
Site 206001
Chiang Mai, Thailand
Site 206007
Chiang Rai, Thailand
Site 206003
Khon Kaen, Thailand
Site 206002
Nakhon Nayok, Thailand
Site 206006
Songkhla, Thailand
Site 112002
Aryanah, Tunisia
Site 112003
Aryanah, Tunisia
Site 112004
Aryanah, Tunisia
Site 112001
Sfax, Tunisia
Site 112005
Tunis, Tunisia
Site 125017
Adana, Turkey (Türkiye)
Site 125006
Alanya, Turkey (Türkiye)
Site 125001
Ankara, Turkey (Türkiye)
Site 125002
Ankara, Turkey (Türkiye)
Site 125004
Ankara, Turkey (Türkiye)
Site 125008
Ankara, Turkey (Türkiye)
Site 125009
Ankara, Turkey (Türkiye)
Site 125019
Ankara, Turkey (Türkiye)
Site 125003
Istanbul, Turkey (Türkiye)
Site 125010
Istanbul, Turkey (Türkiye)
Site 125011
Istanbul, Turkey (Türkiye)
Site 125012
Istanbul, Turkey (Türkiye)
Site 125018
Istanbul, Turkey (Türkiye)
Site 125015
Izmir, Turkey (Türkiye)
Site 125023
Sakarya, Turkey (Türkiye)
Site 125013
Samsun, Turkey (Türkiye)
Site 125007
Tekirdağ, Turkey (Türkiye)
Site 125014
Yüreğir, Turkey (Türkiye)
Share this trial
Data from ClinicalTrials.gov. AI-assisted translation, last sync: 8/28/2026.
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