A Clinical Study of MK-4716 in People With Certain Solid Tumors (MK-4716-001)

Purpose

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.

Condition

  • Malignant Neoplasm

Eligibility

Eligible Ages
Over 18 Years
Eligible Sex
All
Accepts 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 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

Study Design

Phase
Phase 1
Study Type
Interventional
Allocation
Non-Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
MK-4716 Dose Escalation 		Participants receive MK-4716 at varying dose levels and schedules.
  • Drug: MK-4716
    Oral administration
Experimental
MK-4716 + Pembrolizumab 		Participants will receive MK-4716 + Pembrolizumab
  • Drug: MK-4716
    Oral administration
  • Biological: Pembrolizumab
    Intravenous administration
    Other names:
    • Keytruda
    • MK-3475
Experimental
MK-4716 + Cetuximab 		Participants will receive MK-4716 + Cetuximab
  • Drug: MK-4716
    Oral administration
  • Biological: Cetuximab
    Intravenous administration

Recruiting Locations

Rutgers Cancer Institute of New Jersey ( Site 0052)
New Brunswick, New Jersey 08903
Contact:
Study Coordinator
732-253-3939

NEXT Oncology ( Site 0051)
Irving, Texas 75039
Contact:
Study Coordinator
972-893-8800

NEXT Virginia ( Site 0054)
Fairfax, Virginia 22031
Contact:
Study Coordinator
703-783-4510

More Details

Status
Recruiting
Sponsor
Merck Sharp & Dohme LLC

Study Contact

Toll Free Number
1-888-577-8839
Trialsites@msd.com