- ICH GCP
- Registr klinických studií v USA
- Klinická studie NCT02212730
A Study Evaluating the Effect of Pembrolizumab (MK-3475) in Participants With Renal Cell Cancer (MK-3475-031)
22. června 2020 aktualizováno: Merck Sharp & Dohme LLC
A Clinical Trial to Evaluate the Effect of Neoadjuvant MK-3475 (Pembrolizumab) Therapy on Intratumoral Immune Infiltrates in Renal Cell Cancer (RCC) Patients Undergoing Surgical Resection
This study will examine the effect of treatment with the neoadjuvant antibody pembrolizumab (MK-3475) on tumors of participants with renal cell cancer (RCC).
The primary hypotheses are that pembrolizumab is well tolerated in participants undergoing RCC tumor resection; and that pembrolizumab will stimulate a 2-fold or greater increase in intratumoral lymphocytic infiltration in at least 30% of participants with RCC.
Přehled studie
Postavení
Ukončeno
Podmínky
Typ studie
Intervenční
Zápis (Aktuální)
10
Fáze
- Fáze 1
Kritéria účasti
Výzkumníci hledají lidi, kteří odpovídají určitému popisu, kterému se říká kritéria způsobilosti. Některé příklady těchto kritérií jsou celkový zdravotní stav osoby nebo předchozí léčba.
Kritéria způsobilosti
Věk způsobilý ke studiu
18 let a starší (Dospělý, Starší dospělý)
Přijímá zdravé dobrovolníky
Ne
Pohlaví způsobilá ke studiu
Všechno
Popis
Inclusion Criteria:
- Have a newly diagnosed RCC, with a primary tumor diameter of more than 4 cm (>= T1b), not previously treated, and be a candidate for operative tumor resection
- Be willing and able to undergo pre-treatment baseline image-guided core biopsy of their primary RCC
- Have a performance status of 0 or 1 on the Eastern Cooperative Oncology Group (ECOG) Performance Scale
- Demonstrate adequate organ function
- Female is not breast feeding, is postmenopausal or surgically sterile; demonstrates non-pregnant state, and agrees to use two acceptable methods of birth control throughout the trial, until 120 days after the last dose of treatment
- Male with female partner of childbearing potential agrees to use adequate method of contraception throughout study, until 120 days after last dose of treatment or last blood draw.
Exclusion Criteria:
- Is currently participating in, or has participated in a study with an investigational agent or device within 4 weeks prior to first dose of study therapy
- Has a diagnosis of immunosuppression or has received systemic steroid therapy, or any other form of immunosuppressive therapy within 4 weeks prior to first dose of study therapy
- Has had prior chemotherapy, targeted small molecule, or radiation therapy for treatment of RCC
- Has a known additional (other than RCC) malignancy that is progressing or requires active treatment
- Has known active central nervous system (CNS) metastases and/or carcinomatous meningitis
- Has an active, or documented history of autoimmune disease, with the exceptions of vitiligo or resolved childhood asthma/atopy
- Has a history of (non-infectious) pneumonitis that required treatment with steroids or current pneumonitis.
- Has an active infection requiring systematic therapy
- Is receiving anticoagulant therapy, with the exception of low dosage aspirin
- Has severe cardiovascular disease or symptomatic ischemic heart disease
- Has hepatic decompensation
- Has uncontrolled thyroid dysfunction
- Has uncontrolled diabetes mellitus
- Has known psychiatric or substance abuse disorders
- Female is pregnant or breastfeeding
- Is expecting to conceive children within the projected maximum duration of the trial, extending through 120 days after the last dose of treatment or the last blood draw
- Has received prior therapy with any antibody or drug (including ipilimumab) specifically targeting T-cell co-stimulation or checkpoint pathway
- Has a known history of human immunodeficiency virus (HIV)
- Has known active hepatitis B or C
- Has received a live vaccine within 30 days prior to screening
Studijní plán
Tato část poskytuje podrobnosti o studijním plánu, včetně toho, jak je studie navržena a co studie měří.
