A Phase 2, Open-label Clinical Study to Evaluate the Safety and Efficacy of MK-2010 as Monotherapy and in Combination
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 入组人数
- 480
- 主要终点
- Number of Participants with Adverse Events (AEs)
研究概览
简要总结
Researchers are looking for new ways to treat certain types of advanced solid tumors. Solid tumors are cancers mostly in organs and tissues in the body, not in the blood or other fluids. Advanced means the cancer has spread nearby or to other parts in the body and cannot be removed with surgery.
In this trial, researchers want to learn if the trial medicine called MK-2010, given alone or with other treatments, can treat advanced solid tumors. MK-2010 is designed to help the immune system fight cancer.
The goals of this trial are to learn:
- About the safety of MK-2010 as monotherapy and in combinations and if participants tolerate them. Tolerate means participants will receive trial treatment unless they need to stop it due to health problems.
- How many participants who receive MK-2010 as monotherapy and in combination respond to treatment. Respond means the cancer gets smaller or goes away.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non 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
- •Has radiographically measurable disease per protocol
- •If to receive oral study treatment, has the ability to swallow and retain oral medication and does not have gastrointestinal abnormalities that may alter absorption
- •Has well-controlled human immunodeficiency virus (HIV) on antiretroviral therapy (ART) if diagnosed with HIV
- •Has adequate organ function per protocol
排除标准
- •Has a history of Kaposi's sarcoma and/or Multicentric Castleman's Disease if diagnosed with HIV
- •Has a history of posterior reversible encephalopathy syndrome (PRES) or seizure disorder
- •Has hepatic encephalopathy, hepatorenal syndrome, or Child-Pugh class B or more severe liver cirrhosis
- •Has a history of confirmed inflammatory bowel disease
- •Has a serious active nonhealing wound, ulcer, and/or bone fracture
- •Has a history of myocarditis or cardiomyopathy
- •Has a history of or current severe cardiovascular and cerebrovascular diseases
- •Is currently receiving any anticoagulants
- •Has a diagnosis of immunodeficiency
- •Has a known additional malignancy that is progressing or required active treatment within the past 3 years
- •Has known active central nervous system metastases and/or carcinomatous meningitis
- •Has active autoimmune disease that required systemic treatment in the past 2 years (hormonal supplementation [eg, thyroxine, insulin, or physiologic corticosteroid] is allowed)
- •Has a history of (noninfectious) pneumonitis/interstitial lung disease (ILD) that required steroids or has current pneumonitis/ILD
- •Has a history of stem cell/solid organ transplant
- •Has not adequately recovered from major surgery or from central venous access device placement, or has ongoing surgical complications
研究组 & 干预措施
MK-2010 + FOLFOX
Participants receive MK-2010 intravenously in combination with FOLFOX chemotherapy (comprising Leucovorin or Levoleucovorin, 5-Fluorouracil, and Oxaliplatin).
干预措施: MK-2010 (Biological)
Pembrolizumab + FOLFOX
Participants receive Pembrolizumab intravenously in combination with FOLFOX chemotherapy (comprising Leucovorin or Levoleucovorin, 5-Fluorouracil, and Oxaliplatin).
干预措施: Leucovorin or Levoleucovorin (Drug)
Pembrolizumab + FOLFOX
Participants receive Pembrolizumab intravenously in combination with FOLFOX chemotherapy (comprising Leucovorin or Levoleucovorin, 5-Fluorouracil, and Oxaliplatin).
干预措施: 5-Fluorouracil (Drug)
MK-2010 + Belzutifan
Participants receive MK-2010 intravenously in combination with oral Belzutifan.
干预措施: Epinephrine (Drug)
MK-2010 + Carboplatin and Paclitaxel/Nab-paclitaxel
Participants receive MK-2010 intravenously in combination with Carboplatin and either Paclitaxel or Nab-paclitaxel chemotherapy.
干预措施: Epinephrine (Drug)
MK-2010 + Gemcitabine/Cisplatin
Participants receive MK-2010 intravenously in combination with Gemcitabine and Cisplatin chemotherapy.
干预措施: Epinephrine (Drug)
MK-2010 + Gemcitabine/Cisplatin
Participants receive MK-2010 intravenously in combination with Gemcitabine and Cisplatin chemotherapy.
干预措施: Cisplatin (Drug)
MK-2010 + FOLFOX
Participants receive MK-2010 intravenously in combination with FOLFOX chemotherapy (comprising Leucovorin or Levoleucovorin, 5-Fluorouracil, and Oxaliplatin).
干预措施: 5-Fluorouracil (Drug)
MK-2010 + Carboplatin and Paclitaxel/Nab-paclitaxel
Participants receive MK-2010 intravenously in combination with Carboplatin and either Paclitaxel or Nab-paclitaxel chemotherapy.
干预措施: Nab-paclitaxel (Drug)
MK-2010 + Pemetrexed and Cisplatin/Carboplatin
Participants receive MK-2010 intravenously in combination with Pemetrexed and either Cisplatin or Carboplatin chemotherapy.
干预措施: Pemetrexed (Drug)
MK-2010 + FOLFOX
Participants receive MK-2010 intravenously in combination with FOLFOX chemotherapy (comprising Leucovorin or Levoleucovorin, 5-Fluorouracil, and Oxaliplatin).
干预措施: Leucovorin or Levoleucovorin (Drug)
MK-2010 + FOLFOX
Participants receive MK-2010 intravenously in combination with FOLFOX chemotherapy (comprising Leucovorin or Levoleucovorin, 5-Fluorouracil, and Oxaliplatin).
