Tutkimus Cemiplimab Plus -kemoterapiasta verrattuna Cemiplimab Plus -kemoterapiaan ja muihin syöpähoitoihin aikuispotilaille, joilla on operatiivista ei-pienisoluista keuhkosyöpää (NSCLC)
Satunnaistettu vaiheen 2 alustatutkimus Cemiplimab Plus -kemoterapian ja Cemiplimab Plus -kemoterapian ja muiden syöpähoitojen arvioimiseksi leikkaushoitoon tarkoitettujen potilaiden, joilla on ei-pienisoluinen keuhkosyöpä, perioperatiiviseen hoitoon
This study will enroll adult participants with early-stage (stage II-IIIB) non-small cell lung cancer (NSCLC) for whom surgery is planned, in the resectable NSCLC portion.
The aim of the resectable NSCLC portion is to find out whether an investigational treatment (consisting of the immunotherapy drug cemiplimab plus chemotherapy plus a third drug) works better than cemiplimab plus chemotherapy without the additional drug.
For each investigational arm, the available data will be reviewed to decide whether safety testing with chemotherapy is needed before moving the treatment combination to the main resectable NSCLC portion of the study. If safety testing with chemotherapy is required, adult participants whose tumour has spread to other organs or cannot be removed by surgery, will be enrolled in the unresectable/metastatic NSCLC portion of the study called the "safety lead-in."
The aim of the unresectable/metastatic NSCLC safety lead-in portion is to evaluate the safety of the combination of Cemiplimab, chemotherapy, and an additional drug in participants with unresectable or metastatic NSCLC.
For the resectable NSCLC portion, the study is also looking at several other research questions, including:
- What are the side effects associated with the investigational treatments in comparison to the control treatment
- Do the investigational treatments or the control treatment have an effect on the type of surgery that is performed
- How much of the study drug(s) are in the blood at a given time
- Does the body make antibodies against the study drug(s) (which could make the drug(s) less effective or could lead to side effects)
For the unresectable/metastatic NSCLC portion, the study is also looking at several other research questions, including:
- What are the side effects associated with the additional drug in combination with cemiplimab and chemotherapy
- How does the additional drug work in combination with cemiplimab and chemotherapy
Tutkimuksen yleiskatsaus
Tila
Interventio / Hoito
Opintotyyppi
Ilmoittautuminen (Arvioitu)
Vaihe
- Vaihe 2
Yhteystiedot ja paikat
Opiskelupaikat
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São Paulo, Brasilia, 01323-903
- Hospital Alemao Oswaldo Cruz
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Espírito Santo
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Cachoeiro de Itapemirim, Espírito Santo, Brasilia, 29306014
- Oncology Clinical Research Center
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Minas Gerais
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Belo Horizonte, Minas Gerais, Brasilia, 30380-472
- Instituto Mario Penna
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Pouso Alegre, Minas Gerais, Brasilia, 37554-238
- Instituto Sul Mineiro De Oncologia LTDA
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Pernambuco
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Recife, Pernambuco, Brasilia, 50070-902
- Instituto de Medicina Integral Professor Fernando Figueira
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Rio Grande do Norte
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Natal, Rio Grande do Norte, Brasilia, 59060-195
- Liga Norte Riograndense Contra o Cancer
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Rio Grande do Sul
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Porto Alegre, Rio Grande do Sul, Brasilia, 90610-000
- Hospital Sao Lucas da PUCRS
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Porto Alegre, Rio Grande do Sul, Brasilia, 90110-270
- Hospital Mae de Deus Integrated Oncology Center
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Santa Catarina
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Florianópolis, Santa Catarina, Brasilia, 88020-210
- Ynova Pesquisa Clinica
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São Paulo
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Sorocaba, São Paulo, Brasilia, 18065-100
- Unimed Sorocaba
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São José do Rio Preto, São Paulo, Brasilia, 15090-000
- Fundacao Faculdade Regional de Medicina de Sao Jose do Rio Preto
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Madrid, Espanja, 28046
- Hospital Universitario La Paz
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Madrid, Espanja, 28040
- Hospital Universitario Clinico San Carlos
