Malignant NeoplasmPhase 1NCT07247110
A Clinical Study of MK-4716 in People With Certain Solid Tumors (MK-4716-001)
A Phase 1 study testing MK-4716, Pembrolizumab and Cetuximab in people with Malignant Neoplasm, run by Merck Sharp & Dohme LLC at 21 sites in 7 countries.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Malignant Neoplasm
- What is being tested?
- MK-4716, Pembrolizumab and Cetuximab
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 250 participants
- Where
- 21 sitesin 7 countries
- Study dates
- 16 Dec 2025to 1 Dec 2030
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 11Show fewer
- 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
Trial locations and contacts
21 sites in 7 countries. Contact the study team or a site near you to ask about taking part.
21 sites in 7 countries
Australia4 sites, 4 recruiting
- Recruiting
Monash Health ( Site 0452)
Clayton, Victoria, 3168
Study Coordinator, +61474769510
- Recruiting
The Alfred Hospital ( Site 0453)
Melbourne, Victoria, 3004
Study Coordinator, +61 3 9076 3129
- Recruiting
One Clinical Research ( Site 0454)
Nedlands, Western Australia, 6009
Study Coordinator, +61862799466
- Recruiting
Blacktown Hospital ( Site 0455)
Sydney, New South Wales, 2148
Study Coordinator, 98818000
United States3 sites, 3 recruiting
- Recruiting
NEXT Virginia ( Site 0054)
Fairfax, Virginia, 22031
Study Coordinator, 703-783-4510
- Recruiting
NEXT Oncology ( Site 0051)
Irving, Texas, 75039
Study Coordinator, 972-893-8800
- Recruiting
Rutgers Cancer Institute of New Jersey ( Site 0052)
New Brunswick, New Jersey, 08903
Study Coordinator, 732-253-3939
Canada3 sites, 3 recruiting
- Recruiting
Centre Hospitalier de l'Université de Montréal ( Site 0003)
Montreal, Quebec, H2X 0A9
Study Coordinator, 5148908000
- Recruiting
Centre intégré de cancérologie du CHU de Québec Université Laval, Hôpital de l'Enfant-Jésus ( Site 0002)
Québec, Quebec, G1J 1Z4
Study Coordinator, 418-525-4444
- Recruiting
Princess Margaret Cancer Centre ( Site 0001)
Toronto, Ontario, M5G 2M9
Study Coordinator, 4165865371
Chile3 sites, 3 recruiting
- Recruiting
FALP-UIDO ( Site 0101)
Santiago, Region M. de Santiago, 7500921
Study Coordinator, +56962290773
- Recruiting
Pontificia Universidad Catolica de Chile-CICUC ( Site 0103)
Santiago, Region M. de Santiago, 8330073
Study Coordinator, +56934331806
- Recruiting
Bradfordhill ( Site 0102)
Santiago, Region M. de Santiago, 8420383
Study Coordinator, +56229490970
Israel3 sites, 3 recruiting
- Recruiting
Rambam Health Care Campus ( Site 0252)
Haifa, 3109601
Study Coordinator, +97247772688
- Recruiting
Rabin Medical Center ( Site 0253)
Petah Tikva, 4941492
Study Coordinator, +97239377377
- Recruiting
Sheba Medical Center ( Site 0251)
Ramat Gan, 5265601
Study Coordinator, +97235303030
Spain3 sites, 3 recruiting
- Recruiting
Hospital General Universitari Vall d Hebron ( Site 0360)
Barcelona, 08035
Study Coordinator, +34932746000
- Recruiting
Hospital Clinic de Barcelona ( Site 0362)
Barcelona, 08036
Study Coordinator, +34932274208
- Recruiting
Hospital Universitario Fundacion Jimenez Diaz ( Site 0361)
Madrid, 28040
Study Coordinator, +34915504800x2805
South Korea2 sites, 2 recruiting
- Recruiting
Seoul National University Hospital ( Site 0501)
Seoul, 03080
Study Coordinator, 82-2-2072-0242
- Recruiting
Asan Medical Center ( Site 0502)
Seoul, 05505
Study Coordinator, 82-2-3010-1727
About this study
Official title: A Phase 1, Open-Label, Multicenter Study to Assess Safety, Tolerability, Pharmacokinetics, and Efficacy of MK-4716 as Monotherapy and as Part of Combination Therapy in Participants With KRAS-Altered Advanced or Metastatic Solid Tumors
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
- Malignant Neoplasm
- Being tested
- MK-4716, Pembrolizumab, Cetuximab
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MK-4716Drug
Oral administration
PembrolizumabBiological
Also called Keytruda, MK-3475
Intravenous administration
CetuximabBiological
Intravenous administration
| Study group | Role | What they receive |
|---|---|---|
| MK-4716 Dose Escalation | Experimental | Participants receive MK-4716 at varying dose levels and schedules. Receives: Drug: MK-4716 |
| MK-4716 + Pembrolizumab | Experimental | Participants will receive MK-4716 + Pembrolizumab Receives: Drug: MK-4716; Biological: Pembrolizumab |
| MK-4716 + Cetuximab | Experimental | Participants will receive MK-4716 + Cetuximab Receives: Drug: MK-4716; Biological: Cetuximab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants Who Experience One or More Dose-Limiting Toxicities (DLT)
A DLT is defined as the occurrence of protocol-specified toxicities, unless clearly related to disease progression or intercurrent illness.
