Delstudie 01I: En studie av utredningsmedel hos deltagare med tidigare behandlade stadium IV skivepitelcancer, icke-småcellig lungcancer (NSCLC) (MK-3475-01I/KEYMAKER-U01I)
KEYMAKER-U01 Delstudie 01I: En fas 2, randomiserad, paraplystudie med rullande armar av utredningsagenter hos deltagare med tidigare behandlad stadium IV skivepitelcancer icke-småcellig lungcancer (NSCLC)
Researchers are looking for other ways to treat metastatic squamous non-small cell lung cancer (NSCLC). Squamous NSCLC is cancer that starts in squamous cells, which are flat cells that line the inside of the airways in the lungs. Metastatic means the cancer has spread to other parts of the body.
Standard treatment (usual treatment) for metastatic squamous NSCLC is immunotherapy with or without chemotherapy. Immunotherapy is a treatment that helps the immune system fight cancer. Chemotherapy is medicine that destroys cancer cells or stops them from growing. However, standard treatment may not work or may stop working to treat metastatic squamous NSCLC.
Researchers want to learn if study treatments that are antibody drug conjugates (ADCs) can treat metastatic squamous NSCLC that did not respond (get smaller or go away) to standard treatment. An ADC attaches to a protein on cancer cells and delivers treatment to destroy those cells.
The main goals of this study are to learn about:
- The cancer response to the study treatments compared to chemotherapy
- The safety of the study treatments and if people tolerate them
This study is one of the substudies being conducted under one pembrolizumab umbrella master protocol (MK-3475-U01/KEYMAKER-U01).
Studieöversikt
Status
Betingelser
Intervention / Behandling
Detaljerad beskrivning
The master screening protocol is MK-3475-U01 (KEYMAKER-U01) - NCT04165798
Studietyp
Inskrivning (Beräknad)
Fas
- Fas 2
Kontakter och platser
Studiekontakt
- Namn: Toll Free Number
- Telefonnummer: 1-888-577-8839
- E-post: Trialsites@msd.com
Studieorter
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Region M. de Santiago
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Santiago, Region M. de Santiago, Chile, 7500653
- Rekrytering
- Centro de Estudios Clínicos SAGA ( Site 0161)
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Kontakt:
- Study Coordinator
- Telefonnummer: +56991612199
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Santiago, Region M. de Santiago, Chile, 8420383
- Rekrytering
- Bradfordhill ( Site 0162)
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Kontakt:
- Study Coordinator
- Telefonnummer: +56229490970
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Santiago, Region M. de Santiago, Chile, 7500921
- Rekrytering
- Fundación Arturo López Pérez ( Site 0160)
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Kontakt:
- Study Coordinator
- Telefonnummer: 56227128000
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Kentucky
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Lexington, Kentucky, Förenta staterna, 40536-0293
- Rekrytering
- University of Kentucky Chandler Medical Center ( Site 0019)
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Kontakt:
- Study Coordinator
- Telefonnummer: 859-257-1000
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Maryland
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Baltimore, Maryland, Förenta staterna, 21237
- Rekrytering
- MedStar Franklin Square Medical Center ( Site 0033)
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Kontakt:
- Study Coordinator
- Telefonnummer: 443-777-7147
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Texas
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Dallas, Texas, Förenta staterna, 75246-2046
- Rekrytering
- Texas Oncology - DFW ( Site 8003)
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Kontakt:
- Study Coordinator
- Telefonnummer: 214-370-1067
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Virginia
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Fairfax, Virginia, Förenta staterna, 22031
- Rekrytering
- Virginia Cancer Specialists (VCS) ( Site 0408)
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Kontakt:
- Study Coordinator
- Telefonnummer: 703-280-5390
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Thessaloniki, Grekland, 570 01
- Rekrytering
- European Interbalkan Medical Center-Oncology Department ( Site 0205)
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Kontakt:
- Study Coordinator
- Telefonnummer: 0030 2310400213
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Attica
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Athens, Attica, Grekland, 115 27
- Rekrytering
- THORACIC GENERAL HOSPITAL OF ATHENS "I SOTIRIA" ( Site 0204)
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Kontakt:
- Study Coordinator
- Telefonnummer: 0030 2107700220
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Athens, Attica, Grekland, 116 34
- Rekrytering
- F. THERAPIS GENERAL ( Site 0206)
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Kontakt:
