Health Trials

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

ConditionsCutaneous Squamous Cell CarcinomaSCC - Squamous Cell CarcinomaBasal Cell CarcinomaBCCBCC - Basal Cell CarcinomaMelanomaMerkel Cell CarcinomaSebaceous CarcinomaExtramammary Paget DiseaseKaposi SarcomaHead and Neck Squamous Cell CarcinomaHNSCCAdnexal CarcinomaAngiosarcomaCutaneous NeoplasmAdvanced CancerMetastatic CancerRefractory CancerSolid 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

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

Treatments tested in this trial

  • MQ719
  • Pembrolizumab

Treatment groups

56 Participants
are divided into 2 treatment groups

Sponsors and collaborators

Memorial Sloan Kettering Cancer Center

Lead sponsor

Source ClinicalTrials.gov