Neoplasms

All Conditions

Respiratory Tract (Lung and Bronchial) Diseases

Rare Diseases

Carcinoma

Small Cell Lung Carcinoma

Lung Neoplasms

Carcinoma, Bronchogenic

Bronchial Neoplasms

Respiratory Tract Neoplasms

Thoracic Neoplasms

Lung Diseases

Respiratory Tract Diseases

Small Cell Lung Cancer

Antineoplastic Agents

All Drugs and Chemicals

Pharmaceutical Solutions

Carboplatin

Etoposide

Cisplatin

Ipilimumab

Etoposide phosphate

Enzyme Inhibitors

Antineoplastic Agents, Immunological

Immune Checkpoint Inhibitors

Ipilimumab: IV solution, Intravenous (IV), 10 mg/kg, Once every 3 weeks for 4 doses, then every 12 weeks, Until progression of disease or unacceptable toxicity, or until the maximum treatment period of 3 years is reached

Etoposide: IV solution, IV, 100 mg/m2, Days 1-3 every 3 weeks, 4 cycles

Cisplatin: IV solution, IV, 75 mg/m2, Once every 3 weeks, 4 doses

Carboplatin: IV Solution, IV, Area Under the Curve (AUC) 5, Once every 3 weeks, 4 doses

Placebo matching Ipilimumab: IV solution, IV, 0 mg/kg, Once every 3 weeks for 4 doses, then every 12 weeks, Until progression of disease or unacceptable toxicity, or until the maximum treatment period of 3 years is reached

Etoposide: IV solution, IV, 100 mg/m2, Days 1-3 every 3 weeks, 4 cycles

Cisplatin: IV solution, IV, 75 mg/m2, Once every 3 weeks, 4 doses

Carboplatin: IV Solution, IV, Area Under the Curve (AUC) 5, Once every 3 weeks, 4 doses

Placebo matching Ipilimumab

Bristol-Myers Squibb

The purpose of the study is to determine whether the addition of Ipilimumab to Etoposide and Platinum therapy will extend the lives of patients with Extensive-Stage Disease Small Cell Lung Cancer (ED-SCLC) more than Etoposide and Platinum therapy alone.

Trial in Extensive-Disease Small Cell Lung Cancer (ED-SCLC) Subjects Comparing Ipilimumab Plus Etoposide and Platinum Therapy to Etoposide and Platinum Therapy Alone

Randomized, Multicenter, Double-Blind, Phase 3 Trial Comparing the Efficacy of Ipilimumab Plus Etoposide/Platinum Versus Etoposide/Platinum in Subjects With Newly Diagnosed Extensive-Stage Disease Small Cell Lung Cancer (ED-SCLC)

Overall Survival was defined as the time from the date of randomization until the date of death from any cause. For participants without documentation of death, OS was censored on the last date the participant was known to be alive.

Progression-Free Survival was defined as the time from the date of randomization to the date of progression per modified World Health Organization (mWHO) criteria or death, whichever occured first. A participant who died without reported progression per mWHO criteria was considered progressed on the date of death. For those participants who remained alive and did not progress, PFS was censored on the date of last evaluable tumor assessment. For those participants who remained alive and had no recorded post-baseline tumor assessment, PFS was censored on the day of randomization.

10 MG/KG IPILIMUMAB + PLATINUM/ETOPOSIDE

PLACEBO + PLATINUM/ETOPOSIDE

Participants received platinum/etoposide (investigator's choice of platinum) every 3 weeks for 4 cycles with ipilimumab (10 mg/kg IV) every 3 weeks from cycle 3-6 of Induction phase. During the maintenance phase, ipilimumab (10 mg/kg IV) was administered every 12 weeks, beginning 9-12 weeks after the last induction dose, for a maximum treatment period of 3 years from the first dose of ipilimumab.

Ipilimumab and Platinum/Etoposide

Participants received platinum/etoposide (investigator's choice of platinum) every 3 weeks for 4 cycles with placebo every 3 weeks from cycle 3-6 during the Induction phase. During the maintenance phase, placebo was administered every 12 weeks, beginning 9-12 weeks after the last Induction dose, for a maximum treatment period of 3 years from the first dose of placebo.

Placebo and Platinum/Etoposide

Total

Age, Continuous

Sex: Female, Male

All randomized participants who received at least one dose of blinded study therapy

BMS Study Director

Participants received platinum/etoposide (investigator's choice of carboplatin or cisplatin) every 3 weeks for 4 cycles with ipilimumab (10 mg/kg IV) every 3 weeks from cycle 3-6 of Induction phase. During the maintenance phase, ipilimumab (10 mg/kg IV) was administered every 12 weeks, beginning 9-12 weeks after the last induction dose, for a maximum treatment period of 3 years from the first dose of ipilimumab.

Participants received platinum/etoposide (investigator's choice of carboplatin or cisplatin) every 3 weeks for 4 cycles with placebo every 3 weeks from cycle 3-6 during the Induction phase. During the maintenance phase, placebo was administered every 12 weeks, beginning 9-12 weeks after the last Induction dose, for a maximum treatment period of 3 years from the first dose of placebo.

Overall Survival (OS) in Participants Who Received at Least One Dose of Blinded Study Therapy

Overall Survival in All Randomized Participants

Progression Free Survival (PFS) Time in Participants Who Have Received at Least One Dose of Blinded Study Therapy

During the lead-in chemotherapy (induction) phase, participants received platinum/etoposide (investigator's choice of platinum) every 3 weeks for 4 cycles, with ipilimumab (10 mg/kg IV) every 3 weeks for cycles 3-6. During the treatment with blinded study therapy phase, ipilimumab (10 mg/kg IV) was administered every 12 weeks, beginning 9-12 weeks after the last induction dose, for a maximum treatment period of 3 years from the first dose of ipilimumab.

During the lead-in chemotherapy (induction) phase, participants received platinum/etoposide (investigator's choice of platinum) every 3 weeks for 4 cycles, with placebo every 3 weeks for cycles 3-6. During the treatment with blinded study therapy phase, placebo was administered every 12 weeks, beginning 9-12 weeks after the last induction dose, for a maximum treatment period of 3 years from the first dose of placebo.

Randomization

Lead-in Chemotherapy

Treatment With Blinded Study Therapy

Symptoms and General Pathology

Skin and Connective Tissue 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

Nivolumab

Immunomodulating Agents

Placebo matching Nivolumab

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

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
Trial in Extensive-Disease Small Cell Lung Cancer (ED-SCLC) Subjects Comparing Ipilimumab Plus Etoposide and Platinum Therapy to Etoposide and Platinum Therapy Alone	NCT01450761	Small Cell Lung...	Ipilimumab Placebo matchin... Etoposide Cisplatin Carboplatin	18 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
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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