PER-056-07已完成未知
A Multi-center, Randomized, Double-Blind, Two-Arm, Phase III Study in Patients With Untreated Stage III (Unresectable) or IV Melanoma Receiving Dacarbazine Plus 10 mg/kg Ipilimumab (MDX-010) vs. Dacarbazine With Placebo
BRISTOL MYERS SQUIBB PERU S.A.,0 个研究点目标入组 0 人开始时间: 2007年9月21日最近更新:
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 发起方
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
入选标准
- •1) Disposition and ability to give written informed consent.
- •2) Have a histological diagnosis of malignant melanoma.
- •3) Stage III untreated and unresectable melanoma with macroscopic lymph nodes N3 or metastasis in transit / satellites or stage IV melanoma.
- •4) Measurable / evaluable disease within 28 days before the first dose of the experimental drug.
- •5) Life expectancy> 16 weeks.
- •6) General condition according to the ECOG scale of 0 or 1.
- •7) Have a complete set of digital images and radiographic images of the lesions in the initial moment.
- •8) Have the required values for the initial laboratory tests.
- •9) Negative screening tests for HIV, hepatitis B and hepatitis C.
- •10) Accessible for treatment and monitoring.
- •11) Men and women of> 18 years.
排除标准
- •1) WOCBPs that are not willing or able to use an acceptable method to prevent pregnancy during the entire study period and up to 8 weeks after the study.
- •2) Women who are pregnant or breastfeeding.
- •3) Women with a positive pregnancy test.
- •4) Sexually active fertile men whose partners are WOCBP, unless they use adequate contraceptive methods.
- •5) Evidence of cerebral metastases in brain images.
- •6) Any other neoplasm of which the patient has been free of disease for less than 5 years.
- •7) Ocular or primary mucosal melanoma.
- •8) Autoimmune disease.
- •9) Any underlying medical or psychiatric illness.
- •10) Previous or concomitant treatment with some antineoplastic, immunosuppressive agents, surgery or radiotherapy, other experimental anticancer therapies, or the chronic use of corticosteroids.
- •11) Any treatment with non-oncological vaccines used for the prevention of infectious diseases.
- •12) Previous treatment with a CD137 agonist or a CTLA-4 inhibitor or agonist.
- •13) Previous participation in another clinical trial with ipilimumab.
- •14) Treatment with other experimental products within 4 weeks prior to randomization in this study.
- •15) Prisoners or persons who are mandatorily detained for the treatment of any psychiatric or physical illness should not be randomized in this study.
研究者
相似试验
招募中
1 期
A research study to evaluate if ELGN-2112 is safe for the treatment of Intestinal Malabsorption in Preterm InfantsIntestinal Malabsorption in Preterm InfantsMedDRA version: 20.0Level: LLTClassification code 10032413Term: Other preterm infants, 750-999 gramsSystem Organ Class: 100000004868MedDRA version: 20.0Level: LLTClassification code 10032407Term: Other preterm infants, 1,250-1,499 gramsSystem Organ Class: 100000004868MedDRA version: 20.0Level: LLTClassification code 10032409Term: Other preterm infants, 1,750-1,999 gramsSystem Organ Class: 100000004868MedDRA version: 20.0Level: LLTClassification code 10032411Term: Other preterm infants, 2,500+ gramsSystem Organ Class: 100000004868MedDRA version: 20.0Level: LLTClassification code 10032415Term: Other preterm infants, unspecified {weight}System Organ Class: 100000004868MedDRA version: 20.0Level: LLTClassification code 10032412Term: Other preterm infants, 500-749 gramsSystem Organ Class: 100000004868MedDRA version: 20.0Level: LLTClassification code 10032406Term: Other preterm infants, 1,000-1,249 gramsSystem Organ Class: 100000004868MedDRA version: 20.0Level: LLTClassification code 10032408Term: Other preterm infants, 1,500-1,749 gramsSystem Organ Class: 100000004868MedDRA version: 20.0Level: LLTClassification code 10032410Term: Other preterm infants, 2,000-2,499 gramsSystem Organ Class: 100000004868EUCTR2022-004195-42-ATELGAN Pharma360
