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Nivolumab Combined With Ipilimumab Followed by Nivolumab Monotherapy as First-Line Treatment for Patients With Advanced Melanoma (CheckMate 401)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02599402
Recruitment Status : Active, not recruiting
First Posted : November 6, 2015
Last Update Posted : November 19, 2019
Sponsor:
Information provided by (Responsible Party):
Bristol-Myers Squibb

Tracking Information
First Submitted Date  ICMJE November 5, 2015
First Posted Date  ICMJE November 6, 2015
Last Update Posted Date November 19, 2019
Actual Study Start Date  ICMJE December 8, 2015
Estimated Primary Completion Date December 20, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 5, 2015)
Rate and frequency for high-grade (CTCAE v4.0 Grade 3-5) treatment-related, select adverse events in study subjects [ Time Frame: approximately 24 months ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: November 30, 2018)
  • Incidence of all high-grade (Grades 3-5), select adverse events [ Time Frame: approximately 24 months ]
  • Median time to onset (Grades 3-4) of select adverse events [ Time Frame: approximately 24 months ]
  • Median time to resolution (Grades 3-4) of select adverse events [ Time Frame: approximately 24 months ]
  • Resolution of an Adverse Event (AE) [ Time Frame: approximately 24 months ]
    It is defined as a subject experiencing complete resolution or improvement to the baseline grade for the AE
  • Overall survival time from first dosing date to the date of death. [ Time Frame: approximately 2 years ]
    It is defined as a subject who has not died will be censored at last known date alive
  • Safety will be measured by the incidence of all AEs, treatment-related AEs, serious AEs, deaths, laboratory abnormalities, and select AEs [ Time Frame: approximately 2 years ]
    Select AEs such as pulmonary, gastrointestinal, skin, renal, hepatic, pancreatic, neurologic, endocrine, infusion-related, or hypersensitivity
  • Tolerability will be measured by the incidence of all AEs, treatment-related AEs, serious AEs, deaths, laboratory abnormalities, and select AEs [ Time Frame: approximately 2 years ]
  • ORR [ Time Frame: approximately 2 years ]
    ORR is defined as the number of subjects with a best overall response (BOR) of a complete response (CR) or partial response (PR) divided by the number of all treated subjects
  • Investigator-assessed Progression free survival (PFS) [ Time Frame: approximately 2 years ]
    Investigator-assessed PFS is defined as radiological evidence of progression, significant clinical symptomatic progression, or the need to introduce a non-study drug therapy.
Original Secondary Outcome Measures  ICMJE
 (submitted: November 5, 2015)
  • Incidence of all high-grade (Grades 3-5), select adverse events [ Time Frame: approximately 24 months ]
  • Median time to onset (Grades 3-4) of select adverse events [ Time Frame: approximately 24 months ]
  • Median time to resolution (Grades 3-4) of select adverse events [ Time Frame: approximately 24 months ]
  • Resolution of an Adverse Event (AE) [ Time Frame: approximately 24 months ]
    It is defined as a subject experiencing complete resolution or improvement to the baseline grade for the AE
  • Overall survival time from first dosing date to the date of death. [ Time Frame: approximately 5 years ]
    It is defined as a subject who has not died will be censored at last known date alive
  • Safety will be measured by the incidence of all AEs, treatment-related AEs, serious AEs, deaths, laboratory abnormalities, and select AEs [ Time Frame: approximately 5 years ]
    Select AEs such as pulmonary, gastrointestinal, skin, renal, hepatic, pancreatic, neurologic, endocrine, infusion-related, or hypersensitivity
  • Tolerability will be measured by the incidence of all AEs, treatment-related AEs, serious AEs, deaths, laboratory abnormalities, and select AEs [ Time Frame: approximately 5 years ]
  • ORR [ Time Frame: approximately 5 years ]
    ORR is defined as the number of subjects with a best overall response (BOR) of a complete response (CR) or partial response (PR) divided by the number of all treated subjects
  • Investigator-assessed Progression free survival (PFS) [ Time Frame: approximately 5 years ]
    Investigator-assessed PFS is defined as radiological evidence of progression, significant clinical symptomatic progression, or the need to introduce a non-study drug therapy.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Nivolumab Combined With Ipilimumab Followed by Nivolumab Monotherapy as First-Line Treatment for Patients With Advanced Melanoma
Official Title  ICMJE Clinical Trial of Nivolumab (BMS-936558) Combined With Ipilimumab Followed by Nivolumab Monotherapy as First-Line Therapy of Subjects With Histologically Confirmed Stage III (Unresectable) or Stage IV Melanoma CheckMate 401: CHECKpoint Pathway and nivoluMAb Clinical Trial Evaluation 401
Brief Summary The purpose of this study is to determine the effects of combination treatment of Nivolumab with Ipilimumab followed by Nivolumab monotherapy in patients with previously untreated advanced Melanoma.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Melanoma
Intervention  ICMJE
  • Drug: Nivolumab
  • Drug: Ipilimumab
Study Arms  ICMJE
  • Experimental: Combination therapy: Nivolumab + Ipilimumab
    Nivolumab + Ipilimumab specified dose on specified days
    Interventions:
    • Drug: Nivolumab
    • Drug: Ipilimumab
  • Experimental: Monotherapy: Nivolumab
    Nivolumab specified dose on specified days
    Intervention: Drug: Nivolumab
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Active, not recruiting
Estimated Enrollment  ICMJE
 (submitted: November 5, 2015)
615
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 20, 2021
Estimated Primary Completion Date December 20, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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

