ClinicalTrials.gg
RecruitingNCT05859074Updated Aug 12, 2026

A Study of MQ710 With and Without Pembrolizumab in People With Solid Tumor Cancer

A Phase 1 interventional study of MQ719 and Pembrolizumab in Cutaneous Squamous Cell Carcinoma, SCC - Squamous Cell Carcinoma and Basal Cell Carcinoma, sponsored by Memorial Sloan Kettering Cancer Center. Recruiting at 7 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-08-12.

Primary conditionSquamous Cell Carcinoma of Head and NeckRegistry: Carcinoma, Squamous CellReclassifiedWhy we changed it
Registry
Carcinoma, Squamous Cell — the first condition term the registry derived for this study.
ClinicalTrials.gg
Squamous Cell Carcinoma of Head and Neck
Why
  1. The study's listed conditions name Squamous Cell Carcinoma of Head and Neck, a narrower term within Carcinoma, Squamous Cell.
Confidence
High: the new condition is named in the study's own listed conditions. Of 351 hand-checked studies reclassified this way, 68% were exactly right and 84% in the right disease family; the registry's first term was right for 5% (measured 2026-10-21). How we classify →
Wrong?
Tell us the study's main condition →

Sponsored by Memorial Sloan Kettering Cancer Center · Phase 1, Interventional, and Treatment

From the registry’s dates

  • Started May 2023; still recruiting 3 years 6 months later.
Phase
Phase 1
Study type
Interventional
Enrollment
56
Allocation
Non-randomized
Ages
18 Years and older
Sex
All
01

Study summary

Participants of this study will have a diagnosis of a solid tumor cancer that has come back to its original location or spread beyond its original location (advanced), came back (relapsed) or worsened (refractory) after standard treatments, or no standard treatments are available for the participants' cancer. The purpose of this study if to find the highest dose of MQ710 that causes few or mild side effects in participants with a solid tumor cancer diagnosis.

02

Conditions studied

  • Cutaneous Squamous Cell Carcinoma
  • SCC - Squamous Cell Carcinoma
  • Basal Cell Carcinoma
  • BCC
  • BCC - Basal Cell Carcinoma
  • Melanoma
  • Merkel Cell Carcinoma
  • Sebaceous Carcinoma
  • Extramammary Paget Disease
  • Kaposi Sarcoma
  • Head and Neck Squamous Cell Carcinoma
  • HNSCC
  • Adnexal Carcinoma
  • Angiosarcoma
  • Cutaneous Neoplasm
  • Advanced Cancer
  • Metastatic Cancer
  • Refractory Cancer
  • Solid Tumor

Keywords

  • Cutaneous Squamous Cell Carcinoma
  • SCC - Squamous Cell Carcinoma
  • Basal Cell Carcinoma
  • BCC
  • Melanoma
  • Merkel Cell Carcinoma
  • Sebaceous Carcinoma
  • Extramammary Paget Disease
  • Kaposi Sarcoma
  • Head and Neck Squamous Cell Carcinoma
  • HNSCC
  • Adnexal Carcinoma
  • Angiosarcoma
  • Cutaneous Neoplasm
  • Advanced Cancer
  • Metastatic Cancer
  • Refractory Cancer
  • MQ710
  • Memorial Sloan Kettering Cancer Center
  • 22-278
  • Solid Tumor
03

In context

Squamous Cell Carcinoma of Head and Neck Reclassified

2,018 studies on the registry are indexed under Squamous Cell Carcinoma of Head and Neck; 573 are open to participants now.

This study's planned enrollment of 56 is above the median of 48 across 1,653 interventional studies indexed under Squamous Cell Carcinoma of Head and Neck.

Browse Squamous Cell Carcinoma of Head and Neck studies →

Lead sponsor

Memorial Sloan Kettering Cancer Center is the lead sponsor of 1,964 studies on the registry; 327 are open to participants now.

Of its 135 completed or terminated interventional studies of FDA-regulated products, 71 (53%) have results posted.

