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A Phase 1 Study of Nivolumab (BMS-936558) in Subjects With Advanced or Recurrent Malignancies (MDX1106-03)

1. december 2021 opdateret af: Bristol-Myers Squibb

A Phase 1, Open-Label, Multicenter, Multidose, Dose Escalation Study of BMS-936558 (Nivolumab) in Subjects With Selected Advanced or Recurrent Malignancies

The purpose of this study is to determine the safety and effectiveness of MDX-1106 in patients with certain types of cancer. Another purpose is to determine how MDX-1106 is absorbed and distributed within the body, and how it's eventually eliminated.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

395

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
    • Arizona
      • Scottsdale, Arizona, Forenede Stater, 85258
        • Pinnacle Oncology Hematology
    • Connecticut
      • New Haven, Connecticut, Forenede Stater, 06520
        • Yale University School of Medicine
    • Florida
      • Tampa, Florida, Forenede Stater, 33612-9497
        • H. Lee Moffitt Cancer Center & Research Institute
    • Maryland
      • Baltimore, Maryland, Forenede Stater, 21231
        • Johns Hopkins University
    • Massachusetts
      • Boston, Massachusetts, Forenede Stater, 02215
        • Beth Israel Deaconess Medical Center
      • Boston, Massachusetts, Forenede Stater, 02215
        • Dana Farber Cancer Institute
      • Boston, Massachusetts, Forenede Stater, 02215
        • Massachusetts General Hospital
    • Michigan
      • Ann Arbor, Michigan, Forenede Stater, 48109
        • University of Michigan Cancer Center
    • New York
      • New York, New York, Forenede Stater, 10065
        • Memorial Sloan Kettering Nassau
    • North Carolina
      • Huntersville, North Carolina, Forenede Stater, 28078
        • Carolina BioOncology Institute
    • Ohio
      • Cincinnati, Ohio, Forenede Stater, 45219
        • Christ Hospital
    • Tennessee
      • Nashville, Tennessee, Forenede Stater, 37203
        • Sarah Cannon Research Institute
      • Nashville, Tennessee, Forenede Stater, 37232
        • Vanderbilt-Ingram Cancer Ctr

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

For more information regarding BMS clinical trial participation, please visit www.BMSStudyConnect.com

Inclusion Criteria:

  • Subjects must have mCRPC,RCC, MEL, Non-small-cell lung cancer (NSCLC), or Colorectal Cancer (CRC), that is advanced (non-resectable), or recurrent and for which no alternative, curative standard exists
  • Eastern Cooperative Oncology Group (ECOG) Performance Status of 0-2
  • Must have at least 1 measurable lesion
  • Subjects with mCRPC and with only non-measurable bone lesions must have either progression new lesions or have Prostate-specific antigen (PSA) progression within the 6-week period before study administration
  • At least 1 and up to 5 prior systemic therapies for advanced/recurrent disease
  • Prior treated brain or meningeal metastases must be without Magnetic resonance imaging (MRI) evidence of progression for at least 8 weeks and off immunosuppressive doses of systemic steroids for at least 2 weeks before study drug administration
  • Prior systemic radiation therapy must have been completed at least 4 weeks before study drug administration. Prior focal radiotherapy completed at least 2 weeks prior to study drug administration
  • Immunosuppressive doses of systemic medications, such as steroids or absorbed topical steroids must be discontinued at least 2 weeks before study drug administration
  • Prior surgery that required general anesthesia must be completed at least 2 weeks before study drug administration. Surgery requiring local/epidural anesthesia must be completed at least 72 hours before study drug administration

Exclusion Criteria:

