MQ710 with or without Pembrolizumab for Solid Tumor Cancers
This study is testing MQ710, a biological treatment, by itself or with pembrolizumab (a drug often used in cancer treatment) in people with advanced solid tumor cancers. These are cancers that have returned, spread, or worsened after standard treatments, or for which no standard treatments exist. The study aims to find the safest dose of MQ710 and understand its side effects. You may be eligible if you are 18 or older and have a solid tumor cancer that has progressed after at least two prior treatments, or if fewer than two treatments are approved for your cancer. The study plans to enroll 56 participants, but its current recruitment status is unclear.
- Study design
- This is an interventional study with a planned enrollment of 56 participants. It is not specified if it is randomized or blinded.
- What's involved
- Not specified in the trial record.
- Compensation
- Not stated in the trial record.
- Follow-up
- Your safety will be monitored for up to 2 years after treatment.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
NCT05859074
A Study of MQ710 With and Without Pembrolizumab in People With Solid Tumor Cancer
Recruiting
PHASE1Ages 18+InterventionalTreatmentMemorial Sloan Kettering Cancer CenterInvestigator-initiated
~56 participants
Updated 2026-08-12 on ClinicalTrials.gov
What's tested:MQ719Pembrolizumab
At a glance
Recruiting sites
5 of 7 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Safety of MQ710 by review of AEs and SAEs
Measured over Up to 2 years
Conditions
Where it's being run
7 sites across 2 statesNew York4
New Jersey3
Study leadership
- Lara Dunn, MD · PRINCIPAL_INVESTIGATOR · Memorial Sloan Kettering Cancer Center
Who to contact
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Do you actually qualify for this trial?
Add a private profile and we'll compare every criterion below against your situation — and tell you which ones are met, uncertain, or excluding.
Eligibility criteria
Inclusion
Age 18 or over
Histologically or cytologically documented advanced or metastatic cancer that has relapsed from or is refractory to standard treatment in two lines of prior therapy 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 RECIST measurable disease if in Part 2. Note: One lesion will be biopsied (if possible)
Mandatory initial screening biopsy
Eastern Cooperative Oncology Group (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 contraindications to standard therapy
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 anti-PD-1 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 life expectancy of 3 months or more (in both Part 1 and Part 2)
Participant or their legally authorized representative (LAR able to provide written informed consent 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
Adequate bone marrow and hematologic function
Females of child-bearing potential must have a negative pregnancy test within 14 days prior to enrollment and on day of treatment. All patients must agree to use adequate contraception 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 washout period is required for Part 1b and 2b.
Exclusion
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 hepatitis B virus, hepatitis C virus, human immunodeficiency virus (HIV) with CD4 count \<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 New York Heart Association 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 PD-1/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, investigational drug, or major surgery 28 days prior to enrollment or has not recovered to Common Terminology Criteria for Adverse Events (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 CNS metastases and/or carcinomatous meningitis
Received live vaccine 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 autoimmune disease that has required systemic treatment in the past 2 years (i.e., with use of disease modifying agents, corticosteroids, or immunosuppressive 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 allogeneic 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 informed consent
Known allergy to MQ710 transgene products or formulation.
Patient requires anticoagulation therapy, such as warfarin.
What this trial measures
- Safety of MQ710 by review of AEs and SAEsUp to 2 years
Review the safety and tolerability of MQ710 by review of AE's and SAE's by CTCAE v 5.0