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Study of Neoadjuvant Nivolumab in Patients With Non-metastatic Stage II-IV Clear Cell Renal Cell Carcinoma

10. juni 2020 opdateret af: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Phase I Study of Neoadjuvant Nivolumab in Patients With Non-metastatic High-risk Clear Cell Renal Cell Carcinoma

This study will evaluate the use of nivolumab before surgery in patients with high-risk clear cell renal cell carcinoma who are eligible for nephrectomy. Nivolumab is an antibody that may help activate the immune system by blocking the function of an inhibitory molecule, Programmed cell death-1 (PD-1).

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

17

Fase

  • Fase 1

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

  • Forenede Stater
    • Maryland
      • Baltimore, Maryland, Forenede Stater, 21287
        • The Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

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 (abbreviated):

  1. Confirmed non-metastatic high-risk clear cell renal cell carcinoma (T2a-T4NanyM0 or TanyN1M0)
  2. Schedule to undergo either partial or radical nephrectomy as part of treatment plan
  3. Patient agrees to have a tumor biopsy
  4. ECOG performance status of 0 or 1
  5. Adequate organ and marrow function defined by study-specified laboratory tests
  6. Must use acceptable form of birth control while on study and for approximately 31 weeks post-treatment completion
  7. Willingness and ability to comply with scheduled visits, treatment plans, lab tests and other study procedures

Exclusion Criteria (abbreviated):

  1. Other active malignancies within last 3 years (with some exceptions for skin, prostate, cervical, or breast cancer)
  2. Need for urgent or emergent nephrectomy to relieve symptoms
  3. Prior treatment for RCC including surgery, radiation, thermoablation or systemic therapy
  4. Surgery within 28 days of starting study treatment (some exceptions for minor procedures)
  5. Received live vaccine for infectious diseases within 28 days of starting study treatment
  6. Prior treatment with any antibody or drug targeting T-cell costimulation or immune checkpoint pathways (anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CTLA-4, etc)
  7. Use of immunosuppressive doses of systemic medications within 14 days prior to starting study drug.
  8. Current use of immunosuppressive agents
  9. History of severe hypersensitivity reaction to other monoclonal antibodies
  10. Current signs or symptoms of severe progressive or uncontrolled hepatic, hematologic, gastrointestinal, endocrine, pulmonary or cardiac disease other than directly related to RCC
  11. Uncontrolled psychiatric illness/social situations that would limit compliance with study requirements.
  12. Active infection requiring therapy.
  13. Known human immunodeficiency virus (HIV) or acquired immunodeficiency syndrome (AIDS)-related illness.
  14. Positive tests for Hepatitis B surface antigen or Hepatitis C ribonucleic acid (RNA).
  15. History of autoimmune disease or syndrome requiring systemic steroids or immunosuppressants (some exceptions apply).
  16. Pulse oximetry of <92% on room air
  17. Pregnant or breastfeeding women

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: N/A
  • Interventionel model: Enkelt gruppeopgave
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: Nivolumab
3 mg/kg, IV (in the vein) on day 1 of each 2-week cycle, for a total of 3 doses prior to nephrectomy.
Medicin: Nivolumab
3 mg/kg, IV (in the vein) on day 1 of each 2-week cycle, for a total of 3 doses prior to nephrectomy.
Andre navne:
  • BMS-936558
  • MDX-1106
  • Opdivo

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Safety as assessed by number of participants experiencing adverse events
Tidsramme: From the first dose of nivolumab treatment through 100 days post-surgery
Number of participants experiencing any adverse event as defined by Common Terminology Criteria for Adverse Events version 4.0 (CTCAE v4.0)
From the first dose of nivolumab treatment through 100 days post-surgery

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Objective Tumor Response Rate (by RECIST)
Tidsramme: Assessed at baseline, prior to surgery, and 3 months after surgery
Number of patients achieving a complete response (CR) or partial response (PR) by Response Evaluation Criteria in Solid Tumors (RECIST)
Assessed at baseline, prior to surgery, and 3 months after surgery
Objective Tumor Response Rate (by irRC)
Tidsramme: Assessed at baseline, prior to surgery, and 3 months after surgery
Number of patients achieving a complete response (CR) or partial response (PR) by immune-related response criteria (irRC)
Assessed at baseline, prior to surgery, and 3 months after surgery
Quality of Life as assessed by the Functional Assessment of Cancer Therapy-Kidney Symptom Index (FKSI) -15 questionnaire
Tidsramme: Baseline, 2 weeks, 4 weeks, prior to surgery, and at 1-, 3-, 6-, and 12-months after surgery
Total score range 0-60 with higher scores indicating a less symptomatic respondent.
Baseline, 2 weeks, 4 weeks, prior to surgery, and at 1-, 3-, 6-, and 12-months after surgery
Metastasis-Free Survival
Tidsramme: 12 months post-operatively, then every 6 months for 5 years
Number of months without evidence of metastasis.
12 months post-operatively, then every 6 months for 5 years
Overall Survival
Tidsramme: 12 months post-operatively, then every 6 months for 5 years
Number of months alive.
12 months post-operatively, then every 6 months for 5 years

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Samarbejdspartnere

Bristol-Myers Squibb

Efterforskere

  • Ledende efterforsker: Mohamad E Allaf, M.D, Department of Urology and The Brady Urological Institute 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 (Faktiske)

1. februar 2016

Primær færdiggørelse (Faktiske)

9. juni 2020

Studieafslutning (Faktiske)

9. juni 2020

Datoer for studieregistrering

Først indsendt

6. oktober 2015

Først indsendt, der opfyldte QC-kriterier

13. oktober 2015

Først opslået (Skøn)

14. oktober 2015

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

12. juni 2020

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

10. juni 2020

Sidst verificeret

1. juni 2020

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • J15179
  • IRB00068726 (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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Betingelser

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