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
Sex
ALL
Min age
18 Years
Max age
—
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
Primary outcome measure(s)
Number of Participants Who Experience One or More Dose-Limiting Toxicities (DLT) — Up to approximately 28 days A DLT is defined as the occurrence of protocol-specified toxicities, unless clearly related to disease progression or intercurrent illness.
Number of Participants Who Experience an Adverse Event (AE) — Up to approximately 4 years An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a study intervention.
Number of Participants Who Discontinue Study Intervention Due to an AE — Up to approximately 4 years An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a study intervention.
Trial sites (21)
Facility
City
Region
Status
Rutgers Cancer Institute of New Jersey ( Site 0052)
New Brunswick
New Jersey
Recruiting
NEXT Oncology ( Site 0051)
Irving
Texas
Recruiting
NEXT Virginia ( Site 0054)
Fairfax
Virginia
Recruiting
Blacktown Hospital ( Site 0455)
Sydney
New South Wales
Recruiting
Monash Health ( Site 0452)
Clayton
Victoria
Recruiting
The Alfred Hospital ( Site 0453)
Melbourne
Victoria
Recruiting
One Clinical Research ( Site 0454)
Nedlands
Western Australia
Recruiting
Princess Margaret Cancer Centre ( Site 0001)
Toronto
Ontario
Recruiting
Centre Hospitalier de l'Université de Montréal ( Site 0003)
Montreal
Quebec
Recruiting
Centre intégré de cancérologie du CHU de Québec Université Laval, Hôpital de l'Enfant-Jésus ( Site 0002)
Québec
Quebec
Recruiting
FALP-UIDO ( Site 0101)
Santiago
Region M. de Santiago
Recruiting
Pontificia Universidad Catolica de Chile-CICUC ( Site 0103)
Santiago
Region M. de Santiago
Recruiting
Bradfordhill ( Site 0102)
Santiago
Region M. de Santiago
Recruiting
Rambam Health Care Campus ( Site 0252)
Haifa
Israel
Recruiting
Rabin Medical Center ( Site 0253)
Petah Tikva
Israel
Recruiting
Sheba Medical Center ( Site 0251)
Ramat Gan
Israel
Recruiting
Seoul National University Hospital ( Site 0501)
Seoul
South Korea
Recruiting
Asan Medical Center ( Site 0502)
Seoul
South Korea
Recruiting
Hospital General Universitari Vall d Hebron ( Site 0360)
Barcelona
Spain
Recruiting
Hospital Clinic de Barcelona ( Site 0362)
Barcelona
Spain
Recruiting
Hospital Universitario Fundacion Jimenez Diaz ( Site 0361)
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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