Jak je studie koncipována?
Detaily designu
- Primární účel: Léčba
- Přidělení: Randomizované
- Intervenční model: Paralelní přiřazení
- Maskování: Žádné (otevřený štítek)
Zbraně a zásahy
Skupina účastníků / Arm |
Intervence / Léčba |
|---|---|
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Experimentální: Neoadjuvant Pembrolizumab + RCC Resection
Participants received pembrolizumab, 200 mg intravenously (IV) once every 3-week cycle for up to 2 cycles followed by standard of care (SOC) renal cell carcinoma (RCC) surgical resection; and then received post-resection pembrolizumab 200 mg IV once every 3 week cycle for up to approximately 1 year (17 cycles).
Post-resection pembrolizumab was only administered to participants who enrolled after Protocol Amendment 04.
|
200 mg administered by IV, once every 3-week cycle for a maximum of 2 cycles
Ostatní jména:
Standard of care surgical resection of RCC tumor
200 mg administered by IV, once every 3-week cycle for a maximum of 17 cycles
Ostatní jména:
|
|
Experimentální: RCC Resection
Participants received SOC renal cell carcinoma (RCC) surgical resection; and then may have received post-resection pembrolizumab 200 mg IV once every 3 week cycle for up to approximately 1 year (17 cycles).
Post-resection pembrolizumab was only administered to participants who enrolled under Protocol Amendment 04.
|
Standard of care surgical resection of RCC tumor
200 mg administered by IV, once every 3-week cycle for a maximum of 17 cycles
Ostatní jména:
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Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
|
Number of Participants With an Adverse Event (AE) During the Neoadjuvant Pembrolizumab Regimen
Časové okno: Up to Week 16
|
An AE was defined as any untoward medical occurrence in a participant administered study treatment and which did not necessarily have to have a causal relationship with this treatment.
The number of participants who experienced an AE during their regimen of neoadjuvant pembrolizumab was presented.
|
Up to Week 16
|
|
Number of Participants Who Discontinued Treatment Due to an Adverse Event
Časové okno: Up to 56 weeks
|
An AE was defined as any untoward medical occurrence in a participant administered study treatment and which did not necessarily have to have a causal relationship with this treatment.
The number of participants who discontinued study drug due to an adverse event is presented.
|
Up to 56 weeks
|
|
Number of Participants Treated With Neoadjuvant Pembrolizumab With a 2-fold or Greater Change From Baseline in Intratumoral CD3+ Lymphocytic Infiltration
Časové okno: Baseline and Week 7
|
The number of participants who received neoadjuvant pembrolizumab and showed a 2-fold or greater change from baseline in intratumoral CD3+ lymphocytic infiltration is presented.
Evaluations were based on pathologist score.
|
Baseline and Week 7
|
|
Number of Participants Treated With Neoadjuvant Pembrolizumab With a 2-fold or Greater Change From Baseline in Intratumoral CD8+ Lymphocytic Infiltration
Časové okno: Baseline and Week 7
|
The number of participants who received neoadjuvant pembrolizumab and showed a 2-fold or greater change from baseline in intratumoral CD8+ lymphocytic infiltration is presented.
Evaluations were based on pathologist score.
|
Baseline and Week 7
|
|
Number of Participants Treated With Neoadjuvant Pembrolizumab With a 2-fold or Greater Change From Baseline in Intratumoral FoxP3+ Lymphocytic Infiltration
Časové okno: Baseline and Week 7
|
The number of participants who received neoadjuvant pembrolizumab and showed a 2-fold or greater change from baseline in intratumoral FoxP3+ (forkhead box protein P3 positive) lymphocytic infiltration is presented.
