EUCTR2014-002351-26-ES进行中（未招募）不适用
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 RecurrencePharmacogenetics Blood Sample Amendment 01 (site-specific)- dated 03-dec-2014 - CheckMate 238: CHECKpoint pathway and nivoluMAb clinical Trial Evaluation 238)
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 1,070
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •-Man and woman, 15 years or older (in some countries, only subjects aged 18 years or older will be recruited)
- •-Completely removed melanoma by surgery performed within 12 weeks of randomization
- •-Stage IIIb/C or Stage IV before complete resection
- •-No previous anti-cancer treatment
- •-Adequate function of the blood, kidney, and liver
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range: 10
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 870
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 190
排除标准
- •-Ocular or uveal melanoma
- •-History of carcinomatosis meningitis
- •-History of auto-immune disease
- •-Previous non-melanoma cancers unless complete remission since 3 years
- •-Treatment directed against the resected melanoma that is administrated after the surgery
- •-Postive testing for hepatitis B, hepatitis C, or known HIV
研究者
相似试验
进行中（未招募）
1 期
Study comparing nivolumab to ipilimumab in prevention of recurrence of melanoma after complete resection of stage IIIb/c or Stage IV melanomaHigh risk, completely resected Stage IIIb/c and IV melanoma subjects.MedDRA version: 19.1Level: LLTClassification code 10053571Term: MelanomaSystem Organ Class: 100000004864EUCTR2014-002351-26-IEBristol-Myers Squibb International Corporation1,070
进行中（未招募）
1 期
Study comparing nivolumab to ipilimumab in prevention of recurrence of melanoma after complete resection of stage IIIb/c or Stage IV melanomaHigh risk, completely resected Stage IIIb/c and IV melanoma subjects.MedDRA version: 21.1Level: LLTClassification code 10053571Term: MelanomaSystem Organ Class: 100000004864EUCTR2014-002351-26-GBBristol-Myers Squibb International Corporation1,070
进行中（未招募）
1 期
A Phase 3 Study of Nivolumab versus Placebo for Participants with Hepatocellular Cancer Who Are at High Risk of Recurrence after Hepatic Resection or AblatioMedDRA version: 20.0Level: PTClassification code 10073071Term: Hepatocellular carcinomaSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)Hepatocellular CarcinomaEUCTR2017-002755-29-BEBristol-Myers Squibb International Corporation883
招募中
3 期
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.Fully resected (Stage IIIb/c or Stage IV) melanoma & Adjuvant therapy10040900NL-OMON55473Bristol-Myers Squibb20
进行中（未招募）
1 期
Adjuvant Immunotherapy with Relatlimab and Nivolumab Fixed-dose Combination versus Nivolumab Monotherapy after Complete Resection of Stage III-IV Melanomaparticipants with completely resected Stage III or Stage IV melanomaMedDRA version: 21.1Level: PTClassification code 10025671Term: Malignant melanoma stage IVSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)MedDRA version: 21.1Level: PTClassification code 10025670Term: Malignant melanoma stage IIISystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)EUCTR2021-001641-13-CZBristol-Myers Squibb International Corporation1,313