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

1. prosince 2021 aktualizováno: 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.

Přehled studie

Postavení

Dokončeno

Podmínky

Intervence / Léčba

Typ studie

Intervenční

Zápis (Aktuální)

395

Fáze

  • Fáze 1

Kontakty a umístění

Tato část poskytuje kontaktní údaje pro ty, kteří studii provádějí, a informace o tom, kde se tato studie provádí.

Studijní místa

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

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

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

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: Nerandomizované
  • Intervenční model: Přiřazení jedné skupiny
  • Maskování: Žádné (otevřený štítek)

Zbraně a zásahy

Skupina účastníků / Arm
Intervence / Léčba
Experimentální: Melanoma - BMS-936558 (MDX-1106)
Biologický: BMS-936558 (MDX-1106)
Solution, Intravenous, 0.1 mg/kg - 10 mg/kg, Every 2 weeks, 3 years depending on response
Ostatní jména:
  • BMS-936558
Biologický: BMS-936558 (MDX-1106)
Solution, Intravenous, 1 - 10 mg/kg, Every 2 weeks, 3 years depending on response
Ostatní jména:
  • BMS-936558
Biologický: BMS-936558 (MDX-1106)
Solution, Intravenous, 10 mg/kg, Every 2 weeks, 3 years depending on response
Ostatní jména:
  • BMS-936558
Experimentální: RCC - BMS-936558 (MDX-1106)
Biologický: BMS-936558 (MDX-1106)
Solution, Intravenous, 0.1 mg/kg - 10 mg/kg, Every 2 weeks, 3 years depending on response
Ostatní jména:
  • BMS-936558
Biologický: BMS-936558 (MDX-1106)
Solution, Intravenous, 1 - 10 mg/kg, Every 2 weeks, 3 years depending on response
Ostatní jména:
  • BMS-936558
Biologický: BMS-936558 (MDX-1106)
Solution, Intravenous, 10 mg/kg, Every 2 weeks, 3 years depending on response
Ostatní jména:
  • BMS-936558
Experimentální: mCRPC - BMS-936558 (MDX-1106)
Biologický: BMS-936558 (MDX-1106)
Solution, Intravenous, 0.1 mg/kg - 10 mg/kg, Every 2 weeks, 3 years depending on response
Ostatní jména:
  • BMS-936558
Biologický: BMS-936558 (MDX-1106)
Solution, Intravenous, 1 - 10 mg/kg, Every 2 weeks, 3 years depending on response
Ostatní jména:
  • BMS-936558
Biologický: BMS-936558 (MDX-1106)
Solution, Intravenous, 10 mg/kg, Every 2 weeks, 3 years depending on response
Ostatní jména:
  • BMS-936558
Experimentální: NSCLC - BMS-936558 (MDX-1106)
Biologický: BMS-936558 (MDX-1106)
Solution, Intravenous, 0.1 mg/kg - 10 mg/kg, Every 2 weeks, 3 years depending on response
Ostatní jména:
  • BMS-936558
Biologický: BMS-936558 (MDX-1106)
Solution, Intravenous, 1 - 10 mg/kg, Every 2 weeks, 3 years depending on response
Ostatní jména:
  • BMS-936558
Biologický: BMS-936558 (MDX-1106)
Solution, Intravenous, 10 mg/kg, Every 2 weeks, 3 years depending on response
Ostatní jména:
  • BMS-936558
Experimentální: CRC - BMS-936558 (MDX-1106)
Biologický: BMS-936558 (MDX-1106)
Solution, Intravenous, 0.1 mg/kg - 10 mg/kg, Every 2 weeks, 3 years depending on response
Ostatní jména:
  • BMS-936558
Biologický: BMS-936558 (MDX-1106)
Solution, Intravenous, 1 - 10 mg/kg, Every 2 weeks, 3 years depending on response
Ostatní jména:
  • BMS-936558
Biologický: BMS-936558 (MDX-1106)
Solution, Intravenous, 10 mg/kg, Every 2 weeks, 3 years depending on response
Ostatní jména:
  • BMS-936558

Co je měření studie?

Primární výstupní opatření

Měření výsledku
Popis opatření
Časové okno
Number of Participants With Severe Adverse Events (AEs), Serious Adverse Events (SAEs), Treatment-Related AEs, Deaths, Discontinuation of Study Drug Due to AEs
Časové okno: 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
Časové okno: 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
Časové okno: 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

Sekundární výstupní opatření

Měření výsledku
Popis opatření
Časové okno
Immunogenicity Assessment
Časové okno: 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
Časové okno: 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
Časové okno: 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)
Časové okno: 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)
Časové okno: 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
Časové okno: 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)
Časové okno: 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)
Časové okno: 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

Spolupracovníci a vyšetřovatelé

Zde najdete lidi a organizace zapojené do této studie.

Sponzor

Bristol-Myers Squibb

Spolupracovníci

Ono Pharmaceutical Co. Ltd

Publikace a užitečné odkazy

Osoba odpovědná za zadávání informací o studiu tyto publikace poskytuje dobrovolně. Mohou se týkat čehokoli, co souvisí se studiem.

Obecné publikace

Užitečné odkazy

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)

30. října 2008

Primární dokončení (Aktuální)

4. února 2013

Dokončení studie (Aktuální)

22. prosince 2020

Termíny zápisu do studia

První předloženo

4. srpna 2008

První předloženo, které splnilo kritéria kontroly kvality

7. srpna 2008

První zveřejněno (Odhad)

8. srpna 2008

Aktualizace studijních záznamů

Poslední zveřejněná aktualizace (Aktuální)

3. prosince 2021

Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality

1. prosince 2021

Naposledy ověřeno

1. listopadu 2021

Více informací

Termíny související s touto studií

Další relevantní podmínky MeSH

Další identifikační čísla studie

  • CA209-003
  • MDX1106-03 (Jiný identifikátor: BMS)

Informace o lécích a zařízeních, studijní dokumenty

Studuje lékový produkt regulovaný americkým FDA

Ano

Studuje produkt zařízení regulovaný americkým úřadem FDA

Ne

produkt vyrobený a vyvážený z USA

Ne

Tyto informace byly beze změn načteny přímo z webu clinicaltrials.gov. Máte-li jakékoli požadavky na změnu, odstranění nebo aktualizaci podrobností studie, kontaktujte prosím register@clinicaltrials.gov. Jakmile bude změna implementována na clinicaltrials.gov, bude automaticky aktualizována i na našem webu .

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Zdravotní podmínky

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Podmínky

Vzácné nemoci

Drogové intervence

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