Actively Recruiting

Phase 1
Age: 18Years +
All Genders
NCT07247110

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

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

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
Not Eligible

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

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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

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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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