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Madrid, Espanja, 28033
- MD Anderson Cancer Center
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Madrid, Espanja, 28050
- Hospital Universitario HM Sanchinarro
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Seville, Espanja, 41013
- Hospital Virgen del Rocio
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Valencia, Espanja, 46014
- Consorci Hospital General Universitario de Valencia
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Valencia, Espanja, 46010
- Hospital Clinico Universitario Valencia
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Zaragoza, Espanja, 50009
- Hospital Clinico Lozano Blesa
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Barcelona
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Badalona, Barcelona, Espanja, 08916
- Catalan Instituye of Oncology Badalona
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Cantabria
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Santander, Cantabria, Espanja, 39008
- Hospital Valdecilla
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Las Palmas
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Las Palmas de Gran Canaria, Las Palmas, Espanja, 35016
- Hospital Universitario Insular de Gran Canaria
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Navarre
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Pamplona, Navarre, Espanja, 31008
- Clinica Universidad de Navarra
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Bayonne, Ranska, 64100
- Clinique Belharra
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Bayonne, Ranska, 64100
- Centre Hospitalier de la Cote Basque
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Grenoble, Ranska, 38330
- CHU Grenoble Alpes
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Montpellier, Ranska, 34295
- Montpellier Academic Hospital
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Brittany Region
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Rennes, Brittany Region, Ranska, 35033
- CHU Rennes
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Var
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Toulon, Var, Ranska, 83055
- Centre Hospitalier Intercommunal Toulon - CHITS
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Île-de-France Region
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Paris, Île-de-France Region, Ranska, 75005
- Institut Curie
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Aachen, Saksa, 52074
- University Hospital RWTH Aachen
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Hesse
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Kassel, Hesse, Saksa, 34125
- Klinikum Kassel GmbH, Hauttumorzentrum
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Lower Saxony
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Göttingen, Lower Saxony, Saksa, 37083
- University Medicine Gottingen
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Saxony
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Leipzig, Saxony, Saksa, 04103
- University of Leipzig
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Istanbul, Turkki (Türkiye), 34295
- Florya Medical Park Hospital
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California
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Orange, California, Yhdysvallat, 92868
- University of California Irvine
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Illinois
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Skokie, Illinois, Yhdysvallat, 60077
- Orchard Healthcare Research Inc.
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Michigan
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Detroit, Michigan, Yhdysvallat, 48201
- Karmanos Cancer Institute
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Farmington Hills, Michigan, Yhdysvallat, 48334
- Detroit Clinical Research Center
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Ohio
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Cincinnati, Ohio, Yhdysvallat, 45245
- Oncology Hematology Care Clinical Trials LLC
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Oregon
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Portland, Oregon, Yhdysvallat, 97213
- Providence Portland Medical Center
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Portland, Oregon, Yhdysvallat, 97213
- University Of Nebraska Medical Center
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Rhode Island
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Providence, Rhode Island, Yhdysvallat, 02903
- Lifespan Cancer Institute
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South Dakota
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Watertown, South Dakota, Yhdysvallat, 57201
- Prairie Lakes Healthcare System