  • History of severe hypersensitivity reactions to other Monoclonal antibody (mAb)s
  • Subjects with any active autoimmune disease or a documented history of autoimmune disease, or history of syndrome that required systemic steroids or immunosuppressive medications, except for subjects with vitiligo or resolved childhood asthma/atopy
  • Prior therapy with an anti-Programmed death-1 (PD-1), anti-PD-L1, anti-PD-L2, or anti- Cytotoxic t-lymphocyte antigen-4 (CTLA-4) antibody (or any other antibody targeting T cell co-stimulation pathways)
  • Known history of Human Immunodeficiency Virus
  • Active infection requiring therapy, positive tests for Hepatitis B surface antigen or Hepatitis C ribonucleic acid (RNA)
  • Underlying medical conditions that will make the administration of study drug hazardous
  • Concurrent medical condition requiring the use of immunosuppressive medications, or immunosuppressive doses of systemic or absorbable topical corticosteroids
  • Use of other investigational drugs (drugs not marketed for any indication) within 28 days or at least 5 half-lives (whichever is longer) before 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: Enkelt gruppeopgave
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: Melanoma - BMS-936558 (MDX-1106)
Biologisk: BMS-936558 (MDX-1106)
Solution, Intravenous, 0.1 mg/kg - 10 mg/kg, Every 2 weeks, 3 years depending on response
Andre navne:
  • BMS-936558
Biologisk: BMS-936558 (MDX-1106)
Solution, Intravenous, 1 - 10 mg/kg, Every 2 weeks, 3 years depending on response
Andre navne:
  • BMS-936558
Biologisk: BMS-936558 (MDX-1106)
Solution, Intravenous, 10 mg/kg, Every 2 weeks, 3 years depending on response
Andre navne:
  • BMS-936558
Eksperimentel: RCC - BMS-936558 (MDX-1106)
Biologisk: BMS-936558 (MDX-1106)
Solution, Intravenous, 0.1 mg/kg - 10 mg/kg, Every 2 weeks, 3 years depending on response
Andre navne:
  • BMS-936558
Biologisk: BMS-936558 (MDX-1106)
Solution, Intravenous, 1 - 10 mg/kg, Every 2 weeks, 3 years depending on response
Andre navne:
  • BMS-936558
Biologisk: BMS-936558 (MDX-1106)
Solution, Intravenous, 10 mg/kg, Every 2 weeks, 3 years depending on response
Andre navne:
  • BMS-936558
Eksperimentel: mCRPC - BMS-936558 (MDX-1106)
Biologisk: BMS-936558 (MDX-1106)
Solution, Intravenous, 0.1 mg/kg - 10 mg/kg, Every 2 weeks, 3 years depending on response
Andre navne:
  • BMS-936558
Biologisk: BMS-936558 (MDX-1106)
Solution, Intravenous, 1 - 10 mg/kg, Every 2 weeks, 3 years depending on response
Andre navne:
  • BMS-936558
Biologisk: BMS-936558 (MDX-1106)
Solution, Intravenous, 10 mg/kg, Every 2 weeks, 3 years depending on response
Andre navne:
  • BMS-936558
Eksperimentel: NSCLC - BMS-936558 (MDX-1106)
Biologisk: BMS-936558 (MDX-1106)
Solution, Intravenous, 0.1 mg/kg - 10 mg/kg, Every 2 weeks, 3 years depending on response
Andre navne:
  • BMS-936558
Biologisk: BMS-936558 (MDX-1106)
Solution, Intravenous, 1 - 10 mg/kg, Every 2 weeks, 3 years depending on response
Andre navne:
  • BMS-936558
Biologisk: BMS-936558 (MDX-1106)
Solution, Intravenous, 10 mg/kg, Every 2 weeks, 3 years depending on response
Andre navne:
  • BMS-936558
Eksperimentel: CRC - BMS-936558 (MDX-1106)
Biologisk: BMS-936558 (MDX-1106)
Solution, Intravenous, 0.1 mg/kg - 10 mg/kg, Every 2 weeks, 3 years depending on response
Andre navne:
  • BMS-936558
Biologisk: BMS-936558 (MDX-1106)
Solution, Intravenous, 1 - 10 mg/kg, Every 2 weeks, 3 years depending on response
Andre navne:
  • BMS-936558
Biologisk: BMS-936558 (MDX-1106)
Solution, Intravenous, 10 mg/kg, Every 2 weeks, 3 years depending on response
Andre navne:
  • BMS-936558

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Number of Participants With Severe Adverse Events (AEs), Serious Adverse Events (SAEs), Treatment-Related AEs, Deaths, Discontinuation of Study Drug Due to AEs
Tidsramme: Day 1 to 70 days following last dose of study drug up to June 2013, approximately 4 years

AE=any new unfavorable symptom, sign or disease or worsening of a preexisting condition that may not have a causal relationship with treatment.

