Trial · NCT05080790
Treatment With Dinutuximab Beta, Zoledronic Acid and Low-dose Interleukin (IL-2) in Patients With Leiomyosarcoma
NCT05080790, Phase 2, Completed, Institut für Klinische Krebsforschung IKF GmbH at Krankenhaus Nordwest
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Treatment With Dinutuximab Beta, Zoledronic Acid and Low-dose Interleukin (IL-2) in Patients With Leiomyosarcoma. Trials, record NCT05080790. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT05080790
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Treatment With Dinutuximab Beta, Zoledronic Acid and Low-dose Interleukin (IL-2) in Patients With Leiomyosarcoma
- NCT number
- NCT05080790
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 7 participants, actual
- Lead sponsor
- Institut für Klinische Krebsforschung IKF GmbH at Krankenhaus Nordwest
- Conditions
- Leiomyosarcoma
- Interventions
- Dinutuximab Beta, Zoledronic acid, Interleukin-2
- First posted
- 2021-10-18
- Last updated
- 2025-08-17
Source ClinicalTrials.gov
Registered outcomes6
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | The primary objective of this study is to assess the feasibility of the combined treatment with dinutuximab beta, zoledronic acid and low-dose interleukin 2. | 3 years, at EOS | Feasibility rate, defined as the number of patients still on treatment and progression-free at Cycle 4 Day 5 divided by the number of all treated subjects. |
| Secondary | A secondary objective of this study is to assess the safety and tolerability of the combined treatment with dinutuximab beta, zoledronic acid and low-dose interleukin 2. | 3 years, at EOS | To assess the safety and tolerability of the combined treatment of dinutuximab beta, zoledronic acid and low-dose interleukin-2 in patients with leiomyosarcomas, all adverse events will be assessed, and any alteration to the protocol in relation to study treatment will be assessed (e.g. discontinuation, reduction or delay of the treatment including the reasons for alterations of the predefined study treatment schedule). |
| Secondary | An additional secondary objective of this study is to assess the efficacy of the combined treatment with dinutuaseximab beta, zoledronic acid and low-dose interleukin 2. | 3 years, at EOS | Progression-free Survival (PFS) and Progression-free Survival after 6 months (PFSR6) |
| Secondary | An additional secondary objective of this study is to assess the efficacy of the combined treatment with dinutuaseximab beta, zoledronic acid and low-dose interleukin 2. | 3 years, at EOS | Masurement of Overall Response Rate (ORR). |
| Secondary | An additional secondary objective of this study is to assess the efficacy of the combined treatment with dinutuaseximab beta, zoledronic acid and low-dose interleukin 2. | 3 years, at EOS | Measurement of Overall Survival (OS). |
| Other | Tertiary/exploratory objective of this study is to evaluate and compare GD-2 immuno-histochemistry staining on cryopreserved and paraffin-embedded sarcoma tissue samples for future assessment of patient eligibility for anti-GD-2 therapy. | 3 years, at EOS | To evaluate the GD2 immuno-histochemistry staining on cryopreserved and paraffin-embedded sarcoma tissue samples to identify patients eligible for treatment with dinutuximab beta, the staining methods and scores of GD2 expression on the different tissues will be compared. |
Source ClinicalTrials.gov
Outcomes0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
None in this release.
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow0
How many started, completed or left each group, period by period.
None in this release.
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals0
The totals the trial posted for each group.
None in this release.
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT05080790
GET https://conductscience.org/api/trials/v1/NCT05080790/registered