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
Merck Sharp & Dohme LLC
Summary
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.
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
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…
Interventions
- DrugMK-4716
Oral administration
- BiologicalPembrolizumab
Intravenous administration
- BiologicalCetuximab
Intravenous administration
Locations (15)
- Rutgers Cancer Institute of New Jersey ( Site 0052)New Brunswick, New Jersey
- NEXT Oncology ( Site 0051)Irving, Texas
- NEXT Virginia ( Site 0054)Fairfax, Virginia
- Blacktown Hospital ( Site 0455)Sydney, New South Wales
- One Clinical Research ( Site 0454)Nedlands, Western Australia
- Pontificia Universidad Catolica de Chile-CICUC ( Site 0103)Santiago, Region M. de Santiago