Recruiting NCT07247110
A Clinical Study of MK-4716 in People With Certain Solid Tumors (MK-4716-001)
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: MK-4716, Pembrolizumab, Cetuximab.
- Who it may be relevant to
- Registry conditions: Malignant Neoplasm. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States, Australia, Canada, Chile, Israel +2
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
A Phase 1, Open-Label, Multicenter Study to Assess Safety, Tolerability, Pharmacokinetics, and Efficacy of MK-4716 as Monotherapy and as Part of Combination Therapy in Participants With KRAS-Altered Advanced or Metastatic Solid Tumors
Overview
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.
Interventions
- Drug MK-4716
Oral administration - Biological Pembrolizumab
Intravenous administration - Biological Cetuximab
Intravenous administration
Primary outcome measures
- Number of Participants Who Experience One or More Dose-Limiting Toxicities (DLT) [Time frame: Up to approximately 28 days]
- Number of Participants Who Experience an Adverse Event (AE) [Time frame: Up to approximately 4 years]
- Number of Participants Who Discontinue Study Intervention Due to an AE [Time frame: Up to approximately 4 years]
Secondary outcome measures (4)
- Area Under the Concentration-Time Curve (AUC) of MK-4716 [Time frame: At designated timepoints (up to approximately 58 days)]
- Maximum Plasma Concentration (Cmax) of MK-4716 [Time frame: At designated timepoints (up to approximately 58 days)]
- Trough Plasma Concentration (Ctrough) of MK-4716 [Time frame: At designated timepoints (up to approximately 19 months)]
- Half-Life (t1/2) of MK-4716 [Time frame: At designated timepoints (up to approximately 58 days)]
Eligibility criteria
Inclusion 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
Exclusion criteria
- 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 within 7 days prior to the first dose of study intervention
- 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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Non-randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
Australia · 4 centers
- Blacktown Hospital ( Site 0455) — Sydney
- Monash Health ( Site 0452) — Clayton
- The Alfred Hospital ( Site 0453) — Melbourne
- One Clinical Research ( Site 0454) — Nedlands
United States · 3 centers
- Rutgers Cancer Institute of New Jersey ( Site 0052) — New Brunswick
- NEXT Oncology ( Site 0051) — Irving
- NEXT Virginia ( Site 0054) — Fairfax
Israel · 3 centers
- Rambam Health Care Campus ( Site 0252) — Haifa
- Rabin Medical Center ( Site 0253) — Petah Tikva
- Sheba Medical Center ( Site 0251) — Ramat Gan
Spain · 3 centers
- Hospital General Universitari Vall d Hebron ( Site 0360) — Barcelona
- Hospital Clinic de Barcelona ( Site 0362) — Barcelona
- Hospital Universitario Fundacion Jimenez Diaz ( Site 0361) — Madrid
Canada · 2 centers
- Princess Margaret Cancer Centre ( Site 0001) — Toronto
- Centre intégré de cancérologie du CHU de Québec Université Laval, Hôpital de l'Enfant-Jésu — Québec
Chile · 2 centers
- Pontificia Universidad Catolica de Chile-CICUC ( Site 0103) — Santiago
- Bradfordhill ( Site 0102) — Santiago
South Korea · 2 centers
- Seoul National University Hospital ( Site 0501) — Seoul
- Asan Medical Center ( Site 0502) — Seoul
Identifiers
NCT: NCT07247110 · 4716-001 · 2025-522495-84 · U1111-1323-3663 · MK-4701-001