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

NCT05561491 | Withdrawn Phase 2 FDA Drug

• 1 other identifier: SOPHOS-213
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief 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).

Conditions

Melanoma

Keywords

ONCOS-102; balstilimab; checkpoint inhibitor; oncolytic virus; PD-1; PD-L1; refractory; metastatic

Outcome Measures

Primary Outcomes (2)

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

  To determine the incidence of treatment emergent adverse events including treatment emergent serious adverse events assessed by CTCAE v5.0, treatment interruptions and discontinuations.

  90 days after last treatment

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

  The proportion of patients achieving confirmed complete (CR) or partial response (PR) per RECIST v1.1 criteria

  Up to 27 months after the last patient first dose

Secondary Outcomes (6)

• To evaluate the duration of response (DoR) in individual cohorts

  Up to 27 months after the last patient first dose

• To evaluate progression-free survival (PFS) in the individual cohorts using the Kaplan-Meier method

  Up to 27 months after last patient recruited per cohort

• To evaluate overall survival (OS) in individual cohorts using the Kaplan-Meier method

  Up to 27 months after last patient recruited per cohort

• To evaluate PFS rate estimates at 3, 6 and 12 months in individual cohorts

  3, 6 and 12 months after last patient recruited per cohort

• To evaluate systemic exposure of ONCOS-102

  Up to 24 months after last patient in the PK sampling group

Study Arms (2)

ONCOS-102

EXPERIMENTAL

ONCOS-102 will be administered by intratumoral (IT) injection at 1.0×10\^12 VP/dose with the potential to de-escalate dosing to 3.0×10\^11 VP/dose.

Biological: ONCOS-102

ONCOS-102 and balstilimab

EXPERIMENTAL

ONCOS-102 will be administered by IT injection at 3.0×10\^11 VP/dose with planned dose escalation to 1.0×10\^12 VP/dose. Balsitilmab will be administered at a fixed dose of 300 mg by intravenous (IV) injection.

Biological: ONCOS-102; Biological: Balstilimab

Interventions

ONCOS-102 BIOLOGICAL

Oncolytic virus

ONCOS-102; ONCOS-102 and balstilimab

Balstilimab BIOLOGICAL

Anti PD-1

ONCOS-102 and balstilimab

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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:
• Received at least 1 prior anti-PD-\[L\]1 immunotherapy regimen for a minimum of 6 weeks.
• Prior progression must be either on treatment with anti-PD-(L)1 or ≤ 12 weeks from last dose in metastatic setting or relapse ≤ 24 weeks from completion of therapy in adjuvant setting.
• Has demonstrated disease progression (PD) after anti-PD-(L)1 as defined by RECIST v1.1. The initial evidence of PD is to be confirmed by a second assessment (i.e., a confirmatory scan no less than 4 weeks from the date of the first documented PD), in the absence of clear clinical progression.
• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Targovax Oy: lead
• Agenus Inc.: collaborator

MeSH Terms

Conditions

Melanoma; Neoplasm Metastasis

Interventions

balstilimab

Condition Hierarchy (Ancestors)

Neuroendocrine Tumors; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Nerve Tissue; Nevi and Melanomas; Skin Neoplasms; Neoplasms by Site; Skin Diseases; Skin and Connective Tissue Diseases; Neoplastic Processes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Douglas B Johnson, MD, MSCI

  Vanderbilt Institute for Infection, Immunology and Inflammation

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: 2 part dose escalation and multiple expansion phase 2 trial.

Study Record Dates

• First Submitted: September 27, 2022
• First Posted: September 30, 2022
• Study Start: January 1, 2024
• Primary Completion (Estimated): June 1, 2027
• Study Completion (Estimated): June 1, 2027
• Last Updated: June 22, 2023

Record last verified: 2023-05