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

Melanoma Clinical Trial

— CheckMate 401  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02599402
• Other study ID #: CA209-401
• Secondary ID: 2015-001274-17
• Status: Completed
• Phase: Phase 3
• Start date: December 20, 2015
• Est. completion date: February 10, 2020

Study information

• Verified date: May 2021
• Source: Bristol-Myers Squibb
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 533
• Est. completion date: February 10, 2020
• Est. primary completion date: February 10, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Melanoma

Intervention

Drug:
• Nivolumab

• Ipilimumab

Locations

Country	Name	City	State
Australia	Local Institution	Adelaide	South Australia
Australia	Local Institution	Bedford Park	South Australia
Australia	Local Institution	Brisbane	Queensland
Australia	Local Institution	Cairns	Queensland
Australia	Local Institution	Camperdown	New South Wales
Australia	Local Institution	Coffs Harbour	New South Wales
Australia	Local Institution	Garran	Australian Capital Territory
Australia	Local Institution	Gateshead	New South Wales
Australia	Local Institution	Greenslopes	Queensland
Australia	Local Institution	Hobart	Tasmania
Australia	Local Institution	Melbourne	Victoria
Australia	Local Institution	Melbourne	Victoria
Australia	Local Institution	Melbourne	Victoria
Australia	Local Institution	Murdoch	Western Australia
Australia	Local Institution	Nedlands	Western Australia
Australia	Local Institution	North Sydney	New South Wales
Australia	Local Institution	Southport	Queensland
Australia	Local Institution	Tiwi	Northern Territory
Austria	Local Institution	Graz
Austria	Local Institution	Innsbruck
Austria	Local Institution	Salzburg
Austria	Local Institution	Vienna
Belgium	Local Institution	Brussel
Belgium	Local Institution	Bruxelles
Finland	Local Institution	Helsinki
Finland	Local Institution	Oulu
Finland	Local Institution	Tampere
Finland	Local Institution	Turku
France	Local Institution	Angers Cedex 9
France	Local Institution	Bordeaux
France	Local Institution	Boulogne Billancourt
France	Local Institution	Clermont-Ferrand
France	Local Institution	Dijon
France	Local Institution	Grenoble Cedex 09
France	Local Institution	Le Mans Cedex 9
France	Local Institution	Lille
France	Local Institution	Marseille
France	Local Institution	Montpellier
France	Local Institution	Nantes Cedex 01
France	Local Institution	Nice
France	Local Institution	Paris
France	Local Institution	Pierre Benite Cedax
France	Local Institution	Rennes Cedex
France	Local Institution	Rouen Cedex
France	Local Institution	TOULOUSE Cedex 9
France	Local Institution	Vandoeuvre-les-Nancy
France	Local Institution	Villejuif
Germany	Local Institution	Berlin
Germany	Local Institution	Dresden
Germany	Local Institution	Erfurt
Germany	Local Institution	Erlangen
Germany	Local Institution	Frankfurt
Germany	Local Institution	Freiburg
Germany	Local Institution	Gottingen
Germany	Local Institution	Hannover
Germany	Local Institution	Kiel
Germany	Local Institution	Leipzig
Germany	Local Institution	Ludwigshafen
Germany	Local Institution	Luebeck
Germany	Local Institution	Mainz	Rhineland-palladium
Germany	Local Institution	Mannheim
Germany	Local Institution	Regensburg
Germany	Local Institution	Schwerin
Germany	Local Institution	Stade
Ireland	Local Institution	Cork
Ireland	Local Institution	Dublin
Ireland	Local Institution	Dublin
Ireland	Local Institution	Dublin
Ireland	Local Institution	Dublin
Ireland	Local Institution	Galway
Italy	Local Institution	Bari
Italy	Local Institution	Bergamo
Italy	Local Institution	Genova
Italy	Local Institution	Meldola
Italy	Local Institution	Milan
Italy	Local Institution	Milano
Italy	Local Institution	Napoli
Italy	Local Institution	Padova
Italy	Local Institution	Pisa
Italy	Local Institution	Roma
Italy	Local Institution	Roma
Italy	Local Institution	Siena
Italy	Local Institution	Terni
Italy	Local Institution	Torino
Norway	Local Institution	Oslo
Norway	Local Institution	Stavanger
Sweden	Local Institution	Eskilstuna
Sweden	Local Institution	Gävle
Sweden	Local Institution	Karlskrona
Sweden	Local Institution	Linköping
Sweden	Local Institution	Stockholm
Sweden	Local Institution	Sundsvall
Sweden	Local Institution	Vasteras
Sweden	Local Institution	Växjö
Switzerland	Local Institution	Basel
Switzerland	Local Institution	Lausanne
United Kingdom	Local Institution	Cambridge
United Kingdom	Local Institution	Cottingham
United Kingdom	Local Institution	Glasgow
United Kingdom	Local Institution	Headington
United Kingdom	Local Institution	London
United Kingdom	Local Institution	London	Greater London
United Kingdom	Local Institution	Manchester
United Kingdom	Local Institution	Newcastle Upon Tyne	Tyne And Wear
United Kingdom	Mount Vernon Hospital	Northwood
United Kingdom	Local Institution	Nottingham
United Kingdom	Local Institution	Preston
United Kingdom	Local Institution	Sheffield
United Kingdom	Local Institution	Southampton
United Kingdom	Local Institution	Swansea
United Kingdom	Local Institution	Truro

