Malignant NeoplasmPhase 1NCT06894771
A Study of MK-4700 Alone or With Pembrolizumab in Participants With Advanced or Metastatic Solid Tumors (MK-4700-001)
A Phase 1 study testing MK-4700 and Pembrolizumab in people with Malignant Neoplasm, run by Merck Sharp & Dohme LLC at 7 sites in 3 countries.
Trial summary
The goal of this study is to learn about the safety of different doses of MK-4700 and if people tolerate them. The study will also measure what happens in a person's body over time when MK-4700 is given alone or with pembrolizumab (MK-3475) in order to find a dose that is safe, tolerated, and may work to treat certain… 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-4700 and Pembrolizumab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 5 participants
- Where
- 7 sitesin 3 countries
- Study dates
- 23 Apr 2025to 8 Dec 2025
- Phase
- Phase 1
- Are there results?
- None posted in the registry
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
- The key inclusion criteria include but are not limited to the following:
- Has histologically or cytologically confirmed advanced/metastatic solid tumor by pathology report who have experienced disease progression on or after prior anti-cancer treatments, or been intolerant to, or refused all treatment known to confer clinical benefit
- Has head and neck squamous cell carcinoma (HNSCC), melanoma (cutaneous), non-small cell lung cancer (NSCLC), cervical cancer, triple negative breast cancer (TNBC), urothelial carcinoma (UC), or renal cell carcinoma (RCC; clear cell, papillary)
- If human immunodeficiency virus (HIV) infected, must have well controlled HIV on antiretroviral therapy (ART)
- Has normal cardiac function
Who cannot join
- The key exclusion criteria include but are not limited to the following:
- If HIV-infected with a history of Kaposi's sarcoma and/or Multicentric Castleman's Disease
- Has known additional malignancy that is progressing or has required active treatment within the past 2 years
- Has known active central nervous system (CNS) metastases and/or carcinomatous meningitis
- Has active autoimmune disease that has required systemic treatment in the past 2 years except replacement therapy
- Has history of (noninfectious) pneumonitis/interstitial lung disease that required steroids
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- Has current pneumonitis/interstitial lung disease
- Has active infection requiring systemic therapy
- Has known history of Hepatitis B (defined as Hepatitis B surface antigen reactive) or known active Hepatitis C virus infection
- Has had an allogeneic tissue/solid organ transplant in the last 5 years
Trial locations and contacts
7 sites in 3 countries.
7 sites in 3 countries
Israel3 sites
Rambam Health Care Campus ( Site 0201)
Haifa, 3109601
Rabin Medical Center ( Site 0202)
Petah Tikva, 4941492
Sheba Medical Center ( Site 0200)
Ramat Gan, 5265601
United States2 sites
John Theurer Cancer Center at Hackensack University Medical Center ( Site 0301)
Hackensack, New Jersey, 07601
NEXT Oncology ( Site 0300)
San Antonio, Texas, 78229
Canada2 sites
Centre intégré de cancérologie du CHU de Québec Université Laval, Hôpital de l'Enfant-Jésus ( Site 0102)
Québec, Quebec, G1J 1Z4
Princess Margaret Cancer Center ( Site 0101)
Toronto, Ontario, M5G 2M9
About this study
Official title: A Phase 1 Open-label, Multicenter Study to Assess the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of MK-4700 as Monotherapy and in Combination With Pembrolizumab in Participants With Advanced or Metastatic Solid Tumors
The goal of this study is to learn about the safety of different doses of MK-4700 and if people tolerate them. The study will also measure what happens in a person's body over time when MK-4700 is given alone or with pembrolizumab (MK-3475) in order to find a dose that is safe, tolerated, and may work to treat certain types of cancer.