Evaluations were based on pathologist score.
|
Baseline and Week 7
|
Sekundární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
|
Change From Baseline in Levels of Gene Expression of Immune Modulatory Receptors in Tumors of Participants Treated With Neoadjuvant Pembrolizumab
Časové okno: Baseline and Week 7
|
The change from baseline in levels of gene expression of immune modulatory receptors in tumors of participants treated with neoadjuvant pembrolizumab was presented.
|
Baseline and Week 7
|
|
Change From Baseline in Number of T Cells in Tumors of Participants Treated With Neoadjuvant Pembrolizumab
Časové okno: Baseline and Week 7
|
The change from baseline in number of T cells in tumors of participants treated with neoadjuvant pembrolizumab was presented.
|
Baseline and Week 7
|
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Change From Baseline in Number of Activated T Cells in Peripheral Blood of Participants Treated With Neoadjuvant Pembrolizumab
Časové okno: Baseline and Week 7
|
The change from baseline in the number of activated T cells in peripheral blood of participants treated with neoadjuvant pembrolizumab was presented.
|
Baseline and Week 7
|
|
Change From Baseline in Levels of Programmed Cell Death 1 Ligand 1 (PD-L1) Protein in Tumors of Participants Treated With Neoadjuvant Pembrolizumab
Časové okno: Baseline and Week 7
|
The change from baseline in levels of programmed cell death 1 ligand 1 (PD-L1) protein in tumors of participants treated with neoadjuvant pembrolizumab in participants who received neoadjuvant pembrolizumab was presented.
|
Baseline and Week 7
|
|
Change From Baseline in Levels of Programmed Cell Death 1 Ligand 2 (PD-L2) Protein in Tumors of Participants Treated With Neoadjuvant Pembrolizumab
Časové okno: Baseline and Week 7
|
The change from baseline in levels of programmed cell death 1 ligand 2 (PD-L2) protein in tumors of participants treated with neoadjuvant pembrolizumab in participants who received neoadjuvant pembrolizumab was presented.
|
Baseline and Week 7
|
Spolupracovníci a vyšetřovatelé
Zde najdete lidi a organizace zapojené do této studie.
Sponzor
Termíny studijních záznamů
Tato data sledují průběh záznamů studie a předkládání souhrnných výsledků na ClinicalTrials.gov. Záznamy ze studií a hlášené výsledky jsou před zveřejněním na veřejné webové stránce přezkoumány Národní lékařskou knihovnou (NLM), aby se ujistily, že splňují specifické standardy kontroly kvality.
Hlavní termíny studia
Začátek studia (Aktuální)
3. prosince 2014
Primární dokončení (Aktuální)
5. července 2019
Dokončení studie (Aktuální)
5. července 2019
Termíny zápisu do studia
První předloženo
6. srpna 2014
První předloženo, které splnilo kritéria kontroly kvality
6. srpna 2014
První zveřejněno (Odhad)
8. srpna 2014
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Aktuální)
16. července 2020
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
22. června 2020
Naposledy ověřeno
1. června 2020
Více informací
Termíny související s touto studií
Další relevantní podmínky MeSH
- Novotvary podle histologického typu
- Novotvary
- Urologické novotvary
- Urogenitální novotvary
- Novotvary podle místa
- Onemocnění ledvin
- Urologická onemocnění
- Adenokarcinom
- Karcinom
- Novotvary, žlázové a epiteliální
- Novotvary ledvin
- Karcinom, renální buňka
- Antineoplastická činidla
- Antineoplastická činidla, Imunologická
- Pembrolizumab
Další identifikační čísla studie
- 3475-031
- 2014-002526-12 (Číslo EudraCT)
- MK-3475-031 (Jiný identifikátor: Merck)
- KEYNOTE-031 (Jiný identifikátor: Merck)
Plán pro data jednotlivých účastníků (IPD)
Plánujete sdílet data jednotlivých účastníků (IPD)?
ANO
Popis plánu IPD
http://engagezone.msd.com/doc/ProcedureAccessClinicalTrialData.pdf
Informace o lécích a zařízeních, studijní dokumenty
Studuje produkt zařízení regulovaný americkým úřadem FDA
Ne
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