Sponsors (1)

Lead Sponsor	Collaborator
Bristol-Myers Squibb

Countries where clinical trial is conducted

Australia,  Austria,  Belgium,  Finland,  France,  Germany,  Ireland,  Italy,  Norway,  Sweden,  Switzerland,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of Participants With High-Grade (CTCAE v4.0 Grade 3-5) Treatment-Related Select Adverse Events	Incidence of participants with high-grade (CTCAE v4.0 grade 3-5) treatment-related, select adverse events of potentially immune-mediated etiology including pulmonary, gastrointestinal, skin, renal, hepatic, endocrine, infusion-related, or hypersensitivity	From first dose to 30 days after last dose (up to approximately 37 months)
Secondary	Incidence of Participants With All High-Grade (Grades 3-5) Select Adverse Events	Incidence of participants with high-grade (grade 3-5) select adverse events including pulmonary, gastrointestinal, skin, renal, hepatic, infusion-related, or hypersensitivity	From first dose to 30 days after last dose (up to approximately 37 months)
Secondary	Median Time to Onset (Grades 3-4) of Select Adverse Events	Median time to onset (grades 3-4) of select adverse events including pulmonary, gastrointestinal, skin, renal, hepatic, endocrine, infusion-related, or hypersensitivity	From first dose to 30 days after last dose (up to approximately 37 months)
Secondary	Median Time to Resolution (Grades 3-4) of Select Adverse Events	Median time to resolution (Grades 3-4) of select adverse events including pulmonary, gastrointestinal, skin, renal, hepatic, endocrine, infusion-related, or hypersensitivity	From first dose to 30 days after last dose (up to approximately 37 months)
Secondary	Time to Resolution of an Adverse Event (AE)	Resolution of an adverse event (AE) is defined as a participant experiencing complete resolution or improvement to the baseline of any grade AE including pulmonary, gastrointestinal, skin, renal, hepatic, endocrine, infusion-related, or hypersensitivity	From first dose to 30 days after last dose (up to approximately 37 months)
Secondary	Overall Survival (OS)	Overall survival is defined from the time of first dosing date to the date of death. A participant who has not died will be censored at the last known date alive	Up to approximately 37 months
Secondary	Incidence of Participants With Adverse Events	The assessment of safety is measured by the incidence of participants who experienced any grade of adverse events (AEs), treatment-related AEs, serious adverse events (SAEs), and deaths	From first dose to 30 days after last dose (up to approximately 37 months)
Secondary	Incidence of Participants With Select Adverse Events	The assessment of safety is measured by the incidence of participants who experienced any grade of select adverse events including pulmonary, gastrointestinal, skin, renal, hepatic, endocrine, infusion-related, or hypersensitivity	From first dose to 30 days after last dose (up to approximately 37 months)
Secondary	Incidence of Participants With Laboratory Abnormalities - Liver	Safety assessment is measured by the incidence of participants who experienced a liver laboratory abnormality in Aspartate aminotransferase (AST), Alanine aminotransferase (ALT), Upper Limit of Normal (ULN)	From first dose to 30 days after last dose (up to approximately 37 months)
Secondary	Incidence of Participants With Laboratory Abnormalities - Thyroid	Safety assessment is measured by the incidence of participants who experienced a thyroid laboratory abnormality in Free T3 (FT3), Free T4 (FT4), Lower Limit of Normal (LLN)	From first dose to 30 days after last dose (up to approximately 37 months)
Secondary	Objective Response Rate (ORR)	Objective response rate is defined as the percentage of participants with a best overall response (BOR) of a complete response (CR) or partial response (PR) divided by the number of all treated participants	Up to approximately 37 months
Secondary	Progression Free Survival (PFS)	Progression free survival per investigator assessment is defined as radiological evidence of progression, significant clinical symptomatic progression, or the need to introduce a non-study drug therapy.	Up to approximately 37 months

External Links

•   BMS Clinical Trial Information
•   BMS Clinical Trial Patient Recruiting
•   FDA Safety Alerts and Recalls