ClinicalTrials.gov
ClinicalTrials.gov Menu

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 : August 1, 2018
Sponsor:
Information provided by (Responsible Party):
Bristol-Myers Squibb

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.

Condition or disease Intervention/treatment Phase
Melanoma Drug: Nivolumab Drug: Ipilimumab Phase 3

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 615 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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
Actual Study Start Date : December 8, 2015
Estimated Primary Completion Date : December 19, 2021
Estimated Study Completion Date : December 20, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Melanoma

Arm Intervention/treatment
Experimental: Combination therapy: Nivolumab + Ipilimumab
Nivolumab + Ipilimumab specified dose on specified days
Drug: Nivolumab
Drug: Ipilimumab
Experimental: Monotherapy: Nivolumab
Nivolumab specified dose on specified days
Drug: Nivolumab



Primary Outcome Measures :
  1. 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 ]

Secondary Outcome Measures :
  1. Incidence of all high-grade (Grades 3-5), select adverse events [ Time Frame: approximately 24 months ]
  2. Median time to onset (Grades 3-4) of select adverse events [ Time Frame: approximately 24 months ]
  3. Median time to resolution (Grades 3-4) of select adverse events [ Time Frame: approximately 24 months ]
  4. 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

  5. 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

  6. 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

  7. 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 ]
  8. 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

  9. 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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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 The subjects who received previous primary treatment and any additional treatment (which is given after the primary treatment) are permitted if it was completed at least 6 weeks prior to study entry and if the side effects of the treatment are resolved If subjects received any of the following primary treatment previously; they are not permitted to be enrolled in the study (anti-CTLA-4, anti-PD-1, anti-PD-L1, anti-PD-L2, or any other drug specifically targeting T-cell costimulation or checkpoint pathways such as anti-CD-137)
  • 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:

  • There is no current (and not previously treated) disease spread to the brain
  • Subjects who received prior therapy with an anti-CTLA-4, anti-PD-1, anti PD-L1 or anti-PD-L2, anti-CD-137 agents (or any other antibody or drug specifically targeting T-cell costimulation or checkpoint pathways) for adjuvant, neo-adjuvant, or advanced melanoma treatment or as part of clinical trial
  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02599402


  Show 111 Study Locations
Sponsors and Collaborators
Bristol-Myers Squibb
Investigators
Study Director: Bristol Myers Squibb Bristol-Myers Squibb

Additional Information:
Responsible Party: Bristol-Myers Squibb
ClinicalTrials.gov Identifier: NCT02599402     History of Changes
Other Study ID Numbers: CA209-401
2015-001274-17 ( EudraCT Number )
First Posted: November 6, 2015    Key Record Dates
Last Update Posted: August 1, 2018
Last Verified: July 2018

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

Additional relevant MeSH terms:
Melanoma
Neuroendocrine Tumors
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Nerve Tissue
Nevi and Melanomas
Nivolumab
Antibodies, Monoclonal
Antineoplastic Agents
Immunologic Factors
Physiological Effects of Drugs