- Study Coordinator
- Telefonnummer: +302107291111
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Haifa, Israel, 3109601
- Rekrytering
- Rambam Health Care Campus ( Site 0076)
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Kontakt:
- Study Coordinator
- Telefonnummer: +972 47776234
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Jerusalem, Israel, 9103102
- Rekrytering
- Shaare Zedek Medical Center ( Site 0075)
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Kontakt:
- Study Coordinator
- Telefonnummer: +972-2-6555768
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Kfar Saba, Israel, 4428164
- Rekrytering
- Meir Medical Center ( Site 0071)
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Kontakt:
- Study Coordinator
- Telefonnummer: +97297472414
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Petah Tikva, Israel, 4941492
- Rekrytering
- Rabin Medical Center ( Site 0074)
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Kontakt:
- Study Coordinator
- Telefonnummer: +97239378101
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Ramat Gan, Israel, 5265601
- Rekrytering
- Sheba Medical Center ( Site 0070)
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Kontakt:
- Study Coordinator
- Telefonnummer: +97235307032
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Tel Aviv, Israel, 6423906
- Rekrytering
- Sourasky Medical Center ( Site 0077)
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Kontakt:
- Study Coordinator
- Telefonnummer: +972-3-6973082
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Florence, Italien, 50134
- Rekrytering
- Azienda Ospedaliera Universitaria Careggi ( Site 0173)
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Kontakt:
- Study Coordinator
- Telefonnummer: +393209225506
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Milan, Italien, 20132
- Rekrytering
- IRCCS Ospedale San Raffaele ( Site 0171)
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Kontakt:
- Study Coordinator
- Telefonnummer: +390223903829
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Milan, Italien, 20133
- Rekrytering
- Fondazione IRCCS Istituto Nazionale dei Tumori ( Site 0175)
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Kontakt:
- Study Coordinator
- Telefonnummer: 390223902190
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Roma, Italien, 00168
- Rekrytering
- Fondazione Policlinico Universitario Agostino Gemelli IRCCS - Università Cattolica del Sacro Cuore ( Site 0174)
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Kontakt:
- Study Coordinator
- Telefonnummer: +390630156318
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Beijing Municipality
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Beijing, Beijing Municipality, Kina, 100142
- Rekrytering
- Beijing Cancer Hospital ( Site 0301)
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Kontakt:
- Study Coordinator
- Telefonnummer: 010-88121122
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Chongqing Municipality
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Chongqing, Chongqing Municipality, Kina, 400030
- Rekrytering
- Chongqing University Cancer Hospital ( Site 0304)
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Kontakt:
- Study Coordinator
- Telefonnummer: +86023-65311341
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Fujian
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Fuzhou, Fujian, Kina, 350014
- Rekrytering
- Fujian Provincial Cancer Hospital ( Site 0310)
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Kontakt:
- Study Coordinator
- Telefonnummer: 0591-83660063
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Guangxi
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Nanning, Guangxi, Kina, 530201
- Rekrytering
- Guangxi Medical University Cancer Hospital ( Site 0303)
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Kontakt:
- Study Coordinator
- Telefonnummer: 0771-5323175
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Henan
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Zhengzhou, Henan, Kina, 450000
- Rekrytering
- Henan Cancer Hospital ( Site 0311)
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Kontakt:
- Study Coordinator
- Telefonnummer: +8613837174273
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Jiangsu
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Nanjing, Jiangsu, Kina, 210008
- Rekrytering
- Nanjing Drum Tower Hospital JiangBei International Branch Hospital ( Site 0309)
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Kontakt:
- Study Coordinator
- Telefonnummer: +86021-65115006
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Shanghai Municipality
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Shanghai, Shanghai Municipality, Kina, 200433
- Rekrytering
- Shanghai Pulmonary Hospital ( Site 0300)
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Kontakt:
- Study Coordinator
- Telefonnummer: 021-65115006
