AzTrials
AzTrials

MelanomaPhase 2NCT05561491

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

A Phase 2 study testing ONCOS-102 and Balstilimab in people with Melanoma, run by Targovax Oy.

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Official record
Search all trials

Trial 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). Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Melanoma
What is being tested?
ONCOS-102 and Balstilimab
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
0 participants
Where
No sites listed yet
Study dates
Jan 2024to Jun 2027
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.
Show all 9Show fewer
  • 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.

Who cannot join

  • 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.
  • If prior severe toxicity occurred during combination treatment with anti-PD-(L)1 + anti-cytotoxic lymphocyte associated antigen 4 (CTLA-4) but subsequent treatment with anti-PD-(L)1 as monotherapy was tolerated, the patient may be eligible for inclusion after discussion with the medical monitor.
  • Has known (current or previously treated) central nervous system metastases and/or carcinomatous meningitis.

About this study

Official title: An Open-Label, Two-Part, Dose-Exploration and Multiple Expansion, Phase 2 Study of ONCOS-102 in Combination With Novel Immune-Targeted Anti-Cancer Agents in Patients With Unresectable or Metastatic Cutaneous Melanoma Resistant to Anti-PD-(L)1 Treatment

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).

Read the detailed description

This study will test ONCOS-102 in combination with novel immune-targeted anti-cancer agents in patients with unresectable or metastatic cutaneous melanoma resistant to anti-PD (L)1 treatment. The purpose of this study is to further evaluate safety and tolerability, as well as anti-tumour activity of ONCOS-102 (both as monotherapy and in combination with anti-PD-1 balstilimab) in the target population.

Following a safety run-in period, up to approximately 63 participants with cutaneous melanoma who previously progressed on anti-PD-1/L1-based therapy will be allocated 1:1 to receive either ONCOS-102 alone or ONCOS-102 plus balstilimab.

Part 1 - Dose Exploration Run-in: Part 1 of the study will evaluate and further optimise the dose of ONCOS-102; a recommended phase 2 dose (RP2D) for ONCOS-102 will be identified.

Part 2 - Multiple Expansion: In the expansion phase, ONCOS-102 alone or in combination with balstilimab will be further evaluated in Cohorts 1 and 2 using the RP2D identified in Part 1.

The study is structured to allow for additional combination cohorts to be added to the study following a protocol amendment.

Conditions
Melanoma
Being tested
ONCOS-102, Balstilimab
Keywords
ONCOS-102, balstilimab, checkpoint inhibitor, oncolytic virus, PD-1, PD-L1, refractory, metastatic
Medical subject headings
Melanoma, Neoplasm Metastasis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • ONCOS-102Biological

    Oncolytic virus

  • BalstilimabBiological

    Anti PD-1

Study groups in NCT05561491
Study groupRoleWhat they receive
ONCOS-102ExperimentalONCOS-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.
Receives: Biological: ONCOS-102
ONCOS-102 and balstilimabExperimentalONCOS-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.
Receives: Biological: ONCOS-102; Biological: Balstilimab

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: 90 days after last treatment

  2. 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

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

Secondary outcomes (6)

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

    Time from observed objective response to first occurrence of disease progression or death based on Investigator assessment according to RECIST v1.1

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

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

    Time from treatment initiation to first occurrence of disease progression or death based on Investigator assessment according to RECIST v1.1

    Measured: Up to 27 months after last patient recruited per cohort

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

    Time from treatment initiation to death that occurred up to 24 months after the last patient recruited per cohort

    Measured: Up to 27 months after last patient recruited per cohort

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

    Proportion of patients with a partial or complete response to treatment observed at Month 3 (Month 6 and Month 12) based on RECIST v1.1

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

  5. To evaluate systemic exposure of ONCOS-102

    Concentration of virus particles in blood and non-compartmental PK parameters as data allow.

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

  6. To estimate baseline presence and incidence of ONCOS-102 anti-drug antibodies (ADA) and neutralising antibodies (NAb) during study

    ADA (screening, confirmatory results: positive or negative; titres), NAb (titres)

    Measured: Up to 24 months after last patient in the pharmacokinetic sampling group

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted30 Sep 2022
  2. Study startJan 2024 (estimated)
  3. Primary completionJun 2027 (estimated)
  4. Study completionJun 2027 (estimated)

Why it stopped: Strategic reasons

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
2 part dose escalation and multiple expansion phase 2 trial.
Masking
None (open label)
Enrolment
0 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05561491
Sponsor's protocol ID
SOPHOS-213
Status last verified
May 2023
First submitted
27 Sep 2022
Last updated
22 Jun 2023
Results posted
No
FDA-regulated drug
Yes
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing ONCOS-102 and Balstilimab in people with Melanoma, run by Targovax Oy.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 9 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: withdrawn, as of the sponsor's last update on 22 Jun 2023. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study was withdrawn before enrolling participants, so there are no results.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Incidence of treatment-emergent adverse events [safety and tolerability] of ONCOS-102 monotherapy and ONCOS-102 plus balstilimab. (time frame: 90 days after last treatment). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05561491.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jun 2023.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in