SAE=a medical event that at any dose results in death, persistent or significant disability/incapacity or drug dependency/abuse; is life-threatening, an important medical event or a congenital anomaly/birth defect; or requires or prolongs hospitalization. Treatment-related=having certain, probable, possible or missing relationship to study drug. Death=during the study and up to 28 days past study discontinuation. The select AEs were determined using the Medical Dictionary for Regulatory Activities (MedDRA, v15.1) and graded using the Cancer Therapy Evaluation Program Common Terminology Criteria for Adverse Events (CTCAE), Version 3.0.
Day 1 to 70 days following last dose of study drug up to June 2013, approximately 4 years
Number of Participants With Abnormal Serum Chemistry Laboratory Values
Tidsramme: Day 1 up to June 2013, approximately 4 years
Alkaline phosphatase (ALP), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Creatinine and Total Bilirubin. National Cancer Institute Common Terminology Criteria (CTC) version (v) 3.0 was used to determine Grade (Gr). Abnormal values for ALP, ALT and AST were based on grades; Gr 1: > 1.0 - 2.5 * upper limits of normal (ULN); Gr 2: > 2.5 - 5.0 * ULN; Gr 3: > 5.0 - 20.0 * ULN; Gr 4: > 20.0 * ULN. Abnormal values for Creatinine were based on Gr 1: > 1.0 - 1.5*ULN; Gr 2: > 1.5 - 3.0*ULN; Gr 3: > 3.0 - 6.0*ULN; Gr 4: > 6.0*ULN. Abnormal values for Total Bilirubin were based on Gr 1: > 1.0 - 1.5 * upper limits of normal (ULN); Gr 2: > 1.5 - 3.0 * ULN; Gr 3: > 3.0 - 10.0 * ULN; Gr 4: > 10.0 * ULN.
Day 1 up to June 2013, approximately 4 years
Number of Participants With Abnormal Hematology Laboratory Values
Tidsramme: Day 1 up to June 2013, approximately 4 years
Hemoglobin, Lymphocytes, Neutrophils, Platelets and Leukocytes. National Cancer Institute Common Terminology Criteria (CTC) version (v) 3.0 was used to determine Grade (Gr). Abnormal values for Hemoglobin were based on Gr 1: 10.0 - less than (<) lower limit of normal (LLN); Gr 2: 8.0 - < 10.0; Gr 3: 6.5 - < 8.0; Gr 4: < 6.5. Abnormal values for Lymphocytes were based on Gr 1: 0.8 - < 1.5; Gr 2: 0.5 - < 0.8; Gr 3): 0.2 - < 0.5; Gr 4: < 0.2. Abnormal values for Neutrophils were based on Gr 1: 1.5 - < 2.0; Gr 2: 1.0 - < 1.5; Gr 3: 0.5 - < 1.0; Gr 4: < 0.5. Abnormal values for Platelets were based on Gr 1: 75.0 - < lower limits of normal (LLN); Gr 2: 50.0 - < 75.0; Gr 3: 25.0 - < 50.0; Gr 4: < 25.0. Abnormal values for Leukocytes were based on Gr 1: 3.0 - < LLN; Gr 2: 2.0 - < 3.0; Gr 3: 1.0 - < 2.0; Gr4: < 1.0.
Day 1 up to June 2013, approximately 4 years