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Shanghai, Shanghai Municipality, Kina, 200030
- Rekrytering
- Shanghai Chest Hospital ( Site 0308)
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Kontakt:
- Study Coordinator
- Telefonnummer: 021-63846590
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Greater Poland Voivodeship
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Poznan, Greater Poland Voivodeship, Polen, 60-569
- Rekrytering
- Wielkopolskie Centrum Pulmonologii i Torakochirurgii ( Site 0153)
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Kontakt:
- Study Coordinator
- Telefonnummer: +48616654242
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Masovian Voivodeship
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Warsaw, Masovian Voivodeship, Polen, 02-781
- Rekrytering
- Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie - Panstwowy Instytut Badawczy w Warszawie ( Site 0151)
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Kontakt:
- Study Coordinator
- Telefonnummer: +48225463066
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Pomeranian Voivodeship
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Gdansk, Pomeranian Voivodeship, Polen, 80-214
- Rekrytering
- Uniwersyteckie Centrum Kliniczne-Early Clinical Trials Unit ( Site 0150)
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Kontakt:
- Study Coordinator
- Telefonnummer: +48585844466
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West Pomeranian Voivodeship
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Koszalin, West Pomeranian Voivodeship, Polen, 75-581
- Rekrytering
- Szpital Wojewódzki im. Mikoaja Kopernika w Koszalinie ( Site 0152)
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Kontakt:
- Study Coordinator
- Telefonnummer: +48943488930
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Madrid, Spanien, 28223
- Rekrytering
- Hospital Universitario Quiron Madrid ( Site 0091)
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Kontakt:
- Study Coordinator
- Telefonnummer: 34914521987
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Seville, Spanien, 41009
- Rekrytering
- Hospital Universitario Virgen Macarena ( Site 0094)
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Kontakt:
- Study Coordinator
- Telefonnummer: +34 671560092
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Barcelona
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L'Hospitalet de Llobregat, Barcelona, Spanien, 08908
- Rekrytering
- Institut Català d'Oncologia - L'Hospitalet ( Site 0090)
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Kontakt:
- Study Coordinator
- Telefonnummer: 0034932607744
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Catalonia
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Barcelona, Catalonia, Spanien, 08036
- Rekrytering
- Hospital Clinic de Barcelona ( Site 0092)
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Kontakt:
- Study Coordinator
- Telefonnummer: 34 932275402
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Adana, Turkiet (Türkiye), 01250
- Rekrytering
- Baskent University Dr. Turgut Noyan Research and Training Center-ONCOLOGY ( Site 0141)
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Kontakt:
- Study Coordinator
- Telefonnummer: +905353067506
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Ankara, Turkiet (Türkiye), 06230
- Rekrytering
- Hacettepe Universitesi Tip Fakultesi Hastanesi ( Site 0140)
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Kontakt:
- Study Coordinator
- Telefonnummer: +90 312 305 43 36
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Ankara, Turkiet (Türkiye), 06800
- Rekrytering
- Ankara Bilkent Şehir Hastanesi. ( Site 0142)
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Kontakt:
- Study Coordinator
- Telefonnummer: +903125529999
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Istanbul, Turkiet (Türkiye), 34098
- Rekrytering
- Istanbul Universitesi Cerrahpasa Tip Fakultesi ( Site 0144)
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Kontakt:
- Study Coordinator
- Telefonnummer: +902124143000
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İzmir
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Izmir, İzmir, Turkiet (Türkiye), 35100
- Rekrytering
- Ege Universitesi Hastanesi ( Site 0143)
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Kontakt:
- Study Coordinator
- Telefonnummer: +90 232 343 43 43
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Berlin, Tyskland, 13353
- Rekrytering
- Charite-Universitaetsmedizin Berlin ( Site 0191)
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Kontakt:
- Study Coordinator
- Telefonnummer: +49 30 450 553 044
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Baden-Wurttemberg
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Tübingen, Baden-Wurttemberg, Tyskland, 72076
- Rekrytering
- UniversitaetsklInikum Tuebingen ( Site 0192)
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Kontakt:
- Study Coordinator
- Telefonnummer: +4970712982795