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Tennessee
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Knoxville, Tennessee, Yhdysvallat, 37920
- University of Tennessee Medical Center
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Nashville, Tennessee, Yhdysvallat, 37203
- Sarah Cannon Research Institute (SCRI) Oncology Partners
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Virginia
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Blacksburg, Virginia, Yhdysvallat, 24060
- BRCC/Oncology & Hematology Associates of SW Virginia
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Osallistumiskriteerit
Kelpoisuusvaatimukset
Opintokelpoiset iät
Hyväksyy terveitä vapaaehtoisia
Sukupuolet, jotka voivat opiskella
Kuvaus
Neoadjuvant Resectable NSCLC General Key Inclusion Criteria:
- Histologically confirmed stage II through IIIB (N2) NSCLC, that is considered resectable with curative intent, as described in the protocol
- Measurable disease per Response Evaluation Criteria In Solid Tumors (RECIST) criteria version 1.1
- Available formalin-fixed paraffin-embedded (FFPE) tumor sample blocks for submission, as described in the protocol
- Eastern Cooperative Oncology Group Performance Status scale (ECOG PS) of 0 to 1
- Adequate organ and bone marrow function, as described in the protocol
Arm Specific Inclusion Criteria:
Unresectable/Metastatic NSCLC Safety Lead-in - Arm 2:
- Non-squamous or squamous histology NSCLC with stage IIIB or stage IIIC disease who are not candidates for surgical resection or definitive chemoradiation per investigator assessment or stage IV (metastatic disease), who received no prior systemic treatment for recurrent or metastatic NSCLC
- Availability of an archival or on-trial FFPE tumor tissue sample
- ECOG performance status of 0 or 1
- Per investigator judgment, life expectancy of at least 3 months
Neoadjuvant Resectable NSCLC General Key Exclusion Criteria:
- Any systemic anti-cancer therapy or radiotherapy for the current tumor, as described in the protocol
- Presence of actionable oncogenic alterations in the tumor for which an approved targeted therapy is available or for which perioperative chemoimmunotherapy is not considered an appropriate standard of care treatment, as described in the protocol
- Presence of grade≥ 2 peripheral neuropathy
- Another malignancy that is progressing or requires active treatment, as described in the protocol
Arm Specific Exclusion Criteria:
Neoadjuvant Resectable NSCLC - Arm 1:
- Grade ≥3 hypercalcemia, as defined in the protocol
- Any central nervous system (CNS) pathology that could increase the risk of immune effector cell-associated neurotoxicity syndrome (ICANS), as described in the protocol
- Has marked baseline prolongation of the time from the start of the Q wave to the end of the T wave in electrocardiogram (QT)/corrected QT interval (QTc) interval or risk factors for prolonged QTc, as described in the protocol
Unresectable/Metastatic NSCLC Safety Lead-in - Arm 2:
- Untreated or active primary brain tumor, CNS metastases, leptomeningeal disease, or spinal cord compression, as described in the protocol
- Presence of actionable oncogenic alterations in the tumor for which a chemotherapy plus programmed cell death protein 1 (PD1) inhibitor backbone is not the appropriate initial therapy as standard of care
- Known allergy or hypersensitivity to any components of trial interventions
- Any condition requiring ongoing/continuous corticosteroid therapy, as described in the protocol
Neoadjuvant Resectable NSCLC - Arm 2:
1. History of encephalitis, meningitis, organic brain disease, or uncontrolled seizures within 1 year prior to the first dose of trial interventions.
Note: Other protocol-defined Inclusion/Exclusion criteria apply.
Opintosuunnitelma
Miten tutkimus on suunniteltu?
Suunnittelun yksityiskohdat
- Ensisijainen käyttötarkoitus: Hoito
- Jako: Satunnaistettu
- Inventiomalli: Rinnakkaistehtävä
- Naamiointi: Ei mitään (avoin tarra)
Aseet ja interventiot
Osallistujaryhmä / Arm |
Interventio / Hoito |
|---|---|
|
Active Comparator: Neoadjuvant Resectable NSCLC - Control Arm
|
Administered per the protocol
Muut nimet:
Administered per the protocol |
|
Kokeellinen: Neoadjuvant Resectable NSCLC - Arm 1
|
Administered per the protocol
Muut nimet:
Administered per the protocol
Muut nimet:
Administered per the protocol |
|
Kokeellinen: Unresectable/Metastatic NSCLC Safety Lead-in - Arm 2
|
Administered per the protocol
Muut nimet:
Administered per the protocol Administered per the protocol
Muut nimet:
|
|
Kokeellinen: Neoadjuvant Resectable NSCLC - Arm 2
|
Administered per the protocol
Muut nimet:
Administered per the protocol Administered per the protocol
Muut nimet:
|
Mitä tutkimuksessa mitataan?