Compared within Squamous Cell Carcinoma of Head and Neck, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is Carcinoma, Squamous Cell. The counts are of registry records indexed under each term, refreshed daily. How we classify →

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Age 18 or over
  • or cytologically documented advanced or cancer that has from or is refractory to standard treatment in two in the advanced setting unless there are fewer than two FDA approved lines of therapy for the particular disease, or for which no standard treatment is available
  • At least 2 tumors suitable for direct or ultrasound-guided injection defined as at least one cutaneous, subcutaneous, or nodal lesion or aggregate of lesions, ≥0.5 cm for any single lesion and cumulative lesion dimensions. One lesion must meet criteria for if in Part 2. Note: One lesion will be biopsied (if possible)
  • Mandatory initial screening

    a. For patients undergoing surgical excision/resection: i. Tumor deemed accessible and safe for biopsy by the Investigator ii. Willing to consent to biopsy and surgical procedure iii. Patient able to undergo surgical procedure and appropriate anesthesia b. For patients not undergoing surgical excision/resection to obtain mandatory screening biopsy: i. Tumor deemed accessible and safe for biopsy by the Investigator ii. Willing to consent to initial tumor biopsy

  • (ECOG) performance status 0 or 1
  • Patients with no curative treatment options available including surgery and/or definitive radiation or patients in which these modalities are associated with significant morbidity
  • Patients with advanced disease who have received and progressed on standard therapy or have disease for which there is no standard therapy or have to standard therapy

Part 1a: Patients with cutaneous squamous cell carcinoma (cSCC), basal cell carcinoma (BCC), melanoma, Merkel cell carcinoma, sebaceous carcinoma, extramammary Paget's disease, Kaposi sarcoma, HNSCC, adnexal carcinoma, and angiosarcoma, as well as patients with cutaneous neoplasms that are separate primaries with morbidity from multiple surgeries that have failed standard therapy. Any with superficial cutaneous or subcutaneous lesions or palpable lymph nodes may be eligible based on the discretion of the investigator.

  • Part 2a: Patients with cutaneous squamous cell carcinoma (cSCC), basal cell carcinoma (BCC), melanoma, Merkel cell carcinoma, sebaceous carcinoma, extramammary Paget's disease, Kaposi sarcoma, HNSCC, adnexal carcinoma, and angiosarcoma, as well as patients with cutaneous neoplasms that are separate primaries with morbidity from multiple surgeries that have failed standard therapy. BCC will also be included, given that pembrolizumab has not been approved for this condition, although cemiplimab is approved.
  • Parts 1b and 2b: Patients must have cSCC, Merkel cell carcinoma, melanoma, or head and neck squamous cell carcinoma. These patients should be refractory to therapy, with the exception of patients with HNSCC with PD-L1 expression \<1.
  • Parts 1a, 2a and 2b: Patients with BRAF-mutated melanoma should have received BRAF-targeted therapy.
  • Predicted of 3 months or more (in both Part 1 and Part 2)
  • Participant or their legally authorized representative (LAR able to provide written to participate
  • Ability to comply with study procedures in the Investigator's opinion
  • Adequate renal function as defined by Cr \<2 mg/dL
  • Adequate hepatic function

    1. Serum ≤1.5 x
    2. and ALT ≤2.5 ULN (no liver mets)
    3. AST and ALT ≤5.0 ULN (for patients with liver mets)
  • Adequate bone marrow and hematologic function

    1. Coagulation function adequate (PT and within x1.5 ULN)
    2. ≥ 75,000/mm\^2
    3. ≥ 1000/uL
  • Females of must have a negative pregnancy test within 14 days prior to enrollment and on day of treatment. All patients must agree to use adequate prior to study entry, for the duration of study participation, and up to 90 days after the last dose of MQ710
  • Part 2 only: at least one measurable site of disease according to RECIST criteria
  • Prior non-immunotherapy, anti-tumor treatment including endocrine, chemical/radiotherapy, targeted therapy, or major surgery (but not anti-PD1/- L1 therapies) was discontinued for more than 4 weeks prior to enrollment
  • Patients who have failed prior anti-PD1/-PDL1 may be included. Washout of anti-PD1/-PDL1 at least 3 weeks prior to initiation of therapy in Part 1a and 2a. No is required for Part 1b and 2b.