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Bács-Kiskun county
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Kecskemét, Bács-Kiskun county, Ungern, 6000
- Rekrytering
- Bacs-Kiskun Varmegyei Oktatokorhaz ( Site 0063)
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Kontakt:
- Study Coordinator
- Telefonnummer: +3676516700
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Győr-Moson-Sopron
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Győr, Győr-Moson-Sopron, Ungern, 9024
- Rekrytering
- Petz Aladar Egyetemi Oktato Korhaz ( Site 0062)
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Kontakt:
- Study Coordinator
- Telefonnummer: +3696507900
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Jász-Nagykun-Szolnok
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Szolnok, Jász-Nagykun-Szolnok, Ungern, 5000
- Rekrytering
- Jasz-Nagykun-Szolnok Varmegyei Hetenyi Geza Korhaz-Rendelointezet ( Site 0061)
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Kontakt:
- Study Coordinator
- Telefonnummer: +3656503603
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Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
Tar emot friska volontärer
Kön som är behöriga för studier
Beskrivning
Inclusion Criteria:
The main inclusion criteria include but are not limited to the following:
- Histologically or cytologically confirmed diagnosis of Stage IV squamous non-small cell lung cancer (NSCLC)
- Has documented disease progression per Response Evaluation Criteria In Solid Tumors 1.1 (RECIST 1.1), as assessed by investigator after receiving an anti-programmed cell death protein 1 (anti-PD-1)/programmed cell death ligand 1 (PD-L1) treatment and platinum-based chemotherapy for Stage IV disease
- Human immunodeficiency virus (HIV)-infected participants must have well controlled HIV on antiretroviral therapy (ART)
- Participants who are Hepatitis B surface antigen (HBsAg) positive are eligible if they have received Hepatitis B virus (HBV) antiviral therapy for at least 4 weeks, and have undetectable HBV viral load
- Participants with history of Hepatitis C virus (HCV) infection are eligible if HCV viral load is undetectable
Exclusion Criteria:
The main exclusion criteria include but are not limited to the following:
- Diagnosis of small cell lung cancer or, for mixed tumors, presence of small cell elements
- Has uncontrolled or significant cardiovascular disorder
- Clinically severe pulmonary compromise resulting from intercurrent pulmonary illnesses including, but not limited to, any underlying pulmonary disorder (ie, pulmonary emboli within 3 months, severe asthma, severe chronic obstructive pulmonary disease, restrictive lung disease, pleural effusion, etc), or any autoimmune, connective tissue, or inflammatory disorders with pulmonary involvement (ie, rheumatoid arthritis, Sjogren's syndrome, sarcoidosis, etc), or prior pneumonectomy
- Participants who have adverse events (AEs) (other than alopecia) due to previous anticancer therapies must have recovered to ≤Grade 1 or baseline
- Has clinically significant corneal disease
- Has previously received docetaxel as monotherapy or in combination with other therapies
- Known additional malignancy that is progressing or has required active treatment within the past 3 years
- Has known untreated central nervous system (CNS) metastases and/or carcinomatous meningitis
- Evidence of any leptomeningeal disease
- Has one or more of the following indicators of interstitial lung disease (ILD)/pneumonitis: any history of ILD/pneumonitis irrespective of steroid use (except for a history of radiation pneumonitis that did not require steroids), current diagnosis of ILD, clinical or radiographic suspicion of ILD
- Active autoimmune disease that has required systemic treatment in the past 2 years. Replacement therapy (eg, thyroxine, insulin, or physiologic corticosteroid) is allowed
- Active infection requiring systemic therapy
- HIV-infected participants with a history of Kaposi's sarcoma and/or Multicentric Castleman's Disease
- Active inflammatory bowel disease requiring immunosuppressive medication or previous clear history of inflammatory bowel disease (eg, Crohn's disease, ulcerative colitis, or chronic diarrhea)
- Known history of, or active, neurologic paraneoplastic syndrome
- History of allogeneic tissue/solid organ transplant
- Has not adequately recovered from major surgery or have ongoing surgical complications
Studieplan
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Behandling
- Tilldelning: Randomiserad
- Interventionsmodell: Parallellt uppdrag
- Maskning: Enda
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
|
Experimentell: Arm 1: Raludotatug deruxtecan (R-DXD)
Participants receive 5.6 mg/kg of R-DXD, every 3 weeks (Q3W) (Day 1 of every 21-day cycle) via intravenous (IV) infusion until progressive disease (PD) or discontinuation. |
IV Infusion
Andra namn:
