A First-In-Human Phase I, Open Label, Safety and Tolerability Study of Escalating Multiple Doses of Intratumoral MQ710, a Multi-Transgene Expressing Modified Vaccinia Virus Ankara-Based Virotherapy, Alone and in Combination With the Systemic Checkpoint Inhibitor Pembrolizumab in Solid Tumors
Memorial Sloan Kettering Cancer Center
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.
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: * 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 lesi…
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.
- DrugPembrolizumab
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.
Locations (7)
- Memorial Sloan Kettering Basking Ridge (Limited Protocol Activities)Basking Ridge, New Jersey
- Memorial Sloan Kettering Monmouth (Limited protocol activities)Middletown, New Jersey
- Memorial Sloan Kettering Bergen (Limited Protocol Activities)Montvale, New Jersey
- Memorial Sloan Kettering Suffolk-Commack (Limited Protocol Activities)Commack, New York
- Memorial Sloan Kettering Westchester (Limited Protocol Activities)Harrison, New York
- Memorial Sloan Kettering Cancer Center (All Protocol Activities)New York, New York