Measured: Up to approximately 28 days
Number of Participants Who Experience an Adverse Event (AE)
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.
Measured: Up to approximately 4 years
Number of Participants Who Discontinue Study Intervention Due to an AE
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.
Measured: Up to approximately 4 years
Secondary outcomes (4)
Area Under the Concentration-Time Curve (AUC) of MK-4716
Blood samples will be collected to determine the AUC of MK-4716.
Measured: At designated timepoints (up to approximately 58 days)
Maximum Plasma Concentration (Cmax) of MK-4716
Blood samples will be collected to estimate Cmax of MK-4716.
Measured: At designated timepoints (up to approximately 58 days)
Trough Plasma Concentration (Ctrough) of MK-4716
Blood samples will be collected to determine the Ctrough of MK-4716.
Measured: At designated timepoints (up to approximately 19 months)
Half-Life (t1/2) of MK-4716
Blood samples will be collected to determine the t1/2 of MK-4716.
Measured: At designated timepoints (up to approximately 58 days)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Nov 2025
- Study start16 Dec 2025
- Primary completion1 Dec 2030 (estimated)
- Study completion1 Dec 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Malignant NeoplasmStudies of the same condition, open and under way.
- More trials run by Merck Sharp & Dohme LLCThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 250 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Merck Sharp & Dohme LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Medical Director, Study director, Merck Sharp & Dohme LLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07247110
- Sponsor's protocol ID
- 4716-001
- Other IDs
- 2025-522495-84, U1111-1323-3663, MK-4701-001, 2025
- Status last verified
- Oct 2026
- First submitted
- 19 Nov 2025
- Last updated
- 30 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: https://trialstransparency.msdclinicaltrials.com/pdf/ProcedureAccessClinicalTrialData.pdf
Study at a glance
From the registry record, last updated by the sponsor on 30 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1, Open-Label, Multicenter Study to Assess Safety, Tolerability, Pharmacokinetics, and Efficacy of MK-4716 as Monotherapy and as Part of Combination Therapy in Participants With KRAS-Altered Advanced or Metastatic Solid Tumors
- ClinicalTrials.gov ID
- NCT07247110
- Acronym / sponsor ID
- 4716-001
- Conditions
- Malignant Neoplasm
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 250 participants (estimated)
- Lead sponsor
- Merck Sharp & Dohme LLCIndustry (pharma, biotech, devices)
- Study start
- 16 Dec 2025 (actual)
- Primary completion
- 1 Dec 2030 (estimated)
- Study completion
- 1 Dec 2030 (estimated)
- First posted
- 25 Nov 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| MK-4716 Dose Escalation | Experimental | Drug: MK-4716Participants receive MK-4716 at varying dose levels and schedules. |
| MK-4716 + Pembrolizumab | Experimental | Drug: MK-4716, Biological: PembrolizumabParticipants will receive MK-4716 + Pembrolizumab |
| MK-4716 + Cetuximab | Experimental | Drug: MK-4716, Biological: CetuximabParticipants will receive MK-4716 + Cetuximab |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (11 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MK-4716Oral administration | Drug | MK-4716 + Cetuximab, MK-4716 + Pembrolizumab, MK-4716 Dose Escalation |
| PembrolizumabAlso: Keytruda, MK-3475Intravenous administration | Biological | MK-4716 + Pembrolizumab |
| CetuximabIntravenous administration | Biological | MK-4716 + Cetuximab |
Primary outcome
Number of Participants Who Experience One or More Dose-Limiting Toxicities (DLT)
Time frame: 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)
Time frame: 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
Time frame: 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.
4 secondary outcomes
Area Under the Concentration-Time Curve (AUC) of MK-4716
Time frame: At designated timepoints (up to approximately 58 days)
Maximum Plasma Concentration (Cmax) of MK-4716
Time frame: At designated timepoints (up to approximately 58 days)
Trough Plasma Concentration (Ctrough) of MK-4716
Time frame: At designated timepoints (up to approximately 19 months)
Half-Life (t1/2) of MK-4716
Time frame: At designated timepoints (up to approximately 58 days)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Oct 2026.
- Merck Clinical Trials InformationLink provided by the sponsor.
- Plain Language SummaryLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. https://trialstransparency.msdclinicaltrials.com/pdf/ProcedureAccessClinicalTrialData.pdf
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Medical Director study director
Merck Sharp & Dohme LLC
21 sites in 7 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing MK-4716, Pembrolizumab and Cetuximab in people with Malignant Neoplasm, run by Merck Sharp & Dohme LLC at 21 sites in 7 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 30 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 21 sites in Australia, United States, Canada, Chile, Israel and 2 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Toll Free Number (1-888-577-8839, Trialsites@msd.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants Who Experience One or More Dose-Limiting Toxicities (DLT) (time frame: Up to approximately 28 days). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Oct 2026.