Ensisijaiset tulostoimenpiteet
Tulosmittaus |
Toimenpiteen kuvaus |
Aikaikkuna |
|---|---|---|
|
Major Pathologic Response (MPR) rate as determined by central Blinded Independent Pathology Review (BIPR)
Aikaikkuna: Up to 12 weeks
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Up to 12 weeks
|
|
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Occurrence of Treatment-Emergent Adverse Events (TEAEs)
Aikaikkuna: Up to 9 weeks
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Unresectable/Metastatic NSCLC Safety Lead-in - Arm 2 |
Up to 9 weeks
|
|
Occurrence of TEAEs leading to death
Aikaikkuna: Up to 9 weeks
|
Unresectable/Metastatic NSCLC Safety Lead-in - Arm 2 |
Up to 9 weeks
|
|
Occurrence of TEAEs leading to treatment discontinuation
Aikaikkuna: Up to 9 weeks
|
Unresectable/Metastatic NSCLC Safety Lead-in - Arm 2 |
Up to 9 weeks
|
|
Occurrence of Serious Adverse Events (SAEs)
Aikaikkuna: Up to 9 weeks
|
Unresectable/Metastatic NSCLC Safety Lead-in - Arm 2 |
Up to 9 weeks
|
|
Occurrence of grade ≥3 laboratory abnormalities
Aikaikkuna: Up to 9 weeks
|
Unresectable/Metastatic NSCLC Safety Lead-in - Arm 2 As assessed by the Common Terminology Criteria for Adverse Events (CTCAE) grading system version 5.0 (for all grades) |
Up to 9 weeks
|
|
Number of participants unable to receive cemiplimab and chemotherapy for 2 consecutive cycles due to REGN10597-related toxicities during the first 3 cycles
Aikaikkuna: Up to 9 weeks
|
Unresectable/Metastatic NSCLC Safety Lead-in - Arm 2 |
Up to 9 weeks
|
Toissijaiset tulostoimenpiteet
Tulosmittaus |
Toimenpiteen kuvaus |
Aikaikkuna |
|---|---|---|
|
Kokonaiseloonjääminen (OS)
Aikaikkuna: Jopa 5 vuotta
|
Jopa 5 vuotta
|
|
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TEAE:n vakavuus
Aikaikkuna: Jopa 76 viikkoa
|
Jopa 76 viikkoa
|
|
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TEAE:n vuoksi viivästyneiden leikkausten osuus
Aikaikkuna: Jopa 76 viikkoa
|
Jopa 76 viikkoa
|
|
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TEAE:n vuoksi peruuntuneiden leikkausten osuus
Aikaikkuna: Jopa 76 viikkoa
|
Jopa 76 viikkoa
|
|
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Pathologic Complete Response (pCR) rate as determined by central BIPR
Aikaikkuna: Up to 12 weeks
|
Up to 12 weeks
|
|
|
Residual Viable Tumor (RVT) as determined by central BIPR
Aikaikkuna: Up to 12 weeks
|
Up to 12 weeks
|
|
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Event-Free Survival (EFS)
Aikaikkuna: Up to 5 years
|
Up to 5 years
|
|
|
Objective Response by investigator assessment
Aikaikkuna: Up to 9 weeks
|
Up to 9 weeks
|
|
|
Duration of Response (DoR) by investigator assessment
Aikaikkuna: Up to 2 years
|
Unresectable/Metastatic NSCLC Safety Lead-in - Arm 2 |
Up to 2 years
|
|
Occurrence of TEAEs
Aikaikkuna: Up to 76 weeks
|
Up to 76 weeks
|
|
|
Occurrence of TEAEs leading to death
Aikaikkuna: Up to 76 weeks
|
Up to 76 weeks
|
|
|
Occurrence of TEAEs leading to treatment discontinuation
Aikaikkuna: Up to 76 weeks
|
Up to 76 weeks
|
|
|
Occurrence of SAEs
Aikaikkuna: Up to 76 weeks
|
Up to 76 weeks
|
|
|
Severity of SAEs
Aikaikkuna: Up to 76 weeks
|
Up to 76 weeks
|
|
|
Occurrence of Adverse Events of Special Interest (AESIs)
Aikaikkuna: Up to 76 weeks
|
Up to 76 weeks
|
|
|
Severity of AESIs
Aikaikkuna: Up to 76 weeks
|
Up to 76 weeks
|
|
|