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Immunogenicity Assessment
Tidsramme: Day 1 up to June 2013, approximately 4 years
Classification of participants host immune response was based on the following definitions: Anti-Drug Antibody (ADA) Positive Subjects have with at least one ADA positive sample at any time after initiation of treatment. ADA positive subjects were further classified into categories with Persistent Positive defined as an ADA positive sample at 2 or more sequential timepoints at least 8 weeks apart.
Day 1 up to June 2013, approximately 4 years
Objective Response Rate
Tidsramme: Day 1 up to June 2013, approximately 4 years
Tumor response was evaluated by the sponsor based on tumor assessments by the investigator according to Response Evaluation Criteria in Solid Tumors (RECIST) v1.0. Objective response rate (ORR) was defined as the proportion of participants who's confirmed best overall response (BOR) is either complete (CR) or partial (PR), where the denominator is the number of treated participants in the population of interest. Response was based on tumor measurements. Responders= complete response (CR) or partial response (PR). CR=disappearance of all target and non-target lesions; PR=at least a 30% decrease in the sum of the longest diameter of target lesions, taking as reference the screening sum longest diameter. 95% Confidence intervals (CIs) were computed using the Clopper Pearson method.
Day 1 up to June 2013, approximately 4 years
Duration of Tumor Response
Tidsramme: Day 1 up to June 2013, approximately 4 years
Duration of tumor response (DOR) was calculated from the first date of response of complete response (CR) or partial response (PR) to the date of the first progressive disease (PD) or the date of death. Duration of response was censored at the last tumor assessment date if a responder did not have PD or death. Nonresponders were not included in the analysis. Median DOR was estimated by Kaplan-Meier analysis.
Day 1 up to June 2013, approximately 4 years
Geometric Mean Maximum Serum Concentration (Cmax)
Tidsramme: 1,4,8,24,48 and 96 hours post-dose timepoints on Day 1 of cycles 1 and 3
Nivolumab in human serum was assayed by PPD® (Richmond, Virginia) using a cross-validated enzyme-linked immunosorbent assay (ELISA). Blood samples were assessed at all doses from a subset of participants. The pharmacokinetic (PK) parameter of Cmax was measured in micrograms per milliliter (µg/mL).
1,4,8,24,48 and 96 hours post-dose timepoints on Day 1 of cycles 1 and 3
Median Time of Maximum Serum Concentration (Tmax)
Tidsramme: 1,4,8,24,48 and 96 hours post-dose timepoints on Day 1 of cycles 1 and 3
Nivolumab in human serum was assayed by PPD® (Richmond, Virginia) using a cross-validated ELISA. Blood samples were assessed Blood samples were assessed at all doses from a subset of participants. The PK parameter of Tmax was measured in hours (h).
1,4,8,24,48 and 96 hours post-dose timepoints on Day 1 of cycles 1 and 3
Geometric Mean Area Under the Curve (AUC[TAU]) in One Dosing Interval Observed Post-Single Dose
Tidsramme: 1,4,8,24,48 and 96 hours post-dose timepoints on Day 1 of cycles 1 and 3
Nivolumab in human serum was assayed by PPD® (Richmond, Virginia) using a cross-validated ELISA. Blood samples were assessed at all doses from a subset of participants. The PK parameter of AUC was measured in micrograms*hours per milliliter (μg*h/mL).
1,4,8,24,48 and 96 hours post-dose timepoints on Day 1 of cycles 1 and 3
Geometric Mean Total Body Clearance of Drug From Serum (CLT)
Tidsramme: 1,4,8,24,48 and 96 hours post-dose timepoints on Day 1 of cycle 3
Nivolumab in human serum was assayed by PPD® (Richmond, Virginia) using a cross-validated ELISA. Blood samples Blood samples were assessed at all doses from a subset of participants. The PK parameter of CLT was measured in milliliters per hour (mL/h).
1,4,8,24,48 and 96 hours post-dose timepoints on Day 1 of cycle 3
Mean Effective Half-life (T-HALFeff)
Tidsramme: 1,4,8,24,48 and 96 hours post-dose timepoints on Day 1 of cycle 3
Nivolumab in human serum was assayed by PPD® (Richmond, Virginia) using a cross-validated ELISA. Blood samples were assessed at all doses from a subset of participants. The PK parameter of T-HALFeff was measured in hours (h).
1,4,8,24,48 and 96 hours post-dose timepoints on Day 1 of cycle 3

Samarbejdspartnere og efterforskere

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

Sponsor

Bristol-Myers Squibb

Samarbejdspartnere

Ono Pharmaceutical Co. Ltd

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

Generelle publikationer

Hjælpsomme links

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)

30. oktober 2008

Primær færdiggørelse (Faktiske)

4. februar 2013

Studieafslutning (Faktiske)

22. december 2020

Datoer for studieregistrering

Først indsendt

4. august 2008

Først indsendt, der opfyldte QC-kriterier

7. august 2008

Først opslået (Skøn)

8. august 2008

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

3. december 2021

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

1. december 2021

Sidst verificeret

1. november 2021

Mere information

Begreber relateret til denne undersøgelse

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • CA209-003
  • MDX1106-03 (Anden identifikator: BMS)

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

Studerer et amerikansk FDA-reguleret lægemiddelprodukt

Ja

Studerer et amerikansk FDA-reguleret enhedsprodukt

Ingen

produkt fremstillet i og eksporteret fra U.S.A.

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 .

Kliniske forsøg med Nyrecellekarcinom

Kliniske forsøg med BMS-936558 (MDX-1106)

Søg i lignende forsøg

Sponsorer og samarbejdspartnere

Medicinske tilstande

Narkotikainterventioner

CROs by country

CROs in Thailand

Betingelser

Sjældne sygdomme

Narkotikainterventioner

Kosttilskud

Sponsor / samarbejdspartnere

Placeringer

Abonner