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New treatment option for Malignant Neoplasm
Official title A Clinical Study of MK-4716 in People With Certain Solid Tumors (MK-4716-001)
ClinicalTrials.gov ID: NCT07247110
What this study is testing
What is MK-4716?
MK-4716 is an investigational medicine, given as a pill taken by mouth, being studied as a potential treatment for malignant neoplasm.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- Researchers are looking for new ways to treat certain advanced or metastatic solid tumors. The goal of this study is to learn about the safety of MK-4716 and if people tolerate it when taken alone or with other treatments.
- Phase 1: an early, usually small safety study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Subset of arm MK-4716 Dose Escalation and subset of arm MK-4716 + Cetuximab: Has a confirmed diagnosis of locally advanced unresectable or metastatic...
- Subset of arm MK-4716 Dose Escalation and subset of arm MK-4716 + Cetuximab: Must demonstrate presence of Kirsten rat sarcoma viral oncogene homolog...
- Subset of arm MK-4716 Dose Escalation and subset of arm MK-4716 + Cetuximab: Has received at least 1 prior line of systemic therapy for locally...
- Arm MK-4716 + Pembrolizumab: Has a confirmed diagnosis of metastatic non-small cell lung cancer
- Arm MK-4716 + Pembrolizumab: Must demonstrate presence of KRAS alteration
You likely can't join if
- Arm MK-4716 + Pembrolizumab: Has a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy (in dosing exceeding 10 mg daily of...
- Arm MK-4716 + Pembrolizumab: Has received any prior immunotherapy and was discontinued from that treatment
- Arm MK-4716 + Pembrolizumab: Has active autoimmune disease that has required systemic treatment in the past 2 years. Hormonal supplementation (eg...
- History of human immunodeficiency virus infection
- Has a known additional malignancy that is progressing or has required active treatment within the past 2 years
- Has a known active central nervous system metastases and/or carcinomatous meningitis
See the full eligibility criteria
- Subset of arm MK-4716 Dose Escalation and subset of arm MK-4716 + Cetuximab: Has a confirmed diagnosis of locally advanced unresectable or metastatic solid tumor
- Subset of arm MK-4716 Dose Escalation and subset of arm MK-4716 + Cetuximab: Must demonstrate presence of Kirsten rat sarcoma viral oncogene homolog (KRAS) alteration
- Subset of arm MK-4716 Dose Escalation and subset of arm MK-4716 + Cetuximab: Has received at least 1 prior line of systemic therapy for locally advanced unresectable or metastatic disease
- Arm MK-4716 + Pembrolizumab: Has a confirmed diagnosis of metastatic non-small cell lung cancer
- Arm MK-4716 + Pembrolizumab: Must demonstrate presence of KRAS alteration
- Arm MK-4716 + Pembrolizumab: Must be untreated
- Has measurable disease
- Has the ability to swallow and retain oral medication
- Arm MK-4716 + Pembrolizumab: Has a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy (in dosing exceeding 10 mg daily of prednisone equivalent) or any other form of immunosuppressive therapy...
- Arm MK-4716 + Pembrolizumab: Has received any prior immunotherapy and was discontinued from that treatment
- Arm MK-4716 + Pembrolizumab: Has active autoimmune disease that has required systemic treatment in the past 2 years. Hormonal supplementation (eg, thyroxine, insulin, or physiologic corticosteroid) is allowed
- History of human immunodeficiency virus infection
- Has a known additional malignancy that is progressing or has required active treatment within the past 2 years
- Has a known active central nervous system metastases and/or carcinomatous meningitis
- History of (noninfectious) pneumonitis/interstitial lung disease that required steroids or has current pneumonitis/interstitial lung disease
- Has active infection requiring systemic therapy
- Has Hepatitis B or Hepatitis C virus infection
- History of stem cell/solid organ transplant
- Has not adequately recovered from major surgery or has ongoing surgical complications
The study team makes the final eligibility decision.
Where it's taking place
- New Brunswick, New Jersey, United States
- Irving, Texas, United States
- Fairfax, Virginia, United States
- Sydney, New South Wales, Australia
- Clayton, Victoria, Australia
- Melbourne, Victoria, Australia
- Nedlands, Western Australia, Australia
- Toronto, Ontario, Canada
- Québec, Quebec, Canada
- Santiago, Region M. de Santiago, Chile
- Haifa, Israel
- Petah Tikva, Israel
- Ramat Gan, Israel
- Seoul, South Korea
- Barcelona, Spain
- Madrid, Spain
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, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include New Brunswick, New Jersey, United States; Irving, Texas, United States; Fairfax, Virginia, United States; Sydney, New South Wales, Australia; Clayton, Victoria, Australia; Melbourne, Victoria, Australia and 10 more location(s). 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 ClinicalTrials.gov; the study team decides eligibility.