Neoantigen Vaccine Plus Locally Administered Ipilimumab and Systemic Nivolumab in Advanced Melanoma (NCT03929029) | Clinical Trial Compass
Active — Not RecruitingPhase 1
Neoantigen Vaccine Plus Locally Administered Ipilimumab and Systemic Nivolumab in Advanced Melanoma
United States11 participantsStarted 2020-11-11
Plain-language summary
This research study is investigating a new type of personalized neoantigen vaccine, NeoVax, plus Montanide® in combination with Ipilimumab (Yervoy™) and Nivolumab (Opdivo®) as a possible treatment for cutaneous melanoma.
The drugs involved in this study are:
* Personalized Neoantigen Vaccine
* Poly-ICLC (Hiltonol®)
* Montanide®
* Ipilimumab (Yervoyâ„¢)
* Nivolumab (Opdivo®)
Who can participate
Age range18 Years
SexALL
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Inclusion Criteria:
* Participant is willing and able to give written informed consent
* Participants must have histologically confirmed cutaneous melanoma that is unresectable stage III or stage IV; at least one site of disease must be resectable, partially-resectable, or amenable to core biopsies to provide tumor tissue for sequence analysis. Participants with mucosal or uveal melanoma are excluded.
* Participants must have measurable disease by RECIST v1.1 that has not been treated with local therapy within the last 12 months of study treatment. The measurable lesion and the lesion used for surgical or core biopsies can be identical as long as it remains measurable after biopsy
* Age ≥ 18 years
* ECOG performance status of 0 or 1
* Recovered from all toxicities associated with prior treatment, to acceptable baseline status (as to Lab toxicity see below limits for inclusion) or a National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 4, Grade of 0 or 1, except for toxicities not considered a safety risk, such as alopecia or vitiligo
* Participants must have normal organ and marrow function as defined below:
* WBC ≥3,000/µL
* ANC ≥1,500/µL
* Platelets ≥100,000/µL
* Hemoglobin ˃ 9.0 g/dL
* Total Bilirubin ≤ 1.5 x ULN (except subjects with Gilbert Syndrome, who can have total bilirubin \< 3.0 mg/dL)
* AST(SGOT)/ALT(SGPT) ≤ 3 x ULN
* Creatinine ≤ 1.5 x ULN OR
* Creatinine clearance ≥40 mL/min/1.73 m2 for participants with …
What they're measuring
1
Number of Participants With Dose-Limiting Toxicity (DLT)