- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT02381314
Safety Study of Enoblituzumab (MGA271) in Combination With Ipilimumab in Refractory Cancer
A Phase 1, Open-Label, Dose Escalation Study of MGA271 in Combination With Ipilimumab in Patients With Melanoma, Non-Small Cell Lung Cancer, and Other Cancers
연구 개요
상세 설명
This study is a Phase 1 open-label, dose escalation, and cohort expansion study of enoblituzumab administered intravenously (IV) on a weekly schedule for up to 51 doses in combination with IV ipilimumab administered on an every-3-week schedule for 4 doses.
The dose escalation phase is designed to characterize the safety and tolerability of the combination of enoblituzumab and ipilimumab and to define the maximum tolerated or administered dose (MTD/MAD) in patients with B7-H3 expressing mesothelioma, urothelial cancer, NSCLC, SCCHN, Clear cell renal cell carcinoma (ccRCC), ovarian cancer, melanoma, thyroid cancer, Triple negative breast cancer (TNBC), pancreatic cancer, colon cancer, soft tissue sarcoma, or prostate cancer.
The cohort expansion phase, 2 cohorts of 16 patients each will be enrolled to further evaluate the safety and potential efficacy of the combination administered at the MTD/MAD dose in patients with melanoma and NSCLC.
All tumor evaluations will be carried out by both Response Evaluation Criteria in Solid Tumors (RECIST) and immune-related response criteria (irRC).
연구 유형
등록 (실제)
단계
- 1단계
연락처 및 위치
연구 장소
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California
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Los Angeles, California, 미국, 90095
- UCLA Hematology-Oncology Clinic
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Connecticut
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New Haven, Connecticut, 미국, 06520
- Yale University
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Florida
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Miami Beach, Florida, 미국, 33140
- Mount Sinai Medical Center
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Illinois
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Chicago, Illinois, 미국, 60637
- University of Chicago
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Indiana
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Indianapolis, Indiana, 미국, 46202
- Indiana University Simon Cancer Center
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Missouri
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Saint Louis, Missouri, 미국, 63110
- Washington University School of Medicine in St. Louis
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New York
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New York, New York, 미국, 10032
- Columbia University Medical Center
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Oregon
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Portland, Oregon, 미국, 97213
- Providence Portland Medical Center
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Texas
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Houston, Texas, 미국, 77030
- Center for Oncology and Blood Disorders
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Wisconsin
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Madison, Wisconsin, 미국, 53792
- University of Wisconsin
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
Inclusion Criteria - Cohort Expansion Phase:
Histologically-proven, unresectable, locally advanced or metastatic melanoma or NSCLC
- Melanoma: Advanced or metastatic melanoma patients may be systemic therapy naïve or may have received systemic treatment for unresectable locally advanced or metastatic disease. A patient who previously received systemic therapy must have had progression on a checkpoint inhibitor (e.g., anti-PD-L1, anti-PD-1, anti-CTLA-4) as the most recent prior therapy.
- NSCLC: NSCLC that has progressed during or following 1 or more prior systemic therapies for unresectable locally advanced or metastatic disease. Patients who are intolerant of, or have refused treatment with standard first line cancer therapy, will be allowed to enroll. Patients must not have had more than 5 prior systemic regimens (excluding experimental therapies) for unresectable locally advanced or metastatic disease.
- B7-H3 expression is not required for eligibility in this study; however, tumor expression of B7-H3 will be evaluated for all patients.
- Measurable disease per RECIST 1.1 criteria
- ECOG performance status 0 or 1
- Acceptable laboratory parameters and adequate organ reserve.
Exclusion Criteria - Cohort Expansion Phase:
- Patients with a history of symptomatic central nervous system metastases, unless treated and asymptomatic
- Patients with history of autoimmune disease with certain exceptions
- History of allogeneic bone marrow, stem cell, or solid organ transplant
- Treatment with systemic cancer therapy or investigational therapy within 4 weeks; radiation within 2 weeks; trauma or major surgery within 4 weeks
- History of clinically-significant cardiovascular disease; gastrointestinal perforation; gastrointestinal bleeding, acute pancreatitis or diverticulitis within 4 weeks;
- Active viral, bacterial, or systemic fungal infection requiring parenteral treatment within 7 days; positive for human immunodeficiency virus or AIDS, hepatitis B or C.
- Known hypersensitivity to recombinant proteins, polysorbate 80, or any excipient contained in the drug or vehicle formulation for MGA271 or ipilimumab.
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 해당 없음
- 중재 모델: 단일 그룹 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
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실험적: enoblituzumab plus ipilimumab
Enoblituzumab: Fc-optimized, humanized monoclonal antibody.
Ipilimumab: Yervoy; recombinant, fully humanized IgG-1 CTLA-4 blocking antibody approved by the US Food and Drug Administration and the European Medicines Agency for the treatment of unresectable or metastatic melanoma.
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enoblituzumab is administered by IV infusion once per week.
Ipilimumab is administered by IV infusion every 3 weeks for up to 4 doses.
다른 이름들:
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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Number of participants with adverse events
기간: 1 year
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Adverse events, serious adverse events
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1 year
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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Peak plasma concentration
기간: 7 weeks
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PK of MGA271 in combination with ipilimumab
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7 weeks
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Number of participants that develop anti-drug antibodies
기간: 7 weeks
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Proportion of patients who develop anti-MGA271 antibodies, immunogenicity
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7 weeks
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Change in tumor volume
기간: Weeks 9, 18, 27, 39, and 51
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Anti-tumor activity of MGA271 in combination with ipilimumab using both conventional RECIST 1.1 and immune-related RECIST criteria.
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Weeks 9, 18, 27, 39, and 51
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공동 작업자 및 조사자
스폰서
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
기본 완료 (실제)
연구 완료 (실제)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (추정)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
추가 관련 MeSH 약관
기타 연구 ID 번호
- CP-MGA271-02
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .
enoblituzumab plus ipilimumab에 대한 임상 시험
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NYU Langone Health종료됨
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Istituto Clinico Humanitas Mater Domini아직 모집하지 않음
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Universitätsklinikum KölnZKS Köln빼는자궁경부암 ≥ FIGO IIB 및/또는 림프절 전이
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University of Colorado, Denver아직 모집하지 않음
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Carme Ferré GrauAdministração Regional de Saúde do Norte, Portugal알려지지 않은