- Conditions
- Malignant Neoplasm
- Being tested
- MK-4700, Pembrolizumab
- Keywords
- Head and Neck Squamous Cell Carcinoma, Melanoma, Non-small Cell Lung Cancer, Cervical Cancer, Triple Negative Breast Cancer, Urothelial Carcinoma, Renal Cell Carcinoma
- Medical subject headings
- Neoplasms, Squamous Cell Carcinoma of Head and Neck, Melanoma, Carcinoma, Non-Small-Cell Lung, Uterine Cervical Neoplasms, Triple Negative Breast Neoplasms, Carcinoma, Transitional Cell, Carcinoma, Renal Cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MK-4700Biological
Administered via subcutaneous (SC) injection
PembrolizumabBiological
Also called MK-3475, KEYTRUDA®
Administered via intravenous infusion
| Study group | Role | What they receive |
|---|---|---|
| Arm 1: MK-4700 | Experimental | Participants receive escalating doses every three weeks (Q3W) of MK-4700 for a maximum of 35 cycles (approximately 2 years; cycles are 21 days in length). Eligible participants enrolled in Arm 1 who experience progressive disease (PD) may cross over to Arm 2 to receive MK-4700 and pembrolizumab combination therapy. Receives: Biological: MK-4700 |
| Arm 2: MK-4700 + Pembrolizumab | Experimental | Participants will receive MK-4700 and pembrolizumab Q3W for up to 35 cycles (approximately 2 years) or until PD, death, toxicity, or withdrawal of consent. Receives: Biological: MK-4700; Biological: Pembrolizumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Dose-Limiting Toxicity (DLT)
The occurrence of any of the following toxicities during Cycle 1 will be considered a DLT, if assessed by the investigator related to study intervention administration:
- Grade 4 nonhematologic toxicity
- Grade 4 hematologic toxicity lasting ≥7 days, except thrombocytopenia
- Any nonhematologic AE ≥Grade 3 in severity, with exceptions
- Any Grade 3 or Grade 4 nonhematologic laboratory value, as with pre-specified exceptions
- Any Grade 3 or Grade 4 laboratory abnormalities, with the exceptions
- Febrile neutropenia Grade 3 or Grade 4
- Prolonged delay (>2 weeks) in initiating Cycle 2 due to intervention-related toxicity
- Any study drug toxicity that causes the participant to discontinue study drug during Cycle 1
- Missing >25% of MK-4700 doses as a result of drug-related AEs during the first cycle
- Grade 5 toxicity
Measured: Cycle 1 (up to 21 days)
Percentage 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.
Measured: Up to approximately 4.5 years
Percentage of Participants who Discontinue Study Treatment 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.
Measured: Up to approximately 4.5 years
Secondary outcomes (3)
Area Under the Concentration-Time Curve of MK-4700
AUC is defined as the area under the concentration versus time curve. Blood samples will be collected at pre-specified timepoints to determine AUC.
Measured: Predose and at prespecified time points during Cycles 1, 2, 3, 4, 5, 6, 7, and 10 up to approximately 7 months (Cycle length is 21 days)
Maximum Plasma Concentration (Cmax) of MK-4700
Cmax is defined as the maximum concentration of MK-4700 observed in plasma after its administration and just prior to administration of the next dose. Blood samples will be collected at pre-specified timepoints to determine Cmax.
Measured: Predose and at prespecified time points during Cycles 1, 2, 3, 4, 5, 6, 7, and 10 up to approximately 7 months (Cycle length is 21 days)
Minimum Plasma Concentration (Cmin) of MK-4700
Cmin is defined as the minimum concentration of MK-4700 observed in plasma after its administration and just prior to administration of the next dose. Blood samples will be collected at pre-specified timepoints to determine Cmin.
Measured: Predose and at prespecified time points during Cycles 1, 2, 3, 4, 5, 6, 7, and 10 up to approximately 7 months (Cycle length is 21 days)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Mar 2025
- Study start23 Apr 2025
- Primary completion8 Dec 2025
- Study completion8 Dec 2025
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
- Sequential
- Masking
- None (open label)
- Enrolment
- 5 participants (actual)
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
- NCT06894771
- Sponsor's protocol ID
- 4700-001
- Other IDs
- MK-4700-001
- Status last verified
- Mar 2026
- First submitted
- 3 Mar 2025
- Last updated
- 16 Mar 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 16 Mar 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 the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of MK-4700 as Monotherapy and in Combination With Pembrolizumab in Participants With Advanced or Metastatic Solid Tumors
- ClinicalTrials.gov ID
- NCT06894771
- Acronym / sponsor ID
- 4700-001
- Conditions
- Malignant Neoplasm
- Keywords
- Head and Neck Squamous Cell Carcinoma, Melanoma, Non-small Cell Lung Cancer, Cervical Cancer, Triple Negative Breast Cancer, Urothelial Carcinoma, Renal Cell Carcinoma
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 5 participants (actual)
- Lead sponsor
- Merck Sharp & Dohme LLCIndustry (pharma, biotech, devices)
- Study start
- 23 Apr 2025 (actual)
- Primary completion
- 8 Dec 2025 (actual)
- Study completion
- 8 Dec 2025 (actual)
- First posted
- 25 Mar 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.
