Efficacy and Safety Study of Acasunlimab as Monotherapy and in Combination With Pembrolizumab in Subjects With Relapsed/Refractory, Unresectable Locally Advanced or Metastatic Cutaneous Melanoma That Progressed On or After Treatment With a Checkpoint Inhibitor (ABBIL1TY MELANOMA-07)
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 发起方
- Genmab
- 入组人数
- 1
- 试验地点
- 2
- 主要终点
- Objective Response Rate (ORR)
研究概览
简要总结
The goal of this clinical trial is to learn about the effectiveness and safety of the bispecific antibody acasunlimab (also known as DuoBody®-PD-L1x4-1BB) when given either alone or together with the cancer drug pembrolizumab in participants with locally advanced or metastatic melanoma of the skin. All participants will receive active drugs; no one will be given a placebo.
The trial duration will be approximately 15 months for each participant, including a 28-day screening period and estimated 4-month treatment and 10-month follow-up periods; however, the duration of the treatment and follow-up periods may vary for each participant.
Participants will have regular check-ups while on treatment, with visits every week initially, and then every 3 weeks later in the trial.
详细描述
This is a Phase 2, randomized, open-label, multicenter trial evaluating the efficacy and safety of acasunlimab as monotherapy and in combination with pembrolizumab in adult participants with relapsed/refractory, unresectable locally advanced or metastatic cutaneous melanoma who progressed on or after prior checkpoint inhibitor (CPI)-containing therapy. Participants will be randomized in a 1:1 ratio to receive acasunlimab and pembrolizumab or acasunlimab alone.
Eligible participants must have received a minimum of 2 cycles of an approved anti-programmed cell death protein 1 (PD-1) containing therapy. Participants whose tumor harbors a B-Raf proto-oncogene, serine/threonine kinase (BRAF) V600 mutation are eligible for the trial if they have received a BRAF-directed therapy (with or without a mitogen-activated protein kinase [MEK] inhibitor) prior to enrollment in the trial, unless the investigator has deemed a BRAF-directed therapy not clinically indicated. BRAF V600 mutational status must be determined by local assessment and documented.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Participants ≥ 18 years of age with histologically or cytologically confirmed diagnosis of relapsed/refractory, locally advanced unresectable (Stage IIIB, IIIC, or IIID) or metastatic (Stage IV) cutaneous melanoma, per American Joint Committee on Cancer (8th edition) staging.
- •Participant must have radiographic progression based on RECIST v1.1 on or following ≥ 1 prior systemic therapy, according to local and international guidelines, including a programmed cell death protein 1 blocking antibody (anti-PD-1) treatment or combination treatment containing an anti-PD-
- •Participant must have received a minimum of 2 cycles of an approved anti-PD-1 as monotherapy or a combination therapy containing an anti-PD-
- •Neoadjuvant and/or adjuvant systemic therapy count as the first line of prior systemic therapy if there is documented disease progression ≤ 6 months after completion of therapy.
- •Participants with a BRAF V600 mutation should have received prior BRAF-directed therapy (with or without a MEK inhibitor) prior to enrollment in the trial, unless deemed not clinically indicated by the Investigator due to concurrent medical condition or prior toxicity.
- •Participant has an Eastern Cooperative Oncology Group performance status of 0 or 1 within 7 days prior to Cycle 1 Day
排除标准
- •Participants with non-cutaneous or acral melanoma.
- •Participants with newly identified or known unstable or symptomatic central nervous system metastases or history of carcinomatous meningitis.
- •Note: Other protocol-defined Inclusion and Exclusion criteria may apply.
研究组 & 干预措施
Acasunlimab in Combination with Pembrolizumab
Participants with relapsed/refractory, unresectable locally advanced or metastatic cutaneous melanoma that progressed on/after prior CPI(s) will receive acasunlimab once every 6 weeks (Q6W) in combination with pembrolizumab Q6W.
干预措施: Acasunlimab (Biological)
Acasunlimab in Combination with Pembrolizumab
Participants with relapsed/refractory, unresectable locally advanced or metastatic cutaneous melanoma that progressed on/after prior CPI(s) will receive acasunlimab once every 6 weeks (Q6W) in combination with pembrolizumab Q6W.
干预措施: Pembrolizumab (Biological)
Acasunlimab
Participants with relapsed/refractory, unresectable locally advanced or metastatic cutaneous melanoma that progressed on/after prior CPI(s) will receive acasunlimab Q6W.
干预措施: Acasunlimab (Biological)
结局指标
主要结局
Objective Response Rate (ORR)
时间窗: Up to approximately 12 months
Assessed by the investigator per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1.
次要结局
- Time to Response (TTR)(Up to approximately 15 months)
- Duration of Response (DOR)(Up to approximately 15 months)
- Progression-free Survival (PFS)(Up to approximately 15 months)
- Overall Survival (OS)(Up to approximately 15 months)
- Number of Participants with Treatment-emergent Adverse Events (TEAEs)(Up to approximately 15 months)
- Time to Treatment Discontinuation Due to Adverse Events (AEs)(Up to approximately 15 months)