Exclusion criteria

Exclusion Criteria:

  • Splenectomy
  • Active infections requiring antibiotics, physician monitoring or recurrent fevers (>38.0 ℃) associated with a clinical diagnosis of active infection
  • Acute or chronic active viral disease or positive test for virus, virus, (HIV) with \<100mg/m3, or received treatment with antivirals or nucleoside analogs such as those used in the treatment of hepatitis B (e.g. lamivudine, adefovir, tenofovir, telbivudine, entecavir), ribavirin, cidofovir, diaminopurine analogs, methyladenosine analogs, or interferon alpha within 4 weeks of initiation of study treatment .a. Patients with HIV are allowed on study if CD4 count is >100 cells/mm3.
  • Incomplete recovery from surgery, incomplete healing of an incision site
  • Any of the following in the 3 months before the first dose of study treatment: Grade 3 or 4 gastrointestinal bleeding/haemorrhage (unless due to resected tumour), treatment-resistant peptic ulcer disease, erosive oesophagitis or gastritis, infectious or inflammatory bowel disease, diverticulitis, pulmonary embolism or other uncontrolled thrombo-embolic event, history or evidence of haemoptysis or menorrhagia
  • History of myocardial infarction, myocarditis, congestive heart failure (as defined by Functional Classsification III or IV), unstable angina, serious uncontrolled cardiac arrhythmia,or significant cardiovascular or cerebrovascular event in the 6 months before the first dose of study treatment
  • Uncontrolled infection within 6 months prior to study entry.
  • History of significant bleeding requiring hospitalization in the 12 months before the first dose of study treatment
  • Treatment with /programmed death ligand (PD-L1), cytotoxic T-lymphocyte associated protein 4 (CTLA-4), or any other (including experimental) immune checkpoint inhibitor or immune-stimulatory treatment in the 3 weeks before the first dose of study treatment
  • Prior chemotherapy, radiotherapy, biological cancer therapy (not including anti-PD1/-L1 immunotherapies), targeted therapy, drug, or major surgery 28 days prior to enrollment or has not recovered to (CTCAE) grade 1 or better from adverse event due to cancer therapy administered more than 28 days prior to enrollment with the exception of grade 2 or better for alopecia and neuropathy.
  • Has known active and/or carcinomatous meningitis
  • Received within 28 days prior to enrollment
  • Patient is pregnant or breast-feeding, or expecting to conceive or father children within the duration of the trial
  • Patients with tumor that directly contacts, encases or penetrates a major blood vessel, pericardium, gastrointestinal tract, or other hollow organs that may lead to perforation due to tumor necrosis
  • Patients at risk of airway compromise in the event of post-injection tumor swelling/inflammation based on investigator judgement
  • History or evidence of disease that has required systemic treatment in the past 2 years (i.e., with use of disease modifying agents, , or drugs)
  • History of chronic liver disease or evidence of hepatic cirrhosis
  • History of idiopathic pulmonary fibrosis, pneumonitis (including drug induced), organizing pneumonia, active interstitial lung disease (ILD) requiring treatment with systemic steroids
  • Baseline pulse oximetry less than 92% on room air
  • History of re-irradiation to a field which includes the carotid arteries
  • History of leukemia: ALL and CLL (patients with a history of aggressive lymphomas in remission or patients with a history of stem cell transplants are eligible if no longer on immunosuppressive therapy and without evidence of GvHD)
  • Current use of steroids such as prednisone 10 mg/daily or greater (or its equivalent) or immunosupressants within 2 weeks of initiation of study treatment
  • Any serious or uncontrolled medical disorder that, in the opinion of the Investigator or the Medical Monitor, may increase the risk associated with study participation or study treatment administration, impair the ability of the patient to receive protocol therapy or interfere with the interpretation of study results
  • Any other medical or psychological condition that would preclude participation in the study or compromise ability to give
  • Known allergy to MQ710 transgene products or formulation.
  • Patient requires anticoagulation therapy, such as warfarin.
Terms in these criteria, in plain language(35)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Histologically or cytologically confirmed

The diagnosis was confirmed by looking at a sample under a microscope: tissue from a biopsy or surgery (histology), or cells from a fluid or needle sample (cytology).

Your pathology report is the document that shows this.

Metastases

Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.

Relapsed and refractory

Relapsed: the illness came back after treatment had worked. Refractory: it did not respond to treatment, or stopped responding while still on it.

Line of therapy

A line of therapy is one course of treatment, which may combine several drugs. First-line is the first course given; second-line follows when that stops working or is not tolerated.

“Two prior lines” means two courses that count separately under the study’s rules — not simply two drugs. Ask the study team if you are unsure how yours are counted.

RECIST

The standard rules for measuring tumours on CT or MRI scans, to tell whether a cancer is shrinking, stable or growing during treatment.

“Measurable disease per RECIST 1.1” usually means at least one tumour 10 mm or more at its longest on a CT scan, or a lymph node 15 mm or more across its short axis.

Measurable disease

The amount of disease can be tracked with a defined measurement, so the study can see whether it shrinks or grows. It might be a tumour measured on a scan or, in some blood cancers such as myeloma, a marker measured in blood or urine.

