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Roginolisib

Clinical trials are studying Roginolisib in several cancers and blood diseases. These studies look at safety, tolerability, and how well the treatment works in people with advanced metastatic ocular/uveal melanoma, myelofibrosis, relapsed or refractory peripheral T-cell lymphomas, and advanced non-squamous non-small cell lung cancer.

Table of contents

Overview of the clinical trials

Four authorised interventional studies are investigating Roginolisib in different disease settings.[1][2][3][4]

These studies are in Phase 1 or Phase 2, which means they are still testing important research questions such as safety, dose, and possible benefit.[1][2][3][4]

The trials include both single-treatment and combination-treatment designs, so researchers are looking at Roginolisib by itself and together with other cancer treatments.[1][2][4]

Advanced metastatic ocular/uveal melanoma study

This Phase 2 study is enrolling people with advanced metastatic ocular/uveal melanoma, and it is authorised.[1]

The main goal is to compare Roginolisib as a single agent against the investigator’s choice of therapy, with overall survival as the key outcome.[1]

Overall survival means the time from randomisation until death from any cause.[1]

This trial plans to enrol 85 participants.[1]

Myelofibrosis study

This Phase 1 study is for people with myelofibrosis who are unresponsive to JAK inhibitors, and it is authorised.[2]

The study looks at the safety and tolerability of Roginolisib when given in combination with ruxolitinib.[2]

Safety is measured using adverse events, 12-lead ECG, serum chemistry and haematology laboratory tests, vital signs, and physical examinations.[2]

This trial plans to enrol 27 participants.[2]

Relapsed or refractory peripheral T-cell lymphoma study

This authorised Phase 1 platform trial is studying relapsed or refractory peripheral T-cell lymphomas.[3]

A platform trial is a study design that can test more than one treatment option in the same overall trial structure.[3]

For the Roginolisib-related sub-study, the early goal is to find the maximum tolerated dose and the recommended phase II dose.[3]

The study uses dose-limiting toxicities to help decide the maximum tolerated dose.[3]

In the later phase, the study measures modified progression-free survival, which counts disease progression, relapse after response, extra unplanned anti-lymphoma treatment, or death.[3]

This trial plans to enrol 80 participants.[3]

Advanced non-squamous non-small cell lung cancer study

This authorised Phase 1/IIa study is for advanced non-squamous non-small cell lung cancer.[4]

The trial is testing Roginolisib with dostarlimab, with or without docetaxel.[4]

One main goal is to evaluate safety and tolerability of the combinations.[4]

Another goal is to compare treatment arms by looking at the proportion of patients who have a reduction in peripheral blood Tregs, which are regulatory T cells in the blood.[4]

The primary outcome also includes a change from baseline of at least 50% by Day 42 as measured by mass cytometry, a lab method that measures many cell markers at once.[4]

This trial plans to enrol 51 participants.[4]

Main outcomes being measured

The trials focus on different outcomes depending on the disease and phase.[1][2][3][4]

  • Overall survival is used in the melanoma study to see how long people live after randomisation.[1]

  • Safety and tolerability are central in the myelofibrosis and lung cancer studies, because early trials need to know whether the treatment can be given safely.[2][4]

  • Maximum tolerated dose and recommended phase II dose are important in the lymphoma study because they help define a usable dose for later research.[3]

  • Modified progression-free survival is used in the lymphoma study to track whether the disease gets worse or whether other major treatment changes are needed.[3]

  • Immune cell changes, including peripheral blood Tregs, are measured in the lung cancer study to compare how the treatment arms affect the immune system in the blood.[4]

Who the trials are for

These studies are not for a general population; each one targets a specific group with advanced or hard-to-treat disease.[1][2][3][4]

  • People with advanced metastatic ocular/uveal melanoma are being studied in one Phase 2 trial.[1]

  • People with myelofibrosis unresponsive to JAK inhibitors are being studied in one Phase 1 trial.[2]

  • People with relapsed or refractory peripheral T-cell lymphomas are being studied in one Phase 1 platform trial.[3]

  • People with advanced non-squamous non-small cell lung cancer are being studied in one Phase 1/IIa trial.[4]

Trial ID Phase Condition studied Status Enrollment
2024-514333-37-00 Phase 2 Advanced metastatic ocular/uveal melanoma Authorised 85
2024-515252-20-00 Phase 1 Myelofibrosis unresponsive to JAK inhibitors Authorised 27
2024-514954-63-00 Phase 1 Relapsed or refractory peripheral T-cell lymphomas Authorised 80
2024-517741-14-00 Phase 1 Advanced non-squamous non-small cell lung cancer Authorised 51

FAQ

  • What is being studied in Roginolisib trials? The trials are testing Roginolisib in different cancer and blood disease settings. They look at safety, tolerability, and signs that the treatment may help people.
  • Who may take part in these trials? Each trial has a different target group. The studies include people with advanced metastatic ocular/uveal melanoma, myelofibrosis unresponsive to JAK inhibitors, relapsed or refractory peripheral T-cell lymphomas, and advanced non-squamous non-small cell lung cancer.
  • What phases are the Roginolisib trials in? The trials are in Phase 1 and Phase 2. Phase 1 studies usually focus on safety and dose finding, while Phase 2 studies look more closely at how well the treatment works.
  • What outcomes are the trials measuring? The studies measure different outcomes such as overall survival, safety results, maximum tolerated dose, recommended phase II dose, modified progression-free survival, and changes in immune cell levels. These outcomes help show whether the treatment may be useful.
  • Are Roginolisib trials testing it alone or with other treatments? Both are being studied. One trial tests Roginolisib as a single agent, while others study it in combination with treatments such as ruxolitinib, dostarlimab, and docetaxel.

Ongoing Clinical Trials on Roginolisib

  • Study on Azacitidine, Roginolisib, and Golcadomide for Patients with Relapsed or Refractory Peripheral T-Cell Lymphomas

    Recruiting

    1 1 1 1
    Investigated diseases:
    Investigated drugs:
    France

  • Study of Roginolisib for Patients with Advanced Uveal Melanoma

    Recruiting

    2 1 1 1
    Investigated diseases:
    Investigated drugs:
    Italy Spain

  • Study on the Safety of Roginolisib and Ruxolitinib for Patients with Myelofibrosis Unresponsive to JAK Inhibitors

    Recruiting

    1 1 1 1
    Investigated diseases:
    Investigated drugs:
    Italy Spain

  • Study of roginolisib, dostarlimab and docetaxel combination for patients with advanced non-small cell lung cancer who did not respond to previous immunotherapy and chemotherapy

    Not recruiting

    1 1 1 1
    Investigated diseases:
    Investigated drugs:
    Belgium Italy Spain

Glossary

  • Interventional study: A trial where researchers give a treatment or combination of treatments and then watch what happens.
  • Phase 1: An early trial phase that mainly checks safety, tolerability, and dose.
  • Phase 2: A trial phase that looks more closely at whether the treatment may help and what results it produces.
  • Safety: How well a treatment can be used without causing unacceptable problems.
  • Tolerability: How well people can handle a treatment and its effects.
  • Overall survival (OS): The time from randomisation until death from any cause.
  • Randomisation: A method that places people into study groups by chance.
  • Dose-limiting toxicities (DLTs): Side effects that are severe enough to help decide the highest safe dose.
  • Maximum tolerated dose (MTD): The highest dose that most people can take without too many serious side effects.
  • Progression-free survival (PFS): The time during and after treatment when the disease does not get worse.
  • Modified progression-free survival (mPFS): A study measure that counts disease progression, relapse, new unplanned anti-lymphoma treatment, or death.
  • Tregs: Regulatory T cells, a type of immune cell that can be measured in the blood in some studies.

References

  1. https://clinicaltrials.gov/study/2024-514333-37-00
  2. https://clinicaltrials.gov/study/2024-515252-20-00
  3. https://clinicaltrials.gov/study/2024-514954-63-00
  4. https://clinicaltrials.gov/study/2024-517741-14-00