Actively Recruiting
A Clinical Study of MK-4716 in People With Certain Solid Tumors (MK-4716-001)
Led by Merck Sharp & Dohme LLC · Updated on 2026-05-14
250
Participants Needed
17
Research Sites
258 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
A Clinical Study of MK-4716 in People With Certain Solid Tumors (MK-4716-001)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Confirmed diagnosis of locally advanced unresectable or metastatic solid tumor for MK-4716 Dose Escalation and MK-4716 + Cetuximab arms
- Presence of KRAS alteration for MK-4716 Dose Escalation and MK-4716 + Cetuximab arms
- Received at least 1 prior systemic therapy for locally advanced unresectable or metastatic disease for MK-4716 Dose Escalation and MK-4716 + Cetuximab arms
- Confirmed diagnosis of metastatic non-small cell lung cancer for MK-4716 + Pembrolizumab arm
- Presence of KRAS alteration for MK-4716 + Pembrolizumab arm
- Must be untreated for MK-4716 + Pembrolizumab arm
- Measurable disease
- Ability to swallow and retain oral medication
You will not qualify if you...
- Immunodeficiency or receiving chronic systemic steroid therapy exceeding 10 mg daily prednisone equivalent or other immunosuppressive therapy within 7 days before first dose for MK-4716 + Pembrolizumab arm
- Prior immunotherapy treatment discontinued for MK-4716 + Pembrolizumab arm
- Active autoimmune disease requiring systemic treatment within past 2 years for MK-4716 + Pembrolizumab arm (hormonal supplementation allowed)
- History of human immunodeficiency virus infection
- Known additional malignancy progressing or requiring treatment within past 2 years
- Active central nervous system metastases or carcinomatous meningitis
- History or current pneumonitis/interstitial lung disease requiring steroids
- Active infection requiring systemic therapy
- Hepatitis B or C virus infection
- History of stem cell or solid organ transplant
- Incomplete recovery from major surgery or ongoing surgical complications
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 17 locations
1
Rutgers Cancer Institute of New Jersey ( Site 0052)
New Brunswick, New Jersey, United States, 08903
Actively Recruiting
2
NEXT Oncology ( Site 0051)
Irving, Texas, United States, 75039
Actively Recruiting
3
NEXT Virginia ( Site 0054)
Fairfax, Virginia, United States, 22031
Actively Recruiting
4
Blacktown Hospital ( Site 0455)
Sydney, New South Wales, Australia, 2148
Actively Recruiting
5
Monash Health ( Site 0452)
Clayton, Victoria, Australia, 3168
Actively Recruiting
6
The Alfred Hospital ( Site 0453)
Melbourne, Victoria, Australia, 3004
Actively Recruiting
7
One Clinical Research ( Site 0454)
Nedlands, Western Australia, Australia, 6009
Actively Recruiting
8
Pontificia Universidad Catolica de Chile-CICUC ( Site 0103)
Santiago, Region M. de Santiago, Chile, 8330073
Actively Recruiting
9
Bradfordhill ( Site 0102)
Santiago, Region M. de Santiago, Chile, 8420383
Actively Recruiting
10
Rambam Health Care Campus ( Site 0252)
Haifa, Israel, 3109601
Actively Recruiting
11
Rabin Medical Center ( Site 0253)
Petah Tikva, Israel, 4941492
Actively Recruiting
12
Sheba Medical Center ( Site 0251)
Ramat Gan, Israel, 5265601
Actively Recruiting
13
Seoul National University Hospital ( Site 0501)
Seoul, South Korea, 03080
Actively Recruiting
14
Asan Medical Center ( Site 0502)
Seoul, South Korea, 05505
Actively Recruiting
15
Hospital General Universitari Vall d Hebron ( Site 0360)
Barcelona, Spain, 08035
Actively Recruiting
16
Hospital Clinic de Barcelona ( Site 0362)
Barcelona, Spain, 08036
Actively Recruiting
17
Hospital Universitario Fundacion Jimenez Diaz ( Site 0361)
Madrid, Spain, 28040
Actively Recruiting
Research Team
T
Toll Free Number
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
3
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