2024-519818-31-01招募中3 期
A Phase 3 Randomized, Open-label Study of Rinatabart Sesutecan (Rina-S) Versus Treatment of Investigator’s Choice (IC) in Patients With Endometrial Cancer After Platinum-Based Chemotherapy and PD(L)-1 Therapy
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 发起方
- Genmab A/S
- 入组人数
- 290
- 试验地点
- 92
- 主要终点
- 1. Progression-free survival (PFS) per Response Criteria in Solid Tumors (RECIST) v1.1, as Determined by Blinded independent central review (BICR) [Time Frame: Up to approximately 3 years]
研究概览
简要总结
To compare clinical efficacy of Rina-S to treatment of investigator’s choice (IC) in patients with recurrent or progressive endometrial cancer (EC) following prior therapy
入排标准
- 年龄范围
- 18 years 至 65+ years（18-64 Years, 65+ Years）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Participants must have histologically or cytologically confirmed recurrent or progressive endometrial cancer (EC; any subtype excluding neuroendocrine tumors, carcinosarcoma, or endometrial sarcoma) following prior therapy.
- •Participants must have received at least 1, but not more than 3, prior lines of therapy:
- •Participants must have received prior platinum-based chemotherapy and a programmed death (ligand)-1 (PD(L)-1) inhibitor, either separately or in combination
- •If the tumor recurred more than 12 months after completion of platinum-based chemotherapy, additional platinum-based chemotherapy must be administered for recurrent disease unless the participant is ineligible for further platinum-based chemotherapy, in which case the reason for ineligibility must be documented. Note: If Immunotherapy-based treatment is administered in the advanced / recurrent setting, then platinum rechallenge is not required, regardless of the duration of the platinum-free interval from prior platinum-based chemotherapy. In such cases, the reason for ineligibility for platinum-based chemotherapy must be documented.
- •Prior induction plus maintenance is considered 1 line of therapy
- •Hormonal therapy alone (ie, without chemotherapy) will not be counted as a separate line of therapy.
- •Therapy changed due to toxicity in the absence of progression will be considered part of the same line of therapy (i.e., will not be counted independently as a separate line of therapy)
- •Participants must have progressed radiographically on or after their most recent line of therapy
排除标准
- •Prior therapy with an antibody-drug conjugate containing a topoisomerase 1 inhibitor.
- •Has a past or current malignancy other than the inclusion diagnosis before the planned first dose of study drug, or any evidence of residual disease from a previously diagnosed malignancy. Exceptions are malignancies with a negligible risk of metastasis or death (eg, 5-year OS ≥90%), including, but not limited to, adequately treated cervical carcinoma of Stage 1B or less, noninvasive basal cell or squamous cell skin carcinoma, noninvasive superficial bladder cancer, ductal carcinoma in situ, or any past malignancy considered cured for ≥3 years (ie, eligible participants must have complete response of ≥3 years duration).
- •Known active central nervous system metastases or carcinomatous meningitis. Participants with previously treated brain metastases may participate provided they are clinically stable for at least 4 weeks prior to study entry after completion of brain metastasis treatment, they have no new or enlarging brain metastases, and are off corticosteroids and anticonvulsants prescribed for symptoms associated with brain metastases for at least 7 days prior to the planned first dose of study drug. Participants with suspected brain metastases at screening should undergo a computed tomography (CT)/magnetic resonance imaging (MRI) of the brain prior to study entry.
- •Hospitalization or clinical symptoms due to gastrointestinal obstruction within the past 91 days or radiographic evidence of gastrointestinal obstruction at the time of screening. Enrollment of participants who currently require parenteral nutrition must be discussed with the study medical monitor to determine eligibility
研究组 & 干预措施
PACLITAXEL
Comparator
干预措施: PACLITAXEL (Drug)
DOXORUBICIN
Comparator
干预措施: DOXORUBICIN (Drug)
Rinatabart Sesutecan
Test
干预措施: Rinatabart Sesutecan (Drug)
结局指标
主要结局
1. Progression-free survival (PFS) per Response Criteria in Solid Tumors (RECIST) v1.1, as Determined by Blinded independent central review (BICR) [Time Frame: Up to approximately 3 years]
1. Progression-free survival (PFS) per Response Criteria in Solid Tumors (RECIST) v1.1, as Determined by Blinded independent central review (BICR) [Time Frame: Up to approximately 3 years]
1. Progression-free survival (PFS) per Response Criteria in Solid Tumors (RECIST) v1.1, as Determined by independent central review (BICR) [Time Frame: Up to approximately 3 years]
1. Progression-free survival (PFS) per Response Criteria in Solid Tumors (RECIST) v1.1, as Determined by independent central review (BICR) [Time Frame: Up to approximately 3 years]
2. Overall Survival (OS) [Time Frame: Up to approximately 3 years]
2. Overall Survival (OS) [Time Frame: Up to approximately 3 years]
次要结局
- Objective Response Rate (ORR), per RECIST v1.1, as Determined by BIRC
- PFS, per RECIST v1.1, as determined by investigator assessment
- ORR, per RECIST v1.1, as Determined by investigator assessment
- Duration of Objective Response (DOR), per RECIST v1.1, as Determined by Investigator Assessment
- DOR, per RECIST v1.1, as Determined by BICR
- Number of Participants with Treatment-emergent Adverse Events (TEAEs)
- Change from Baseline in Global Health Status/Quality of Life (GHS/Qol)
- Time to Deterioration (TTD) in GHS/Qol
研究者
Genmab Trial Information
Scientific
Genmab A/S
研究点 (92)
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