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New treatment option for Cutaneous Squamous Cell Carcinoma
Official title A Study of MQ710 With and Without Pembrolizumab in People With Solid Tumor Cancer
ClinicalTrials.gov ID: NCT05859074
What this study is testing
What is MQ719?
MQ719 is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for cutaneous squamous cell carcinoma.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 1: an early, usually small safety study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- 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...
- At least 2 tumors suitable for direct or ultrasound-guided injection defined as at least one cutaneous, subcutaneous, or nodal lesion or aggregate of...
- Mandatory initial screening biopsy a. For patients undergoing surgical excision/resection: i. Tumor deemed accessible and safe for biopsy by the...
- Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1
You likely can't join if
- 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 \...
- 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...
- History of myocardial infarction, myocarditis, congestive heart failure (as defined by New York Heart Association Functional Classsification III or...
See the full eligibility criteria
Who can join
- 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...
- 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...
- Mandatory initial screening biopsy 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...
- 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 1a: Patients with cutaneous...
- 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...
- 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...
- 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
- Serum bilirubin ≤1.5 x ULN
- AST and ALT ≤2.5 ULN (no liver mets)
- AST and ALT ≤5.0 ULN (for patients with liver mets)
- Adequate bone marrow and hematologic function
- Coagulation function adequate (PT and aPTT within x1.5 ULN)
- Platelets ≥ 75,000/mm\^2
- ANC ≥ 1000/uL
- 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...
- 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.
What rules you out
- 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 \ 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...
- 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...
- 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...
- 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...
- 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...
- 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...
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Basking Ridge, New Jersey, United States
- Middletown, New Jersey, United States
- Montvale, New Jersey, United States
- Commack, New York, United States
- Harrison, New York, United States
- New York, New York, United States
- Uniondale, New York, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Basking Ridge, New Jersey, United States; Middletown, New Jersey, United States; Montvale, New Jersey, United States; Commack, New York, United States; Harrison, New York, United States; New York, New York, United States and 1 more location(s). Enter your location above to see the nearest site and check your eligibility.
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BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.