Inclusion Criteria:

  • Potential subjects must have advanced Melanoma (stage III or IV as confirmed by biopsy) with spread to other sites in the body and unable to be removed by surgery.
  • Potential subjects must be newly diagnosed with advanced melanoma and received no treatment for the advanced disease.

NOTE: Prior adjuvant or neoadjuvant melanoma therapy (including anti-CTLA-4, anti-PD-1, anti-PD-L1, anti-PD-L2, or any other antibody or drug specifically targeting T-cell costimulation or checkpoint pathways, such as anti-CD-137) is permitted if the therapy was used in the adjuvant or neoadjuvant setting but not in the metastatic setting. These drugs must be discontinued 6 months prior to study entry and the side effects related to the prior therapy resolved.

  • Potential subjects (with disease spread to brain) who previously received primary treatment are permitted if there was no evidence of disease as confirmed by the MRI (at least 2 weeks after the primary treatment is complete and with in 6 weeks of the first dose of the study drug). Potential subjects must not have received intravenous steroid treatment (>10 mg/day) intravenously for at least 2 weeks prior to study drug administration.

Exclusion Criteria:

  • Leptomenigeal metastases
  • Subjects with autoimmune disease. Subjects with Type I diabetes mellitus, hypothyroidism only requiring hormone replacement, skin disorders (such as vitiligo, psoriasis, or alopecia) not requiring systemic treatment, or conditions not expected to recur in the absence of an external trigger are permitted to enroll.
  • All side effects from previous primary treatments other than alopecia, fatigue, or peripheral neuropathy must have resolved to Grade 1 or baseline before administration of study drug.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Australia,   Austria,   Belgium,   Finland,   France,   Germany,   Ireland,   Italy,   Norway,   Sweden,   Switzerland,   United Kingdom
Removed Location Countries United States
 
Administrative Information
NCT Number  ICMJE NCT02599402
Other Study ID Numbers  ICMJE CA209-401
2015-001274-17 ( EudraCT Number )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: Yes
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Bristol-Myers Squibb
Study Sponsor  ICMJE Bristol-Myers Squibb
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Bristol Myers Squibb Bristol-Myers Squibb
PRS Account Bristol-Myers Squibb
Verification Date November 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP