A Study of Tilsotolimod in Combo With Ipilimumab vs Ipilimumab Alone in Subjects With Anti-PD-1 R… (NCT03445533) | Clinical Trial Compass
TerminatedPhase 3
A Study of Tilsotolimod in Combo With Ipilimumab vs Ipilimumab Alone in Subjects With Anti-PD-1 Refractory Melanoma
Stopped: Lack of Efficacy
United States481 participantsStarted 2018-05-30
Plain-language summary
A Phase 3 comparison of ipilimumab with and without IMO-2125 in advanced melanoma
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. Subjects must be willing and able to sign the informed consent and comply with the study protocol.
✓. Subjects must be ≥18 years of age.
✓. Subjects must have histologically confirmed metastatic melanoma with measurable (by RECIST v1.1), stage III (lymph node or in transit lesions) or stage IVA, IVB, or IVC disease that is accessible for injection.
✓. Patients must have confirmed progression during or after treatment with a PD-1 inhibitor (cannot be part of a bi-specific antibody) e.g. nivolumab or pembrolizumab. Confirmed progression is defined as:
✓. No intervening anti-cancer therapy between the last course of PD-1 inhibitor treatment and the first dose of study treatment is allowed except for local measures (e.g., surgical excision or biopsy, focal radiation therapy).
✓. The interval between last PD-1 inhibitor and start of study treatment should be at least 21 days with no residual anti-PD-1-related immune toxicities in excess of Grade 1 severity.
✓. If BRAF mutation status is unknown, before randomization the subject must have BRAF testing performed using an approved assay method.
✓. Patients with BRAF-positive tumor(s) are eligible for the study if they received prior treatment with a BRAF inhibitor (alone of in combination with a MEK inhibitor) or declined targeted therapy.
Exclusion criteria
✕. Ocular melanoma.
✕. Prior therapy with a toll-like receptor (TLR) agonist, excluding topical agents.
What they're measuring
1
Summary of Independent Reviewer-Assessed Objective Response Rate (ORR) by RECIST v1.1
Timeframe: Response is measured from the date of randomization, until disease progression, death, or start of new anti-cancer therapy (up to 36 months).
2
Summary of Overall Survival
Timeframe: OS is measured from the date of randomization to the date of death from any cause (up to 36 months).
✕. Prior ipilimumab treatment with the exception of adjuvant treatment completed ≥6 months prior to enrollment
✕. Systemic treatment with interferon (IFN)-α within the previous 6 months.
✕. Known hypersensitivity to any oligodeoxynucleotide.
✕. Active autoimmune disease requiring disease-modifying therapy at the time of Screening.
✕. Subjects requiring systemic steroid therapy receiving \>10 mg/day of prednisone (or equivalent) for the 2 weeks preceding start of study.
✕. Subjects with another primary malignancy that has not been in remission for at least 3 years, with the exception of non-melanoma skin cancer, curatively treated localized prostate cancer with non-detectable prostate-specific antigen, cervical carcinoma in situ on biopsy or a squamous intraepithelial lesion on Papanicolaou (Pap) smear, and thyroid cancer (except anaplastic).