Participants receive rescue medications consisting of a combination regimen to include corticosteroids with a 5-hydroxytryptamine subtype 3 receptor antagonist and/or a neurokinin-1 receptor antagonist, all per approved product label and following institutional standards or local guidelines. |
|
Experimentell: Arm 3: I-DXD Low Dose
Participants receive 8 mg/kg of I-DXD, Q3W (Day 1 of every 21-day cycle) via IV infusion until PD or discontinuation. |
Participants receive rescue medications consisting of a combination regimen to include corticosteroids with a 5-hydroxytryptamine subtype 3 receptor antagonist and/or a neurokinin-1 receptor antagonist, all per approved product label and following institutional standards or local guidelines. IV Infusion
Andra namn:
|
|
Aktiv komparator: Arm 4: Docetaxel
Participants receive 75 mg/m^2 of Docetaxel, Q3W (Day 1 of every 21-day cycle) via IV infusion until PD or discontinuation. |
IV Infusion
Andra namn:
Participants are premedicated with corticosteroids per approved product label and following institutional standards or local guidelines. |
|
Experimentell: Arm 2: Ifinatamab deruxtecan (I-DXD) High Dose
Participants receive 12 mg/kg of I-DXD, Q3W (Day 1 of every 21-day cycle) via IV infusion until PD or discontinuation. |
Participants receive rescue medications consisting of a combination regimen to include corticosteroids with a 5-hydroxytryptamine subtype 3 receptor antagonist and/or a neurokinin-1 receptor antagonist, all per approved product label and following institutional standards or local guidelines. IV Infusion
Andra namn:
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Objective Response Rate (ORR)
Tidsram: Up to approximately 81 months
|
ORR is defined as the percentage of participants with Complete Response (CR: disappearance of all target lesions) or Partial Response (PR: at least a 30% decrease in the sum of diameters of target lesions) as assessed per Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1). ORR will be assessed by Blinded Independent Central Review (BICR). The percentage of participants who experience CR or PR as assessed by the investigator will be presented. |
Up to approximately 81 months
|
|
Number of participants who experience one or more adverse events (AEs)
Tidsram: Up to approximately 81 months
|
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. The number of participants who experience an AE will be reported. |
Up to approximately 81 months
|
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Number of participants who discontinue study intervention due to an AE
Tidsram: Up to approximately 81 months
|
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. The number of participants who discontinue study treatment due to an AE will be reported. |
Up to approximately 81 months
|
Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Duration of Response (DOR)
Tidsram: Up to approximately 81 months
|
For participants who demonstrate a confirmed CR (disappearance of all target lesions) or PR (at least a 30% decrease in the sum of diameters of target lesions) per RECIST 1.1, DOR is defined as the time from first documented evidence of CR or PR until PD or death. Per RECIST 1.1, PD is defined as at least a 20% increase in the sum of diameters of target lesions. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. The appearance of one or more new lesions is also considered PD. DOR as assessed by BICR will be presented. |
Up to approximately 81 months
|
|
Progression-free Survival (PFS)
Tidsram: Up to approximately 81 months
|
PFS is defined as the time from randomization to the first documented PD or death due to any cause, whichever occurs first as assessed by (RECIST 1.1). PD is defined as ≥20% increase in the sum of diameters of target lesions. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of ≥5 mm. The appearance of one or more new lesions is also considered PD. PFS as assessed by BICR will be presented. |
Up to approximately 81 months
|
|
Overall Survival (OS)
Tidsram: Up to approximately 81 months
|
OS is defined as time from randomization to death due to any cause. |
Up to approximately 81 months
|
Samarbetspartners och utredare
Sponsor
Samarbetspartners
Utredare
- Studierektor: Medical Director, Merck Sharp & Dohme LLC
Publikationer och användbara länkar
Användbara länkar
Studieavstämningsdatum
Studera stora datum
Studiestart (Faktisk)
Primärt slutförande (Beräknad)
Avslutad studie (Beräknad)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Faktisk)
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- 3475-01I
- MK-3475-01I (Annan identifierare: MSD)
- U1111-1314-2392 (Registeridentifierare: UTN)
- KEYMAKER-01I (Annan identifierare: MSD)
- 2024-518839-11-00 (Registeridentifierare: EU CT)
Plan för individuella deltagardata (IPD)
Planerar du att dela individuella deltagardata (IPD)?
IPD-planbeskrivning
https://trialstransparency.msdclinicaltrials.com/pdf/ProcedureAccessClinicalTrialData.pdf
Läkemedels- och apparatinformation, studiedokument
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