Occurrence of immune-mediated Adverse Events (imAEs)
Aikaikkuna: Up to 76 weeks
|
Up to 76 weeks
|
|
|
Severity of imAEs
Aikaikkuna: Up to 76 weeks
|
Up to 76 weeks
|
|
|
Occurrence of Infusion-Related Reactions (IRRs)
Aikaikkuna: Up to 76 weeks
|
Up to 76 weeks
|
|
|
Severity of IRRs
Aikaikkuna: Up to 76 weeks
|
Up to 76 weeks
|
|
|
Occurrence of grade ≥3 laboratory abnormalities
Aikaikkuna: Up to 76 weeks
|
As assessed by the Common Terminology Criteria for Adverse Events (CTCAE) grading system version 5.0 (for all grades) |
Up to 76 weeks
|
|
Occurrence of Anti-Drug Antibodies (ADAs) to cemiplimab
Aikaikkuna: Up to 67 weeks
|
Up to 67 weeks
|
|
|
Magnitude of ADAs to cemiplimab
Aikaikkuna: Up to 67 weeks
|
Up to 67 weeks
|
|
|
Occurrence of ADAs to marlotamig
Aikaikkuna: Up to 67 weeks
|
Up to 67 weeks
|
|
|
Magnitude of ADAs to marlotamig
Aikaikkuna: Up to 67 weeks
|
Up to 67 weeks
|
|
|
Occurrence of ADAs to REGN10597
Aikaikkuna: Up to 67 weeks
|
Up to 67 weeks
|
|
|
Magnitude of ADAs to REGN10597
Aikaikkuna: Up to 67 weeks
|
Up to 67 weeks
|
Yhteistyökumppanit ja tutkijat
Sponsori
Tutkijat
- Opintojohtaja: Clinical Trial Management, Regeneron Pharmaceuticals
Opintojen ennätyspäivät
Opi tärkeimmät päivämäärät
Opiskelun aloitus (Todellinen)
Ensisijainen valmistuminen (Arvioitu)
Opintojen valmistuminen (Arvioitu)
Opintoihin ilmoittautumispäivät
Ensimmäinen lähetetty
Ensimmäinen toimitettu, joka täytti QC-kriteerit
Ensimmäinen Lähetetty (Todellinen)
Tutkimustietojen päivitykset
Viimeisin päivitys julkaistu (Todellinen)
Viimeisin lähetetty päivitys, joka täytti QC-kriteerit
Viimeksi vahvistettu
Lisää tietoa
Tähän tutkimukseen liittyvät termit
Avainsanat
Muita asiaankuuluvia MeSH-ehtoja
Muut tutkimustunnusnumerot
- R2810-ONC-2268
- 2023 (Yhdysvaltain NIH-apuraha/sopimus)
- 2023-509806-31-00 (Ctis)
Yksittäisten osallistujien tietojen suunnitelma (IPD)
Aiotko jakaa yksittäisten osallistujien tietoja (IPD)?
IPD-suunnitelman kuvaus
All Individual Patient Data (IPD) that underlie publicly available results will be considered for sharing.
IPD-jaon aikakehys
When Regeneron has:
- received marketing authorization from major health authorities (e.g., FDA, European Medicines Agency (EMA), Pharmaceuticals and Medical Devices Agency (PMDA), etc.) for the product and indication or has globally discontinued development of the product for all indications on or after April 2020 and has no plans for future development
- made the study results publicly available (e.g., scientific publication, scientific conference, clinical trial registry)
- the legal authority to share the data, and
- ensured the ability to protect participant privacy
IPD-jaon käyttöoikeuskriteerit
Qualified researchers can submit a proposal for access to individual patient or aggregate level data from a Regeneron-sponsored clinical trial through Vivli. Regeneron's Independent Research Request Evaluation Criteria can be found at: https://www.regeneron.com/sites/default/files/Regeneron-External-Data-Sharing-Policy-and-Independent-Research-Request-Evaluation-Criteria.pdf
IPD-jakamista tukeva tietotyyppi
- STUDY_PROTOCOL
- MAHLA
- ICF
- ANALYTIC_CODE
- CSR
Lääke- ja laitetiedot, tutkimusasiakirjat
Tutkii yhdysvaltalaista FDA sääntelemää lääkevalmistetta
Tutkii yhdysvaltalaista FDA sääntelemää laitetuotetta
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