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

ConditionsCutaneous 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

Trial statusRecruiting

Trial phasePhase 1

Trial typeInterventional

Biological sexAll

Age18+

SponsorMemorial Sloan Kettering Cancer Center

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial design

Design model

Sequential

Treatments tested in this trial

MQ719
Biological/Vaccine
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.
Pembrolizumab
Drug
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.

Treatment groups

56 Participants

are divided into 2 treatment groups

Group A: Dose Escalation GroupExperimental treatment 1 intervention

Group B: Dose Expansion GroupExperimental treatment 2 interventions

Trial outcomes

Primary outcomes

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

Locations7

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Sponsors and contacts

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Memorial Sloan Kettering Cancer Center

Lead sponsor

Source ClinicalTrials.gov

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