The criteria or the study team say which measurement counts — having no tumour visible on a scan does not by itself rule you out.

Biopsy and archival tissue

A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.

Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.

ECOG performance status

A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.

0
Fully active, no restrictions.
1
Limited in strenuous activity, but walking and able to do light work, such as housework or office work.
2
Walking and able to look after yourself, but unable to work; up and about more than half of waking hours.
3
Able to look after yourself only in part; in bed or a chair more than half of waking hours.
4
Unable to look after yourself at all; in bed or a chair all day.

Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.

Contraindication

A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.

Cancer (malignancy)

Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.

Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.

PD-1, PD-L1 and checkpoint inhibitors

PD-1, PD-L1 and CTLA-4 are proteins that act as brakes on the immune system. Checkpoint inhibitors, such as pembrolizumab or nivolumab, block them so the immune system can attack a cancer.

PD-L1 can also be measured in a tumour sample. Some scores count stained tumour cells only (TPS); others also count certain immune cells (CPS). The study names the score and the minimum it uses.

Life expectancy

The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

Bilirubin

A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.

Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.

ULN (upper limit of normal)

The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.

“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.

ALT and AST (liver enzymes)

Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.

Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.

INR, PT and aPTT (clotting tests)

Blood tests of how long blood takes to clot. The INR is the prothrombin time (PT) put on a common scale; about 1 is usual for someone not taking a blood thinner.

Criteria often make an exception for people on a blood thinner such as warfarin, whose INR is raised on purpose.

Platelets

Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.

Absolute neutrophil count (ANC)

The number of neutrophils, white blood cells that help fight infection, in a given amount of blood. Too few raises the risk of infection.

It is a count, not a percentage of the white cells. Limits are written in units that mean the same: ≥ 1.5 × 10⁹/L is ≥ 1,500 per mm³ (µL). Each lab has its own reference range.

Childbearing potential

Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).

Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.

Contraception

Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.

Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.

Washout period

A planned gap after a treatment, so that its effects can lessen before the study treatment or a study assessment. Ask the study team and the doctor who prescribed it before changing any medicine.

Hepatitis B tests

Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.

Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.

Hepatitis C tests

Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.

After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.

HIV

The human immunodeficiency virus, which weakens the immune system.

Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.

CD4 count

The number of CD4 cells, a type of white blood cell, in a given amount of blood. It is used to follow how well the immune system is doing in HIV.

NYHA class (heart failure)

The New York Heart Association’s four classes of how much heart failure limits physical activity.

I
No limits: ordinary activity causes no undue tiredness or breathlessness.
II
Slight limits: comfortable at rest, ordinary activity causes symptoms.
III
Marked limits: comfortable at rest, less than ordinary activity causes symptoms.
IV
Symptoms even at rest; any activity makes them worse.

Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.

Investigational drug or device

A drug or device being studied in a clinical trial.

It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.

CTCAE grade

The US National Cancer Institute’s scale of how severe an adverse event is — any unwanted medical event during a study, such as a symptom, an illness or an abnormal test result, whether or not a treatment caused it. Whether it did is judged separately.

1
Mild.
2
Moderate.
3
Severe.
4
Life-threatening.
5
Death due to the event.

“Side effects of earlier treatment resolved to grade 1 or less” means they have settled to mild or gone.

Brain metastases

Cancer deposits in the brain from a cancer that started elsewhere in the body (CNS metastases include the spinal cord).

Studies differ: some leave out any brain metastases, some accept ones treated and stable for some weeks. Check what this study allows.

Live vaccines

Vaccines made with a weakened form of the germ, such as measles–mumps–rubella (MMR), chickenpox and yellow fever. They can be risky when the immune system is weakened. Flu injections are not live; the nasal flu spray is.

Autoimmune disease

A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.

Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.

Corticosteroids (steroids)

Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.

Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.

Immunosuppression

A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.

Read whether the line is about a condition or about medicines, and which medicines and doses it means.

Allogeneic and autologous transplant

Stem cell (bone marrow) transplants. Allogeneic uses cells from a donor; autologous uses your own cells, collected earlier and given back.

05

Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Non-randomized
Intervention model
Sequential assignment
Masking
None (open label)
Enrollment
56 participants (estimated)

Study arms

  • Experimental
    Dose Escalation Group

    MQ710 The dose levels will be escalated following a standard 3+3 dose escalation scheme.

