Phase 2 Trial of Voyager V1 in Combination With Cemiplimab in Cancer Patients
Age: 18 years - 66+
Healthy Subjects: No
Study Phase: Phase 2
Recruitment Status: Recruiting
Start Date: April 24, 2020
End Date: March 01, 2023
1. Age ≥18 years on day of signing informed consent.
2. Specific by tumor cohorts: a. For the NSCLC cohort, histologically confirmed diagnosis of advanced and/or metastatic NSCLC suitable for first line immunotherapy. NSCLC harboring an activating EGFR mutation or anaplastic lymphoma kinase (ALK) rearrangement must have progressed following available EGFR or ALK targeted therapy in addition to treatment with platinum-based chemotherapy (unless ineligible for platinum therapy). i. Able to supply archival (or fresh) formalin-fixed, paraffin- embedded tumor tissue collected within 6 months prior to enrollment for determination of programmed death ligand 1 (PD- L1) status. ii. PD-L1 status of ≥50% per local standardized testing. Samples should be provided to the central lab for post-hoc centralized testing. b. For the melanoma cohorts, histologically confirmed diagnosis of advanced and/or metastatic cutaneous melanoma in which radiological progression has been demonstrated during therapy with a PD-(L)1 immune checkpoint inhibitor and for which no existing options are considered to provide clinical benefit (only one line of PD-(L)1 therapy is permitted). Progression on ipilumumab is not required. BRAF V600 mutation patients must have progressed on, or are intolerant to, BRAF +/- MEK inhibitor therapy. Note: For IV/IT melanoma cohort: i. At least one tumor lesion amenable to IT injection via palpation or ultrasound. Injection of deep visceral lesions is not permitted. ii. Agrees to provide a newly obtained biopsy of injected lesions prior to start of study treatment, and to repeat biopsies twice during study treatment, and to providing the acquired tissue for biomarker analysis. Tissue obtained for the biopsy must not be previously irradiated, but a new or progressing lesion in the radiation field is acceptable.
3. For patients treated with prior anti-PD-(L)1 therapy, last dose of anti-PD-(L)1 must be within 16 weeks of initiating study treatment.
4. Measurable disease based on RECIST 1.1.
5. Performance status of 0 or 1 on the ECOG Performance Scale
6. Life expectancy of >3 months. Exclusion: Patients meeting any of the following exclusion criteria at screening/Day -1 of first dosing will not be enrolled in the study:
1. Availability of and patient acceptance of an alternative curative therapeutic option.
2. Recent or ongoing serious infection, including any active Grade 3 or higher per the NCI CTCAE, v5.0 viral, bacterial, or fungal infection within 2 weeks of registration.
3. Patients who have a diagnosis of ocular, mucosal or acral melanoma.
4. Known seropositivity for and with active infection with HIV.
5. Seropositive for and with evidence of active viral infection with HBV.
6. Seropositive for and with active viral infection with HCV.
7. Known history of active or latent TB.
8. Any concomitant serious health condition, which, in the opinion of the investigator, would place the patient at undue risk from the study, including uncontrolled hypertension and/or diabetes, clinically significant pulmonary disease (e.g., chronic obstructive pulmonary disease requiring hospitalization within 3 months) or neurological disorder (e.g., seizure disorder active within 3 months).
10. NYHA classification III or IV, known symptomatic coronary artery disease, or symptoms of coronary artery disease on systems review, or known cardiac arrhythmias (atrial fibrillation or SVT).
11. Any known or suspected active organ-threatening autoimmune disease, such as inflammatory bowel disease, autoimmune hepatitis, lupus, or pneumonitis, with the exception of hypothyroidism and type 1 diabetes that are controlled with treatment 12. Immunodeficiency or immunosuppression, including systemic corticosteroids at >10 mg/day prednisone or equivalent within 1 week prior to planned start of study treatment.
13. Known concurrent malignancy.