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A Phase 2 Study of MK-4280A for the Treatment of Selected Solid Tumors
EU CTIS ID: 2023-505022-34-00
What this study is testing
1. Cohort A: To evaluate clinical benefit in participants treated with MK-4280A or pembrolizumab 2. 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
- Therapeutic exploratory (Phase II)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- 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
You likely can't join if
- 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
See the full eligibility criteria
- 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 M1. 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. 8. - Cohort A
- 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
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Canada
- Malaysia
- Taiwan
- Australia
- Turkey
- United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 65+ years, 18-64 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Canada; Malaysia; Taiwan; Australia; Turkey; United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.