    Biological: MQ719

  • Experimental
    Dose Expansion Group

    MQ710 + pembrolizumab Approximately 8 patients will be recruited into the dose expansion group for monotherapy dosing of MQ710. Approximately 12 patients will be recruited for dosing at the MTD/maximally administered dose established in combination with pembrolizumab.

    Biological: MQ719 · Drug: Pembrolizumab

Interventions

  • BiologicalMQ719

    Patients will receive either multidose monotherapy with MQ710 or multidose combination therapy with MQ710 and pembrolizumab. The applicable dose of MQ710 will be injected directly into the patient's tumor (intratumorally), and standard dosing of pembrolizumab (200 mg) will be administered intravenously at a 3-week interval.

  • Patients will receive either multidose monotherapy with MQ710 or multidose combination therapy with MQ710 and pembrolizumab. The applicable dose of MQ710 will be injected directly into the patient's tumor (intratumorally), and standard dosing of pembrolizumab (200 mg) will be administered intravenously at a 3-week interval.

06

What researchers measure

Primary outcomes

  1. Safety of MQ710 by review of AEs and SAEs

    Review the safety and tolerability of MQ710 by review of AE's and SAE's by CTCAE v 5.0

    Time frame: Up to 2 years

07

Study locations

5 of 7 sites recruiting
  • Memorial Sloan Kettering Basking Ridge (Limited Protocol Activities)
    Basking Ridge, New Jersey 07920, United States
    Recruiting
    • Lara Dunn, MD · Contact646-608-3787
  • Memorial Sloan Kettering Monmouth (Limited protocol activities)
    Middletown, New Jersey 07748, United States
    Recruiting
    • Lara Dunn, MD · Contact646-608-3787
  • Memorial Sloan Kettering Bergen (Limited Protocol Activities)
    Montvale, New Jersey 07645, United States
    Recruiting
    • Lara Dunn, MD · Contact646-608-3787
  • Memorial Sloan Kettering Suffolk-Commack (Limited Protocol Activities)
    Commack, New York 11725, United States
    Active, not recruiting

    Not enrolling at this site.

  • Memorial Sloan Kettering Westchester (Limited Protocol Activities)
    Harrison, New York 10604, United States
    Active, not recruiting

    Not enrolling at this site.

  • Memorial Sloan Kettering Cancer Center (All Protocol Activities)
    New York, New York 10065, United States
    Recruiting
    • Lara Dunn, MD · Contact646-608-3787
  • Memorial Sloan Kettering Nassau (Limited Protocol Activities)
    Uniondale, New York 11553, United States
    Recruiting
    • Lara Dunn, MD · Contact646-608-3787
08

References and documents

Individual participant data

Plan to share: Yes — Memorial Sloan Kettering Cancer Center supports the international committee of medical journal editors (ICMJE) and the ethical obligation of responsible sharing of data from clinical trials. The protocol summary, a statistical summary, and informed consent form will be made available on clinicaltrials.gov when required as a condition of Federal awards, other agreements supporting the research and/or as otherwise required. Requests for deidentified individual participant data can be made beginning 12 months after publication and for up to 36 months post publication. Deidentified individual participant data reported in the manuscript will be shared under the terms of a Data Use Agreement and may only be used for approved proposals. Requests may be made to: crdatashare@mskcc.org.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started May 2023 (actual). Primary completion is estimated for May 2028, 60 months after the start.

Of 113 non-industry phase 1 interventional studies under Squamous Cell Carcinoma of Head and Neck, half reached primary completion within 43 months of starting (the median), counting those still running; a quarter within 32 and three quarters within 61. This study's planned 60 months is above that.

Counting every sponsor, half of 267 studies reached it within 49 months; a quarter within 33 and three quarters within 66.

How these figures are worked out, and which studies are left out of them.

Registered
May 4, 2023
First posted
May 15, 2023
StartActual
May 4, 2023
Primary completionEst.
May 4, 2028
CompletionEst.
May 4, 2028
Last update
Aug 12, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Aug 12, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05859074
Responsible party
Sponsor
First posted
May 15, 2023
Start date
May 4, 2023
Primary completion
May 4, 2028 (estimated)
Completion
May 4, 2028 (estimated)
Last update
Aug 12, 2026

Study contacts

Lara Dunn, MD
Contact
dunnl1@mskcc.org
646-608-3787
Anthony Rossi, MD
Contact
rossia@mskcc.org
646-608-2311
Lara Dunn, MD
principal investigator · Memorial Sloan Kettering Cancer Center

Oversight

FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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