Actively Recruiting
A Phase 1 Study to Assess Safety and Tolerability of MK-4716 Alone or With Pembrolizumab or Cetuximab in People With KRAS-Altered Advanced or Metastatic Solid Tumors
Led by Merck Sharp & Dohme LLC · Updated on 2026-06-03
250
Participants Needed
19
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the safety and tolerability of MK-4716 in people with certain advanced or metastatic solid tumors, specifically those with KRAS alterations. The study includes participants with locally advanced unresectable or metastatic solid tumors or metastatic non-small cell lung cancer. This phase 1, open-label trial aims to understand how well MK-4716 is tolerated alone or in combination with other treatments. Participants receive MK-4716 by mouth at different dose levels and schedules. Some participants will receive MK-4716 combined with pembrolizumab or cetuximab, both given intravenously. The study includes different arms for dose escalation and combination therapies, focusing on safety, pharmacokinetics, and initial efficacy. During the study, participants will be monitored for dose-limiting toxicities and adverse events up to about four years. Researchers will measure MK-4716 levels in the blood at specific times, track how participants respond to treatment, and note any reasons for stopping the study drug. The total duration and detailed follow-up will provide important information about the treatment's safety and how the body processes MK-4716.
CONDITIONS
Brief 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...
- Adults aged 18 years and older
- Confirmed diagnosis of locally advanced unresectable or metastatic solid tumor or metastatic non-small cell lung cancer
- Presence of KRAS alteration confirmed
- For some groups, must be untreated; for others, must have received at least one prior systemic therapy
- Measurable disease present
- Ability to swallow and retain oral medication
You will not qualify if you...
- Diagnosis of immunodeficiency or use of high-dose steroids or immunosuppressive therapy within 7 days before study start (for MK-4716 + Pembrolizumab group)
- Prior immunotherapy with discontinuation (for MK-4716 + Pembrolizumab group)
- Active autoimmune disease requiring systemic treatment within past 2 years (except certain hormonal therapies)
- History of HIV infection
- Known additional malignancy progressing or treated in past 2 years
- Active central nervous system metastases or carcinomatous meningitis
- History or current pneumonitis or interstitial lung disease requiring steroids
- Active infection needing systemic therapy
- Hepatitis B or C infection
- History of stem cell or solid organ transplant
- Recent major surgery without full recovery or ongoing surgical complications
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to approximately 4 years
Participants receive MK-4716 alone or in combination with Pembrolizumab or Cetuximab to assess safety and tolerability.
Visits as per dosing and safety monitoring schedules
Trial Site Locations
Total: 19 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
Princess Margaret Cancer Centre ( Site 0001)
Toronto, Ontario, Canada, M5G 2M9
Actively Recruiting
9
Centre intégré de cancérologie du CHU de Québec Université Laval, Hôpital de l'Enfant-Jésus ( Site 0002)
Québec, Quebec, Canada, G1J 1Z4
Actively Recruiting
10
Pontificia Universidad Catolica de Chile-CICUC ( Site 0103)
Santiago, Region M. de Santiago, Chile, 8330073
Actively Recruiting
11
Bradfordhill ( Site 0102)
Santiago, Region M. de Santiago, Chile, 8420383
Actively Recruiting
12
Rambam Health Care Campus ( Site 0252)
Haifa, Israel, 3109601
Actively Recruiting
13
Rabin Medical Center ( Site 0253)
Petah Tikva, Israel, 4941492
Actively Recruiting
14
Sheba Medical Center ( Site 0251)
Ramat Gan, Israel, 5265601
Actively Recruiting
15
Seoul National University Hospital ( Site 0501)
Seoul, South Korea, 03080
Actively Recruiting
16
Asan Medical Center ( Site 0502)
Seoul, South Korea, 05505
Actively Recruiting
17
Hospital General Universitari Vall d Hebron ( Site 0360)
Barcelona, Spain, 08035
Actively Recruiting
18
Hospital Clinic de Barcelona ( Site 0362)
Barcelona, Spain, 08036
Actively Recruiting
19
Hospital Universitario Fundacion Jimenez Diaz ( Site 0361)
Madrid, Spain, 28040
Actively Recruiting
Research Team
T
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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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