Symptoms and General Pathology

All Conditions

Neoplasms

Skin and Connective Tissue Diseases

Rare Diseases

Recurrence

Melanoma

Neuroendocrine Tumors

Neuroectodermal Tumors

Neuroectodermal Tumors, Primitive

Neoplasms, Germ Cell and Embryonal

Neoplasms by Histologic Type

Neoplasms, Nerve Tissue

Nevus, Pigmented

Nevus

Nevi and Melanomas

Skin Neoplasms

Skin Diseases

Disease Attributes

Neuroendocrine Tumor

Neuroepithelioma

Antineoplastic Agents

All Drugs and Chemicals

Nivolumab

Immunomodulating Agents

Ipilimumab

Antineoplastic Agents, Immunological

Immune Checkpoint Inhibitors

Placebo matching Ipilimumab

Placebo matching Nivolumab

Bristol-Myers Squibb

The purpose of this study is to determine whether nivolumab is better than ipilimumab to prevent recurrence of melanoma.

Efficacy Study of Nivolumab Compared to Ipilimumab in Prevention of Recurrence of Melanoma After Complete Resection of Stage IIIb/c or Stage IV Melanoma

A Phase 3, Randomized, Double-blind Study of Adjuvant Immunotherapy With Nivolumab Versus Ipilimumab After Complete Resection of Stage IIIb/c or Stage IV Melanoma in Subjects Who Are at High Risk for Recurrence (CheckMate 238: CHECKpoint Pathway and nivoluMAb Clinical Trial Evaluation 238)

RFS is defined as the time between the date of randomization and the date of first recurrence (local, regional or distant metastasis), new primary melanoma, or death (whatever the cause), whichever occurs first.

OS is defined as as the time between the date of randomization and the date of death.

the safety and tolerability of Nivolumab and Ipilimumab was measured by the incidence of adverse events

The Safety and Tolerability of nivolumab and ipilimumab was measured by the incidence of serious adverse events

the safety and tolerability of Nivolumab and Ipilimumab wasmeasured by the incidence of Deaths

The Safety and Tolerability of Nivolumab and Ipilimumab measured by the incidence of Laboratory abnormalities.

Recurrence-free survival by PD-L1 Expression(5% tumor cell membrane expression)

HRQoL was measured by mean changes from baseline in EORTC-QLQ-C30 global health status/QoL composite scale and in remaining EORTC QLQ-C30 scales in all randomized participants.

EORTC QLQ-C30 is the most commonly used QoL instrument in melanoma clinical studies, is a 30-item instrument that has gained wide acceptance in oncology clinical studies and comprises 5 functional scales (physical functioning, cognitive functioning, emotional functioning, social functioning and global quality of life) as well as nine symptom scales (fatigue, pain, nausea/vomiting, dyspnea, insomnia, appetite loss, constipation, diarrhea, and financial difficulties). Except for the overall health status and global quality of life items, responses for all items are 4 point categorical scales ranging from 1 (Not at all) to 4 (Very much). The overall health status/quality of life responses are 7-point Likert scales for which higher score reflects higher health status/quality of life for the 7-point Likert scale.

Ono Pharmaceutical Co. Ltd

Nivolumab 3 mg/kg IV q2 wks and Ipilimumab placebo IV q3 wks for 4 doses then q12 wks starting at Wk 24

Nivolumab 3 mg/kg

Ipilimumab 10 mg/kg IV q3 wks for 4 doses then q12 wks starting at Wk 24 and Nivolumab placebo IV q2 wks

Ipilimumab 10 mg/kg

Total

Age, Continuous

Sex: Female, Male

Ethnicity (NIH/OMB)

Race (NIH/OMB)

Bristol-Myers Squibb Study Director

Recurrence-free Survival (RFS)

Overall Survival (OS)

Grade 3-4

Any grade

The Safety and Tolerability of Nivolumab and Ipilimumab Measured by the Incidence of Adverse Events

The Safety and Tolerability of Nivolumab and Ipilimumab Measured by the Incidence of Serious Adverse Events

the Safety and Tolerability of Nivolumab and Ipilimumab Measured by the Incidence of Deaths

Heamoglobin (grade1-4)

Heamoglobin (Grade 3-4)

Platelet count (grade1-4)

Platelet count ( grade 3-4)

Leukocytes (grade1-4)

Leukocytes (grade 3-4)

Lymphocytes (grade1-4)

Lymphocytes (grade 3-4)

Absolute Neutrophil count (Grade1-4)

Absolute Neutrophil count (Grade3-4)

Alkaline Phosphatase (grade1-4)

Alkaline Phosphatase (Grade3-4)

Aspartate Aminotransferase (grade 1-4)

Aspartate Aminotransferase(grade 3-4)

Alkaline Aminotransferase (grade 1-4)

Alkaline Aminotransferase(grade 3-4)

Total Bilirubin (grade 1-4)

Total Bilirubin (grade 3-4)

Creatinine ( grade1-4)

Creatinine (grade 3-4)

Total Amylase ( grade1-4)

Total Amylase (grade 3-4)

Total Lipase ( grade1-4)

Total Lipase (grade 3-4)

Hypernatremia ( grade1-4)

Hypernatremia (grade 3-4)

Hyponatremia ( grade1-4)

Hyponatremia (grade 3-4)

Hyperkalemia ( grade1-4)

Hyperkalemia (grade 3-4)

Hypokalemia ( grade1-4)

Hypokalemia(grade 3-4)

Hypercalcemia ( grade1-4)

Hypercalcemia(grade 3-4)

Hypocalcemia ( grade1-4)

Hypocalcemia(grade 3-4)

Hypermagnesemia ( grade1-4)

Hypermagnesemia(grade 3-4)

Hypomagnesemia ( grade1-4)

Hypomagnesemia(grade 3-4)

Participants with a CTC graded Laboratory Result for the given parameter from both Baseline and On-treatment

The Safety and Tolerability of Nivolumab and Ipilimumab Measured by the Incidence of Laboratory Abnormalities

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Efficacy Study of Nivolumab Compared to Ipilimumab in Prevention of Recurrence of Melanoma After Complete Resection of Stage IIIb/c or Stage IV Melanoma	NCT02388906	Melanoma	Ipilimumab Nivolumab Placebo matchin... Placebo matchin...	15 Years -	Bristol-Myers Squibb
Efficacy Study of Nivolumab Compared to Ipilimumab in Prevention of Recurrence of Melanoma After Complete Resection of Stage IIIb/c or Stage IV Melanoma	NCT02388906	Melanoma	Ipilimumab Nivolumab Placebo matchin... Placebo matchin...	15 Years -	Bristol-Myers Squibb

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