2023-505022-34-00已完成2 期
A Multicenter, Randomized, Double-Blind, Phase 2, Basket Study of MK-4280A, a Coformulation of Favezelimab (MK-4280) with Pembrolizumab (MK-3475) in Selected Solid Tumors (KeyForm-010)
干预措施
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 19
- 试验地点
- 13
- 主要终点
- Clinical Benefit - Cohort A
研究概览
简要总结
-
Cohort A: To evaluate clinical benefit in participants treated with MK-4280A or pembrolizumab
-
Cohort B: To evaluate lenvatinib in combination with MK-4280A or pembrolizumab with respect to objective response rate (ORR) per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 as assessed by investigator
入排标准
- 年龄范围
- 18 years 至 65+ years（65+ Years, 18-64 Years）
- 接受健康志愿者
- 否
入选标准
- •Histologically confirmed diagnosis of resectable cutaneous squamous cell carcinoma cSCC as the primary site of malignancy (metastatic skin involvement from another primary cancer or from an unknown primary cancer is not permitted) - Cohort A
- •Is assigned female sex at birth, at least 18 years of age at the time of providing the informed consent - Cohort B
- •Has adequately controlled blood pressure without antihypertensive medication - Cohort B
- •Agrees to follow contraception guidelines if a participant of childbearing potential
- •Has a life expectancy >3 years per investigator assessment
- •Has adequate organ function
- •Has Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
- •If positive for hepatitis B, has received antiviral therapy for ≥4 weeks and undetectable viral load prior to randomization
- •If positive for hepatitis C, has undetectable viral load at screening
- •If positive for human immunodeficiency virus (HIV), has well-controlled HIV on a stable highly active antiretroviral therapy
- •Stage II to Stage IV disease without M
- •cSCC tumors arising in the head and neck will be staged according to AJCC Ed. 8 and cSCC tumors arising in non-head and neck locations will be staged according to UICC Ed.
- •Is systemic treatment naïve. - Cohort A
- •Archival tumor tissue sample, or newly obtained surgical resection, or biopsy sample of a tumor lesion not previously irradiated has been provided - Cohort A
- •Is an individual of any sex/gender, at least 18 years of age at the time of providing the informed consent - Cohort A
- •Histologically confirmed diagnosis of EC that is not dMMR (pMMR) as documented by a local test report. - Cohort B
- •Documented evidence of stage IVB (per 2009 International Federation of Gynecology and Obstetrics (FIGO) staging), recurrent, or metastatic EC, and are not candidates for curative surgery or radiation - Cohort B
- •Has radiographic evidence of disease progression after 1 prior systemic, platinum-based chemotherapy regimen for EC in any setting - Cohort B
- •Measurable disease per Response Evaluation Criteria In Solid Tumors (RECIST 1.1) by investigator (before first dose of study intervention) - Cohort B
排除标准
- •Has known hypersensitivity to active substances or their excipients including previous clinically significant hypersensitivity reaction to treatment with other monocloncal antibody (mAb)
- •Has clinically significant cardiovascular disease within 12 months from first dose of study intervention - Cohort B
- •History of allogeneic tissue/solid organ transplant
- •Received prior radiotherapy to the index lesion (in-field lesion) - Cohort A
- •Participants for whom the primary site of cSCC was anogenital area (penis, scrotum, vulva, perianal region) are not eligible - Cohort A
- •Has had major surgery within 3 weeks prior to first dose of study interventions - Cohort B
- •Has preexisting ≥Grade 3 gastrointestinal or non-gastrointestinal fistula - Cohort B
- •Has urine protein ≥1 g/24 hours - Cohort B
- •Has a left ventricle ejection fraction (LVEF) below the institutional (or local laboratory) normal range, as determined by multigated acquisition (MUGA) or echocardiogram (ECHO) - Cohort B
- •Has radiographic evidence of encasement or invasion of a major blood vessel, or of intratumoral cavitation - Cohort B
研究组 & 干预措施
MK-4280A
Test
干预措施: MK-4280A (Drug)
KEYTRUDA 25 mg/mL concentrate for solution for infusion
Comparator
干预措施: KEYTRUDA 25 mg/mL concentrate for solution for infusion (Drug)
Lenvatinib, Lenvatinib
Comparator
干预措施: Lenvatinib (Drug)
结局指标
主要结局
Clinical Benefit - Cohort A
Clinical Benefit - Cohort A
Objective Response Rate (ORR) per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) as assessed by Investigator – Cohort B
Objective Response Rate (ORR) per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) as assessed by Investigator – Cohort B
次要结局
- Major Pathologic Response (mPR) - Cohort A
- ORR per RECIST 1.1 as assessed by Investigator - Cohort A
- Number of participants with an adverse event (AE) - Cohorts A and B
- Number of participants discontinuing from study therapy due to AE - Cohorts A and B
- Number of participants experiencing perioperative complications - Cohort A
- Number of participants with an AE that precludes surgery - Cohort A
- Pathologic Complete Response (pCR) – Cohort A
研究者
Roman Groisberg
Scientific
Merck Sharp & Dohme LLC
研究点 (13)
Loading locations...
相似试验
招募中
3 期
MK-1084 with Pembrolizumab in 1L Locally Advanced or Metastatic NSCLC With KRAS G12C Mutations and PD-L1 ≥50%Non-small cell lung cancer2023-507776-42-00Merck Sharp & Dohme LLC194
招募中
3 期
Clinical trial of MK-2870 in combination with pembrolizumab in people who have had surgery to treat triple negative breast cancer2023-504962-52-00Merck Sharp & Dohme LLC571
招募中
2 期
A basket study to investigate the efficacy and safety of SKB264 in combination with pembrolizumab in subjects with solid tumorsProstate cancerOvarian cancerCervical cancer2022-502654-14-00Sichuan Kelun-Biotech Biopharmaceutical Co. Ltd.101
招募中
3 期
Study of Pembrolizumab/Vibostolimab Coformulation (MK-7684A) in Combination with Chemotherapy Versus Pembrolizumab Plus Chemotherapy as First Line Treatment for Participants with Metastatic Non-Small Cell Lung Cancer (MK-7684A-007/KEYVIBE-007)2023-506074-12-00Merck Sharp & Dohme LLC190
已完成
3 期
Pembrolizumab with Lenvatinib versus Docetaxel for Metastatic NSCLC after Platinum Doublet Chemotherapy and Immunotherapy2022-501439-18-00Merck Sharp & Dohme LLC206