- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT02864316
Phase 2 Study of Nivolumab in Solid Tumors Induced by Prior Radiation Exposure
9. august 2019 opdateret af: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
The purpose of this study is to determine whether Nivolumab is effective in the treatment of radiation-induced solid tumors.
Studieoversigt
Status
Afsluttet
Betingelser
Intervention / Behandling
Undersøgelsestype
Interventionel
Tilmelding (Faktiske)
6
Fase
- Fase 2
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
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Maryland
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Baltimore, Maryland, Forenede Stater, 21231
- Sidney Kimmel Cancer Center @ Johns Hopkins
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Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
18 år og ældre (Voksen, Ældre voksen)
Tager imod sunde frivillige
Ingen
Køn, der er berettiget til at studere
Alle
Beskrivelse
Inclusion Criteria:
- Histologically confirmed metastatic or unresectable solid tumor which standard curative or palliative measures do not exist or are no longer effective. The primary site of the metastatic or unresectable tumor must have arisen within a previously irradiated site and be considered a radiation-induced tumor.
- Pre-treatment tumor specimen available. Patients with no available archived specimen must be willing to undergo a pre-treatment tumor biopsy.
- Measurable disease.
- Progressive disease on study entry.
- Received adjuvant or neoadjuvant chemotherapy and developed recurrent or metastatic disease within 6 months of completing therapy.
- Age >18 years.
- Eastern Cooperative Oncology Group (ECOG) performance status <2.
- Life expectancy of greater than 3 months.
- Adequate organ and marrow function as defined below:
- White Blood Cell >2,000/per microliter
- Absolute neutrophil count >1,500/per microliter
- Platelets >100,000/per microliter
- Hemoglobin ≥9.0 g/dL
- Total bilirubin ≤1.5 times the institutional upper limit of normal (ULN) (except subjects with Gilbert Syndrome, who can have total bilirubin < 3.0 mg/dL)
- Aspartate Aminotransferase(SGOT)/Alanine Aminotransferase (SGPT) <3 X institutional ULN
- Creatinine ≤1.5 X institutional ULN OR
- Creatinine clearance >40 mL/min for patients with creatinine Levels above institutional normal (calculated using the Cockcroft-Gault formula below)
- Female Creatinine Clearance = (140 - age in years) x weight in kg x 0.85 72 x serum creatinine in mg/dL
- Male Creatinine Clearance = (140 - age in years) x weight in kg x 1.00 72 x serum creatinine in mg/dL
- Women of childbearing potential (WOCBP) and men must agree to use adequate contraception prior to study entry and for the duration of study participation and up to 31 weeks after the last dose of nivolumab.
- Women of childbearing potential (WOCBP) must have a negative serum or urine pregnancy test within 24 hours prior to the start of nivolumab.
- Ability to understand and the willingness to sign a written informed consent document.
- Biopsiable disease at the time of enrollment as biopsies after progression are required for participation.
Exclusion Criteria:
- Any active, known or suspected autoimmune disease.
- Requiring continuous supplemental oxygen.
- Chemotherapy or radiotherapy within 2 weeks (6 weeks for nitrosoureas or mitomycin C) prior to entering the study or unresolved toxicity due to agents administered more than 2 weeks earlier.
- Uncontrolled brain metastases.
- History of allergic reactions attributed to compounds of similar chemical or biologic composition to nivolumab.
- Uncontrolled inter-current illness.
- Pregnant or currently breastfeeding.
- Receiving any other anticancer therapy.
- Prior therapy with anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CD137, anti-CTLA- 4 antibody therapies, any other antibody or drug specifically targeting T-cell costimulation or checkpoint pathways.
- History of Human Immunodeficiency Virus (HIV) (HIV 1/2 antibodies).
- Positive test for hepatitis B virus surface antigen (HBV sAg) or hepatitis C virus ribonucleic acid (HCV antibody) indicating ongoing acute or chronic infection.
- Requiring systemic treatment with either corticosteroids (> 10 mg daily prednisone equivalent) or other immunosuppressive medications within 14 days of study drug administration.
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: Ikke-randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
---|---|
Eksperimentel: Radiation-Induced Metastatic Sarcoma
a flat dose of Nivolumab 240 mg will be administered intravenously every 2 weeks until disease progression.
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Andre navne:
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Eksperimentel: Radiation-Induced Non-Sarcoma Metastatic Solid Tumors
a flat dose of Nivolumab 240 mg will be administered intravenously every 2 weeks until disease progression.
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Andre navne:
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
---|---|---|
Best Objective Response Rate
Tidsramme: Up to 24 weeks
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Number of participants with response.
Response will be assessed at baseline (within 4 weeks prior to starting nivolumab) and then every 8 weeks while on Nivolumab, up to 24 weeks.
The best objective response will be assessed at 24 weeks.
Response will be defined based on RECIST 1.1 criteria where complete response (CR)= disappearance of all target lesions, partial response (PR) is =>30% decrease in sum of diameters of target lesions, progressive disease (PD) is >20% increase in sum of diameters of target lesions, stable disease (SD) is <30% decrease or <20% increase in sum of diameters of target lesions.
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Up to 24 weeks
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Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
---|---|---|
Percentage of Patients Progression-free at 24 Weeks From the Time of Enrollment
Tidsramme: 24 weeks
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Disease status at 24 weeks will be compared to disease status at the time of enrollment, and response coded based on RECIST 1.1 criteria.
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24 weeks
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Progression-free Survival
Tidsramme: Up to 22 months
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Number of participants alive without progression.
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Up to 22 months
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Duration of Response
Tidsramme: Up to 22 months
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The duration of overall response is measured from the time measurement criteria are met for Complete Response or Partial Response (whichever is first recorded) until the first date that recurrent or progressive disease is objectively documented, accessed up to 3 years.
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Up to 22 months
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Number of Participants With Treatment-related Adverse Events
Tidsramme: up to 100 days post-intervention
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Number of participants with treatment-related adverse events as defined by CTCAE 4.0 criteria.
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up to 100 days post-intervention
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Overall Survival
Tidsramme: Up to 22 months
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Overall survival was planned to be measured at 5 years post-intervention as the time from enrollment until death.
Instead, due to early termination for low accrual, the number of participants alive at the time of study termination is reported.
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Up to 22 months
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Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Samarbejdspartnere
Efterforskere
- Ledende efterforsker: Patrick Forde, MB, BCH, Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart
1. december 2016
Primær færdiggørelse (Faktiske)
1. august 2018
Studieafslutning (Faktiske)
1. september 2018
Datoer for studieregistrering
Først indsendt
2. august 2016
Først indsendt, der opfyldte QC-kriterier
9. august 2016
Først opslået (Skøn)
12. august 2016
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
28. august 2019
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
9. august 2019
Sidst verificeret
1. august 2019
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- J1695
- IRB00105682 (Anden identifikator: JHMIRB)
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
INGEN
Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .
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