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| ID | Type | Description | Link |
|---|---|---|---|
| MK-4700-001 | Other Identifier | MSD |
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The goal of this study is to learn about the safety of different doses of MK-4700 and if people tolerate them. The study will also measure what happens in a person's body over time when MK-4700 is given alone or with pembrolizumab (MK-3475) in order to find a dose that is safe, tolerated, and may work to treat certain types of cancer.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm 1: MK-4700 | Experimental | Participants receive escalating doses every three weeks (Q3W) of MK-4700 for a maximum of 35 cycles (approximately 2 years; cycles are 21 days in length). Eligible participants enrolled in Arm 1 who experience progressive disease (PD) may cross over to Arm 2 to receive MK-4700 and pembrolizumab combination therapy. |
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| Arm 2: MK-4700 + Pembrolizumab | Experimental | Participants will receive MK-4700 and pembrolizumab Q3W for up to 35 cycles (approximately 2 years) or until PD, death, toxicity, or withdrawal of consent. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| MK-4700 | Biological | Administered via subcutaneous (SC) injection |
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| Measure | Description | Time Frame |
|---|---|---|
| Dose-Limiting Toxicity (DLT) | The occurrence of any of the following toxicities during Cycle 1 will be considered a DLT, if assessed by the investigator related to study intervention administration:
| Cycle 1 (up to 21 days) |
| Percentage of Participants Who Experience an Adverse Event (AE) | 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. | Up to approximately 4.5 years |
| Percentage of Participants who Discontinue Study Treatment Due to an AE | 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. | Up to approximately 4.5 years |
| Measure | Description | Time Frame |
|---|---|---|
| Area Under the Concentration-Time Curve of MK-4700 | AUC is defined as the area under the concentration versus time curve. Blood samples will be collected at pre-specified timepoints to determine AUC. | Predose and at prespecified time points during Cycles 1, 2, 3, 4, 5, 6, 7, and 10 up to approximately 7 months (Cycle length is 21 days) |
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Inclusion Criteria:
The key inclusion criteria include but are not limited to the following:
Exclusion Criteria:
The key exclusion criteria include but are not limited to the following:
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| Name | Affiliation | Role |
|---|---|---|
| Medical Director | Merck Sharp & Dohme LLC | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| John Theurer Cancer Center at Hackensack University Medical Center ( Site 0301) | Hackensack | New Jersey | 07601 | United States | ||
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| Label | URL |
|---|---|
| Merck Clinical Trials Information | View source |
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| Pembrolizumab | Biological | Administered via intravenous infusion |
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| Maximum Plasma Concentration (Cmax) of MK-4700 |
Cmax is defined as the maximum concentration of MK-4700 observed in plasma after its administration and just prior to administration of the next dose. Blood samples will be collected at pre-specified timepoints to determine Cmax. |
| Predose and at prespecified time points during Cycles 1, 2, 3, 4, 5, 6, 7, and 10 up to approximately 7 months (Cycle length is 21 days) |
| Minimum Plasma Concentration (Cmin) of MK-4700 | Cmin is defined as the minimum concentration of MK-4700 observed in plasma after its administration and just prior to administration of the next dose. Blood samples will be collected at pre-specified timepoints to determine Cmin. | Predose and at prespecified time points during Cycles 1, 2, 3, 4, 5, 6, 7, and 10 up to approximately 7 months (Cycle length is 21 days) |
| NEXT Oncology ( Site 0300) |
| San Antonio |
| Texas |
| 78229 |
| United States |
| Princess Margaret Cancer Center ( Site 0101) | Toronto | Ontario | M5G 2M9 | Canada |
| Centre intégré de cancérologie du CHU de Québec Université Laval, Hôpital de l'Enfant-Jésus ( Site 0102) | Québec | Quebec | G1J 1Z4 | Canada |
| Rambam Health Care Campus ( Site 0201) | Haifa | 3109601 | Israel |
| Rabin Medical Center ( Site 0202) | Petah Tikva | 4941492 | Israel |
| Sheba Medical Center ( Site 0200) | Ramat Gan | 5265601 | Israel |
| ID | Term |
|---|---|
| D009369 | Neoplasms |
| D000077195 | Squamous Cell Carcinoma of Head and Neck |
| D008545 | Melanoma |
| D002289 | Carcinoma, Non-Small-Cell Lung |
| D002583 | Uterine Cervical Neoplasms |
| D064726 | Triple Negative Breast Neoplasms |
| D002295 | Carcinoma, Transitional Cell |
| D002292 | Carcinoma, Renal Cell |
| ID | Term |
|---|---|
| D002294 | Carcinoma, Squamous Cell |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
| D006258 | Head and Neck Neoplasms |
| D009371 | Neoplasms by Site |
| D018358 | Neuroendocrine Tumors |
| D017599 | Neuroectodermal Tumors |
| D009373 | Neoplasms, Germ Cell and Embryonal |
| D009380 | Neoplasms, Nerve Tissue |
| D018326 | Nevi and Melanomas |
| D012878 | Skin Neoplasms |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D002283 | Carcinoma, Bronchogenic |
| D001984 | Bronchial Neoplasms |
| D008175 | Lung Neoplasms |
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D014594 | Uterine Neoplasms |
| D005833 | Genital Neoplasms, Female |
| D014565 | Urogenital Neoplasms |
| D002577 | Uterine Cervical Diseases |
| D014591 | Uterine Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D000091662 | Genital Diseases |
| D001943 | Breast Neoplasms |
| D001941 | Breast Diseases |
| D000230 | Adenocarcinoma |
| D007680 | Kidney Neoplasms |
| D014571 | Urologic Neoplasms |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052801 | Male Urogenital Diseases |
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| ID | Term |
|---|---|
| C582435 | pembrolizumab |
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