The goal of this study is to learn about the safety of different doses of MK-4700 and if people tolerate them. The study will also measure what happens in a person's body over time when MK-4700 is given alone or with pembrolizumab (MK-3475) in order to find a dose that is safe, tolerated, and may work to treat certain types of cancer.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm 1: MK-4700 | Experimental | Biological: MK-4700Participants receive escalating doses every three weeks (Q3W) of MK-4700 for a maximum of 35 cycles (approximately 2 years; cycles are 21 days in length). Eligible participants enrolled in Arm 1 who experience progressive disease (PD) may cross over to Arm 2 to receive MK-4700 and pembrolizumab combination therapy. |
| Arm 2: MK-4700 + Pembrolizumab | Experimental | Biological: MK-4700, Biological: PembrolizumabParticipants will receive MK-4700 and pembrolizumab Q3W for up to 35 cycles (approximately 2 years) or until PD, death, toxicity, or withdrawal of consent. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Has histologically or cytologically confirmed advanced/metastatic solid tumor by pathology report who have experienced disease progression on or after prior anti-cancer treatments, or been intolerant to, or refused all treatment known to confer clinical benefit
- Has head and neck squamous cell carcinoma (HNSCC), melanoma (cutaneous), non-small cell lung cancer (NSCLC), cervical cancer, triple negative breast cancer (TNBC), urothelial carcinoma (UC), or renal cell carcinoma (RCC; clear cell, papillary)
- If human immunodeficiency virus (HIV) infected, must have well controlled HIV on antiretroviral therapy (ART)
- Has normal cardiac function
Key exclusion criteria (10 listed)
- If HIV-infected with a history of Kaposi's sarcoma and/or Multicentric Castleman's Disease
- Has known additional malignancy that is progressing or has required active treatment within the past 2 years
- Has known active central nervous system (CNS) metastases and/or carcinomatous meningitis
- Has active autoimmune disease that has required systemic treatment in the past 2 years except replacement therapy
- Has history of (noninfectious) pneumonitis/interstitial lung disease that required steroids
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-4700Administered via subcutaneous (SC) injection | Biological | Arm 1: MK-4700, Arm 2: MK-4700 + Pembrolizumab |
| PembrolizumabAlso: MK-3475, KEYTRUDA®Administered via intravenous infusion | Biological | Arm 2: MK-4700 + Pembrolizumab |
Primary outcome
Dose-Limiting Toxicity (DLT)
Time frame: Cycle 1 (up to 21 days)
The occurrence of any of the following toxicities during Cycle 1 will be considered a DLT, if assessed by the investigator related to study intervention administration: * Grade 4 nonhematologic toxicity * Grade 4 hematologic toxicity lasting ≥7 days, except thrombocytopenia * Any nonhematologic AE ≥Grade 3 in severity, with exceptions * Any Grade 3 or Grade 4 nonhematologic laboratory value, as with pre-specified exceptions * Any Grade 3 or Grade 4 laboratory abnormalities, with the exceptions * Febrile neutropenia Grade 3 or Grade 4 * Prolonged delay (>2 weeks) in initiating Cycle 2 due to intervention-related toxicity * Any study drug toxicity that causes the participant to discontinue study drug during Cycle 1 * Missing >25% of MK-4700 doses as a result of drug-related AEs during the first cycle * Grade 5 toxicity
Percentage of Participants Who Experience an Adverse Event (AE)
Time frame: Up to approximately 4.5 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.
Percentage of Participants who Discontinue Study Treatment Due to an AE
Time frame: Up to approximately 4.5 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.
3 secondary outcomes
Area Under the Concentration-Time Curve of MK-4700
Time frame: Predose and at prespecified time points during Cycles 1, 2, 3, 4, 5, 6, 7, and 10 up to approximately 7 months (Cycle length is 21 days)
Maximum Plasma Concentration (Cmax) of MK-4700
Time frame: Predose and at prespecified time points during Cycles 1, 2, 3, 4, 5, 6, 7, and 10 up to approximately 7 months (Cycle length is 21 days)
Minimum Plasma Concentration (Cmin) of MK-4700
Time frame: Predose and at prespecified time points during Cycles 1, 2, 3, 4, 5, 6, 7, and 10 up to approximately 7 months (Cycle length is 21 days)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Mar 2026.
- Merck Clinical Trials InformationLink 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. This study is not recruiting at the moment.
Medical Director study director
Merck Sharp & Dohme LLC
7 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing MK-4700 and Pembrolizumab in people with Malignant Neoplasm, run by Merck Sharp & Dohme LLC at 7 sites in 3 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 5 inclusion and 10 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: finished, as of the sponsor's last update on 16 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in Israel, United States, Canada. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Dose-Limiting Toxicity (DLT) (time frame: Cycle 1 (up to 21 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 16 Mar 2026.