Safety and Efficacy of p53 Gene Therapy Combined With Immune Checkpoint Inhibitors in Solid Tumors. (NCT03544723) | Clinical Trial Compass
UnknownPhase 2
Safety and Efficacy of p53 Gene Therapy Combined With Immune Checkpoint Inhibitors in Solid Tumors.
United States40 participantsStarted 2018-10-01
Plain-language summary
This is a single arm Phase 2 study of the combination of adenoviral p53 (Ad-p53) gene therapy administered intra-tumorally with approved immune checkpoint inhibitors in patients with recurrent or metastatic cancers. Comparison will be made to historical data. General safety and efficacy using RECIST 1.1 and Immune-Related Response Criteria as well as ECOG performance will be utilized.
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. Signed informed consent.
✓. Male or female greater than or equal to 18 years of age (females of childbearing potential must be non-pregnant with a negative pregnancy test and non-lactating). Males and females must use contraception for the duration of the study.
✓. Primary diagnosis must be histologically confirmed.
✓. Progression or Recurrence of solid tumors or lymphoma suitable for anti-PD-1/anti-PD-L1 therapy.
✓. As far as possible, all target lesions utilized for RECIST response determination should be suitable for ultra-sound, CT or endoscopic guided intra-tumoral injection. If all target lesions cannot be treated with Ad-p53, but the patient is otherwise suitable for the study, this should be reviewed with the Sponsor.
✓. Patients entered on the study must have disease that that is evaluable for response using RECIST 1.1 criteria with a minimum measurable lesion size of the longest axis greater than or equal to 1.0 cm (CT/MRI) or greater than or equal to 2.0 cm (non-helical CT), or nodal shortest diameter greater than or equal to 1.5 cm by CT/MRI.
✓. No brain metastases or treated and stable brain metastases
✓. ECOG Performance Status 0-1
Exclusion criteria
✕. History of allergic reactions to any components of the treatments (Ad-p53 or immune checkpoint inhibitors).
✕. Active alcohol dependence
What they're measuring
1
The primary efficacy endpoint is objective response rate (ORR)
Timeframe: Change in tumor size at the end of Cycle 2 (each cycle is 28 days)
2
Safety assessments of adverse events per CTCAE
Timeframe: Signed Informed Consent through 30 Days following the final treatment
. Neuropathy of less than or equal to grade 2 CTCAE.
✕. Except for ongoing treatment with anti-PD-1 or anti-PD-L1 which is permitted (see Inclusion Criterion #4 above), there should be no other antibody-based therapy, targeted small-molecule therapy, hormonal therapy, chemotherapy, radiation, biological or investigational therapy within 14 days of first administration of Study Treatment (C1D1). Subjects with prior cytotoxic or investigational products less than 2 weeks prior to trial treatment might be eligible after discussion between investigator and Sponsor, if toxicities from the prior treatment have been resolved to Grade 1 (NCI CTCAE). If a patient with HNSCC is receiving combination pembrolizumab plus chemotherapy, the first Ad-p53 Study Treatment should be administered 2 weeks following the completion of final chemotherapy treatments and 5 days before their next anti-PD-1/anti-PD-L1 scheduled dose. Ad-p53 intratumoral injections should not be given within 24 hours of immune checkpoint inhibitor infusions.
✕. Prior additional malignancy within 2 years except for non-melanoma skin cancer, carcinoma in situ of the breast, oral cavity, cervix or other cancers, unless approved by the Sponsor.
✕. Prior autologous or allogenic organ or tissue transplantation.
✕. Severe, active comorbidity, including any of the following:
✕. Active clinically serious infection (grade 2 or greater, CTCAE) or requiring intravenous antibiotics at the time of study treatment.