WithdrawnPhase 2

A Study of ONCOS-102 in Combination With Other Novel Immune-therapies in Advanced Treatment-resistant Melanoma Patients

Stopped: Strategic reasons

0Started 2024-01

Plain-language summary

A Phase 2 study investigating the efficacy and safety of ONCOS-102 alone or in combination with balstilimab (a programmed death receptor-1 \[PD-1\] inhibitor).

Who can participate

Age range18 Years

SexALL

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Inclusion criteria

✓. Be willing and able to provide written informed consent for the study.
✓. Be ≥ 18 years of age on the day of signing the informed consent form (ICF).
✓. Eastern Co-operative Oncology Group (ECOG) performance status 0 or 1.
✓. Histologically confirmed diagnosis of metastatic or unresectable malignant melanoma at screening with measurable disease (by RECIST v1.1) that is accessible for IT injection into cutaneous or subcutaneous lesions.
✓. Resistant to PD-(L)1 blockade (primary or secondary resistance in the advanced setting or relapse after adjuvant therapy) either as monotherapy or in combination with other therapies, as defined by the following criteria:
✓. Has recovered from all adverse events (AEs) due to previous therapies to ≤ Grade 1 or baseline. Patients with ≤ Grade 2 endocrinopathies stable on mediation, stable neuropathy, and alopecia are eligible.

Exclusion criteria

✕. Uveal or mucosal melanoma.
✕. Any history of National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) Grade ≥ 3 immune-mediated toxicity (excluding endocrinopathies and non-necrotising/bullous rash) from prior checkpoint inhibition.
✕. Has known (current or previously treated) central nervous system metastases and/or carcinomatous meningitis.

What they're measuring

Incidence of treatment-emergent adverse events [safety and tolerability] of ONCOS-102 monotherapy and ONCOS-102 plus balstilimab.

Timeframe: 90 days after last treatment

To evaluate the objective response rate (ORR) in individual cohorts using RECIST v1.1

Timeframe: Up to 27 months after the last patient first dose

Trial details

NCT IDNCT05561491

SponsorTargovax Oy

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2027-06

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