招募中
1 期
A research study to evaluate if ELGN-2112 is effective and safe for the treatment of Intestinal Malabsorption in Preterm InfantsIntestinal Malabsorption in Preterm InfantsMedDRA version: 20.0Level: LLTClassification code 10032413Term: Other preterm infants, 750-999 gramsSystem Organ Class: 100000004868MedDRA version: 20.0Level: LLTClassification code 10032407Term: Other preterm infants, 1,250-1,499 gramsSystem Organ Class: 100000004868MedDRA version: 20.0Level: LLTClassification code 10032409Term: Other preterm infants, 1,750-1,999 gramsSystem Organ Class: 100000004868MedDRA version: 20.0Level: LLTClassification code 10032411Term: Other preterm infants, 2,500+ gramsSystem Organ Class: 100000004868MedDRA version: 20.0Level: LLTClassification code 10032415Term: Other preterm infants, unspecified {weight}System Organ Class: 100000004868MedDRA version: 20.0Level: LLTClassification code 10032412Term: Other preterm infants, 500-749 gramsSystem Organ Class: 100000004868MedDRA version: 20.0Level: LLTClassification code 10032406Term: Other preterm infants, 1,000-1,249 gramsSystem Organ Class: 100000004868MedDRA version: 20.0Level: LLTClassification code 10032408Term: Other preterm infants, 1,500-1,749 gramsSystem Organ Class: 100000004868MedDRA version: 20.0Level: LLTClassification code 10032410Term: Other preterm infants, 2,000-2,499 gramsSystem Organ Class: 100000004868EUCTR2021-004890-29-ATELGAN Pharma360
进行中（未招募）
1 期
study that will be conduced in different clinical sites, in which nor the patient neither the doctors will know the treatment given to patient, with 2 different group in which the patients will be assigned randomly, controlled with respect to placebo, that has the aim to estabilish the efficacy and the safety of ELGN2112 on the incapability of preterm baby to absorb sufficient nutrients, a condition known as intestinal malabsorptioIntestinal Malabsorption in Preterm InfantsMedDRA version: 20.0Level: LLTClassification code 10032413Term: Other preterm infants, 750-999 gramsSystem Organ Class: 100000004868MedDRA version: 20.0Level: LLTClassification code 10032407Term: Other preterm infants, 1,250-1,499 gramsSystem Organ Class: 100000004868MedDRA version: 20.0Level: LLTClassification code 10032409Term: Other preterm infants, 1,750-1,999 gramsSystem Organ Class: 100000004868MedDRA version: 20.0Level: LLTClassification code 10032411Term: Other preterm infants, 2,500+ gramsSystem Organ Class: 100000004868MedDRA version: 20.0Level: LLTClassification code 10032415Term: Other preterm infants, unspecified {weight}System Organ Class: 100000004868MedDRA version: 20.0Level: LLTClassification code 10032412Term: Other preterm infants, 500-749 gramsSystem Organ Class: 100000004868MedDRA version: 20.0Level: LLTClassification code 10032406Term: Other preterm infants, 1,000-1,249 gramsSystem Organ Class: 100000004868MedDRA version: 20.0Level: LLTClassification code 10032408Term: Other preterm infants, 1,500-1,749 gramsSystem Organ Class: 100000004868MedDRA version: 20.0Level: LLTClassification code 10032410Term: Other preterm infants, 2,000-2,499 gramsSystem Organ Class: 100000004868EUCTR2021-004890-29-SEELGAN Pharma360
尚未招募
2 期
A Multi-center, Double-Blind, Randomized, Two-Arm, Parallel-Group, Placebo Controlled Basket Study to Assess the Safety of ELGN-2112 in Populations of InterestPrematurity - preterm birthfeeding intoleranceintestinal malabsorption in preterm infants10025477NL-OMON53321ELGAN Pharma10
尚未招募
3 期
A Multi-center, Double-Blind, Randomized, Two-Arm, Parallel-Group, Placebo Controlled Study to Assess the Efficacy and Safety of ELGN-2112 on Intestinal Malabsorption in Preterm InfantsPrematurity - preterm birthfeeding intoleranceintestinal malabsorption in preterm infants10025477NL-OMON53803ELGAN Pharma70