干预措施: Epinephrine (Drug)
MK-2010 + FOLFOX
Participants receive MK-2010 intravenously in combination with FOLFOX chemotherapy (comprising Leucovorin or Levoleucovorin, 5-Fluorouracil, and Oxaliplatin).
干预措施: Oxaliplatin (Drug)
Pembrolizumab + FOLFOX
Participants receive Pembrolizumab intravenously in combination with FOLFOX chemotherapy (comprising Leucovorin or Levoleucovorin, 5-Fluorouracil, and Oxaliplatin).
干预措施: Epinephrine (Drug)
MK-2010 + Belzutifan
Participants receive MK-2010 intravenously in combination with oral Belzutifan.
干预措施: Belzutifan (Drug)
MK-2010 + Carboplatin and Paclitaxel/Nab-paclitaxel
Participants receive MK-2010 intravenously in combination with Carboplatin and either Paclitaxel or Nab-paclitaxel chemotherapy.
干预措施: Paclitaxel (Drug)
Pembrolizumab + FOLFOX
Participants receive Pembrolizumab intravenously in combination with FOLFOX chemotherapy (comprising Leucovorin or Levoleucovorin, 5-Fluorouracil, and Oxaliplatin).
干预措施: Oxaliplatin (Drug)
MK-2010 + Gemcitabine/Cisplatin
Participants receive MK-2010 intravenously in combination with Gemcitabine and Cisplatin chemotherapy.
干预措施: MK-2010 (Biological)
MK-2010 Monotherapy
Participants receive MK-2010 intravenously as monotherapy.
干预措施: MK-2010 (Biological)
Pembrolizumab + FOLFOX
Participants receive Pembrolizumab intravenously in combination with FOLFOX chemotherapy (comprising Leucovorin or Levoleucovorin, 5-Fluorouracil, and Oxaliplatin).
干预措施: Pembrolizumab (Biological)
MK-2010 + Belzutifan
Participants receive MK-2010 intravenously in combination with oral Belzutifan.
干预措施: MK-2010 (Biological)
MK-2010 + Carboplatin and Paclitaxel/Nab-paclitaxel
Participants receive MK-2010 intravenously in combination with Carboplatin and either Paclitaxel or Nab-paclitaxel chemotherapy.
干预措施: MK-2010 (Biological)
MK-2010 + Pemetrexed and Cisplatin/Carboplatin
Participants receive MK-2010 intravenously in combination with Pemetrexed and either Cisplatin or Carboplatin chemotherapy.
干预措施: Carboplatin (Drug)
MK-2010 Monotherapy
Participants receive MK-2010 intravenously as monotherapy.
干预措施: Epinephrine (Drug)
MK-2010 + Gemcitabine/Cisplatin
Participants receive MK-2010 intravenously in combination with Gemcitabine and Cisplatin chemotherapy.
干预措施: Gemcitabine (Drug)
MK-2010 + Pemetrexed and Cisplatin/Carboplatin
Participants receive MK-2010 intravenously in combination with Pemetrexed and either Cisplatin or Carboplatin chemotherapy.
干预措施: Cisplatin (Drug)
MK-2010 + Carboplatin and Paclitaxel/Nab-paclitaxel
Participants receive MK-2010 intravenously in combination with Carboplatin and either Paclitaxel or Nab-paclitaxel chemotherapy.
干预措施: Carboplatin (Drug)
MK-2010 + Pemetrexed and Cisplatin/Carboplatin
Participants receive MK-2010 intravenously in combination with Pemetrexed and either Cisplatin or Carboplatin chemotherapy.
干预措施: MK-2010 (Biological)
MK-2010 + Pemetrexed and Cisplatin/Carboplatin
Participants receive MK-2010 intravenously in combination with Pemetrexed and either Cisplatin or Carboplatin chemotherapy.
干预措施: Epinephrine (Drug)
结局指标
主要结局
Number of Participants with Adverse Events (AEs)
时间窗: Up to approximately 24 months
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a study intervention.
Number of Participants Who Discontinue Study Treatment Due to an AE
时间窗: Up to approximately 24 months
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a study intervention.
Number of Participants Who Experience Dose-Limiting Toxicity (DLT)
时间窗: Up to approximately 28 days
DLT is defined as any drug-related adverse event (AE) observed during the DLT evaluation period that results in a change to a given dose or a delay in initiating the next dose.
Objective Response Rate (ORR)
时间窗: Up to approximately 24 months
ORR is defined as the percentage of participants who have a Complete Response (CR: Disappearance of all target lesions) or a Partial Response (PR: At least a 30% decrease in the sum of diameters of target lesions) per Response Evaluation Criteria in Solid Tumors 1.1 (RECIST 1.1). The percentage of participants who experience CR or PR as assessed by Blinded Independent Central Review (BICR) will be presented.
次要结局
- Duration of Response (DOR)(Up to approximately 48 months)
- Area Under the Curve From Time 0 to Last (AUC0-last) of MK-2010(Predose and at designated time points up to approximately 24 months)
- Area Under the Curve From Time 0 to the End of the Dosing Interval (AUC0-tau) of MK-2010(Predose and at designated time points up to approximately 24 months)
- Trough Concentration (Ctrough) of MK-2010(Predose and at designated time points up to approximately 24 months)
- Maximum Concentration (Cmax) of MK-2010(Predose and at designated time points up to approximately 24 months)
- Incidence of Antidrug Antibodies (ADAs) to MK-2010(Predose and at designated time points up to approximately 24 months)